Wednesday, April 30, 2008

US Patent Reform Proposals Leading to Change from 'First-to-Invent' to 'First-to-File' Will Likely Undermine Private US Patent Rights in China

http://www.ipfrontline.com/depts/article.asp?id=18723&deptid=3


Patents in China - Is There Any Real Protection?


By Thomas Babel, Esq.


April 30, 2008


With increased pressure from the West and the World Trade Organization, China has instituted a number of reforms to its patent system. Much like the United States Patent and Trademark Office (“PTO”), China has a centralized intellectual property office, known as the State Intellectual Property Office ("SIPO"), which processes patent applications, grants patents, and enforces patents in China. At first blush, the patent system and SIPO seem to be modern and in tune with the concepts and protections found in Western patent systems. Unfortunately, the actual functioning of the patent system in China is far different from its official representation of performance.


Comparison to the United States Patent Process


The United States grants three different patent types: utility patents (which cover any new and useful process, machine, article of manufacture, or composition of matter), design patents (which cover any new, original, and ornamental design for an article of manufacture), and plant patents (which cover distinct and new plant varieties). In contrast, China does not recognize plant patents and divides the utility patent concept into two categories: invention patents and utility model patents. China also issues design patents.


An invention patent in China is closest to the utility patent in the United States and protects "any new technical solution relating to a product, a process or improvement" for a period of 20 years from the date of filing the patent application. The application for an invention patent in China requires the submission of information by the applicant much like what is required in the United States for a utility patent, and, like the United States PTO, SIPO conducts a thorough investigation as to the novelty, inventiveness, and usefulness of the innovation before issuing the patent.


A utility model patent in China lies somewhere between a United States utility patent and a design patent in that it protects "any new technical solution relating to the shape, the structure, or their combination, of a product which is fit for practical use." From a practical standpoint, the information provided to SIPO related to the innovation, and the investigation conducted by SIPO, is very limited as compared to an invention patent. More likely than not, if the proper paperwork has been completed as part of the utility model patent application, SIPO will issue a utility model patent to the applicant.


A utility model patent can be granted as quickly as one year after the filing date. As a result, the majority of patent applications in China are for utility model patents. A utility model patent provides protection for ten years.


A design patent in China is much like a design patent in the United States in that it protects "any new design of the shape, pattern, color, or their combination, of a product, which creates an aesthetic feeling and is fit for industrial application." Just as in the United States, the realistic protection afforded by a Chinese design patent is limited. As in the utility model patent process, SIPO undertakes a limited investigation before granting a design patent and, if the proper paperwork has been completed as part of the application, will likely issue the design patent. A design patent in China provides protection for ten years.


China, unlike the United States, is a first-to-file system. This means that if two inventors file a patent application for the same innovation, the first to file the application with SIPO will be granted the patent even if the other inventor was the first to invent. In addition, unlike the United States where an inventor has one year from the date of the first public disclosure of the innovation to file for patent protection, public disclosure prior to filing in China is an absolute bar to the grant of a patent on the disclosed innovation, except in very limited circumstances.


A patent application may be granted in China to an individual, company, state owned entity, or foreign applicant, although a patent application made by a foreign applicant must be filed by an authorized Chinese patent agent.


Problems with the System


The combination of a first-to-file system with a system where a patent may be granted with little or no investigation results in the obvious: patents granted to non-inventors. It is a relatively easy matter, at least as to utility model and design patents, for an interloper to file for and be granted a patent on an innovation created by another person or which has been afforded protection in another jurisdiction, such as the United States. For instance, if a foreign entity has a United States patent but fails to file or register that patent in China, a Chinese company can easily take the innovation and get a utility model patent in China in its own name. The Chinese company then can use its utility model patent to prevent others, including the foreign entity, from producing products in China that incorporate that innovation.


The Chinese Court System


Despite the improvements to the intellectual property system in China, little improvement has been made to the Chinese court system, which remains very archaic. For example, in most cases, only original documents are recognized as evidence. Accordingly, e-mails, copies, and other reproductions generally are not accepted as evidence in the Chinese court system. China also requires that all documents used as evidence in court be notarized through a formal notarization process. Further, only Chinese-born lawyers are permitted to appear in Chinese courts.


Beyond these procedural-type issues, there is also a problem which results from the patent registration system, at least as to utility model and design patents. The issuance of a patent in China, just as in the United States, creates a presumption that the patent is valid. If SIPO had conducted a full investigation prior to issuing a utility model or design patent, as is done by the United States PTO, the use of such presumption would be justified. Since, realistically, a full investigation has not been made by SIPO, the presumption flowing from the Chinese process presents an unfair advantage to those who improperly obtain patents. Since the burden of proof is on the person challenging a patent to show that the innovation in question is that person's property, the various evidentiary and procedural hurdles found in the Chinese court system can make it very difficult, and perhaps impossible, to overcome the presumption and prove that an innovation was stolen by a Chinese company.


How to Protect Your Innovation in China


In addition to filing for patent protection in China, a United States inventor has alternatives for protection of the inventor's innovations when manufacturing products in China. One alternative is to contractually prohibit any Chinese company with which the United States inventor is dealing from filing a patent application related to any innovation found in the product it is producing for its United States customer, and/or to obligate such Chinese company to recognize that any innovation found, discovered, and/or created during the parties’ relationship is the property of the United States customer. This language can help if the Chinese company tries to seek protection of an innovation owned by a United States company. Chinese courts do have a relatively good record of enforcing contracts.


Another alternative is to require arbitration of patent disputes. The Chinese court system recognizes and will enforce arbitration decisions. Arbitration allows parties to adjudicate their disputes without having to adhere to the archaic and problematic evidentiary rules of the Chinese court system. There are a number of organizations located in Beijing and Hong Kong which can render arbitration awards that will be enforced by Chinese courts. Two of the more recognized organizations are the China International Economic and Trade Arbitration Commission in Beijing and the Hong Kong International Arbitration Centre. Many of the arbitrators employed by these organizations are Western trained, which helps to further avoid many of the archaic evidentiary and procedural rules found in the Chinese court system. Therefore, it is advisable to insert an arbitration provision in any contract with a Chinese company.


No protection is foolproof. However, understanding the limitations and risks involved when producing products or components in China can help a company understand the costs of doing business in China and limit its exposure to the loss of patent rights.
Copyright © 2008, Ward and Smith, P.A.

Monday, April 21, 2008

Brazil's IP Opportunism Shines Thru Again in Shadow of Senate Deadlock Over US Patent Reform: Cites Public Interest in Declaring US Drug NonPatentable

http://www.lloyds.com/CmsPhoenix/DowJonesArticle.aspx?id=387526


Brazil Government Declares Gilead AIDS Drug Public Interest -Report


By Bernd Radowitz


Dow Jones Newswires


April 10, 2008


[READERS SHOULD TAKE NOTE THAT BRAZIL'S LATEST ACT WAS NOT RANDOM. IT OCCURRED IN THE SHADOW OF THE U.S. SENATE'S DEBATE OVER U.S. PATENT REFORM WHICH ENDED IN DEADLOCK OVER DAMAGE AWARDS. U.S. DEMOCRATIC SENATOR LEAHY ADVOCATED IN FAVOR OF LIMITED PATENT INFRINGEMENT DAMAGE AWARDS WHICH, IN EFFECT, WOULD WEAKEN U.S. PATENT RIGHTS, BOTH HERE IN THE U.S. AND ABROAD. THE BRAZILIAN GOVERNMENT HAS INFORMED THIS BLOGMASTER THAT IT HAS BEEN CLOSELY MONITORING THE U.S. SENATE PATENT REFORM DEBATE. THIS LEADS ONE TO CONCLUDE THAT THE BRAZILIAN GOVERNMENT HAS ACTED ONCE AGAIN OUT OF IP OPPORTUNISM IN SUPPORT OF THE U.S. DEMOCRATIC PARTY'S GOAL OF GIVING AWAY U.S. PATENT RIGHTS TO FOREIGN GOVERNMENTS THROUGH COMPULSORY LICENSING. ONE NEED ONLY LOOK AT THE OTHER BLOG ENTRIES IN THIS JOURNAL TO SEE HOW U.S. DEMOCRATIC CONGRESSMAN WAXMAN HAS WORKED ALONGSIDE U.S. DEMOCRATIC SENATOR LEAHY TO MORE BROADLY DEFINE COMPULSORY LICENSING AS A WIDELY ACCEPTED & LEGALLY SANCTION PRACTICE BY BOTH U.S. AND INTERNATIONAL LAW. THE OBVIOUS PROBLEM WITH THIS BEHAVIOR, HOWEVER, IS THAT IT EMBOLDENS FOREIGN GOVERNMENTS TO SYSTEMATICALLY VIOLATE U.S. CITIZENS' CONSTITUTIONALLY PROTECTED EXCLUSIVE PRIVATE PROPERTY RIGHTS, WITHOUT EVEN GIVING THE U.S. PUBLIC A 'SAY' IN THE MATTER. IN OTHER WORDS, IT VIOLATES THE CONSTITUTIONAL DUE PROCESS RIGHTS OF U.S. CITIZENS.]




RIO DE JANEIRO -(Dow Jones)- Brazil's health ministry has declared Gilead Sciences Inc.'s (GILD) anti-AIDS drug Tenofovir as of "public interest", the Estado de S.Paulo newspaper said Thursday.

After the move, it is likely that the drug won't be granted a patent in Brazil, the newspaper said.


U.S. authorities about a month ago denied a patent for Tenofovir, arguing the drug doesn't represent any innovation, Estado de S.Paulo said.


Tenofovir is being used by 30,000 patients in Brazil's government free anti-AIDS drug program and costs the government $1,387 per patient a year. The drug represents 10% of government spending for AIDS medications.



If health authorities deny Gilead a patent for Tenofovir, Brazil's government may import the drug from Indian generic producers, who can make it for $170 per patient a year.


Brazil's government a year ago issued a compulsory license to break the patent on the anti-retroviral AIDS drug Efavirenz made by U.S. pharmaceutical giant Merck & Co. (MRK).


AIDS non-governmental organizations welcomed the measure last year, while both Merck and business representatives sharply criticized it.


It was the first time Brazil broke a patent for an AIDS drug, after having threatened to do so for many years in order to obtain price cuts from pharmaceutical companies.

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http://www.reuters.com/article/companyNews/idUSN1034936120080410






UPDATE 1-Brazil may reject Gilead's AIDS drug patent






Thu Apr 10, 2008 12:55pm EDT


(Adds data on Tenofovir use in Brazil, background)


By Maria Pia Palermo


RIO DE JANEIRO, April 10 (Reuters) - Brazil has decreed U.S. pharmaceutical firm Gilead's AIDS drug Tenofovir "in the public interest", signaling it may reject a patent request due to its high price and import a generic version.


The Health Ministry said in a decree published on Wednesday that patenting the drug in Brazil would generate "expectations of monopoly rights with an impact on the price of the product."






Latin America's largest country has an internationally-lauded AIDS prevention and treatment program, in which patients get free antiretroviral treatment.


The ministry said it had requested a priority examination of the patent filing by the company with the Brazilian INPI patent body, which will have to take into account the ministry's objections.






"If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name," a health ministry source told Reuters on Thursday, adding that the case was "not about compulsory licensing" or breaking patents.



[OUTRIGHT PATENT EXTORTION, WHICH IS AN ABUSE OF THE WTO TRIPS AGREEMENT].



A representative of Gilead Sciences Inc in Brazil declined to comment on the issue but said high-ranking Gilead officials were in contact with the ministry to discuss the case.





The Health Ministry said Tenofovir accounts for 10 percent of the money the government spends on its AIDS treatment program, which encompasses a cocktail of various drugs, including Tenofovir in some cases.



[BRAZIL HAS BECOME A WEALTHY EMERGING ECONOMY AND HAS NO NEED TO DECLARE DRUGS NONPATENTABLE OR TO ISSUE COMPULSORY LICENSES TO REDUCE ITS HEALTHCARE COSTS. IT NEED ONLY SPEND THE FOREIGN DIRECT INVESTMENT IT HAS ACQUIRED WISELY, TO REMOVE MILLIONS OF QUALIFIED AND ABLE-BODIED WORKERS FROM HIS PENSION WELFARE SYSTEM, AND TO CLEAN UP ITS MASSIVE PUBLIC CORRUPTION PROBLEMS.]


It said that this year, 31,300 Brazilians would be treated with Tenofovir at a cost of $1,387 per patient. The annual cost per patient, for some 180,000 people treated under Brazil's AIDS program, is about $2,500 worth of medicines a year.


[THE BRAZILIAN GOVERNMENT'S EFFORTS TO EVOKE INTERNATIONAL EMOTION FOR THOSE OF ITS CITIZENS WHO CONTINUE TO INFLICT THEMSELVES WITH HIV/AIDS IS MISPLACED. PERHAPS THE WORLD'S CITIZENS SHOULD BE OUTRAGED ABOUT HOW THE BRAZILIAN GOVERNMENT DOES LITTLE TO NOTHING TO GENERATE INVESTMENTS IN DOMESTIC DRUG INNOVATIONS THROUGH PROTECTION OF PRIVATE PROPERTY RIGHTS, INCLUDING PATENTS AND TRADE SECRETS. THE FAILURE TO CONSISTENTLY RECOGNIZE AND ENFORCE PRIVATE PROPERTY RIGHTS IS THE TRUE CAUSE OF BRAZIL'S HEALTHCARE DILEMMA.]


The Health Ministry source said the case was different from last year's bypassing of a patent on Merck & Co Inc AIDS drug Efavirenz.


[IT MAY APPEAR DIFFERENT, BUT THE RESULT IS THE SAME - DISREGARD OF THE TRIPS AGREEMENT. ACTUALLY, BRAZIL TRIED THIS SAME TRICK BACK DURING 2005. See Slavi Pachovski and Lawrence Kogan, "The Wolf and the Stork", at: http://www.itssd.org/White%20Papers/TheWolf_and_theStork-Brazil_snon-patentabilitylaw.pdf .]


Last May, President Luiz Inacio Lula da Silva authorized Brazil to sidestep the patent on Efavirenz and import a generic version from India. It was the first time Brazil bypassed a patent to acquire cheaper drugs for its AIDS program.



That process also started with the government declaring the drug "in the public interest" and saying it was too expensive.



If the Tenofovir patent is rejected, Brazil may choose to import generic drug using a clause in World Trade Organization rules to flout drug patents in the name of public health.
Other countries, including Canada, Italy and Thailand, have also used the WTO clause to gain access to cheaper AIDS drugs.


The World Health Organization considers Brazil's AIDS strategy -- which also includes large-scale distribution of free condoms as well as free and fast testing for the HIV virus -- a model for developing nations.


Brazil's AIDS infection rate, after climbing until the early 1990s, has steadied and even reversed course. The prevalence of the HIV virus dropped to 0.5 percent in 2006 from 0.6 percent in 2005, its first fall in seven years. The numbers of new AIDS cases and AIDS deaths have also been declining. Brazil has an estimated 600,000 people infected with HIV/AIDS. (Additional reporting by Pedro Fonseca and Andrei Khalip) (Writing by Andrei Khalip; Editing by Tim Dobbyn)

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http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51500


Kaiser Daily HIV/AIDS Report


Monday, April 14, 2008


Drug Access - Brazil Decrees Gilead's Tenofovir in 'Public Interest'


Brazil's Ministry of Health on Wednesday issued a decree signaling that it might reject Gilead's patent request for its antiretroviral drug tenofovir due to its high cost and import a generic version of the drug, Reuters reports. The decree declared the drug "in the public interest," adding that patenting the drug in the country would generate "expectations of monopoly rights with an impact on the price of the product."


The health ministry said that it had asked for a priority review of the patent filing with the Brazilian patent agency INPI, which must consider the ministry's objections. If Brazil rejects the tenofovir patent, the country could decide to use a World Trade Organization agreement allowing generic importation of patented drugs during public health emergencies, according to Reuters. A health ministry source said Thursday that the case was "not about compulsory licensing" or breaking patents, adding, "If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name." A representative of Gilead in Brazil would not comment on the situation but said top Gilead officials were in talks with Brazilian leaders.


[A GOVERNMENT'S DECLARATION THAT A DRUG IS NONPATENTABLE BECAUSE IT IS OF 'PUBLIC INTEREST' IS PER SE ILLEGAL UNDER THE WTO TRIPS AGREEMENT.]


According to the health ministry, tenofovir accounts for 10% of the government's spending on its HIV/AIDS treatment program. The government provides antiretrovirals at no cost to people living with HIV/AIDS in Brazil. This year, 31,300 people in Brazil are expected to be treated with tenofovir at a cost of $1,387 per person. The annual cost per person for the 180,000 people included in Brazil's HIV/AIDS program is about $2,500 worth of medicines each year, Reuters reports (Palermo, Reuters 4/10).

Sunday, April 20, 2008

Waxman the Taxman Calls on USTR to Give Away US Constitutionally Protected Private Patents and Trade Secrets to Foreign Governments for Little Value

http://www.fiercepharma.com/story/dems-back-compulsory-licensing/2008-04-10


Dems back compulsory licensing


Fierce Pharma


April 10, 2008


Now Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. They're questioning U.S. Trade Rep Susan Schwab for her downgrading of Thailand after it issued patent-breaking licenses for three drugs. Though Schwab gave various reasons for putting Thailand on the trade watch list, the reps' letter says the move appears to be a condemnation of compulsory licensing itself. So they're asking Schwab to "reaffirm" the World Trade Organization agreement that allows for those compulsory licenses in public health emergencies at each Member country's discretion.


Can you hear the howling already? As you know, compulsory licensing is controversial in the drug industry; after all, it lets countries bypass the patents on brand-name meds so they can buy cheap copycats. Drugmakers are understandably reluctant. But proponents say that otherwise, patients in poor countries might never get access to the lifesaving meds they need. It's a complex issue, and a contentious one, so you can expect the debate to intensify--especially if Congress decides to get more involved.



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http://oversight.house.gov/documents/20080409144118.pdf


Democrats Urge Trade Ambassador to Focus on Access to Medicines


Committee on Oversight and Government Reform, U.S. House of Representatives


Wednesday, April 09, 2008


In a letter to U.S. Trade Representative Schwab, Chairman Waxman and twenty-six other Members of Congress asked that in reviewing the global state of intellectual property rights the Ambassador act upon the United States’ commitment to respecting measures that improve access to live-saving medicines in developing countries.


"As you conduct the annual "Special 301" review of the global state of intellectual
property rights (IPR) protection and enforcement, we ask you to pay close attention to issues
related to public health and access to medicines. Specifically, in determining whether a public health measure raises concerns regarding the 'adequate and effective' protection of intellectual property rights, you should consider not only the extent to which greater property rights and protections could enhance innovation, but also the United States' commitment to respecting measures that improve access to life-saving medicines in developing countries.


A particular concern we have relates to the issuance of compulsory licenses for medicines. In the 2007 Special 301 Report, you downgraded Thailand to the "Priority Watch List," shortly after it issued compulsory licenses on three pharmaceutical products. The Report appeared to express concern with a perceived "lack of transparency and due process" that occurred when Thailand issued the licenses. Unfortunately, ambiguity in that language has led some to interpret the Report as condemning the issuance of compulsory licenses as inherently indicative of a weakened respect for patents.


[Indeed, Mr. Waxman was quoted in Bangkok Post as stating the following: "Rep. Henry Waxman (D-Calif.) also was supportive of Thailand's actions, according to the Post. 'Thailand is an important U.S. ally that is trying to save the lives of its citizens,' Waxman said in a statement. He added, 'Accordingly, the U.S. should show compassion and provide support to our longtime friend rather than impose punitive actions' -- such as the Office of the U.S. Trade Representative's recent announcement that the country has been put on its Priority Watch List. According to Vichai, the Thai government will continue with its plans for compulsory licenses" (Bangkok Post, 5/23/07). See "Drug Access - Thai, U.S. Officials Have Not Reached Agreement About Compulsory Licenses for Patented Drugs, Thai Health Minister Says", The Global Fund at: http://www.theglobalfund.org/programs/news_summary.aspx?newsid=49&countryid=THA&lang=ru .


[MR. WAXMAN, YOUR ACTIONS ACTUALLY ENCOURAGED THAILAND TO 'TAKE' U.S. OWNED DRUG PATENTS FOR LESS THAN FULL, COMPLETE AND ADEQUATE FAIR MARKET VALUE COMPENSATION FOR A PUBLIC USE - TO FULLFILL ITS ALLEGED HEALTH NEEDS. WILL YOU COMPENSATE THE DRUG COMPANIES FOR THEIR ECONOMIC LOSS? WE STRONGLY DOUBT IT!!]


As you know, the use of compulsory licenses, with 'adequate remuneration' paid to the patentholder, is permitted by the WTO Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPS Agreement"). In the 2001 Doha Declaration, the United States and the other 142 WTO Members committed to respecting 'the right of WTO Members to use, to the full, the provisions of the TRIPS Agreement,' which provide 'flexibilities' to enable a Member 'to protect public health and, in particular, to promote access to medicines for all.' One crucial flexibility is that each Member has 'the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.'


...In fact, TRIPS does not limit compulsory licenses to "emergencies," but rather, as discussed above, permits countries to determine when they are necessary.


[UNFORTUNATELY, MR. WAXMAN, THIS INTERPRETATION OF THE TRIPS DOHA DECLARATION IS THE MOST LIBERAL ONE POSSIBLE. ALSO, 'ADEQUATE REMUNERATION' UNDER U.S. LAW MEANS, FULL, COMPLETE COMPENSATION - FAIR MARKET VALUE UNDER U.S. LAW. IT DOESN'T MEAN ADEQUATE COMPENSATION UNDER A THIRD COUNTRY'S LAW - THAT WOULD CONSTITUTE A U.S. GOVERNMENT 'GIVE-AWAY' OF U.S. PRIVATE INTELLECTUAL PROPERTY RIGHTS IN VIOLATION OF THE U.S. CONSTITUTION.]

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http://oversight.house.gov/documents/20070312150354-57129.pdf


US Trade Policies Restrict Access to Life Saving Medicines


Committee on Oversight and Government Reform, U.S. House of Representatives


Sunday, March 11, 2007


Rep. Waxman and other members write to US Trade Representative Susan Schwab to express their concern that the US is elevating intellectual property protection at the expense of public health in recent Free Trade Agreements with Peru, Colombia and other developing countries.


"[R]ecent U.S. free trade agreements (FTAs) appear to...strip away flexibilities to which countries are entitled under... the 2001 "Doha Declaration" on the [World Trade Organization] Trade-Related Aspects of Intellectual Property Agreement (TRIPS) and public health.


...Under WTO rules, pharmaceutical innovations receive twenty years of patent protection. Recent U.S. FTAs add an additional requirement [contained in US law]: a period of "data exclusivity" that begins when a patented drug receives marketing approval. During this period, regulators cannot rely upon clinical test data submitted for a drug's first approval when considering marketing approval for generic versions. The effect can be to delay the availability of generics even if a patent has already expired.


...For any patient, five years or more without a medicine priced out of reach can be severe.
The consequences are especially serious for patients with HIVIAIDS or other chronic diseases,
where the cost of treatment can mean the difference between life and death. Colombia and Peru, parties to recently negotiated U.S. FTAs, together have more than a quarter million people
infected with HIV and alarmingly low treatment access rates.


...Compulsory licensing is the government granting of a license to a manufacturer other than the patentholder to produce a drug at an affordable price. The Doha Declaration affirmed the TRIPS principle that each WTO member country has 'the fieedom to determine the grounds upon which such licences are granted.' However, the U.S. has included provisions in FTAs to narrow these grounds. USTR has also refused to reference the right to compulsory licensing - or other public health exceptions - in the text of FTAs. Instead, USTR has relied upon the use of vaguely worded "side letters" that are subordinate to the agreements and non-binding on the parties. The letters also fail to provide clear and specific assurances affirming the ability of governments to take various measures to address public health needs.


[MR. WAXMAN, THAT IS ONLY ONE INTERPRETATION OF WHAT THE DOHA DECLARATION SAYS, AND PREDICTABLY, IT IS THE MOST LIBERAL INTERPRETATION. ESSENTIALLY, YOUR PREFERRED SOLUTION OF 'TAKING' U.S. PRIVATE PROPERTY RIGHTS TO FULFILL A FOREIGN GOVERNMENT'S 'PUBLIC USE' WITHOUT PAYMENT OF FULL, ADEQUATE AND JUST COMPENSATION, WOULD EFFECTIVELY CONSTITUTE A HIDDEN TAX ON U.S. DRUG PATENT & TRADE SECRET RIGHTS THAT WOULD SEVERELY DIMINISH THE ABILITY OF THEIR HOLDERS TO SECURE A REASONABLE RETURN ON INVESTMENT & PROFIT MARGIN, IN CONTRAVENTION OF THE U.S. CONSTITUTION.]


...The world's consensus at Doha was that all nations have the right to use the flexibilities
available under TRIPS to 'promote access to medicines for all.' Protecting innovation is
important, but the intellectual property provisions in current FTAs extend pharmaceutical monopolies without sufficient regard to consumer access and public health."



[DEAR MR. WAXMAN, YOU SEEM SO GENEROUS WITH VALUABLE PRIVATE PROPERTY THAT IS NOT YOUR OWN. UNDER YOUR INTERPRETATION, U.S. TAXPAYING DRUG PATENT & TRADE SECRET OWNERS WOULD HAVE NO SAY IN THE PRICE THAT THE U.S. PTO WOULD PAY THEM FOR THEIR INTELLECTUAL PROPERTY, WHICH WOULD SURELY BE LESS THAN FAIR MARKET VALUE. IF YOU BELIEVE THAT THE U.S. GOVERNMENT SHOULD 'TAKE' U.S. PRIVATE PROPERTY FOR A 'PUBLIC USE' IN A 3RD COUNTRY TO PROVIDE IT WITH AFFORDABLE DRUG PRICES' - i.e., PRICES THAT THEY WANT TO PAY IN THEIR MARKET, WHICH ARE PENNIES ON THE DOLLAR, THEN THE USG MUST COMPENSATE THE PROPERTY OWNER WHOLLY. OTHERWISE, THE TAKING ACTUALLY CONSTITUTES A HIDDEN TAX.]

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http://lists.essential.org/pipermail/ip-health/2005-June/008087.html


Rep. Waxman Statement on Brazilian Compulsory License Dispute


June 29, 2005


Back during 2005, Mr. Waxman expressed his disdain for U.S. private patent rights when compared to the rights of foreign governments to 'take' them for their 'public use' at less than full, adequate and just compensation.


BRAZILIAN GOVERNMENT'S DECISION TO ISSUE A COMPULSORY LICENSE FOR LOPINAVIR/RITONAVIR


[Congressional Record: June 28, 2005 (Extensions)][Page E1389-E1390]


Tuesday, June 28, 2005


HON. HENRY A. WAXMAN of california in the house of representatives


[Page 1390]


Mr. WAXMAN. Mr. Speaker, Brazil's HIV/AIDS program has been recognized by the United Nations AIDS program as one of the best in the world in both treatment and prevention.


Working alongside nonprofit organizations,the government has aggressively fought the disease by offeringuniversal antiretroviral treatment. Many of the first-line antiretroviral drugs used in Brazil are locally produced by generic companies, allowing the country to afford to treat tens of thousands of patients.


But other second-line antiretroiviral drugs like the lopinavir/ritonavir combination, efavirenz, and tenofovir have been sold by theirbrand name producers at a high cost. These three drugs alone consume70% of Brazil's AIDS budget. According to Brazilian Health MinisterHumberto Costa, the Brazilian government pays more than $2,600 annuallyper patient to purchase doses of lopinavir/ritonavir.


Some who oppose Brazil's action have claimed that it violates trade rules. In fact, the World Trade Organization's 1994 Agreement on TradeRelated Aspects of Intellectual Property specifically permits compulsory licensing. The 2001 Doha Declaration reaffirmed this option, stating, ``Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.''


As a signatory of the Doha Declaration, the United States should respect the rights of other nations to address important health problems.


[THE PROBLEM HERE IS THAT THE DOHA DECLARATION IS NOT A TREATY AS IS THE WTO TRIPS AGREEMENT, WHICH GOVERNS].

Wednesday, April 16, 2008

Senator Leahy's Prior Bill on Patents Sought Compulsory Licensing For the Benefit of Third Countries: How Can Giving Away US Patents Strenghten Them??

Mr. President: Mr. President, I am today introducing a bill which can be the catalyst for saving the lives or improving the health of millions of families in impoverished nations.


In far too many nations, thousands of children die needlessly each month.


The concept of my bill – called the Life-Saving Medicines Export Act of 2006 -- is easy to summarize.


It allows U.S. companies to make low-cost generic versions of patented medicines for export to impoverished nations that face public health crises but cannot produce those life-saving medicines for themselves.


[IN OTHER WORDS, IT GIVES TO U.S. GENERIC COMPANIES THE PATENTS OF OTHER U.S. COMPANIES]


This bill is based on World Trade Organization agreements permitting nations with pharmaceutical industries to help nations in need.


[CORRECTION, THE BILL IS BASED ON A SELECTIVE INTERPRETATION OF THE WTO AGREEMENTS]


That WTO agreement was labeled by U.S. Ambassador Portman as “a landmark achievement that we hope will help developing countries devastated by HIV and AIDS and other public heath crises.”


Apart from the pressing need for this step in humanitarian terms, passage of this bill could go a long way in improving U.S. relations with large segments of the world’s population.


[IN OTHER WORDS, BY GIVING AWAY THE PRIVATE PROPERTY OF U.S. PATENT HOLDERS AS A MATTER OF FOREIGN POLICY, THE U.S. GOVERNMENT CAN IMPROVE THE U.S. IMAGE ABROAD]


On December 6, 2005, the Office of the U.S. Trade Representative announced that it “welcomes” efforts to “allow countries to override patent rights when necessary to export life-saving drugs to developing countries that face public health crises but cannot produce drugs for themselves.”


[PLEASE REMEMBER, SENATOR, THE OPERATIVE WORDS IN THAT QUOTED PASSAGE ARE "LIFE-SAVING DRUGS TO DEVELOPING COUNTRIES THAT FACE PUBLIC HEALTH CRISES" BUT CANNOT PRODUCE DRUGS FOR THEMSELVES"]


I am concerned, however, that the Administration has taken no steps whatsoever to begin to implement that agreement. No implementing legislation has been provided to the Hill. I was informed just today that the Administration has “no present plans” to propose legislation to implement that international agreement. I am disappointed with that answer but am pleased that the Administration expressed a willingness to work with me on this important effort. I will forward my bill to them later today.


Indeed, the World Health Assembly and the World Health Organization have adopted resolutions urging all WTO member nations with a generic capability to adopt laws that implement that agreement.


The World Bank recently issued a guide and model documents on how best to implement that international agreement. My bill follows their model.


Like a generation ago, infectious and parasitic diseases remain the major killers of children in the developing world. Many of these diseases -- measles, malaria, river blindness -- we can prevent or cure. But those countries still lack the public health systems and the vital medicines.


Every hour, more than 500 African mothers lose a child, mostly from diseases caused by contaminated water.


In some sub-Saharan countries, HIV infection rates range as high as a third of the adult population, and for this reason 35 percent of African children are at higher risk of death than they were a decade ago.


Despite these grim statistics, there is a brighter side.


We are far more aware today of how much our own health depends on what takes place half a world away. Whether it is AIDS, SARS, West Nile Virus, the Avian Flu, or some as yet unknown infectious disease, we are all at risk, and only an airplane flight away, from wherever the outbreak may occur.


[IS THERE 'FEAR' FACTOR' AT PLAY HERE? AND HOW MANY DRUGS FOR HOW MANY DISEASES DOES THE SENATOR HAVE IN MIND? THERE DOESN'T SEEM TO BE A LIMIT...]


Because of this new awareness, global health is finally recognized as an issue of national security.


It may seem obvious today, but even ten years ago it was not.


Health threats that once concerned only medical personnel, now receive the attention of the highest levels of governments.


We are supporting policies and programs to help the poorest countries conduct better surveillance and respond more quickly to protect their own people, and to prevent the spread of disease.


There is a great deal more we need to do. Today, 15 percent of the world’s people consume 91 percent of the world’s pharmaceuticals. The high price of many life-saving medicines -- medicines that we take for granted in this country -- is beyond reach for billions of the world’s most vulnerable populations.


President Franklin Roosevelt said: "The test of our progress is not whether we add more to the abundance of those who have much, it is whether we provide enough for those who have little."


[PRESIDENT ROOSEVELT WAS SPEAKING ABOUT IMPOVERISHED AMERICANS...]


Imagine if you, or a loved one, were dying and you knew the medicine to cure the disease exists and costs only a few dollars, but you have no way to get it or to pay for it. That is a reality for millions of people today.


Reports by UNICEF, UNAIDS, and Doctors without Borders clearly show that the high price of many life-saving medicines is a significant barrier to their availability in many very low income areas of the world. Indeed, the 4th Global Report of UNAIDS notes the extremely low rate of treatment for HIV/AIDS in those areas by pointing out that of the 5 to 6 million urgently in need of antiretroviral medicines, only some 400,000 were receiving them.


With respect to AIDS, a recent book by Philip Hilts called “Prescription for Survival” notes the importance of offering affordable medicines to populations of impoverished nations:


“It was said that the price of the drugs was killing tens of thousands . . . .”


Under my bill, U.S. generic manufacturers would be allowed to make generic versions of patented drugs without the consent of the patent holders.


Those patent holders would receive compensation in the form of a royalty payment under a so-called “compulsory license” and the generic companies would then be required to sell those less-expensive generic drugs only to least-developed or developing nations.


Use of a compulsory license occurs when Congress determines that there is an important need which should be addressed.


[SENATOR, SORRY TO SAY, YOUR DEFINITION IS OVERBROAD. WHAT COMPELLING AMERICAN PUBLIC HEALTH POLICY NEED IS AT STAKE HERE?? IS IT NOT FIRST NECESSARY TO DETERMINE THAT THERE IS A REAL PROBABLE HEALTH RISK (AS OPPOSED TO POSSIBLE HAZARD) TO AMERICAN CITIZENS POSED BY A HEALTH EMERGENCY IN SOME OTHER COUNTRY??? SENATOR, ARE YOU INVOKING INDIRECTLY THE EUROPEAN PRECAUTIONARY PRINCIPLE, AS A PRETENSE FOR THIS BIG GIVE-AWAY??]


For example, most Americans do not realize that their network television programs received by satellite or by cable are provided under a compulsory license. The program owners receive a royalty for their programs under a formula.


[SENATOR, DOES YOUR BILL PROVIDE FOR FULL, ADEQUATE AND JUST COMPENSATION FOR THE U.S. GOVERNMENT 'TAKING', WITHIN THE MEANING OF THE FIFTH AMENDMENT OF THE U.S. CONSTITUTION??? COULDNT' IT BE SAID THAT 28 U.S.C. 1498 APPLIES (NON-COMMERCIAL GOVERNMENT USE???) WE SURE HOPE SO, B/C IT WOULD REQUIRE THE U.S. GOVERNMENT TO PAY FULL, ADEQUATE AND 'JUST' COMPENSATION TO THE PATENT RIGHTS HOLDERS, ESPECIALLY SMALL INVENTORS!!]


This way American families can watch network TV programming over satellite or cable just like it is made available over-the-air. This same compulsory license approach, except with respect to patented medicines, is employed in this bill.


The WTO agreement contains language designed to protect the interests of the patent holders by focusing its benefits on areas of the world where these important medicines would not otherwise be available except for some of the wealthiest residents.


Thus, implementation of the agreement would not take business away from the companies owning the patents, sometimes referred to as the “brand-name” companies, since their medicines are not purchased by low-income families in those impoverished nations.


[THE BRAND NAME MEDICINES OF THE PATENT HOLDERS ARE NOT YET SOLD TO LOW-INCOME FAMILIES IN IMPOVERISHED NATIONS. WOULD THIS CHARACTERIZATION NOT MAKE IT EASY FOR THE BRANDED DRUG TO BE VIEWED AS PRETTY MUCH WORTHLESS IN THESE PARTICULAR MARKETS, SUCH THAT IT WOULD NOT COMMAND A HIGH ROYALTY RATE??? THE SENATOR'S BILL WAS THUS 'TAKE' THESE PATENT HOLDERS' PROPERTY FOR OTHER THAN AN AMERICAN 'PUBLIC USE'. SENATOR, CAN YOU PLEASE SHOW US WHERE, IN THE TEXT OF THE FIFTH AMENDMENT TO THE U.S. CONSTITUTION, OR IN U.S. CONSTITUTIONAL JURISPRUDENCE, IT SAYS THAT THE FIFTH AMENDMENT CONTEMPLATES FOREIGN PUBLIC USE AS FALLING WITHIN THE DEFINITION OF THAT PHRASE??]


In addition, the patent holders will receive royalties from the generic companies under the bill. Third, generic versions of products sold under the agreement have to be clearly marked as not for resale to developed nations. This will mean that the bill should not result in undercutting the high-priced sales of those medicines by the brand-name companies in developed nations.


[THE BILL WOULD NOT HAVE LIKELY AFFECTED THEN CURRENT SALES. BUT WHAT ABOUT FUTURE SALES??]


Thus, the bill addresses both the urgent needs of millions of low-income families in impoverished nations while protecting the interests of the patent owners of these life-saving medicines.


[SENATOR, WITH ALL DUE RESPECT, THAT IS AS INACCURATE A STATEMENT AS CAN BE MADE!!]


There have been significant voluntary efforts made by brand-name pharmaceutical companies, foundations, and non-profits who have donated life-saving medicines and have donated time, personnel and money to help in the fight against deadly diseases in other nations. I commend and greatly appreciate those efforts.


Some funding mechanisms have been started including the Global Fund to Fight AIDS, Tuberculosis and Malaria and President Bush’s Millennium Challenge Account. Nonetheless, much remains to be done.


If this bill is enacted it would complement the above efforts and implement the WTO agreements and make low-cost life-saving pharmaceutical products, and other medicines, available to hundreds of thousands of persons without other access to those products.


To provide a little history, I am very pleased that all the member nations of the World Trade Organization, WTO, agreed to this approach to assist people suffering from life-threatening diseases in least-developed or developing nations. Under this international agreement, nations such as the United States with pharmaceutical industries would be allowed to make and sell generic medicines to nations in need even if the patent owners of those medicines refused to authorize such manufacture and sale.


As I said earlier, On December 6, 2005, the United States announced that it “welcomes” the WTO amendment to “allow countries to override patent rights when necessary to export life-saving drugs to developing countries that face public health crises but cannot produce drugs for themselves.” The amendment will go in effect, for those nations which adopt it, once two/thirds of the member nations adopt it. The current waiver approach, allowing nations to implement it now, will remain in place until the permanent amendment is adopted. This permits that U.S. to move forward with this effort this year. Indeed, Canada has already passed implementing legislation.


[SENATOR, IF YOU HAVEN'T NOTICED, THE U.S. HAS NOT RATIFIED THAT WAIVER]


Participation by any nation which wants to export such generic products is voluntary. In order to participate, each country must pass legislation to implement the WTO agreement. The United States needs to act as soon as possible.


This is a moral issue. I am working with a number of religious groups, humanitarian organizations, international assistance groups, and generic drug companies on this effort. I have also received input from some pharmaceutical brand-name companies and hope a few will step forward and be leaders in this effort. I will also reach out across the aisle to try to form a bipartisan coalition.


[SENATOR, MORAL ISSUES JUSTIFY TAKING THE PRIVATE PROPERTY OF AMERICAN CITIZENS??? IS THAT WHAT 'PUBLIC USE' MEANS IN THE FIFTH AMENDMENT???]


Two recent World Health Organization annual reports, the World Health Reports for 2003 and 2004, demonstrate the enormous scope of the need for supplying these medicines to needy countries. The “Life-Saving Medicines Export Act of 2006” that I am introducing today would allow the U.S. generic industry to respond to these urgent international needs and could save millions of lives in impoverished nations.


Canada, Norway and the Netherlands have already enacted such legislation or rule changes. However, aspects of the Canadian law have been an impediment to the willingness of generic companies to participate. For example, that law allows Canadian generic companies to provide such medicines for at most only four years. The Canadian version permits dilatory and needless litigation, omits important medicines from a complex list of covered drugs, and creates unnecessary bureaucratic hoops.


[THESE COUNTRIES DO NOT HAVE THE U.S. CONSTITUTION AND ITS FIFTH AMENDMENT AS SAFEGUARDS FOR INDIVIDUAL PROPERTY RIGHTS INTERESTS]


I have received input from generic companies and my bill addresses all of those concerns. For example, it would provide that a participating generic manufacturer could provide such medicines for up to fourteen years which makes it much more likely that U.S. generic companies would make the investments needed to make low-cost medicines for export to impoverished areas.


[SENATOR, HOW MUCH EACH YEAR, IN CAMPAIGN AND OTHER $$$, DO YOU RECEIVE/ACCEPT FROM GENERIC DRUG COMPANIES???]

Under my bill, U.S. generic manufacturers would be allowed to make generic versions of patented drugs without the consent of the patent holders. Those patent holders would receive compensation, a royalty payment, under a so-called “compulsory license” and the generic companies would then be required to sell those less-expensive generic drugs only to least-developed or developing nations.


[SENATOR, LEAST-DEVELOPED COUNTRIES ARE DIFFERENT FROM DEVELOPING COUNTRIES. YOU USED THE TERM 'IMPOVERISHED NATIONS'. WHICH ONES ARE YOU REALLY REFERRING TO???]


The WTO agreement contains language designed to protect the interests of the patent holders by focusing its provisions on areas of the world where these important medicines would not otherwise be available except for some of the wealthiest residents. Thus, implementation of the agreement would not take business away from the companies owning the patents, sometimes referred to as the “brand-name patent holders since their medicines are not purchased by low-income families in those impoverished nations. There may be de minimis losses of profits for brand-name patent holders but certainly the humanitarian and self-interest benefits provided by the bill would massively outweigh those concerns.


[SENATOR, THAT IS MIGHT GENEROUS OF YOU TO DECIDE THAT THE PRIVATE INTERESTS OF U.S. PROPERTY HOLDERS MUST YIELD TO OTHER THAN AMERICAN PUBLIC HEALTH INTERESTS]


In addition, the patent holders will receive royalties from the generic companies under the bill. Third, generic versions of products sold under the agreement have to be clearly marked as not for resale to developed nations. This should mean that the bill will not result in undercutting the high-priced sales of the patented medicines in developed nations. Re-exporting of these generic products is prohibited unless it is part of a regional trade alliance among impoverished nations as permitted under the WTO agreements.


[SENATOR, HOW WILL THAT WORK?? IT ALREADY HAPPENS WITH DRUGS SHIPPED BACK INTO THE UNITED STATES FROM CANADA???]


Thus, the bill addresses both the urgent needs of millions of low-income families in impoverished nations while protecting the interests of the patent owners of these life-saving medicines and will hopefully help enhance America’s image in the world.


[IS THIS THE 'PUBLIC USE' THAT JUSTIFIES THE U.S. GOVERNMENT 'TAKING' AMERICAN'S PRIVATE PROPERTY - IMPROVING THE AMERICAN IMAGE ABROAD???]


For those only interested in self-interest rather than humanitarian aid, note that because of the globalization of travel our nation is at risk from failure to contain diseases in other nations.


[NO SENATOR, OUR NATION FACES A POTENTIAL HEALTH HAZARD DUE TO GLOBALIZATION OF TRAVEL, NOT A PROBABLE RISK. LET'S BE CLEAR ABOUT THE NEED TO SPECIFY FACTS AND CIRCUMSTANCES]


America has a strong self-interest in combating diseases in foreign nations. A surprising number of new diseases have emerged in recent years. Some of these new diseases are variations of existing diseases. The volume of people and cargo going to and from distant nations is astounding. According to “Rx for Survival” by Philip Hilts, if you count only travel between nations with a heavy burden of disease and those with less disease, more than a million people a week are making the trip.


The more viruses and bacteria mutant inside animals and people, and the more people and goods travel throughout the world, the more residents living in the United States are at risk of being harmed by dangerous diseases.


The National Intelligence Estimate of January, 2000, published by the CIA and the National Intelligence Council noted that: “New and emerging infectious diseases will pose a rising global health threat, and will complicate U.S. and global security over the next 20 years. These diseases will endanger U.S. citizens at home and abroad, threaten United States armed forces deployed overseas and exacerbate social and political instability in key countries and regions.”
I hope all my colleagues will join me in supporting this effort. Here is my section-by-section summary of the bill.

Section 1: Sets forth the name of the Act as the “Life-Saving Medicines Export Act of 2006.”


Section 2: States that the purpose of the Act is to promote public health under World Trade Organization agreements by permitting the export of generic versions of life-saving patented pharmaceutical products and other medicines including diagnostic tools and vaccines needed to prevent or treat potentially life threatening diseases to residents of impoverished countries with insufficient or no manufacturing capacity to make the medicines. The findings set forth determinations by the World Health Organization concerning the millions of low-income persons without regular access to medicines in lesser-developed or developing nations.


Section 3: This section requires the Director of the United States Patent and Trademark Office to issue a compulsory license (permission to make and sell a patented product under this new Act) to permit generic companies to make and export medicines under the terms of WTO international agreements under several conditions.


The recipient country must be a least-developed nation, as defined by the United Nations, or a developing nation without the ability to manufacture the medicine in question.


[THIS DEFINITION WOULD COVER VERY MANY COUNTRIES. LIKE THE DOHA DECLARATION, IT SHOULD NOT COVER THE 'BRIC' NATIONS OF BRAZIL, RUSSIA, INDIA OR CHINA]


The recipient country, called an “eligible country” in the bill, must notify the WTO of its interest in participating in this program.


Efforts must have been made by the generic company to buy the right to make and sell the medicine under normal business arrangements with the patent holders.


[WHAT INCENTIVE DO GENERIC COMPANIES HAVE TO 'BUY' THE RIGHT AT A MARKET PRICE, IF THE U.S. GOVERNMENT WILL COME IN AND DETERMINE THE PRICE IF THERE IS NO AGREED UPON PRICE??]


The medical product exported under this Act must be for life threatening public health problems and can only be used in least-developed or developing nations, and is not for re-export except in identified circumstances relating to regional trade alliances.


[SENATOR, HOW DO YOU SQUARE THIS DEFINITION WITH THAILAND'S DECISION TO ISSUE COMPULSORY LICENSES AGAINST BRAND NAME HEART (HIGH BLOOD PRESSURE MEDICINES AND CANCER DRUGS - ARE THEY 'PUBLIC HEALTH PROBLEMS', TOO?? HOW MANY DISEASES ARE YOU REFERRING TO??)]


Special labeling and packaging must be used to make clear that the product is sold under the authority of the WTO agreement only for use as allowed under agreement and this bill.


[SENATOR, WHERE ARE THE ENFORCEMENT PROVISIONS WITHIN YOUR BILL?? IS THERE ANY PROVISION FOR CRIMINAL PENALTIES FOR MISLABELING AND SMUGGLING BRAND NAME DRUGS INTO PARALLEL DEVELOPED COUNTRY MARKETS??]


The permission to make and sell the product, the license, can not exceed seven years, except that the license may be extended once.


The holder of the compulsory license shall pay a royalty to the patent holder, as determined by the Director of the PTO within a limited range of possible rates set forth in the bill, taking into account such factors as humanitarian needs, the economic value to the importing nation, and the need for low-cost pharmaceutical products by persons in the importing nation.


[SENATOR, THIS PRETTY MUCH DRIVES DOWN THE U.S. GOVERNMENT DETERMINED PRICE OF THE PATENTED BRANDED DRUG TO WAY BELOW NORMAL U.S. MARKET PRICES - TO PERHAPS LESS THAN A 1% ROYALTY RATE, AS DEMANDED BY HEALTH ACTIVISTS. IN OTHER WORDS, SENATOR, YOUR BILL CALLS FOR THE GIVE-AWAY (ESSENTIALLY A FORCED GIFT) OF PRIVATE U.S. CITIZENS' PROPERTY TO A THIRD NATION - THIS VIOLATES THE U.S. CONSTITUTION AND THE FIFTH AMENDMENT OF THE BILL OF RIGHTS!!]


The maximum royalty for any shipment shall not exceed 4 percent times the commercial value of the pharmaceutical products to be exported under this Act under that supply agreement.


An alternative royalty payment approach, modeled after the approach enacted into law by Canada, would also be permitted with the same 4 percent maximum. In addition, the Director may accept combined applications from multiple eligible countries. Note that in emergency situations the Director may waive provisions of the bill in a manner consistent with the WTO agreements.


Section 4: This section makes clear that compulsory licenses issued under this Act shall not be considered an infringement of a patent.


Section 5: This section creates a diverse advisory board of academic, patent, trade, medical, international aid, and industry experts to advise the Director, and to report to the Congress, on ways to improve implementation of the bill to achieve its purposes. Mandatory funding for the board is provided out of the general fund of the U.S. at $1.5 million in fiscal years 2007 and 2008, with modestly declining amounts provided in subsequent years through 2011.

Tuesday, April 15, 2008

The Leahy-Spector Patent Reform Standoff

http://www.ip-watch.org/weblog/index.php?p=1007


Intellectual Property Watch

15 April 2008



US Patent Reform Stalls as Senate Negotiations Break Down

[THE LEAHY-SPECTER STANDOFF]


By Dugie Standeford for Intellectual Property Watch


United States Senate negotiations on sweeping reform of the patent system foundered late last week as ongoing disputes over key provisions - and possible squabbling over confirmation of federal judges - resulted in S 1145 being pulled from the floor schedule for the time being.


“We are not going to do a patent bill now,” said Senate Majority Leader Harry Reid, Democrat- Arizona [NEVADA], because the chairman and ranking member of the Senate Judiciary Committee cannot agree on the text, he said on 10 April.


But while prospects for the bill’s immediate passage have dimmed, it is not yet dead, observers said.



Judiciary Committee Chairman Patrick Leahy, Democrat-Vermont, intended to announce that a revised version of the measure would be brought to the Senate floor this week, the Intellectual Property Owners Association reported last Friday.



The plan derailed when Leahy failed to agree on several provisions with the panel’s ranking member (lead of the opposing party), Senator Arlen Specter, Republican-Pennsylvania.



“The principal sticking point is the issue of how to assess damages in patent infringement lawsuits,” Specter said on 9 April. The lawmakers thought they had reached agreement, but “the language continued to shift, so we do not yet have a deal on the package,” he added.


The current draft allows damages of “no less than a reasonable royalty” calculated on either the entire market value of the invention, an established royalty based on marketplace licensing, or the proportional contribution of a patented component. Judges and juries must establish an invention’s “specific contribution over prior art” to gauge the actual harm of an infringement. The provision is unpopular with some patent organisations, labour unions and others (IPW, US Policy, 18 March 2008).


Specter said later, as reflected by the Congressional Record, that some in the Republican Party want to hold up S 1145 to pressure Democrats to confirm several judicial nominations. A Democratic Judiciary Committee aide told Intellectual Property Watch that five were approved last week.


Specter’s earlier comments drew criticism from Leahy, who complained that “just a handful of words” had stalled work on a key piece of legislation. The time for patent reform is now, Leahy said. “Unfortunately, some have yet to fully grasp this fact.”


Industry Reaction Muted


Efforts to revamp the US patent system have split the biotechnology and high-tech industry sectors, with the former strongly opposed to many of the changes sought by the latter. Reaction to the stalemate was predictable but muted, with most groups saying they will continue to work toward comprehensive reform.


Leahy is “right to stand firm for meaningful reform” on damages, said Mark Isakowitz, coordinator for The Coalition on Patent Fairness, which represents telecommunications, energy, banking, retail, computer, software and other high-tech sectors. The bill’s sponsors and supporters have made many compromises to address the concerns of critics “who refuse to budge an inch” on the issue, he said.


The Coalition for 21st Century Patent Reform, whose members include companies from the chemical, pharmaceutical and other industry sectors, praised Leahy’s and Specter’s efforts so far and said it hoped a consensus would be reached.


The Biotechnology Industry Organisation said Specter was “right to reject” revisions which jeopardise many economic sectors that rely on strong patent protection.


“Serious issues remain to be resolved,” but “solving damages is the real key to whether this bill moves,” said a spokesman for the Innovation Alliance, whose members are technology companies and patent holders in various sectors.


There are other major problems as well, said Hayden Gregory, IP law consultant in the American Bar Association’s governmental affairs office. Senator Orrin Hatch, Republican-Utah, “is very insistent upon reform of inequitable conduct [improprieties in applying for a patent], and Leahy is very resistant to that,” he told Intellectual Property Watch.


The US Patent and Trademark Office is pushing hard for “Applicant Quality Submissions,” which is “code-speak for a requirement that applicants do a patent search for every application and explain the significant results as part of the application,” Gregory said. Inventors and IP lawyers strongly reject the proposal, not least because “users of the patent systems are paying $2 billion a year so that the USPTO can provide such services,” he said. Offloading the cost to patent-seekers will hike each application fee by $10,000 to $15,000 according to the Congressional Budget, he said.


“Too Early” to Predict Outcome


S 1145 “certainly is not dead” but whether there will be a patent reform law this year is “too close to call,” said Foley & Lardner patent attorney Harold Wegner.



Suspensions of negotiations on legislation are common, so it is “far too early to pronounce” S 1145 dead for the year, the IPO said.


The continuing controversy could keep the bill off the Senate floor for the next few weeks, said the Innovation Alliance spokesman. That will “hopefully allow for a serious negotiation among all stakeholders,” he said.


Separately, the American Civil Liberties Union (ACLU) earlier this month urged a federal court to uphold the denial of a patent for an abstract idea. The applicant sought to patent the concept that the “weather risk” involved in buying and selling commodities could be reduced if sellers had conversations with two buyers instead of one, the ACLU said. Patenting speech or thought risks violating the First Amendment guaranteeing freedom of speech, the organisation said.




Dugie Standeford may be reached at info@ip-watch.ch.

Friday, April 4, 2008

Academic and Healthcare Activists Secretly Discuss Possible Thai Compulsory Licensing Pricing Strategy to Undermine USTR/PhRMA


The following colloquy took place during April 1-4, 2008, between James Love of Knowledge Ecology International (KEI), a George Soros-funded health and human rights activist group, and several left-leaning US, UK and Australian university professors:


Northeastern University Professor Brook Baker, Boston University Professor Kevin Outterson, Cleveland State Univ. College of Law Professor Michael Davis, London School of Economics Professor Ken Shadlen, Australia National University Professor Peter Drahos and an anonymous professor who identifies himself by the pseudonym "Miles Teg" (Miles Teg is a fictional character in the Dune universe created by Frank Herbert... Miles Teg was a military genius and became Supreme Bashar of the Bene Gesserit, winning many victories. He had a very strong sense of honor, loyalty, and had the many characteristics of House Atreides. He is well known for doing the unexpected. See Wikipedia, at: http://64.233.169.104/search?q=cache:bF17aBEckDcJ:en.wikipedia.org/wiki/Miles_Teg+Miles+Teg&hl=en&ct=clnk&cd=1&gl=us ).
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http://lists.essential.org/pipermail/ip-health/2008-April/012421.html


B.Baker@neu.edu mailto:B.Baker%40neu.eduTue Apr 1 11:07:01 2008


I think there are four interest facets of the U.S. statement in the Thai NTB report (reprinted below).


"Thailand's Ministry of Public Health has issued compulsory licenses on certain patented drugs. The United States acknowledges Thailand's ability to issue compulsory licenses to address public health emergencies, subject to Thailand's domestic and international legal obligations as a WTO Member. At the same time, the United States has expressed concern regarding a lack of transparency in the process and about the potentially expansive use of compulsory licenses. The United States has urged Thailand to address judiciously the complexities of the relationship between health and intellectual property policy and to do so in ways that recognize the role of intellectual property in the development of new drugs."


1. The U.S. continues to misinterpret the circumstances where compulsory licenses can be issued, suggesting that they are appropriate only to respond to public health emergencies.


2. The U.S. continues to suggest that the licenses were issued in a non-transparent manner, thereby failing to acknowledge the protracted negotiations that preceded the 2006-07 licenses on efavirenz, clopidrogel, and lopinavir/ritonavir and the even more intensive consultations that preceded the issuance of the four cancer CLs in 2008.


3. The U.S. adds a new concern, namely that the use of compulsory licenses will become "potentially pervasive." Of course, Thailand has been careful to set up a stringent screening process, has established strict needs-based standards, and has issued CLs on only a tiny portion of the medicines patented in Thailand.


4. Finally, the U.S. has used relatively muted language and has not in any sense "signalled" an intention to identify Thailand as a Priority Watch Country, despite earlier publicity about this possibility.


Jamie Love has previously suggested that Thailand (and perhaps other middle-income countries) could address the stated U.S. concern about "contributing to the development of new drugs" by revising upwards the royalty rate on its compulsory licenses (currently ranging from .5%-5% on the generic price). Although international compulsory licensing practice and commercial practice support royalty rates in this range, it is important to note that commercial royalty rates are ordinarily based on sales at monopoly prices, resulting in much higher absolute payments per pill.


Even though it is by no means required to do so, Thailand could gain credibility with U.S. Congressional leaders and undermine USTR/PhRMA attacks, by offering an additional, and perhaps targeted R&D royalty. One idea would be to target the royalty to type-I and type-II (neglected) diseases affecting the Thai population. If the affected drug company were willing to accept the additional royalty on this basis, the R&D could be done anywhere. However, an even better alternative would be that the targeted research be conducted in Thailand in universities, research institutes (if any), or even in the GPO. Agreements would need to be reached in advance about the eventual co-ownership/marketing of innovative products, but this kind of targeted research could entail technology transfer, building of research capacity, and perhaps even expansion of pharmaceutical capacity in Thailand.


There are risks in such a proposal, including that the standard royalty rate will be higher and that fewer patients will be treated from the same health budget, but there may be political advantages from indicating a willingness to pay a little more for innovative R&D as long as it focuses on developing country needs.


Brook

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)


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mko mailto:mko%40bu.eduWed Apr 2 06:26:04 2008


I agree that middle-income countries should explore higher royalty rates on generically-priced drugs sold under a CL. Doing so wouldn't harm access much; indeed if the higher royalty reduced opposition from USTR & IFPMA, then access could be dramatically improved. I've tried to model these CL royalties or patent buy-outs from the opportunity cost in R&D from the foregone revenues:

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=873402


Kevin Outterson
Boston University

Boston University School of Law
765 Commonwealth Ave., Boston MA 02215
617 353 3103
http://ssrn.com/author=340746

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Miles Teg mailto:b.miles.teg%40gmail.comWed Apr 2 09:20:02 2008


Why should developing countries reduce their legal flexibility to determine royalty rates by such "self regulation"? Is it a realistic that opposition to CLs in developing countries would reduce?


bmt

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michael.davis@law.csuohio.edu mailto:michael.davis%40law.csuohio.eduWed Apr 2 09:54:00 2008


There is no reason for them to do that. It is a classic trap, the kind of advice you would give to a prisoner at Guantanamo ("Behave and we won't torture you.") It also smacks too much of the unstated "Trust me," which is never advice you should take from an adversary.


Mickey Davis

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B.Baker@neu.edu mailto:B.Baker%40neu.eduWed Apr 2 14:47:10 2008


Miles and Mickey have raised sensible questions about whether it is politically wise to raise royalty rates in the hopes of encountering less resistance from patent holders and their governmental proxies in the USTR and European Union. It may well be that there is no real appeasing of opponents to lawful utilization of TRIPS-compliant compulsory licenses - that they will always use disinformation and misinformation to challenge CLs and whatever royalties are paid.


Evidence of such continuing opposition can be found in the still strident attacks against Thailand's recent compulsory licenses on cancer drugs, even though Thailand raised the royalty rate from .5% to 5%.


All that Article 31 of the TRIPS Agreement requires is that "the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization." This clause gives wide latitude to governments to assess the circumstances and the economic value of the license. As Jamie Love's detailed study of
remuneration rates showed, countries can make such choice by weighing factors or pursuant to percentage royalty guidelines, so as long as individual determinations are made in each case.


However, contrary to Miles' and Mikey's critique, I think it is useful for ATM activists to speculate about royalty rates that "might" reduce political opposition and about royalty schemes that might actually increase research and development into neglected diseases and/or spur increased R&D activity in developing countries. There is no presumptively "polically correct" royalty rate, and Thailand engaged in a politically astute, self-determined decision to raise its royalty rate on the new cancer CLs. Did they do so as Guantanamo prisoners or as colonial subjects - I think the suggestion is a little insulting.

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)

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mko mailto:mko%40bu.eduWed Apr 2 14:47:32 2008


I'm sure I've been misunderstood here.


My point is simply that CL, while entirely legal under TRIPS, is politically difficult given the sustained attack by USTR and big phrma. Modifying the royalty structure might take away one argument in their quiver: "CL will destroy innovation!"


I'd describe it as disarming your opponents by being reasonable.


Having said that, being reasonable with phrma doesn't have a great track record.


Kevin Outterson
Boston University

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http://lists.essential.org/pipermail/ip-health/2008-April/012434.html


James Love mailto:james.love%40keionline.orgWed Apr 2 15:34:01 2008


My view regarding royalty rates and trade pressures is that royalty payments that are too low will be considered unreasonable, and will not be politically sustainable. As a matter of some recent history, I did not want to defend a .5 percent royalty rate, applied to generic prices, and I don't think it helped the countries that choose that rate. Even if people don't understand much about this topic, .5 percent sounded pretty low.


The more recent higher royalty rates in Thailand have I believe made it easier to Thailand to keep the new compulsory license. Even more important, of course, have been the actions of the Thai activists, who have done the really important work in pushing the Thailand government
to protect consumer interests.


In the longer run, we think that governments in developing countries should simply set aside an appropriate fraction of health or drug purchase budgets, to reward drug developments, and de-monopolize all drug purchases. Some people in the Thai government have suggested doing this, and there is a discussion about whether or not this is a better business model for the Global Fund and other donor funded drug purchases. Agree on how much money goes to innovators, and then buy everything at marginal cost, increasing access and improving outcomes.


Once the negotiation turns to the fraction of the drug budget that goes to innovators, and marginal cost pricing of products is accepted, you can begin to have a rational policy discussion.


Jamie

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http://lists.essential.org/pipermail/ip-health/2008-April/012435.html


Peter Drahos mailto:peter.drahos%40anu.edu.auThu Apr 3 08:10:02 2008


I do not believe that upping the royalty rate will reduce the pressure on countries like Thailand. During the Uruguay Trade Round, the US made a lot of promises about backing off on its trade unilateralism if developing countries signed up to the WTO, TRIPS and its jolly nice dispute resolution mechanism. The FTA IP jihad followed soon after. I also think there may be cases where .5% will be appropriate. Hard to see how a country like Laos can afford much more.


Of course, this Thai saga has in part been about sending a message to other countries in the region about what to expect if they exercise their lawful rights =AD Al Capone and the boys are
gonna pay you a visit and now there=92s a minimum rate you can=92t go below=.


Chomsky somewhere has a nice line about domination in the world today =AD =93the rule of law
for the weak, the rule of force for the strong=94


Peter Drahos

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http://lists.essential.org/pipermail/ip-health/2008-April/012437.html


James Love mailto:james.love%40keionline.orgThu Apr 3 10:40:03 2008


There is no doubt that there is plenty of bullying, lying, angling for industry jobs after leaving the government, and other mean spirited stuff going on here.


Even so, Thailand has benefited at least somewhat from interventions from some sympathetic members of the US Congress and government (and the European Parliament and EC), and this has and I hope will continue to moderate somewhat the full brunt of the fury that PhRMA would like to see unleashed. To this end, the .5 percent royalty rate was unhelpful, bad PR, and almost completely unnecessary in terms of the policy.


To make things more concrete, the price of Plavix dropped from 77 to 1 baht once competition was introduced. A royalty of .5 percent of 1 baht was .005 baht per pill, or 1.825 baht per year, equal to about 6 US cents at current exchange rates. A 5 percent royalty, 10 times as high, would have been a royalty of 18.25 baht per year or 58 US cents, per year.


The price of Plavix before the CL was $888 per year. After the CL, it was $11.53 per year. Arguing about 6 cents versus 58 cents is losing sight of the big picture, I think.


Jamie

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http://lists.essential.org/pipermail/ip-health/2008-April/012447.html


Ken Shadlen mailto:k.shadlen%40lse.ac.ukFri Apr 4 18:04:02 2008


But if the difference between the amount per unit that goes to the originator firm whether the royalty rate is .5% or 5% is so tiny as to be nearly insignificant from the government's perspective, which is what I'm reading here in Jamie's post, then wouldn't it also be insignificant to PhRMA? I see the point about not wasting energy wrangling about 6 cents vs. 58 cents, but I can't see how this would reduce the backlash. To the contrary, I think Jamie has presented a pretty good argument as to why a CL with 5% -- even higher -- would still leave PhRMA far from satisfied in the context of a reduction of ~$775/unit.

I write this without being in Washington or having close daily contact with Washington. Are there people in Congress (or USTR) that would be more sympathetic to the Thai government were they paying .58/unit rather than .06/unit?

Ken




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http://lists.essential.org/pipermail/ip-health/2008-April/012448.html


James Love mailto:james.love%40keionline.orgFri Apr 4 23:05:03 2008


The reduction is per unit of sales. But note also that sales were approximately zero for the bottom 80 percent of the population.


... First off, PhRMA is focused on maintaining the monopoly. In Malaysia, where the "government use" CL proposed a 4 percent royalty, GSk didn't even want to take the money. They thought it would signal an acceptance of and legitimacy for the CL. In some cases, when a country was serious about a CL, the patent owner announced they would give away the drug, to undermine efforts to issue a CL. This was the outcome of the fluconazole case in South Africa, for example. PhRMA is entirely devoted to opposing the use of CLs, because they want to a monopoly, and they believe a monopoly will lead to higher profits than government set royalty payments, and they see each of the CL cases as setting precedents for the future.


Thailand and other countries feel some pressure from PhRMA members, but the biggest pressures come from governments in the North, particularly from the US and the EC and the EU member states. While it may seem so at times, governments in the North do not take their instructions verbatim from the patent owners. The US and the EC have much broader interests and concerns, and the demands of the PhRMA companies are part of a larger calculus that also includes non-PhRMA trade with Thailand and other countries, and genuine concern about the poor in developing countries. If the USTR or DG-Trade goes ballistic in demanding high prices for life saving drugs in Thailand, it can't exactly expect to achieve all of the other demands it might want to make, to address the concerns of other US or EU companies. USTR and DG-Trade spend a fair amount of time fighting off PhRMA lobbying, so they can address the broader trade agenda (which is why we have the 2001 Doha Declaration). In this respect, something like the royalty rate becomes relevant, because it is used in the EU and the US Congress as evidence one way or another that Thailand is acting reasonably.


The Average US royalty rates are probably close to 5 percent, and in fact, that is the number used in some PhRMA submissions to USTR. And profit rates in competitive sectors of the economy probably run around 3 to 5 percent. In this respect, royalties of 3 to 5 percent seem, on their face, pretty reasonable, to a lot of people. Royalties of .5 percent seem pretty low, particularly to hill staffers and others who have little time for detailed economic analysis of the Thai pharmaceutical market.


Our own work on royalties has been more nuanced and sophisticated than this, and in the 2005/WHO/UNDP Tiered Royalty Method (TRM), I recommended a system of royalty setting that is based upon a percentage of the putative value of the medicine in high income countries, adjusted for the relative income of the countries where it is consumed. This is conceptually an appealing way for setting royalties in developing countries, but because it is novel and more complicated than simply using a percent of the generic price, it has not been used.


In general, however, it may be easier just to simplify everything even more, and link the de-monopolization of the drug sector (for marginal cost pricing of products), with a system of rewards for drug developers that is pegged to some fraction of the drug purchase budget or health care budget. The political demand from developing country governments and consumer groups would be to ensure access through marginal cost pricing of products, while conceding the legitimacy of a separate argument over the amount that a country gives to innovators. I think this is an argument that can be won, and it can be the basis for a sustainable long term change in the business model for paying for innovation. The rewards to innovators could be rationally linked to the impact of products on improvements in health outcomes. The more the "ask" makes sense (and is perceived to make sense) in terms of the legitimate interests of both consumers and drug developers, the higher are the odds of really changing things.


Jamie