Sunday, November 8, 2009

US Congress Should NOT Enact Costly Patent Review Procedures That Expose Small Inventors To Big US & Foreign Company IP Poachers

http://online.wsj.com/article/SB125728918217026407.html

Proposed Change in Patent Policy Pits Big Firms vs. Small


By KRISTINA PETERSON


Wall Street Journal


Nov. 4, 2009




WASHINGTON -- Congress is considering an overhaul of U.S. patent policy that would bring the first major changes in more than half a century. But a disagreement between big and small companies over one aspect of the bill could derail its passage.



The effort marks the third time in five years that lawmakers have tried to change the nation's patent laws, as they have struggled to balance the competing interests of big technology companies, small start-ups and individual inventors.
The bill would seek to bring the U.S. patent system in line with international standards and streamline the operations of the U.S. Patent and Trademark Office, which is facing a backlog of applications.



The Senate Judiciary Committee approved one version of the bill in April, shortly after the introduction of a similar measure in the House. Democratic and Republican staff members from the House and Senate committees are negotiating changes, and hope a widely acceptable version will hit the Senate floor this fall.



The most contentious aspect of the bill concerns what happens after the patent office approves an application. The Senate measure proposes expanding the avenues for challengers to ask the patent office to examine already-granted patents.



The office currently has two systems for reviewing approved patents. One method permits challengers to remain more involved in the review, while the requester has only limited participation in the other. In the last fiscal year, there were 2,120 pending re-examinations, including both types.



The new re-examination process would bring complaints on a broader range of challenges in front of patent judges rather than patent examiners to create the atmosphere of a court inside the patent office, but without the expense of litigation. Rulings would occur on a tight timeline: within a year from the filing date. The new bill would also change the way subsequent challenges to the same patent can be made. Critics say it would become easier to launch serial attacks.
The proposed new review process is pitting larger, established companies against smaller or start-up firms.



Many big technology companies argue that the proposed process would strengthen the patents that make it through. The review would be "essential to maintaining high-quality patents because it allows the validity of questionable patents to be tested," said Horacio Gutierrez, deputy general counsel of Microsoft Corp. International Business Machines Corp. in a statement called the process "a low-cost alternative to litigation."



Many small companies and research universities fear that deep-pocketed businesses could attempt through the review to keep innovative products from hitting the market. The National Venture Capital Association and other critics said it could be harder for start-ups to secure funding if their patents were targeted by repeated attacks.



"This may be catastrophic for a start-up or small inventor," said Dean Kamen, inventor of the Segway, a personal electric scooter. "You get this young guy who quit his job to make this gizmo and he shows up at the bank or to his father-in-law. The first thing the bank or that venture capitalist will say is, 'Do you have a patent?'"



A dozen Republican senators voiced support for the smaller firms in an Oct. 15 letter to leaders of both parties. Congressional aides said that unless both sides could reach agreement, lawmakers were unlikely to introduce the bill for a floor vote in the Senate, which is tackling health care and other issues.



David Kappos, director of the U.S. patent office, said he had urged lawmakers to set a high threshold for reviews. He also wants safeguards against serial attacks on patents.



A coalition of major technology companies, the Coalition for Patent Fairness, voiced disagreement in a letter to Mr. Kappos in September. "We would very strongly oppose changes to the Senate and House bills that would dilute in any way the efficacy of post-grant challenges," the letter said.

If this Congress doesn't pass patent legislation, it won't likely come up again soon. In the two previous congressional sessions, attempts at passing patent legislation collapsed.
-------------------------------------------------------------------------------------------------
Senators, Inventors Criticize Patent Bill Favored By Tech Cos
By Kristina Peterson
Of DOW JONES NEWSWIRES
Wall Street Journal
Oct. 15, 2009
WASHINGTON (Dow Jones)--Twelve Republican U.S. senators on Thursday sent a letter to Senate leaders criticizing pending patent legislation, saying the bill "threatens to diminish the value and enforceability of U.S. patent rights."

The Oct. 15 letter backs criticism against the legislation being levied by independent inventors and academics who argue the bills favor major technology companies. If approved the legislation would be the most sweeping rewrite of federal patent law in 50 years.

Critics say two similar bills now in Congress would broadly make it harder for individuals, universities and start-ups to defend their inventions against companies with deeper pockets. Opponents are also upset that Obama administration officials with past ties to International Business Machines Corp. (IBM) and Microsoft Corp. (MSFT) are supporting the bill.

At issue is a provision giving outside challengers expanded ability to initiate review of newly approved patents. "These so-called post-grant review provisions, as currently crafted, are quite problematic," the Republican senators said in the letter written by Sen. Sam Brownback, R-Kan., and signed by 11 other Republicans.

Microsoft and IBM are two of the most active companies involved in filing patents; IBM, for example, earns over $1 billion each year in intellectual property-related income. Both companies have ties to top government officials with authority over patent policy, including U.S. Patent and Trademark Office Director David Kappos.

In testimony before Congress last March, Kappos - who was, back then, the head of intellectual property at IBM - praised the post-grant review. Kappos, who spent 26 years at IBM, said in an interview Thursday that he recuses himself from IBM-specific matters and has taken pains since his appointment to listen to the concerns of independent inventors.

"If I wanted to do the right thing for a specific company, I could have stayed there," he said. IBM declined to comment.

Kappos also said he told lawmakers in private meetings they should establish a high threshold for reviews and include safeguards against serial challenges.

But even one post-grant review can cause an inventor to lose market advantage and venture capital funding.

"Patent certainty is critical to the ability of a venture capitalist to be able to invest," said Kelly Slone, director of the National Venture Capital Association's medical industry group. More than a dozen research universities have also sent letters opposing the post-grant review provision.

Microsoft, too, has connections in the Commerce Department. Marc Berejka, a senior official handling intellectual property matters, worked for Microsoft for the 12 years leading up to his July 2009 hiring, including eight years as a lobbyist for the company.

Commerce Secretary Gary Locke, who endorsed most of the bill in an Oct. 5 letter, received campaign donations from Microsoft employees as Washington state governor. Locke accepted $96,900 in cash donations from company employees while running for re-election in 2000, according to state public records. In total, Locke raised $3.8 million in that election cycle. He also owned between $100,000 and $250,000 of Microsoft stock until divesting it on June 22 as a condition of his appointment.

A Commerce spokesman said the agency is deferring to Congress on how to alter patent laws.

Pat Choate, an economist and board member of American Innovators for Patent Reform, said he was troubled by the process. "Patent policy is suddenly being run by advocates for Microsoft and IBM," Choate said.

But some representatives of small companies say they think the government is trying to work in good faith.

"It is certainly the case that big companies have a lot of very well-qualified people who work with them and then go and do other things," said Brian Pomper, executive director of Innovation Alliance.
-------------------------------------------------------------------------------------------------
Opposition Grows to Post-Grant Review Provisions in Proposed Patent Reform Act of 2009
(I-Newswire) October 20, 2009 - New York, N.Y. – October 20, 2009 – “Patent policy is suddenly being run by advocates for Microsoft and IBM,” says Pat Choate, noted economist and writer, and a board member at American Innovators for Patent Reform (AIPR), a nonprofit organization dedicated to promoting and defending American innovation.
Dr. Choate was quoted in an article, “Senators, Inventors Criticize Patent Bill Favored by Tech Cos,” that appeared in the Friday, October 16, Wall Street Journal and was distributed by the Dow Jones Newswire Service. Dr. Choate’s comment was in response to criticism that U.S. Patent and Trademark Office Director David Kappos spent 26 years at IBM, and Commerce Secretary Gary Locke received campaign contributions from Microsoft employees.
At issue is proposed post-grant review provisions in the pending Patent Reform Act of 2009 that would give third parties – such as IBM, Microsoft and other giant high tech corporations – expanded ability to challenge newly issued patents. The Wall Street Journal article also addressed another challenge to the Patent Reform Act of 2009 that came from 12 Senators who co-signed a letter from Sen. Sam Brownback, a Republican from Kentucky. In the letter, the senators wrote that the proposed legislation “threatens to diminish the value and enforceability of U.S. patent rights.” The letter also stated that the Senators found the proposed bill’s post-grant provisions to be “quite problematic.”
About American Innovators for Patent Reform
Headquartered in New York City, American Innovators for Patent Reform (AIPR) represents a broad constituency of American innovators and innovation stakeholders, including inventors, engineers, researchers, entrepreneurs, patent owners, investors, small businesses, and intellectual property professionals such as patent attorneys, patent agents, tech transfer managers and licensing executives. AIPR opposes the Patent Reform Act of 2009 (H.R. 1260 and S. 515) and its proposed apportionment of damages, post grant opposition and a change to the first-to-file regime. AIPR advocates strengthening the U.S. intellectual property regime and increasing the funding of the U.S. Patent and Trademark Office. AIPR advocates patent reform that creates a multi-tier patent system, synchronizes patent and copyright laws, and clearly strengthens U.S. patents.
For more information about AIPR, please visit www.aminn.org .### About American Innovators for Patent Reform: Trade association representing inventors, patent owners and patent professionals that promotes strengthening the US Patent system.Company Contact Information American Innovators for Patent Reform 244 Fifth Avenue, Suite A253 New York, New York 10001-7604 Phone : 212-726-1114
-------------------------------------------------------------------------------------------------

What Needs To Change
White Paper By: Coalition for Patent Fairness
The Coalition for Patent Fairness supports a modern and efficient patent law that will promote innovation and spurs job creation and economic growth by encouraging commercialization of new and better products and services.

Post Grant Review
Improving the existing process for challenging questionable patents will lead to better patent quality and will benefit everyone: patent holders, patent users and consumers. Allowing third parties to institute a reexamination early in the process will clarify the breadth and applicability of these patents, thereby leading to fewer later challenges. Patent reform legislation should establish a new administrative procedure for review of patent decisions so that wrongfully-issued patents can be effectively reviewed and redressed within the PTO, rather than in the courts.
-------------------------------------------------------------------------------------------------

Myths and Facts of Patent Reform
White Paper By: Coalition for Patent Fairness
(p.3)...

MYTH: Patent Reform Act of 2009 would hurt American competitiveness by empowering Chinese and Indian citizens to both evade their intellectual property obligations and undermine the interests of American inventors.

FACT: This is a fanciful charge without any basis in the provisions of the 2009 bill. Improving patent quality – ensuring that only meritorious inventions receive a patent – is a high priority of the bill. Every witness at the more than 20 hearings held over the past three Congresses testified that poor patent quality creates severe and immediate problems. [THIS IS TRUE]
The Patent and Trademark Office (PTO) proposed establishing a post-grant opposition system to challenge patents. As introduced, HR 1908 (the Patent Reform Act of 2007) adopted the PTO’s proposal. It would have created a post-grant opposition mechanism enabling challenges of patents within 12 months of their being issued, or at any time during the life of the patent – the so-called "second window" – if the challenger could meet certain very rigorous criteria.
The bill as introduced came under considerable criticism, primarily by US drug makers. Their objection was limited to the "second window." They argued that the ability to challenge a patent at any time would empower the very kind of challenges those quoted in the India Times greet with such glee.
The Judiciary Committee took these concerns to heart. The 2009 bill no longer has a "second window" for post-grant opposition. The bill permits challenges only in the first 12 months after a patent is granted. For most drugs, because its takes about 7 years after the patent is granted to begin selling the drug, these challenges will simply not be available when a drug is actually marketed. [PERHAPS. BUT THE PROPOSED POST-GRANT REVIEW PROCEDURES STILL RENDER SMALL INVENTORS AND START-UPS VULNERABLE TO LARGE OPPORTUNISTIC U.S. AND FOREIGN IP POACHERS].
-------------------------------------------------------------------------------------------------
The Patent Reform Act of 2009
The Patent Reform Act of 2009 is a bill that has been causing lots of controversy ever since Senators Orrin Hatch and Patrick Leahy introduced a Senate bill on March 3, 2009 and Representative John Conyers introduced the House version of the bill on the very same day. This bill is very similar to the Patent Reform Acts of 2005 and 2007 and, although some of the controversial parts have been taken out, if this bill is passed, it will be disastrous for small and independent inventors. The good news is you can take part in the effort to stop this bill. We talked to retired patent examiner and registered patent agent, Albert W Davis Jr, Reg. No. 38773, to talk about why the patent office needs change, but how this bill is the wrong kind of change for inventors and what he suggests to do to stop it.

First, we will give you a very brief rundown of a few of the major aspects of the bill.

If the Act was passed, one of the major results would be a big change in the way patent infringement litigation works and the amount of damages an inventor can receive if his or her patent is infringed upon. The Act would do this in the following ways: only allowing the plaintiff to bring a suit in the states where the defendant has a physical place of business, broadening the use of appeals, creating stricter criteria for "willful infringement" and "reasonable royalty" and allows defendants to win with a "good faith" defense, in effect saying they didn't know they were infringing or they thought your patent was unenforceable or invalid. All of these changes greatly favor big businesses that infringe on inventors' patents and greatly limits inventors chance to be reimbursed when a company steals their idea.

Other important aspects of the bill are that it would allow any party to challenge a patent within 12 months of being issued and the system would switch from a first-to-invent system, to a first-to-file system. Both of these changes heavily favor large corporations, with lots of money to spend, and makes it harder for often under-financed small inventors.

One of the difficulties of this bill is that almost everyone is calling for reform of the Patent Office.
As Davis says:
Right now the cost of attaining a patent has risen substantially. That is because the Agent or Attorney for the Applicant (Inventor) has to answer more rejections from the Patent Office. Each rejection costs more money to the Applicant in fees paid to argue the rejection. This situation has been brought about because, for the last 6 years at least, the Patent Office has not been functioning correctly. Examiners are afraid to issue or "allow" patents because of a review by the Quality Group of the Patent Office on applications that are issued into patents. Even the smallest mistake in the allowed or issued patent is treated as a critical error. Then, Quality Review goes back through the last 10 applications that the Examiner has issued or allowed. Again, it is easy to find a minor error in any application. These minor errors are then used to prevent advancement, demote or possibly fire the Examiner.

So, what the Examiners are doing is to reject most applications whether the rejections are good or not. Then, the Applicant can only re-file the application or appeal to the Board of Appeals. All of this costs the Individual Inventor a lot of money. Eventually, the Inventor may run out of money or just give up because the system does not make sense.

But, as Davis adds,
"This bill does nothing to cure the current problems of the Patent Office and adds more expenses to getting a patent by subjecting the patent to more attacks by big companies." So instead of reforming the patent system, the Patent Reform Act is really just an attempt by big businesses to run over small inventors. So why don't more people speak out? "The issues are complex so it is not always obvious that they are bad for the Individual Inventor. But, the bill is bad. Call your congress persons local office and tell them to vote against the bill and save the Individual inventor," says Davis.

So who is supporting the bill? One of the big supporters of the bill is the Coalition for Patent Fairness. Over the period of 1996-2006, seven of the corporations who lead this coalition are responsible for paying out half of all awards given in patent infringement lawsuits! Simply said, this bill is supported by patent infringers who want to continue to steal patents, but not pay for them.

So what can we do to stop this bill? "Call your Congress person every day until they agree to help stop the current bill of Sen. Leahy, really misnamed the Patent Reform Act. It should be named the Patent Deform Act," says Davis. You can find your congress people at this website: http://www.congress.org/.

So does the Patent Office have hope for the right kind of change? "I believe that the Patent Office will become functional in a little while," says Davis, "maybe this year but probably next year."

Davis continues:

While I worked there, the Patent Office changed several times. Currently, there is a money pressure on the Office because they are receiving a lot fewer Maintenance Fees and Allowance fees. Also, there is a big back-up at the Board of Appeals because Applicants have appealed all of the suspect rejections. The Board will not be able to keep up in a timely fashion with this new workload. Congress made the Patent Office guarantee that the average time to abandonment or allowance would not exceed 18 months. The Office is way over 18 months pendency now and has a 1,000,000 applications waiting for a first action. These pressures will eventually cause a change in the Office to a more rational approach to rejecting and a more rational approach to Quality.

Inventors should try to hang in until the change occurs. Inventors can re-file their applications for very little money and add a new set of claims to prevent a first action Final Rejection.
There hasn't been an overhaul of the patent system since 1952, but let's make sure we get the right change. Contact your Congress persons today.
-------------------------------------------------------------------------------------------------
General Patent Corporation Calls New Patent Reform Bill Harmful to Inventors and Entrepreneurs
Reuters
April 13, 2009
SUFFERN, N.Y.--(Business Wire)--General Patent Corporation chairman and CEO Alexander Poltorak, writing in the popular syndicated "Washington Watch" column circulated throughout the country, strongly criticized the proposed Patent Reform Act of 2009, and said that"recycling a piece of failed legislation is not the best way to protect American inventors and spur innovation."
Calling the proposed new bill "a warmed-over version of a proposed policy package that didn`t pass the first time it was introduced in 2007," Dr. Poltorak said "the apportionment of damages and other changes would weaken patents and make it easier for offshore copycats to bring pirated goods into the U.S. This,"he continued, "could have serious consequences for American jobs and thecountry`s competitiveness in the global economy."
The proposed changes would transform the U.S. system for granting patents from a"first-to-invent" basis to the European-style "first-to-file" system, which would lead to a "race to the Patent Office" that favors large corporations over small inventors. "Many critics," Dr. Poltorak said, believe the proposed changes as currently written "will diminish many of the protections offered by the current law and discourage innovation and venture investment, and make it even more difficult to enforce a patent."
Dr. Poltorak`s company, General Patent Corporation, has for the past 22 years assisted inventors and entrepreneurs with licensing and enforcement of their patents, and helped them protect their intellectual rights and property under the law. Dr. Poltorak, a national expert on the U.S. patent system and co-author of two books on the subject, says that the new bill "will devalue patents, and stifle innovation and entrepreneurship."
He is also founder and president of thenon-profit organization American Innovators for Patent Reform (AIPR), andsuggests that readers write to their respective Senators and Congressional Representatives to express their views about the Patent Reform Act of 2009. For further information, contact General Patent Corporation at http://www.generalpatent.com/ , write to info@generalpatent.com or telephone 845-368-4000 x116.
About General Patent Corporation General Patent Corporation (GPC), headquartered in Suffern, New York, is the premier intellectual property (IP) boutique focusing on patent licensing andpatent enforcement, as well as IP strategy and IP valuation. GPC represents clients in assertive licensing, patent infringement claims and patentinfringement litigation on a contingency basis. For more information, visit www.generalpatent.com .
-------------------------------------------------------------------------------------------------
Opposition Mounts to Patent Reform Act of 2009
By Kevin L. Kearns
American Economic Alert
March 18, 2009
Dear Senators Reid and McConnell, Speaker Pelosi and Congressman Boehner:
We are writing to ask you to strongly oppose the passage of The Patent Reform Act of 2009, S. 515 and HR. 1260, legislation sponsored by Senator Leahy and Rep. Conyers, respectively. These bills, under the mantle of "reform," will actually severely damage U.S. international competitiveness and threaten most American businesses - along with the jobs they create - by undermining America's historically strong intellectual property rights. This legislation will threaten America's smaller inventors, large and small domestic manufacturers, venture capitalists, agricultural entities, biotech and pharmaceutical firms, non-profit research consortia, and research universities, among others. Downgrading patent rights – which are fundamentally property rights – will seriously constrict innovation and the ability of domestic manufacturers to turn good ideas into products consumer want, and thus good jobs for working Americans.
A series of U.S. Supreme Court and Federal Circuit decisions have already shifted the legal balance of power to favor patent users, tightening standards of patentability and narrowing patent rights and remedies. These judicial reforms eliminate any need for sweeping legislative changes to the patent system. Foreign interests, who for years have been trying to slow America's innovation engine through measures to weaken and devalue patent rights, are very happy with the proposed changes. In fact, commentary by patent experts in the Chinese and Indian press indicates they believe that intellectual property theft will be much easier under the proposed bill. Unfortunately, these foreign experts are correct in their assessment.
Yongshun Chen, former Senior Judge and Deputy Director of the Intellectual Property Division of Beijing High People's Court China, said this about the patent bill: "This bill will give companies from developing countries more freedom and flexibility to challenge the relative U.S. patent for doing business in the U.S. and make it less costly to infringe.... The bill will weaken the rights of patentees greatly, increase their burden, and reduce the remedies for infringement" (Intellectual Property News, November 2007).
This bill will lead to many additional American factories and jobs, even entire industries, being lost to overseas competitors. During this economic recession, more market uncertainty is the last thing that our economy needs.
To put the matter plainly, this bill is written to devalue patents – to the detriment of almost every industrial, service, and financial sector of the economy. Certain high-tech companies who are pushing this bill want to make it cheaper and easier to infringe others' patents. But Congress should safeguard innovation as the backbone of our economy and reject this legislation.
The patent system is rooted in the Constitution. Congress is charged with "securing for limited times to authors and inventors the exclusive right to their respective discoveries." The Founders understood that protection of intellectual property was vital to innovation and progress. James Madison wrote in the FederalistPapers,"The utility of this power will scarcely be questioned." Yet, today it is being threatened in the Congress.
Small enterprises often drive innovation. About one-third of all patent applications are made by independent inventors, small companies, universities, and nonprofit research groups. Small businesses produce more patents per employee than larger businesses, and small-firm patents are more "innovative" and technologically important than large firm patents. Because small firms must work with others to commercialize and manufacture their innovations, they need strong patents to realize a return on investment.
American manufacturers do about 65 percent of the R&D in this country and hold 60 percent of the patents. Over the last 40 years, we have witnessed a startling transformation of our economy. Whereas previously about two-thirds of a company's wealth was in physical assets, such as land, buildings, and machinery, now the opposite is true. The vast majority of a company's worth is in its intellectual property, not its physical assets. We cannot afford to jeopardize what is in effect America's balance sheet with an ill-advised, special-interest bill, particularly in the midst of a severe economic crisis.
The legislation creates a new, expensive quasi-judicial system within the USPTO to challenge the validity of a patent throughout its entire life. The proposed system would expose patent holders to a perpetual threat of abusive, serial attacks, and, as a result, undermine the benefits of patent ownership for patent-holders and their financial backers. In addition, it would create even greater operational challenges within the USPTO. Incentives to seek patents would be weakened, and venture capitalists, who supply the life blood of the patent system with their investment monies, would face far higher risks when backing new ideas.
The Leahy bill raises multiple barriers to independent innovation. The pending legislation would also make it harder for patent-holders to enforce their rights or win just compensation from those who steal their ideas. Under the bill, it would be harder to prove "willful" infringement, which serves as an important deterrent to deliberate theft. Perhaps, most significantly, the bill strikes at the very core of the patent system by changing the way infringement and resulting damages are treated. Instead of restoring the pre-infringement parity between the patent holder and the potential licensee, the bill calculates damages in an after-the-fact manner that lessens the value assigned to patents in most products. It throws out the window the venerable Georgia Pacific case and with its time-tested factors in determining a patent's value. In effect, the bill invites an infringe-now-and-(maybe)-pay-later business strategy, which destroys the "exclusive use" given to the patentee by the Constitution and the risk/reward ratio that has so successfully driven American innovation for over two centuries.
According to a recent study, the proposed damages amendment would reduce the value of U.S. patents by as much as $85.3 billion; reduce R&D expenditures by up to $66 billion per year; and potentially cost the U.S. economy 298,000 manufacturing jobs. This bill is bad for American businesses; it is bad for American workers; it is bad for American inventors; it is bad for American research universities; thus it is bad for America. We ask that you oppose this legislation, protect the property rights enshrined in the Constitution, and preserve a patent system that for over 200 years has provided great technological advances, material progress, and a high standard of living for all Americans. Thank you for your serious consideration of our views.
Sincerely,
Kevin Kearns US Business and Industry Council David KeaneAmerican Conservative Union Rev. Lou Sheldon Traditional Values CoalitionJim Backlin Christian Coalition of AmericaSusan Carleson American Civil Rights Union Jim Martin60 Plus Association C. Preston Noell III Tradition, Family. Property, Inc.Harry Valentine Capitol Hill Prayer AlertBarrett Duke Ethics and Religious Liberty Commission of the Southern Baptist ConventionGary AldrichCNP Action, Inc John Kwapisz VA Coalition for common sense on Climate Change and EnergyPhyllis Schlafly Eagle Forum Morton Blackwell Conservative Leadership PAC Frank Gaffney Center for Security Policy Colin A. HannaLet Freedom Ring Ron Pearson Council for America Jeffrey Gayner Americans for Sovereignty Alex St. JamesAARLC Organization Connie Marshner American Family Business InstituteJim Backlin Christian Coalition of AmericaCarmen Mercer Minuteman Civil Defense Corps.Mark de Bernardo Council for Employment Law and Equality Laszlo Pasztor National Federation of American Hungarians
-------------------------------------------------------------------------------------------------
And They’re Off: Patent Reform Act of 2009 Unleashed
by Stephen Albainy-Jenei
Patent Baristas
March 3, 2009
Following hot on the heels of the Patent Reform Acts of 2005, 2006, 2007 and 2008, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and former chair Orrin Hatch (R-Utah), along with House Judiciary Committee Chairman John Conyers (D-Mich.) and ranking minority member Lamar Smith (R-Texas), introduced, you guessed it, the “Patent Reform Act of 2009.”

The legislation (S.515 and H.R.1260) is set to pick up where patent-reform efforts left off last year. Controversial provisions remain so get ready to see continued efforts at lobbying for changes. Sens. Leahy and Hatch conceded during a press conference that more work needed to be done on the legislation but said reforms were needed urgently to improve patent quality and create more certainty in patent litigation.

In a nutshell, the Patent Reform Act of 2009 Senate Bill provides for the following:
...Sec. 4. Right of the inventor to obtain damages

Damages. Requires the court to conduct an analysis to ensure that, when a “reasonable royalty” is the award, it reflects the economic value of the patent’s “specific contribution over the prior art”, i.e. the contribution the invention makes to promoting science and the useful arts per the requirement of Article I, Section 8 of the Constitution. The court also is required to identify the factors that will be considered in determining a reasonable royalty, ensuring that the record is clear on what considerations the judge or jury assessed in awarding damages.

Willful infringement. This section changes the doctrine of willful infringement in both procedural and substantive respects. Courts will now require a plaintiff to demonstrate with clear and convincing evidence that the infringer acted in a manner that was objectively reckless, which is also subject to a good faith defense.
Prior User Rights.­ If the same invention is later patented by another party, the prior user may not be liable for infringement to the new patent holder, although all others will be. This section permits the defense to be used by entities controlling or controlled by the prior user.
Sec. 5. Post-grant procedures and other quality enhancements

The section expands the evidence that a party may cite to the USPTO under § 301 to include written statements of the patent owner regarding the scope of the patent claims and evidence that the claimed invention was in public use or on sale in the United States more than one year prior to the application. Requests for reexamination under § 302 can be based on either prior art or prior public use or sale, as can requests for inter partes reexamination under chapter 31. Inter partes reexamination will now be heard by an administrative patent judge in accordance with procedures established by the Director. Inter partes reexamination is further improved by permitting a third-party requester to file written comments.

A third-party requester is estopped from asserting the invalidity of any claim determined to be valid in inter partes reexamination on any ground that was raised in reexamination. Further, the estoppel bar to instituting an inter partes reexamination proceeding after a judicial determination of patent validity is lowered from a “final decision” to a judgment of the district court.

This section also creates a new post-grant review procedure that can be instituted either within 12 months after the issuance of a patent or a reissue patent, or if the patent owner consents. The post-grant review begins with a cancellation petition and moves forward only if the Director determines that there is a substantial new question of patentability. The presumption of validity does not apply in this proceeding, but the burden of proof is on the party advancing a proposition. The Director will prescribe rules governing the proceeding, including rules to sanction abuse. This section prohibits successive filings or filings after a final decision in a civil action.
-------------------------------------------------------------------------------------------------

Calendar No. 46
111TH CONGRESS
1ST SESSION S. 515

To amend title 35, United States Code, to provide for patent reform.

IN THE SENATE OF THE UNITED STATES
MARCH 3, 2009
Mr. LEAHY (for himself, Mr. HATCH, Mr. SCHUMER, Mr. CRAPO, Mr. WHITEHOUSE, Mr. RISCH, Mrs. GILLIBRAND, Ms. KLOBUCHAR, Mr. SPECTER, Mr. CORNYN, and Mrs. FEINSTEIN)
introduced the following bill; which was read twice and referred to the Committee on the Judiciary

APRIL 2, 2009
Reported by Mr. LEAHY, with amendments

SECTION 1. SHORT TITLE; TABLE OF CONTENTS

(a) SHORT TITLE.—This Act may be cited as the ‘‘Patent Reform Act of 2009’’

‘‘CHAPTER 32—POST-GRANT REVIEW PROCEDURES

‘‘Sec.

‘‘321. Petition for post-grant review.
‘‘322. Timing and bases of petition.
‘‘323. Requirements of petition.
‘‘324. Prohibited filings.
‘‘325. Submission of additional information; showing of sufficient grounds.
‘‘326. Conduct of post-grant review proceedings.
‘‘327. Patent owner response.
‘‘328. Proof and evidentiary standards.
‘‘329. Amendment of the patent.
‘‘330. Decision of the Board.
‘‘331. Effect of decision.
‘‘332. Settlement.
‘‘333. Relationship to other pending proceedings.
‘‘334. Effect of decisions rendered in civil action on post-grant review proceedings.
‘‘335. Effect of final decision on future proceedings.
‘‘336. Appeal.

‘‘§ 321. Petition for post-grant review

‘‘Subject to sections 322, 324, 332, and 333, a person who is not the patent owner may file with the Office a petition for cancellation seeking to institute a post-grant review proceeding to cancel as unpatentable any claim of a patent on any ground that could be raised under section 282 (relating to invalidity of the patent or any claim). The Director shall establish, by regulation, fees to be paid by the person requesting the proceeding, in such amounts as the Director determines to be reasonable.

‘‘§ 322. Timing and bases of petition

‘‘A post-grant proceeding may be instituted by the Director under this chapter pursuant to a cancellation petition filed under section 321. Such proceeding may be instituted only if—

‘‘(1) the petition is filed not later than 12 months after the issuance of the patent or a reissue patent, as the case may be; or
‘‘(2) the patent owner consents in writing to the proceeding.

‘‘§ 323. Requirements of petition

‘‘A cancellation petition filed under section 321 may be considered only if—

‘‘(1) the petition is accompanied by payment of the fee established by the Director under section
321;
‘‘(2) the petition identifies the cancellation petitioner;
‘‘(3) for each claim sought to be canceled, the petition sets forth in writing the basis for cancellation and provides the evidence in support thereof, including copies of patents and printed publications, or written testimony of a witness attested to under oath or declaration by the witness, or any other information that the Director may require by regulation; and
‘‘(4) the petitioner provides copies of the petition, including any evidence submitted with the petition and any other information submitted under 2 paragraph (3), to the patent owner or, if applicable, the designated representative of the patent owner.

‘‘§ 324. Prohibited filings

‘‘A post-grant review proceeding may not be instituted under section 322 if the petition for cancellation requesting the proceeding—

‘‘(1) identifies the same cancellation petitioner and the same patent as a previous petition for cancellation filed under such section; or
‘‘(2) is based on the best mode requirement contained in section 112.

‘‘§ 325. Submission of additional information; showing of sufficient grounds

‘‘(a) IN GENERAL.—The cancellation petitioner shall file such additional information with respect to the petition as the Director may require. For each petition submitted under section 321, the Director shall determine if the written statement, and any evidence submitted with the request, establish that a substantial question of patentability exists for at least one claim in the patent. The Director may institute a post-grant review proceeding if the Director determines that the information presented provides sufficient grounds to believe that there is a substantial question of patentability concerning one or more claims of the patent at issue.

‘‘(b) NOTIFICATION; DETERMINATIONS NOT REVIEWABLE.—The Director shall notify the patent owner and each petitioner in writing of the Director’s determination under subsection (a), including a determination to deny the petition. The Director shall make that determination in writing not later than 60 days after receiving the petition. Any determination made by the Director under subsection (a), including whether or not to institute a post-grant review proceeding or to deny the petition, shall not be reviewable.

‘‘§ 326. Conduct of post-grant review proceedings

‘‘(a) IN GENERAL.—The Director shall prescribe regulations, in accordance with section 2(b)(2)—

‘‘(1) establishing and governing post-grant review proceedings under this chapter and their relationship to other proceedings under this title;
‘‘(2) establishing procedures for the submission of supplemental information after the petition for cancellation is filed; and
‘‘(3) setting forth procedures for discovery of relevant evidence, including that such discovery shall be limited to evidence directly related to factual assertions advanced by either party in the proceeding, and the procedures for obtaining such evidence shall be consistent with the purpose and nature of the proceeding.

In carrying out paragraph (3), the Director shall bear in mind that discovery must be in the interests of justice.

‘‘(b) POST-GRANT REGULATIONS.—Regulations under subsection (a)(1)—

‘‘(1) shall require that the final determination in a post-grant proceeding issue not later than one 10 year after the date on which the post-grant review proceeding is instituted under this chapter, except that, for good cause shown, the Director may extend the 1-year period by not more than six months;
‘‘(2) shall provide for discovery upon order of the Director;
‘‘(3) shall provide for publication of notice in the Federal Register of the filing of a petition for post-grant review under this chapter, for publication of the petition, and documents, orders, and decisions relating to the petition, on the website of the Patent and Trademark Office, and for filings under seal exempt from publication requirements;
‘‘(4) shall prescribe sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or to cause unnecessary delay or unnecessary increase in the cost of the proceeding;
‘‘(5) may provide for protective orders governing the exchange and submission of confidential information; and
‘‘(6) shall ensure that any information submitted by the patent owner in support of any amendment entered under section 329 is made available to the public as part of the prosecution history of the patent.

‘‘(c) CONSIDERATIONS.—In prescribing regulations under this section, the Director shall consider the effect on the economy, the integrity of the patent system, and the efficient administration of the Office.

‘‘(d) CONDUCT OF PROCEEDING.—The Patent Trial and Appeal Board shall, in accordance with section 6(b), conduct each post-grant review proceeding instituted by the Director.

‘‘§ 327. Patent owner response

‘‘After a post-grant proceeding under this chapter has been instituted with respect to a patent, the patent owner shall have the right to file, within a time period set by the Director, a response to the cancellation petition.The patent owner shall file with the response, through affidavits or declarations, any additional factual evidence and expert opinions on which the patent owner relies in support of the response.

‘‘§ 328. Proof and evidentiary standards

‘‘(a) IN GENERAL.—The presumption of validity set forth in section 282 shall not apply in a challenge to any patent claim under this chapter.

‘‘(b) BURDEN OF PROOF.—The party advancing a proposition under this chapter shall have the burden of proving that proposition by a preponderance of the evidence.

‘‘§ 329. Amendment of the patent

‘‘(a) IN GENERAL.—In response to a challenge in a petition for cancellation, the patent owner may file one motion to amend the patent in one or more of the following ways:

‘‘(1) Cancel any challenged patent claim.
‘‘(2) For each challenged claim, propose a substitute claim.
‘‘(3) Amend the patent drawings or otherwise amend the patent other than the claims.

‘‘(b) ADDITIONAL MOTIONS.—Additional motions to amend may be permitted only for good cause shown.

‘‘(c) SCOPE OF CLAIMS.—An amendment under this section may not enlarge the scope of the claims of the patent or introduce new matter.

‘‘§ 330. Decision of the Board

‘‘If the post-grant review proceeding is instituted and not dismissed under this chapter, the Patent Trial and Appeal Board shall issue a final written decision addressing the patentability of any patent claim challenged and any new claim added under section 329.

‘‘§ 331. Effect of decision

‘‘(a) IN GENERAL.—If the Patent Trial and Appeal Board issues a final decision under section 330 and the time for appeal has expired or any appeal proceeding has terminated, the Director shall issue and publish a certificate canceling any claim of the patent finally determined to be unpatentable and incorporating in the patent by operation of the certificate any new claim determined to be patentable.

‘‘(b) NEW CLAIMS.—Any new claim held to be patentable and incorporated into a patent in a post-grant review proceeding shall have the same effect as that specified in section 252 for reissued patents on the right of any person who made, purchased, offered to sell, or used within the United States, or imported into the United States, anything patented by such new claim, or who made substantial preparations therefor, before a certificate under subsection (a) of this section is issued.

‘‘§ 332. Settlement

‘‘(a) IN GENERAL.—A post-grant review proceeding shall be terminated with respect to any petitioner upon the joint request of the petitioner and the patent owner, unless the Patent Trial and Appeal Board has issued a written decision before the request for termination is filed. If the post-grant review proceeding is terminated with respect to a petitioner under this paragraph, no estoppel shall apply to that petitioner. If no petitioner remains in the proceeding, the panel of administrative patent judges assigned to the proceeding shall terminate the proceeding.

‘‘(b) AGREEMENT IN WRITING.—Any agreement or understanding between the patent owner and a petitioner, including any collateral agreements referred to in the agreement or understanding, that is made in connection with or in contemplation of the termination of a post-grant review proceeding, must be in writing. A post-grant review proceeding as between the parties to the agreement or understanding may not be terminated until a copy of the agreement or understanding, including any such collateral agreements, has been filed in the Office. If any party filing such an agreement or understanding requests, the agreement or understanding shall be kept separate from the file of the post-grant review proceeding, and shall be made available only to Government agencies on written request, or to any person on a showing of good cause.

‘‘§ 333. Relationship to other proceedings

‘‘(a) IN GENERAL.—Notwithstanding subsection 135(a), sections 251 and 252, and chapter 30, the Director may determine the manner in which any reexamination proceeding, reissue proceeding, interference proceeding (commenced with respect to an application for patent filed before the effective date provided in section 5(k) of the Patent Reform Act of 2009), derivation proceeding, or post-grant review proceeding, that is pending during a post-grant review proceeding, may proceed, including providing for stay, transfer, consolidation, or termination of any such proceeding.

‘‘(b) STAYS.—The Director may stay a post-grant review proceeding if a pending civil action for infringement of a patent addresses the same or substantially the same questions of patentability raised against the patent in a petition for the post-grant review proceeding.

‘‘(c) EFFECT OF COMMENCEMENT OF PROCEEDING.—The commencement of a post-grant review proceeding—

‘‘(1) shall not limit in any way the right of the patent owner to commence an action for infringement of the patent; and
‘‘(2) shall not be cited as evidence relating to the validity of any claim of the patent in any proceeding before a court or the International Trade Commission concerning the patent.

‘‘§ 334. Effect of decisions rendered in civil action on post-grant review proceedings

‘‘If a final decision is entered against a party in a civil action arising in whole or in part under section 1338 of title 28 establishing that the party has not sustained its burden of proving the invalidity of any patent claim—

‘‘(1) that party to the civil action and the privies of that party may not thereafter request a post-grant review proceeding on that patent claim on the basis of any grounds, under the provisions of section 321, which that party or the privies of that party raised or could have raised; and
‘‘(2) the Director may not thereafter maintain a post-grant review proceeding that was requested, before the final decision was so entered, by that party or the privies of that party on the basis of such grounds.

‘‘§ 335. Effect of final decision on future proceedings

‘‘If a final decision under section 330 is favorable to the patentability of any original or new claim of the patent challenged by the cancellation petitioner, the cancellation petitioner may not thereafter, based on any ground that the cancellation petitioner raised during the post-grant review proceeding—

‘‘(1) request or pursue a reexamination of such claim under chapter 31;
‘‘(2) request or pursue a derivation proceeding with respect to such claim;
‘‘(3) request or pursue a post-grant review proceeding under this chapter with respect to such claim;
‘‘(4) assert the invalidity of any such claim in any civil action arising in whole or in part under section 1338 of title 28; or
‘‘(5) assert the invalidity of any such claim in defense to an action brought under section 337 of the Tariff Act of 1930 (19 U.S.C. 1337).

‘‘§ 336. Appeal

‘‘A party dissatisfied with the final determination of the Patent Trial and Appeal Board in a post-grant proceeding under this chapter may appeal the determination under sections 141 through 144. Any party to the post-grant proceeding shall have the right to be a party to the appeal.’’.

(g) CONFORMING AMENDMENT.—The table of chapters for part III of title 35, United States Code, is amended by adding at the end the following:

‘‘32. Post-Grant Review Proceedings ......................................... 321’’.

(h) REPEAL.—Section 4607 of the Intellectual Property and Communications Omnibus Reform Act of 1999, as enacted by section 1000(a)(9) of Public Law 106–113, is repealed.

(i) EFFECTIVE DATES.—

(1) IN GENERAL.—The amendments and repeal made by this section shall take effect at the end of the 1-year period beginning on the date of the enactment of this Act.

(2) APPLICABILITY TO EX PARTE AND INTERPARTES PROCEEDINGS.—Notwithstanding any other provision of law, sections 301 and 311 through 318 of title 35, United States Code, as amended by this section, shall apply to any patent that issues before, on, or after the effective date under paragraph (1) from an original application filed on any date.

(3) APPLICABILITY TO POST-GRANT PROCEEDINGS.—The amendments made by subsections (f) and (g) shall apply to patents issued on or after the effective date under paragraph (1).
(j) REGULATIONS.—The Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (in this subsection referred to as the ‘‘Director’’) shall, not later than the date that is 1 year after the date of the enactment of this Act, issue regulations to carry out chapter 32 of title 35, United States Code, as added by subsection (f).

Obama Asked to Prevent Compulsory Licensing ('Give Away') of US Cleantech Patented Technologies at Upcoming Copenhagen Climate Change Negotiations

http://www.bloomberg.com/apps/news?pid=20601072&sid=aug9aycq0lJw

Clean-Energy Cause Shouldn’t Void Patents, Senators Tell Obama


By Jim Efstathiou Jr.
Bloomberg News
Nov. 4, 2009
Nov. 4 (Bloomberg) -- The U.S. must “stand fast” on patent protection and resist calls from developing nations to share energy-efficient technologies to combat climate change, 42 senators told President Barack Obama.



The administration shouldn’t waver in its “support of American intellectual property, American workers, and American innovators” during climate-change talks next month in Copenhagen, the lawmakers said in the letter to Obama yesterday that was circulated by Senator Evan Bayh, an Indiana Democrat.



Developing nations have cited a World Trade Organization ruling as grounds to break patent protections on drugs in health emergencies. Some seek a similar approach to wind- and solar- energy innovations in the name of curbing global warming. U.S. companies such as General Electric Co., which makes wind turbines, would be forced to give free or low-cost access to patents under such proposals.



“They want companies in the U.S. to give away their technology,” said Lawrence Kogan, head of the Institute for Trade, Standards and Sustainable Development, a Princeton, N.J.- based group that advocates for intellectual property rights. It’s part of an effort to “treat intellectual property as a utilitarian tool to promote development.”



Delegates from about 190 nations will meet in Copenhagen next month in the effort to complete a global-warming treaty. How to help fast-growing developing countries pay for clean- energy technology is one of the unresolved issues.



U.S. officials such as Todd Stern, special envoy for climate change, and Ron Kirk, U.S. trade representative, have said the administration won’t weaken intellectual-property protections.



India, Brazil, China



India, Brazil and China, the world’s largest greenhouse-gas emitter, want easier access to licenses to make and export systems that produce electricity with fewer emissions, said James Love, an economist with Knowledge Ecology International, a Washington-based group that follows intellectual-property negotiations.

“If what you’re trying to do is mobilize the world to do something about climate change, you could actually be in favor of a lot of compulsory licensing,” Love said in an interview. “If you want to deal with climate change, you want buy-in from developing countries.”

World Trade Organization agreements should be interpreted to “allow compulsory licensing of patents for the production of climate-friendly equipment and goods that embed climate-friendly technology,” the United Nations’ Geneva-based Conference on Trade and Development said in a report released on Sept. 7.

The sharing of some clean-energy patents has support from Senator Jay Rockefeller, a Democrat from West Virginia, a coal- producing state. He said he backs development of “national technologies” to reduce carbon dioxide from burning coal that “nobody can put a patent on.”


‘Just Give It’

“If we get a good technology and Wall Street and industry and everybody else buys into it, then I want to give it free of charge to the Chinese and the Indians and to others, anybody who needs it,” Rockefeller told reporters Oct. 30. “Just give it. This is a worldwide problem.”

Senate Democrats began committee debate this week on legislation to limit greenhouse gas-emissions. The House passed a climate-change bill in June.

To contact the reporter on this story: Jim Efstathiou Jr. in New York at jefstathiou@bloomberg.net. Last Updated: November 4, 2009 09:30 EST
-------------------------------------------------------------------------------------------------
Senators Bayh, Voinovich Ask President Obama to Protect American Intellectual Property
Office of U.S. Senator Evan Bayh
Nov. 4, 2009
Washington– U.S. Senators Evan Bayh (D-IN) and George V. Voinovich (R-OH) led a bipartisan letter [http://bayh.senate.gov/imo/media/doc/Bayh%20Letter%20to%20POTUS.pdf ] signed by 42 senators to President Obama calling on the president to protect American intellectual property (IP), jobs and innovation in the United Nations (U.N.) Framework Convention on climate change negotiation.

“Unless we take aggressive action to protect the intellectual property of our entrepreneurs and manufacturers, we will continue to watch profits and jobs migrate overseas,” Sen. Bayh said. “Protecting our innovations in international climate negotiations will encourage the development of more American technology and help us maintain the economic strength we will need to advance our efforts to reduce carbon emissions.”

“We must fight to protect American innovators, entrepreneurs and manufacturers involved in creating our cutting-edge clean energy technologies,” Sen. Voinovich said. “It is universally held that the answer to climate change lies in technology. Now is not the time to take away a major incentive, undermine innovation and weaken our economy. We must protect American IP - thus protecting American jobs, creativity and innovation.”

Bill Keith, President of SunRise Solar in St. John, Indiana praised the letter, saying, “Senator Bayh is bringing attention to the protection of American patents and breakthrough innovations at a critical time. Some countries are using the climate change negotiations as a means to obtain our technological designs. If they succeed, it will cost Indiana jobs and harm our global competitiveness. Our Hoosier-made products contribute to the fight against global warming and stimulate job growth, and environmentally responsible companies like ours must be protected as the climate change debate moves forward.”

The letter sent to the president highlights the importance of safeguarding IP rights for clean technology as the United States takes part in the U.N. climate change negotiations this December in Copenhagen. It recognizes the president’s commitment and asks for his support for IP rights in the United Nations Framework Convention on Climate Change (UNFCCC) and urges further support from American negotiators as the process continues. There are international efforts to weaken IP protections, which the senators strongly oppose.

The senators also recognize the importance of a strong IP system in attracting the research and development dollars needed for investment in new technologies that will bring jobs and solutions to global problems. IP rights allow innovators to attract the investment needed to develop and market their ideas, promoting economic growth and prosperity and creating high-value American jobs.

Sens.Bayh and Voinovich have worked hard to protect American innovation for years. The senators introduced legislation in the 110th Congress designed to address intellectual property rights enforcement issues and to protect American innovation and advancement. The legislation was introduced July 2008 by Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), Ranking Member Arlen Specter (R-Pa.) and Sens. Bayh and Voinovich. The bill was signed into law October 2008.
-------------------------------------------------------------------------------------------------
HATCH URGES OBAMA TO PROTECT INTELLECTUAL PROPERTY RIGHTS Senators On Both Sides Of The Aisle Sign On To Letter
Office of U.S. Senator Orrin Hatch
June 18, 2009
Washington – U.S. Sen. Orrin Hatch (R-Utah) today sent a letter to President Obama urging him to protect intellectual property (IP) rights. In addition to his own, Hatch secured the following signatures for the letter: Sen. Evan Byah (D- Ind.) Sen. Robert F. Bennett (R- Utah) Sen. Debbie Stabenow (D- Mich.) Sen. Charles E. Grassley (R- Iowa) Sen. Arlen Specter (D- Penn.) Sen. George V. Voinovich (R- Ohio) Sen. John Thune (R- S.Dak.) Sen. Judd Gregg (R- Nh.) Sen. David Vitter (R- La.)
“The United States government cannot afford to sit idle while others seek to weaken IP protections,” the senators explain. “America must continue to set the standard for IP protection, and be willing to confront those countries and organizations that attempt to weaken IP rights.
The senators explain that industries based on IP employ 18 million Americans and account for more than $5 trillion of the nation’s GDP and more than half of all our exports. “IP rights have not caused any of the world’s problems, and compulsory licensing is not the key to solving them. Maintaining strong IP rights is essential to economic growth and continued innovation, and protecting IP rights will not only improve the world’s development but America’s as well”, they conclude.
The full letter is attached and below:
June 18, 2009
The President
The White House
Washington, DC 20500
Dear Mr. President:
Protecting intellectual property (IP) rights has been a fundamental concept in the United States since the Founders provided Congress with the power “To promote the Progress of Science and useful Arts” in the Constitution.
Today, America’s commitment to strong IP protection has yielded astounding results. Not only do industries based on IP employ 18 million Americans, but they also account for more than $5 trillion of the nation’s GDP, and more than half of all our exports. The United States’ commitment to strong IP has been a major impetus in propelling it to the forefront of manufacturing.
Today we stand on the cutting edge of the bio-tech, entertainment, energy and consumer electronics industries, to name a few. Further investment in these areas will lead to an improved economy and millions of jobs. To ensure the United States maintains its leadership we must continue to reward the creativity of scientists and inventors and provide incentive for businesses and workers to invest time and resources in improving technology and accelerating innovation.
Despite the overwhelming evidence that strong IP rights lead to scientific progress, there are many governments, NGOs and even UN agencies that seek to weaken IP protections. Many governments mischaracterize IP rights as an obstacle to progress and a barrier to helping others.
Urgently addressing health and environmental crises is a priority that all nations should take seriously. These challenges are handled best when governments and private industry work together. Unfortunately, some governments require compulsory licenses of IP, while others require forced technology transfers. These short-sighted approaches to IP rights will curtail growth and development, and stagnate the very industries that these countries depend on.
For example, China and India claim they cannot meet future global emission requirements without free or significantly discounted access to climate change mitigation technologies.
While addressing global pollution and environmental harm is an important endeavor, sacrificing IP protections to achieve it is not the solution. Weakening IP protections will create a disincentive for inventors and large companies to invest in technologies that reduce global emissions and improve the environment. This disincentive will lead to fewer and less efficient technologies, and will significantly impede our ability to improve the environment.
President Barack Obama Page Two June 18, 2009
The United States government cannot afford to sit idle while others seek to weaken IP protections. America must continue to set the standard for IP protection, and be willing to confront those countries and organizations that attempt to weaken IP rights. The world faces many challenges today. IP rights have not caused any of the world’s problems, and compulsory licensing is not the key to solving them. Maintaining strong IP rights is essential to economic growth and continued innovation, and protecting IP rights will not only improve the world’s development but America’s as well.
Sincerely,
Evan Bayh
Orrin G. Hatch
Robert F. Bennett
Debbie Stabenow
Charles E. Grassley
Arlen Specter
George V. Voinovich
John Thune
Judd Gregg
David Vitter

Monday, October 19, 2009

Socialist NGO IP Ethics Panel Reflects Developing Country Demands for Compulsory Licensing & Open Source Procurement of Climate Change Technologies

http://www.ip-watch.org/weblog/2009/10/16/an-ethical-framework-for-ip-and-climate-change/


Panel Calls For An Ethical Framework For IP And Climate Change
By Kaitlin Mara


IP Watch


October 16, 2009


BANGKOK - Normal negotiation strategy is unlikely to result in an impact on climate change, since the most important stakeholders in fighting it - not yet born - have no seat at the negotiating tables, said a panel last week in Bangkok. An ethical approach is a better way to achieve results, speakers said, and an ethical take on intellectual property rights and alternative forms of innovation may have a place in new climate-friendly economic models.


The changes needed will be extraordinary: In order to meet United Nations Framework Convention on Climate Change targets for reductions in emissions by 2015, there will need to be a tenfold increase in carbon productivity, said economist Nitin Desai, a former senior UN official, who also chaired the panel.



This is “comparable to the increase in labour productivity throughout the entire industrial revolution,” he added.


“This is an aspect [of fighting climate change] that we are not facing up to,” said Desai. The “industrial revolution wasn’t just about technology: it was a whole new world. It’s the scale … that is not being adequately recognised.”


In particular, basic ethical principles of responsibility are useful in looking at ways to tackle the climate issue, said Desai. The collection of speakers was hosted by the Tata Energy Research Institute (TERI), a nongovernmental agency which looks at matters of energy, environment, and development, and took place on 8 October.


Ethical questions on climate change include not just a fair allocation of responsibilities, obligations and costs in fighting it, said Manish Shivastava, a research associate at TERI who is working on a paper entitled “Technology, Ethics, and IPR: The Dilemma in Climate Change Governance.”


They also include a fair allocation to benefits, to the right to development and to various resources, and an elimination of differences in exposure to consequences and unequal protection.

Intellectual Property, Ethics, and Climate Change


As technology is a key factor in combating climate change, ethical issues raised include who will commit what kinds of support for the development and dissemination of technology - generally, developed countries are seen as responsible for financial support, and developing countries as responsible for building favourable policy environments (tariff structures or foreign investment policies) for technology to come in, Shivastava said. And there is general agreement that IP rights encourage innovations and private investment in research and development, said Shivastava.



“But as a side effect, they add cost to users,” he said, both directly (by increasing prices) and indirectly (by increasing transaction costs for acquiring a needed bundle of technologies, or gaining ability to use a technology if a firm is unwilling to licence).

But IP in environmental technology may not look the same as it has in previous debates, such as over pharmaceuticals, in particular as related to HIV/AIDS medications in Africa.

“Most people think about IP and the high cost, taking the example of pharma,” but this may be a different situation, said another speaker who declined to be identified. In pharmaceuticals, the “cost of R&D is so high that IP can constitute something like 90 percent of the price of a technology.” But in green energy the IP is likely not to constitute more than about 10 percent of the product, the speaker asserted.


“There is a clear difference with pharmaceuticals, where IP is linked to a product” than “in the case of energy or environmental technology” which is “much more complex [and necessitates looking] at IP as a part of overall cost, and how to manage cost to make deployment happen,” said Anand Patwardhan, a professor at the Indian Instituteof Technology in Mumbai, with a background in environment, technology and public policy.


If there is a paradigm-shifting technology where the problem is IP rights, then there is already the option of compulsory licensing in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) agreement, the speaker said, which applies to any product and is not limited to pharmaceuticals.


Open Sourcing for the Environment


It is “definitely true that IPR is a social contract that balances public and private interest,” said Patwardhan, adding that “to the extent that there’s a public interest in more rapid development, you might want to think less about compulsory licences but more about how to encourage development that’s more open.” In open source development, “the ability to work collaboratively is enhanced” and “actually speeds up the technology cycle and makes it more diverse.”


Desai agreed. “With climate, we’re talking about process, not product,” he said, referring to the need for an economic paradigm shirt. “So we need a structure … like a transparency requirement.” This fits, he said, into the open source model of revealing source code.


Other solutions suggested by Shivastava included waivers on royalties for publicly funded technology, patent pools, or patent commons where rights holders pledge conditional waivers on their royalties.


Several participants also mentioned how critical it is that financing for both development and diffusion be provided.


Also contributing as research fellows of TERI, though not on IP issues, were Nitu Goel, who wrote on ethics in funding for adaptation to climate change, and Neha Pahuja, who spoke about measurable, reportable and verifiable goals.

-------------------------------------------------------------------------------------------------


Bangkok Climate Meeting Leaves Political Issues, Compulsory Licences Unresolved


By Kaitlin Mara


IP Watch


October 12, 2009


BANGKOK – Humanity may be facing the single greatest threat to its future in history, yet significant political disagreements still stand in the way of common action needed to combat what will be a common crisis. One potential blocking point appears to be whether compulsory licensing may be encouraged for poor countries needing climate technologies.


The Bangkok session of the ongoing UN climate change talks drew to a close Friday with little progress on the most politically difficult issues: who should be obligated to undertake action to combat climate change, what actions should be performed, and who should be footing the bill.


Past UN discussions on this issue place the onus on developed nations to take the lead, citing historical responsibility for the problem. Some developed nations are also calling for commitments from the larger developing countries.


Concessions need to come from developed countries, said Michael Zammitt Cutajar, who chairs one of the working groups at the talks, in response to a question at a press conference on 9 October. “Of course,” he added, there will be no agreement “until developing countries are clear about how they can contribute.”


Time is short to progress on these matters: five negotiating days are left until the UN Framework Convention on Climate Change is meant to come to an agreement in Copenhagen on the next steps to avert a potential global catastrophe. The next meeting of the UNFCCC will be 2-6 November in Barcelona, Spain. The Copenhagen Climate Change Conference will run 7-18 December. The Bangkok session ran from 28 September to 9 October.


The technology-transfer negotiating text – in which intellectual property appears – if anything appears to have grown in length this week. A non-paper released by the chairs[pdf] on the final day, 9 October, contained a fifth option on intellectual property (up from four in the previous non-paper released 2 October IPW, Environment, 6 October 2009).


Creating and Distributing the Right Technology


Technology development and diffusion is one of the linchpins of the long-term strategy to reduce emissions that threaten the planet’s atmosphere. It is the development of new environmental technologies that will make necessary reductions possible, and it is access to new technology - along with capacity building and financial support - that will allow developing and least-developed countries to participate in the new, low-carbon future.


Within this framework, intellectual property is shaping up to be a complex part of the puzzle - perhaps even a deal-breaker if positions remain as diametrically opposed as they currently are - though it is as yet unclear what kind of an effect IP has on the diffusion of environmental technology.


What is clear is the strength of the positions of member states. The United States has said it will refuse an agreement containing compulsory licensing and several other developed country members indicated a lack of willingness to discuss changes the IP system.

On the other hand, a Bolivian submission from September[pdf; Bolivia's submission begins on page 8] that many developing country delegates referred to in Bangkok says proposes the UNFCCC reaffirm “that intellectual property has been a barrier to the transfer of and access to environmentally sound technologies and associated know-how [and] urgent action needs to be taken to overcome this barrier.”


And there has been concern among many developing countries, intergovernmental agencies and non-governmental agencies that climate change will lead to new forms of protectionism that will only further shut developing countries out of the market (see, for example, the recent report of Sangeeta Shashikant of the Third World Network on Climate, IPRs, and Protectionism).


The new paragraph in the text of 9 October, which sources said was added at the request of the “G77” group of developing countries and China reads: “Consistent with their obligations under international treaties and agreements, Parties may compulsorily license specific technologies for the purpose of mitigation and adaptation to climate change, where it can be demonstrated that those patents and licenses act as a barrier to technology transfer and prevent the deployment or diffusion of that technology within a given country.”


With such differentiated stances, the UNFCCC secretariat may lack the technical expertise to address these issues.


US, Others Take Exception to IP Exceptions


The United States signalled dissatisfaction that the section on IP remained in the chair’s text at all during the technology transfer group final informal meeting in Bangkok on 9 October, according to sources.


“The United States will not do compulsory licences,” Jonathan Pershing - deputy special envoy for climate change at the US Department of State - later told Intellectual Property Watch. On intellectual property, he said, the US “will look at things” that increase technology diffusion in the market, not compulsory licensing which “does the opposite.”


They are not alone in this stance. “We will not agree on any change in the system of IPRs,” Anders Turesson, chief negotiator on climate for Sweden on behalf of the European Union, told Intellectual Property Watch. “It would be counterproductive and counter the development of technology we need so badly.” Though, he added, in case of a specific technology need, solutions might be discussed. A separate participant to the technology transfer debates said there was “no willingness on the part of industrialised countries to discuss IP” during the Bangkok meeting.


The US statements are being watched in particular as it is currently the only industrialised nation that has not ratified the Kyoto Protocol, the last major environmental agreement to come out of the UNFCCC, which required a set of developed countries to commit to reductions in their emissions. It is also one of the world’s largest polluters both in aggregate and per capita, so it is seen as particularly important that the country sign on to the next generation of climate protection measures.


“There is no agreement in Copenhagen without the United States in it,” said Cutajar, who chairs the Ad-Hoc Working Group on Long-Term Cooperative Action, which is the umbrella working group under which technology development and transfer issues are being discussed.


There may be domestic difficulties in the US, however, as the Congress is still working on a climate change bill. Not having it complete by December “doesn’t mean that no deal is possible,” said Pershing, but added it was difficult to commit to specific numbers without Congress. The bill that passed the House of Representatives [pdf] earlier this year calls IP a “key driver of investment and research” and says “any weakening of intellectual property rights protection poses a substantial competitive risk to US companies” and says US funding to developing countries should “promote the robust compliance with and enforcement of” IP rights protection.


A draft bill before the Senate lists as one of its purposes in international clean energy deployment as to “promote robust compliance with and enforcement of existing international legal requirements” for IP protection. The bill was introduced by Democratic Sens. Barbara Boxer (California) and John Kerry (Massachusetts).


But is IP the Issue?


Some are questioning whether IP is the key problem in climate change, or whether infrastructure, lack of financing, or lack of capacity might be greater problems.


The “barrier is not IPR,” Turesson. The “barriers lie somewhere else… [in] poor situations, or environments.”


“Barriers to technology transfer look different in different countries, and they should be described” and addressed as such, he added. “Technology goes where capital goes” – so that in countries that are poor and not growing, then capacity building and financing is key.


Thaddeus Burns, senior counsel on IP and trade for General Electric, said tariffs on green technology add more to the price of the good than fees on IP licensing.


Lesotho in a party submission [pdf, Lesotho's submission begins on page 5] from May 2009 on behalf of the least developed countries (LDCs) said low capacity to adapt technology in LDCs might mean IP is of less significance than in “major” developing countries.


Others have said that a UNFCCC agreement with IP in it may not provide any additional rights on top of what is already guaranteed in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights Agreement, which guarantees governments the right to issue compulsory licences, even without prior negotiation with the rights holder, in cases of “extreme urgency” or “public non-commercial use.”


Financing and The Need To Move Forward


Whatever activities are decided, from technology transfer projects to emissions reductions, financing them will be a critical issue. In particular, financial help for developing countries must be available.


“What is the point of taking your llama to a dry watering hole?” said Yvo de Boer, executive secretary of the UNFCCC, referring to the difficulty in securing funding resources. Industrialised country leadership and financial support are needed, he said.


“There’s been very constructive engagement from developing countries,” he added. “But without financial backing, what’s the point?”


Ambassador Di-Aping Lumumba of Sudan said in a press statement that there is a “massive leadership deficit” in developed countries, and called on their citizens to correct this.


These issues and others will be taken up again in Barcelona, during which time many delegates in Bangkok said they hoped substantial issues would be addressed and moved towards resolution.

Thursday, July 30, 2009

Another Likely Casualty of Obama's Healthcare Plan: The US Proprietary Software & ICT Industries and Millions of Highpaying US Jobs

As will be reported in future blog entries, European governments are working collaboratively with the international open source community, certain industry members and academicians to persuade the U.S. government to express a clear preference in federal government procurement regulations for royalty-free open source software based on royalty-free patented technologies disclosed ex ante in open technical standards. The ultimate objective of such stakeholders is to migrate the US government away from proprietary software and information & communication technology (ICT) systems to free of charge open systems.


Aside from the fact that, by expressing an official preference for royalty-free open source software and royalty-free patent-based software and ICT technologies, the US government will knowingly be changing the conditions for competition and thus reshaping free markets, and, by virtue thereof, would effectively be participating in the 'creative destruction' of the VERY internationally competitive US proprietary-based software and ICT industries, it will likely also be violating at least two World Trade Organization (WTO) Agreements - the multilateral Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the plurilateral Government Procurement Agreement.


This blog entry is dedicated only to establishing the facts underpinning how the Obama administration has decided to promote royalty-free patented and copyrighted software and ICT technologies over similarly situated proprietary products when evaluating competing bids for US federal government healthcare contracts, incidental to the administration's efforts to secure passage of already controversial federal universal healthcare legislation. It does not address the facts surrounding European government practices concerning such products, nor the WTO legal issues. Those discussions will be reserved for future blog entries.


THE FACTS:

Indeed, these stakeholders recently formed a nonprofit organization called Open Source for America, “a broad cross-section of more than 50 companies, academic institutions, communities, related groups and individuals that serve as a unified voice for the promotion of open source in the U.S. Federal government sector.” [1]


More than 70 major companies, academic institutions and high profile technologists have launched a campaign to educate US government agencies about the benefits of open source technology. Announced earlier at the O'Reilly Open Source Convention, groups such as Google, RedHat, Novell, Linux, Mozilla, Sun Microsystems and the Electronic Frontiers Foundation have teamed up to create Open Source For America. The joint effort is a coalition aimed at lobbying the US Federal government to consider using open-source software over proprietary code… Nevertheless, lobbying will be no easy feat…[I]n the past government officials have expressed security concerns with open source code. Critics argue that exposed source code can be examined by attackers and therefore poses a risk. Nevertheless, another argument for exposed code can be made in ensuring security. By moving away from proprietary software models and giving free access to a system's source code, governments are no longer dependent on a select few contractors for their defense. Instead, an entire programming community can be deployed to defend against attacks. One of the government's key open source projects is actually with the National Security Agency. The agency already employs open source technologies to address multi-level security on government machines through SELinux.” [2]


A review of the Open Source for America website reveals that OSA's mission is to: 1) "effectuate changes in U.S. Federal government policies and practices so that all the government may more fully benefit from and utilize free and open source software” – in other words, it is to cause the U.S. Federal government to migrate from proprietary software to open source software; and 2) “participate in standards development and other activities that may support its open source mission." [3] OSA cites successful OSS projects with the U.S. National Security Agency [4], the U.S. Navy [5] and the U.S. Veterans Administration, the latter of which specifically entailed the creation of a national Veterans healthcare patient e-records system – the open source-based VistA electronic health record system. [6]


["January 31, 2008 - WorldVistA announces the release and availability of WorldVistA EHR VOE/ 1.0, the only open source EHR that meets Certification Commission for Healthcare Information Technology (CCHITSM) ambulatory electronic health record (EHR) criteria for 2006. WorldVistA EHR VOE/ 1.0 is based on and compatible with the U.S. Department of Veterans Affairs (VA) world renowned EHR, VistA®. After completion of the VOE project, WorldVistA made additional enhancements and successfully submitted WorldVistA EHR for certification by CCHIT. As a CCHIT CertifiedSM product, WorldVistA EHR VOE/ 1.0 has been tested and passed inspection of 100 percent of a set of criteria for functionality (ability to create and manage electronic records for all patients, as well as automating workflow in a physician's office), interoperability (a first step in the ability to receive and send electronic data to other entities such as laboratories), and security (ability to keep patients' information safe)." See WorldVistA EHR, WorldVista.org website at: http://worldvista.org/World_VistA_EHR]


Apparently, during 2006, VistA received the U.S. Department of Veterans Affairs Innovation award, and was recognized as “help[ing] VA save 6,000 lives by improving rates of pneumonia vaccination among veterans with emphysema, cutting pneumonia hospitalizations in half and reducing costs by $40 million per year…In addition to saving money, VistA save[d] lives and ensure[d] continuity of care even under the most extreme circumstances. Many of the thousands of residents who fled the Gulf Coast because of Hurricane Katrina left behind vital health records. Records for the 40,000 veterans in the area were almost immediately available to clinicians across the country, even though the VA Medical Center in Gulfport, Mississippi, was destroyed and the New Orleans VA Medical Center was closed and evacuated.” [7]


And, not surprisingly, Advanced Micro and Sun Microsystems, two promoters of royalty-free OSS and open standards in Europe, are founding OSA members [8], while Rishab Aiyer Ghosh, UNU-MERIT researcher and author of several studies recommending European Union government migration to royalty-free open source software and open standards, is a member of OSA’s Board of Advisors. [9].


What is more, it appears rather clear that President Obama, like European leaders, favors the use of open source software (e.g., VistA) over comparable proprietary software, to create a national federal government-directed e-healthcare system within five years. [10]


For example, during January 2009, it was reported that, “the House Ways and Means Committee [had] completed the Health Information Technology for Economic and Clinical Health Act (HITECH) [11], as part of the American Economic Recovery and Reinvestment Plan (ARRA). The HITECH had “codifie[d] the Office of the National Coordinator (ONC) “responsible for creating a nationwide health information technology infrastructure”, and provided that “the National Coordinator shall support the development and implementation of a qualified electronic health records (EHR) platform (imagine an open source software as a service system for the country), unless the Secretary of HHS determines that the needs concerning EHRs are met in the private market.” [12]



For example, during April 2009, despite industry misgivings about VistA’s reliance on commercially unproven open source software, [13] it was reported that,


President Obama announced the government will use open source software to create a national electronic health records system for the military. By pursuing two open source options -- the Department of Veterans Affairs' VistA medical records system and Connect from Sun Microsystems -- proponents hope the Obama administration is sending a signal that open source software could become a vital part of national reform. How big a role open source may play could be determined by a study in its formative stages now. The American Recovery and Reinvestment Act [P.L. 111-5] calls for a study of open source health IT to be completed by October 2010.[14] How that study is formed and who takes charge may have a lot to do with open source's fate.


Although both the VistA and Connect systems predate his administration, Obama's willingness to pursue them with a relatively loud public endorsement gives open source advocates reason for hope…’ Eventually, health IT is going to have to be open source to be interoperable. That seems like the only logical place to start,’ said Mike Doyle, president and CEO of Medsphere Systems Corporation, a provider of open source health IT… VA's VistA system, considered by many to be one of the nation's most advanced EHR systems, can share data between any VA hospital or health care facility around the world, according to VA officials. The larger, newly announced system will add DOD to the equation, allowing military personnel to be electronically entered and followed in the system from the start of their military life to the end.” [15]



Another open source advocate/ journalist, however, expressed a less sanguine view towards the President’s communication. He believes only that


The President promised to ‘link’ the VA’s current VistA system with the military’s AHLTA system, and he promised our heroes interoperability, but that is all. The same is true in the larger health IT stimulus plan, HITECH. CCHIT [the Certification Commission for Health Information Technology][16] still controls functional requirements needed for certification, which in turn is needed to get paid. But as Fred Trotter notes, whether CCHIT will actually certify open source solutions remains unclear [17]So far, under the Obama Administration, open source has been riding momentum generated during the second Bush Administration [17A]…What open source seems to be getting from the Obama Administration is a shot, a chance, a foot in the door. But there is a big distance between being allowed to present and being given a contract…What we need are policy statements favoring a ‘build’ process over a ‘buy’ process, and demanding open standards, preferably royalty-free standards, for government contracts. We don’t have them yet, so the jury is still out on the Obama Administration and open source in health IT.” [18]


In fact, the federal government’s release during early April 2009, for download and public use, of the federally developed, free and open-source software…called Connect, revealed such a 'build process.”[Connect was] created under the auspices of the Federal Health Architecture initiative led by the Office of the National Coordinator at HHS…[According to Robert Kolodner, the outgoing head of the ONC…The result is a software gateway made available to ‘any public or private-sector organization that wants to use the solution in the future to tie into the NHIN’”. [19]


A second provision within the American Recovery and Reinvestment Act of 2009 (ARRA) has “earmarked nearly $20 billion in stimulus funds as an incentive for hospitals to use electronic records by 2011. And it will penalize those who don't use them, cutting a percentage of their Medicare payments starting in 2015…[which amounts to] about $6 million by the fourth year for the same hospital.” [20] Apparently, the costs of installing and implementing VistA and its ‘enhanced’ version OpenVistA continue to be debated, with proponents arguing that such software would be less expensive, more reliable and easier to install than competing proprietary health IT solutions. [21] At least one major healthcare IT industry association, the Healthcare Information and Management Systems Society (HIMSS), [22] has come out in support of these final provisions. [23]



Previously, however, HIMSS vigorously opposed a provision introduced during September 2008 by California Congressman Peter Stark, Chairman of the House Ways and Means Health Subcommittee, which would have explicitly “create[d] a low-cost, open-source EHR system—much like the one used in the Veterans Affairs Department—as an alternative to vendor-developed ones.” [24] The relevant portions of the Stark bill read as follows:


“(A) The National Coordinator shall provide for coordinating the development, routine updating, and provision of an open source health information technology system that is either new or based on an open source health information technology system, such as VistA, that is in existence as of the date of the enactment of this title and that is in compliance with all applicable standards (for each category described in paragraph (2)(A)) that are adopted under this subtitle. The National Coordinator shall make such system publicly available for use, after appropriate pilot testing, as soon as practicable but not later than 9 months after the date of the adoption by the Secretary of the initial set of standards and guidance under section 3003(c)…(B) In order to carry out subparagraph (A), the National Coordinator shall establish, not later than 6 months after the date of the enactment of this section, a consortium comprised of individuals with technical, clinical, and legal expertise open source health information technology…(D) In this paragraph, the term ‘open source’ has the meaning given such term by the Open Source Initiative. [25]


As industry correctly emphasized, “the Stark bill would have ‘dismantle[d]’ previous government work done by the American Health Information Community and undercut open-market principles with the called-for development of a low cost, open-source health IT system.” [26]


Notwithstanding these political sensitivities, Senator Jay Rockefeller (D Va.) subsequently (during April 2009) introduced the Health Information Technology (IT) Public Utility Act of 2009. This piece of legislation called for the creation of a Federal Consolidated Health Information Technology Board within the office of the National Health Coordinator. [27] It also “called for the government to create an open-source electronic health-records solution [28] and to “offer it at little or no cost to safety-net hospitals and small rural providers.” [29]



“The Health Information Technology Public Utility Act of 2009 will build upon the successful use of ‘open source’ electronic health records by the Department of Veterans Affairs as well as the ‘open source exchange model,’ which was recently expanded among federal agencies through the Nationwide Health Information Network-Connect initiative. Open source software refers to a computer program with unrestricted source code that does not limit the use or distribution by any organization or user. Senator Rockefeller continued, ‘Open source software is a cost-effective, proven way to advance health information technology – particularly among small, rural providers. This legislation does not replace commercial software; instead, it complements the private industry in this field – by making health information technology a realistic option for all providers.’”[30]



Indeed, the Rockefeller bill is viewed by members of the open source community as a broad nuanced “resurrection of an open-source support provision in healthcare IT legislation proposed last year by Rep. Pete Stark (D-Calif.) [which]…ran into opposition from the Healthcare Information and Management Systems Society [HIMSS] and wound up being deleted from the IT provisions of the American Recovery and Reinvestment Act of 2009.” [31] However, whether S.890 and the ARRA will succeed in promoting widespread use of electronic health records may ultimately depend on State privacy laws. [32]



The parallels between the health IT interoperability frameworks proposed by the Obama administration and the European Union and some of its Member States are not coincidental. The EU policy objective of ensuring ‘interoperability’ has been similarly applied beyond the ICT sector to more broadly “facilitate the implementation of EU policies and initiatives” [33] relating to other industry sectors, such as healthcare – i.e., “ehealth interoperability”. [34]


For example, it would appear that Europe’s e-Health Action Plan “Advocates the development of common interoperability approaches and standards for patient identifiers, medical data messaging, [and] electronic health records”, [35] based on adoption of Open Source reference implementations for care services…[and]…open and more free access to future and existing e-Health standards…taking inspiration from models such as the World Wide Web Consortium.” [36] And, it would seem that, in addition to the emphasis placed on information-based ICT and ehealthcare product-service standardization, other product-service industry sectors have also been targeted for ‘interoperability’ standardization improvements to ensure universal access to ‘essential services’ and so-called ‘user rights’. [37] These sectors include energy, transport and broadcasting, among others. European “public authorities [have] classif[ied these product-services] as being of general interest and subject to specific public service obligations. This means that it is essentially the responsibility of public authorities, at the relevant level, to decide on the nature and scope of a service of general interest.” [38]


[
See also
March 2003 ITSSD Comments Concerning SCP/13/2 - STANDARDS AND PATENTS, submitted to the World Intellectual Property Organization Standing Committee on the Law of Patents (March 23, 2009) at: http://www.itssd.org/ITSSD%20Comments%20-%20SCP%2013-2%20Standards%20and%20Patents%20-%203-23-09%20-%20II.doc ; March 2003Executive Summary of ITSSD Comments Concerning (SCP/13/2) Standards and Patents, Institute for Trade, Standards and Sustainable Development, submitted to the WIPO SCP (March 23, 2009), at: http://www.itssd.org/Executive%20Summary%20of%20ITSSD%20Comments%20-%20SCP%2013-2%20Standards%20and%20Patents%20-%203-23-09%20-%20II.doc ].


------------------------------


[1]See Open Source for America Welcomes Lucid Imagination as Its Latest Member in Advocating Open Source in the U.S. Federal Government, MarketWire (July 22, 2009) at: http://socialmedia.ulitzer.com/node/1044612 .


[2] See Dana Oshiro, Open Source for America: The New Government Accountability, Read, Write Web (July 22, 2009) at: http://www.readwriteweb.com/archives/open_source_for_america_the_new_government_account.php .


[3] See Our Mission, Open Source America website at: http://www.opensourceforamerica.org/mission.


[4] See NSA – The National Security Agency’s Challenge, Open Source America website at: http://www.opensourceforamerica.org/case-studies/nsa .


[5] See US Navy Story, Open Source America website at: http://www.opensourceforamerica.org/case-studies/navy.


[6] See Veterans Administration, Case Studies, Open Source America Case website at: http://www.opensourceforamerica.org/case-studies .


[7] See VA Receives 2006 Innovations in Government Award, Office of Public and Intergovernmental Affairs, United States Department of Veteran Affairs, Press Release (July 10, 2006) at: http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1152.


[8] See About Us, Open Source America website at: http://www.opensourceforamerica.org/about .


[9] See Board of Advisors, Open Source America website at: http://www.opensourceforamerica.org/board .


[10] See K.C. Jones, Obama Wants E-Health Records In Five Years, Information Week (Jan. 2, 2009) at: http://www.informationweek.com/news/showArticle.jhtml?articleID=212800199 .


[11] See Health Information Technology for Economic and Clinical Health Act or HITECH Act, House Committee, Ways and Means, at: http://waysandmeans.house.gov/media/pdf/110/hit2.pdf . The HITECH Act comprises Title IV - Health Information Technology of the American Recovery and Reinvestment Act of 2009. See The American Recovery and Reinvestment Act of 2009, online at: http://waysandmeans.house.gov/media/pdf/110/sbill.pdf.


[12] See John D. Halamka, The Greatest Healthcare IT Generation, Technology Review (Jan. 19, 2009) (emphasis added) at: http://www.technologyreview.com/blog/guest/22513 .


[13] “The VA's system, dubbed VistA for the Veteran's Health Information Systems and Technology Architecture, includes those benefits and another that private commercial vendors don't have: standardization that allows hospitals to share information seamlessly. So when you break your leg in Vail, Colo., doctors there can easily retrieve your complete medical biography from your doctor in Minneapolis if both are using an open system. Much in the same way Microsoft guards its proprietary software, commercial systems made by vendors including McKesson Corp. and Cerner Corp. are proprietary technology that don't always allow them to easily talk to other vendors' systems. By contrast, open source providers can share information freely and a worldwide network of software developers, WorldVistA, has emerged to offer new features, much like the community that supports the free Linux computer operating system. But commercial vendors, noting a common complaint against open-source software that is developed by engineers here and there, say that they can provide a more reliable soup-to-nuts system and offer many features that users of the VA system have to tack on, notably billing and financial programs that commercial hospitals need to run their business. PricewaterhouseCoopers consultant Dan Garrett says that while the VA software holds promise for some hospitals, it has not been widely commercially proven, unlike vendor systems.” See Laura Landro, An Affordable Fix for Modernizing Medical Records (April 30, 2009) at: http://online.wsj.com/article/SB124104350516570503.html .


[14] See Section 4104(b)(1) - STUDY AND REPORT ON AVAILABILITY OF OPEN SOURCE HEALTH INFORMATION TECHNOLOGY SYSTEMS, of TITLE IV—MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY; MISCELLANEOUS MEDICARE PROVISIONS of the American Recovery and Reinvestment Act of 2009, P.L. 111-5 (Feb. 17, 2009) accessible at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf . The study will focus on the following issues: “the current availability of open source health information technology systems to Federal safety net providers (including small, rural providers); (ii) the total cost of ownership of such systems in comparison to the cost of proprietary commercial products available; (iii) the ability of such systems to respond to the needs of, and be applied to, various populations (including children and disabled individuals); and (iv) the capacity of such systems to facilitate interoperability (emphasis added). “Not later than October 1, 2010, the Secretary of Health and Human Services shall submit to Congress a report on the findings and the conclusions of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Secretary determines appropriate.” Id., at Section 4104(b)(2).


[15] See George Lauer, Military E-Health Record Plan Gives Open Source a Boost, iHealthBeat (April 16, 2009) (emphasis added) at: http://www.ihealthbeat.org/Features/2009/Military-EHR-Plan-Gives-Open-Source-a-Boost.aspx .


[16] CCHIT “is a nonprofit, 501(c)3 organization with the public mission of accelerating the adoption of health IT…CCHIT [has been] certifying electronic health records (EHRs) since 2006, [and]…established the first comprehensive, practical definition of what capabilities were needed in these systems. The certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the Federal government as a certifying body… In February 2009, Congress acknowledged the value of certification in the language of the American Recovery and Reinvestment Act (ARRA) aimed at stimulating the nation’s economy. The law offers a multi-year series of incentive payments to providers and hospitals for the meaningful use of certified EHR technology.” See About the Certification Commission for Health Information Technology, Certification Commission for Health Information Technology website at: http://www.cchit.org/about .


[17] “As open source gains popularity, it'll have to contend with certification issues. By its nature, the community-based technology is constantly evolving, which makes it difficult to certify by today's standards. The Certification Commission for Healthcare Information Technology (CCHIT) is currently the main certifying body for EHRs, but its criteria do not accommodate the open source approach, critics say.” See Cheryl McEvoy, Open Source EHRs Set to Grow Advance Web (June 17, 2009) at: http://health-information.advanceweb.com/editorial/content/editorial.aspx?cc=200988 .


[17A] See, e.g., March 2003Comments of the Initiative for Software Choice Regarding MITRE’S Use of Free and Open Source Software (FOSS) in the U.S. Department of Defense/ Open Source FAQ Comments (Nov. 26, 2002) at: http://www.softwarechoice.org/download_files/MITRE.Final.Web.pdf (“[T]he ISC does not believe that the DoD should openly promote the use of OSS because in each instance, the DoD should choose the software that best meets its needs and acquisition requirements for the particular environment in which the software will be used… Each software development model – i.e., OSS, hybrid and proprietary – provides its own mix of benefits to the industry, government and taxpayers. No one benefits when otherwise viable software options are completely removed from competition and evaluation by procurement officials… Perhaps more troubling, however, is the framing of the hypothetical itself, which suggests a certain mutual exclusivity not mirrored in the software industry. The hypothetical perpetuates the ‘either-or’ supposition being advanced by the marketers of OSS products and services that OSS and proprietary products cannot – or rather, should not – operate together, in heterogeneous environments. Though the viral nature of some OSS licenses, such as the GNU General Public License (GPL), remains a point of concern for many in the industry (even the Study cautions against accidentally invoking the GPL), it is clear that all models can ‘get along.’ The ISC believes that painting the hypothetical in such stark terms serves only to divide communities that, on their own, already co-exist. Together, the entire industry has benefited and evolved through vigorous, hyperactive competition.”). See also MITRE, Use of Free and Open Source Software (FOSS) in the U.S. Department of Defense, Version 1.2.04 (Jan. 2, 2003) at: http://www.terrybollinger.com/dodfoss/dodfoss_pdf.pdf .


[18] See Dana Blankenhorn, What Obama promised open source health IT, ZDnetHealthcare (April 21, 2009) (emphasis added) at: http://healthcare.zdnet.com/?p=2164 .


[19] See Joseph Conn, Feds Release Open-source NHIN Gateway Software, ModernHealthcare.com (April 7, 2009) (emphasis added) at: http://www.modernhealthcare.com/article/20090407/REG/304079996 .


[20] See Laura Landro, An Affordable Fix for Modernizing Medical Records supra. See also Section 4102 - INCENTIVES FOR HOSPITALS, of of TITLE IV—MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY; MISCELLANEOUS MEDICARE PROVISIONS of the American Recovery and Reinvestment Act of 2009, P.L. 111-5, supra.


[21] “Mike Kappel, senior vice president of government and industry relations at McKesson, says once hospitals pay companies to deploy the VA software and the necessary service, training and upgrades it requires, the cost won't be much different than that of a commercial electronic medical- record system. Big vendors can work with hospitals to provide more reliable systems within their budget, he adds. Many start-up companies adapting VistA for commercial use, including Blue Cliff Inc., MELE Associates Inc., Sequence Managers Software and Medsphere Inc., say their systems will still be less expensive for hospitals to deploy. Medsphere, which put together the system for Midland Hospital, says OpenVistA enables hospitals to run system checks for security problems and bugs. And Chief Executive Mike Doyle says the open-source software community can quickly share information and patches to fix or correct them. Medsphere Chairman Kenneth Kizer, the former undersecretary for health at the VA who oversaw the development of VistA before joining the company, says its enhanced version of the software, called OpenVistA, ‘can be installed in one-third the time and for about one-third the cost of the big-name proprietary systems.’” See Laura Landro, An Affordable Fix for Modernizing Medical Records supra.


[22] “The Healthcare Information and Management Systems Society (HIMSS) is the healthcare industry’s membership organization exclusively focused on providing global leadership for the optimal use of healthcare information technology (IT) and management systems for the betterment of healthcare.” See About HIMSS, at: http://www.himss.org/ASP/aboutHimssHome.asp .


[23] “HIMSS supports the provision to require the Secretary, along with federal counterparts, to conduct a study on the availability, costs, and benefits for providers concerning open source health IT. HIMSS agrees the Secretary ought to make recommendations for such legislation and administrative action, as appropriate. Open source technology provides valuable options for the healthcare industry and health information exchange. HIMSS recommends the Secretary to assess the costs of implementing open source and explore how best to utilize its benefits.” See The American Recovery and Reinvestment Act of 2009 - HIMSS Legislative Overview, Policy Implications, and Healthcare Ramifications (March 10, 2009) at p.115 at: http://www.med.miami.edu/hipaa/public/documents/HIMSS_ARRA.pdf; HIMSS Open Source Fact Sheet at: http://www.himss.org/content/files/HIMSSOpenSource.pdf ; Evaluating Open Source Software for Health Information Exchange, HIMSS Healthcare Information Exchange Open Source Task Force White Paper (June 2008) at: http://www.himss.org/content/files/HIE_FY08_Open_Source.pdf .


[24] See Matthew DoBias, Stark Offers Bill to Expedite E-record Adoption, ModernHealthcare.com (Sept. 16, 2008) (emphasis added) at: http://www.modernhealthcare.com/article/20080916/REG/309169997.


[25] See H.R.6898, Section 3001(a)(4)(A),(B) and (D) - FEDERAL OPEN SOURCE HEALTH IT SYSTEM, of the Health-e Information Technology Act of 2008, (emphasis added) at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h6898ih.txt.pdf .


[26] See Matthew DoBias, HIMSS Letter Opposes Pieces of Stark's IT Legislation, ModernHealthcare.com (Sept. 26, 2008) at: http://www.modernhealthcare.com/article/20080926/REG/309269993. See also George Lauer, Industry Gives Stark's Health IT Bill Mixed Reviews, iHealthBeat (Oct. 1, 2008) at: http://www.ihealthbeat.org/Feature/2008/Industry-Gives-Starks-Health-IT-Bill-Mixed-Reviews.aspx .



[27] See Section 3 (a) of the Health Information Technology (IT) Public Utility Act of 2009 (S.890) at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s890is.txt.pdf .


[28] Id., at Section 3(c).


[29] See Rockefeller Introduced Legislation Calling for Universal Adoption of Electronic Health Record, Press Release, United States Senator Jay Rockefeller for West Virginia, at: http://rockefeller.senate.gov/press/record.cfm?id=311951 .


[30] Id (emphasis added). “The legislation—the first Rockefeller has introduced on open-source technology—springs from the successful experiences of West Virginia providers with open-source healthcare IT systems…Seven state hospitals in West Virginia are running on a version of VistA developed by Medsphere Systems Corp. and about 30 to 40 federally qualified healthcare clinics in the Mountain State run on RPMS...In West Virginia, the RPMS software is distributed to the clinics via an application service provider, or ASP, model of delivery supported by the not-for-profit Community Health Network of West Virginia, based in Scott Depot.” See Joseph Conn, Bill Would Boost Open-source EHRs for Rural Use, ModernHealthcare.com (April 28, 2009) at: http://www.modernhealthcare.com/article/20090428/REG/304289994 .


[31] People in the open-source community who were excited by Stark’s bill see the stimulus language as ‘a vague reference to open source,’ [Peter] Groen [director of the Shepherd University Research Corp., Shepherdstown, W.Va.] said. Having seen the legislature maw, chew up and spit out the earlier version of an open-source funding bill, Groen said he’s hopeful about the Rockefeller bill, but wary about getting his hopes up too high. ‘It’s similar in nature, which is why it always leads me to be cautious,’ Groen said. ‘The open-source community still could use as much of a boost as they could get in terms of funding, political support, visibility, you name it. This is just one more piece of the puzzle. Who knows if this will ever pass, but it might influence other legislation’” (emphasis added). Id. “The most recent gust of federal support hails from West Virginia; Sen. John D. Rockefeller IV proposed legislation in April that promotes open source technology as a way to help providers -- especially small and rural organizations -- launch EHRs that meet government requirements. The Health Information Technology Public Utility Act calls for a new grant program to fund open source implementations and continued conversations among open source suppliers. The legislation now awaits debate…‘I think it's a broader move and a very wise line of thinking at the federal level to support open-source projects,’ said Rick Jung, chief operating officer, Medsphere Systems Corp., noting that the Nationwide Health Information Network, a government pilot for health information exchange, was recently open sourced. It's proof the industry is at a ‘tipping point,’ according to Jung” (emphasis added). See Cheryl McEvoy, Open Source EHRs Set to Grow supra.


[32] See Sindya Bhanoo, EHR Adoption Inhibited by State Level Privacy Laws, The Industry Standard (May 13, 2009) at: http://www.thestandard.com/news/2009/05/13/ehr-adoption-inhibited-state-level-privacy-laws .


[33]
See Francisco García Morán, European Interoperability Strategy, European Commission Directorate General, Informatics (June 13, 2008) at p. 2, at: http://ec.europa.eu/idabc/servlets/Doc?id=31154 ; Francisco García Morán, Proposal for a Community Programme on Interoperability Solutions for European Public Administrations (ISA), European Commission Directorate General, Informatics (June 20, 2008), at p.2, at: http://ec.europa.eu/idabc/servlets/Doc?id=31160 .



[34] See Flora Giorgio-Gerlach, European Commission Strategy for European eHealth Interoperability, DG Information Society and Media, ICT for Health, European Commission (Oct. 2008, Calliope, Crete, Greece) at: http://www.calliope-network.eu/Portals/11/assets/documents/Crete_Presentations/CAL%202008-10-09%20s11%20Giorgio%20%20EC%20Strategy%20Interoperability.pdf .


[35] Id., at p. 8 (emphasis added).


[36] See COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS COM (2004) 356 final (4/30/04), “e-Health - Making Healthcare Better for European Citizens: An Action Plan for a European e-Health Area”, at pp. 16-17, at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0356:FIN:EN:PDF . “The exchange of experience in the use of open standards and open source solutions among health administrations in Member States should be promoted.” Id., at p. 17.


[37] See COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS COM(2007) 725 final (11/20/07), “Accompanying the Communication on ‘A Single Market for 21st Century Europe’ - Services of General Interest, Including Social Services of General Interest: A New European Commitment”, at pp. 7-10, at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0725:FIN:EN:PDF.


[38] Id., at pp. 3-4.


------------------------------------------------------------------------------------------------

http://www.sun.com/aboutsun/pr/2009-04/sunflash.20090406.1.xml


Nationwide Health Information Network Relies on Sun's Open Source Software - NHIN-CONNECT Gateway Solution Links Federal, Local and Private Sectors



SUN System News



April 8, 2009



The Nationwide Health Information Network (NHIN) is an open technology platform using Sun's open source software to connect federal government agencies and health information exchanges via NHIN-CONNECT - a software enabling interoperability across the healthcare sector.

NHIN-CONNECT uses Sun's GlassFish, the Java Composite Application Platform Suite (CAPS) SOA Platform, and the Sun Java Identity Management suite. The United States Department of Health and Human Services (HHS), whose goal is to support the secure exchange of interoperable health information within the federal government and with the tribal, state, local and private sectors, has a commitment to using open source technologies and to enabling increased efficiency, better patient care and improved population health.



Sun reports that the initial demonstration of NHIN-CONNECT involved four major government agencies and 16 private sector organizations, and within six months they were able to share information with the private sector through the NHIN.

"Our progress with the NHIN shows that President Obama's commitment to healthcare reform can become a reality quickly. Here we have the public and private sectors working together as a community to help realize this key vision," said Joe Hartley, vice president of Global Government, Education and Healthcare for Sun Microsystems, as part of the Healthcare Information and Management Systems Society (HIMSS) Conference held April 4-8 in Chicago. "Sun has already seen first-hand the impact of open source technology on healthcare information sharing, and has enjoyed working closely with other vendor partners and federal agencies to make Obama's goals a reality today."



By the end of this year, Sun expects six federal agencies will be participating in NHIN-CONNECT. The goal is for CONNECT to be a platform on which the government and industry can innovate, empowering federal agencies to address the citizen-centric initiatives that are part of the 2009 development plans while also allowing the industry to build better interoperable solutions for the healthcare sector.



Sun anticipates the CONNECT software will be available for download by stakeholders throughout the health information exchange community once it is finalized.



"NHIN is a poster child for all of the benefits that open source software and open standards provide," said Bill Vass, president and COO of Sun Microsystems Federal, Inc. "The federal government has built a working prototype capable of being deployed across multiple agencies in a matter of months with minimal costs. The open nature of the IT foundation is critical to ensuring that government can work with the private healthcare sector to revolutionize the nation's healthcare system."


------------------------------------------------------------------------------------------------

http://www.outlookseries.com/N/Infrastructure/3138_HHS_Taps_Sun_Nationwide_Health_Information_Network_NHIN.htm

HHS Taps Sun For Nationwide Health Information Network NHIN


April 7, 2009



Open source software from Sun Microsystems is enabling the United States Department of Health and Human Services (HHS) to build a secure, open technology platform to connect federal government agencies and health information exchanges in a "network of networks"--the Nationwide Health Information Network (NHIN)--built over the Internet.



The goal of NHIN is to support the secure exchange of interoperable health information within the federal government and with the tribal, state, local and private sectors to enable increased efficiency, better patient care and improved population health.


"NHIN is a poster child for all of the benefits that open source software and open standards provide," said Bill Vass, president and COO of Sun Microsystems Federal, Inc. "The federal government has built a working prototype capable of being deployed across multiple agencies in a matter of months with minimal costs. The open nature of the IT foundation is critical to ensuring that government can work with the private healthcare sector to revolutionize the nation's healthcare system."


As a key member of the NHIN consortium, the federal government needed to build a comprehensive gateway to connect its 26 NHIN member agencies to the NHIN infrastructure, hence the name CONNECT. The HHS has a commitment to using open source technologies to ensure the CONNECT gateway can cost-effectively support the wide variety of operating systems used by the different agencies.


"Our progress with the NHIN shows that President Obama's commitment to healthcare reform can become a reality quickly. Here we have the public and private sectors working together as a community to help realize this key vision," said Joe Hartley, Vice President of Global Government, Education and Healthcare for Sun Microsystems." Sun has already seen first-hand the impact of open source technology on healthcare information sharing, and has enjoyed working closely with other vendor partners and federal agencies to make Obama's goals a reality today."