Showing posts with label ip opportunism. Show all posts
Showing posts with label ip opportunism. Show all posts

Monday, January 26, 2009

Brazil's 'Public Interest' IP Opportunism Knows No Limits - Third Country Transit Points Now Being Used

http://www.reuters.com/article/marketsNews/idUSN2327254420090123

Brazil to Object to Dutch Seizure of Generic Drug


Reuters


By Pedro Fonseca and Reese Ewing


Jan 23, 2009


RIO DE JANEIRO, Jan 23 (Reuters) - Brazil said it would file a complaint at the World Trade Organization over the seizure by Dutch authorities of a shipment of a generic high blood pressure drug made in India.


Local foreign and health ministries said a company claiming to have intellectual property rights to the arterial hypertension drug losartan in the Netherlands requested customs authorities seize a shipment of a generic version of the drug in transit from India to Brazil, two countries where the patent is not protected.


The Brazilian government can withhold intellectual property rights for a drug if it considers it "in the public interest." Its health-care system provides free drug treatment for certain conditions such as AIDS and high blood pressure.


"The Brazilian government feels that the decision by the Dutch authorities to detain the basic material critical for the public health of a developing country ... a serious step backward on the question of universal access to drugs," said the note released by the Brazilian ministries late Thursday.


[SINCE WHEN IS BRAZIL A DEVELOPING COUNTRY??? IT IS AN AGRICULTURAL & ENERGY SUPERPOWER!! AT THE VERY LEAST, IT IS AN EMERGING ECONOMY!! SORRY GUYS. THIS ARGUMENT NO LONGER WORKS!! IT'S TIME TO INVEST IN PUBLIC EDUCATION!]


The statement also said the government would take its complaint to the executive council of the World Trade Organization in Geneva.


High blood pressure is one of the leading causes of death among Brazilians.


[SO MUCH FOR PUBLIC EMERGENCY OR EXIGENT CIRCUMSTANCES OR ANTITRUST ACTIVITY AS AN EXCUSE FOR A 'TAKING'. NOW ALL THAT IS NECESSARY IS THAT THE BRAZILIANS WANT WHAT THE FOREIGN PATENT HOLDERS HAVE!! THIS IS WHAT THEY CALL 'PUBLIC INTEREST'!!]


The cargo of generic losartan that was seized in Rotterdam was sent back to India, where it was manufactured by Dr. Reddy's, the ministries' note said. The drug was being imported by Brazil's EMS.



[NOW, WHY WOULD THE BRAZILIAN SHIPPER USE ROTTERDAM AS A THIRD COUNTRY TRANSIT POINT BETWEEN INDIA AND BRAZIL??? AND WHY WOULD DR. REDDY'S, WHICH IS ALL-TOO FAMILIAR WITH THE LAW OF PATENTS, WANT TO DO THIS??? ARE THERE ANY TARIFF BENEFITS OR FINANCIAL PAYOFFS?? WHY WOULD THE DUTCH GOVERNMENT INTERVENE ON BEHALF OF FRENCH AND AMERICAN PATENT HOLDERS?? DOES IT HAVE A LEGAL DUTY TO DO SO?? ARE THESE DRUGS PATENTED ALSO IN THE NETHERLANDS?? HOW DID THE PATENT HOLDERS GET WIND OF THE SHIPMENT??]



Losartan is the generic name for the drug Cozaar that was co-developed by Merck & Co and DuPont Co.


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Brazil Protests Seizure of Dr. Reddy’s Drugs in the Netherlands


By Joshua Goodman


Jan. 21 (Bloomberg)


Brazil protested the seizure in the Netherlands of shipments from Dr. Reddy’s Laboratories Ltd., India’s second-biggest drugmaker.


Customs authorities in Rotterdam seized shipments of the generic drug Losartan, used to treat high blood pressure, while in transit to Brazil, the South American nation’s foreign ministry said in a statement.


Authorities were acting on the request of an unnamed [???] company that allegedly has patent rights over the drug in the Netherlands, the foreign ministry said. Losartan can be imported freely in Brazil.


“The decision by Dutch authorities to seize a strategic supply for the public health system of a developing country, exported according to international norms, signals a grave step backward in the universal access to medicines,” the ministry said in the statement.


[BRAZIL IS NOT A DEVELOPING COUNTRY!!]


Officials at the Netherlands embassy in Brazil weren’t immediately available to comment after normal business hours.


The Brazil foreign ministry said the seizure “raises doubts about the commitment of European countries to help people in developing countries gain access to medicines.”


[BRAZIL IS NOT A DEVELOPING COUNTRY!!]


Brazil plans to complain to the World Health Organization in Geneva and possibly to the World Trade Organization.

The drug shipment has been returned to India, the foreign ministry said.

Monday, December 8, 2008

Ongoing IP Opportunism in Brazil & India May Trigger Foreign Storks' (Patent Holders') Refusal to Save the Wolf!

http://www.miscositas.com/fontaine1
http://www.miscositas.com/fables1.html



The wolf was choking on a bone and asked the stork to help him. The stork used his long beak to help him get the bone out of his throat, but the ungrateful wolf threatened to eat him in return for his good deed.

Story text and images © Lori Langer de Ramírez




Marc Chagall, "Fables La Fontaine Le Loup et La Cicogne"Limited Edition PrintLithograph 1927

















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

http://www.qworkbooks.com/AZ/AZsamples/AZ_RAS_RC_3.pdf
http://www.your-poetry.com/modules.php?name=pd&file=poetry&pdid=21957





“THE WOLF AND THE STORK”




By French Poet
Jean De La Fontaine




-------------
The wolves are prone to play the glutton.
One, at a certain feast, ‘tis said,
So stuffed himself with lamb and mutton,
He seemed but little short of dead.

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


Deep in his throat a bone stuck fast.
Well for this wolf, who could not speak,

-------------
That soon a stork quite near him passed.
By signs invited, with her beak
The bone she drew



-----------

With slight ado,
And for this skillful surgery
Demanded, modestly, her fee.
“Your fee!” replied the wolf,
In accents rather gruff;
-----------

“And is it not enough
Your neck is safe from such a gulf?
Go, for a wretch ingrate,
Nor tempt again your fate!”


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


[FOR A MODERN & ESPECIALLY RELEVANT APPLICATION OF THIS LA FONTAINE FABLE, CONSIDERING BRAZIL'S ONGOING 'IP OPPORTUNISM', See: Slavi Pachovski and Lawrence Kogan, The Wolf and the Stork: How Brazil's Breaking of Drug Patents Threatens Global Trade and Public Health, ITSSD (June 14, 2005), at: http://www.itssd.org/White%20Papers/TheWolf_and_theStork-Brazil_snon-patentabilitylaw.pdf ].

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http://timesofindia.indiatimes.com/HC_revokes_Roches_patent/rssarticleshow/3798630.cms

HC revokes Roche's patent


Rupali Mukherjee


The Times of India


December 6, 2008


NEW DELHI: In a first-ever instance of a patent being revoked after being granted, the Madras High Court has set aside pharma major Roche's patent on a key drug, valganciclovir on procedural grounds. A patent on valganciclovirwas granted to the company in June 2007.


Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that oftenattacks the retina of people with lower immune systems, such as AIDS patients. In addition, it is crucial for prevention of CMV infection inpatients who have received organ transplant.

The court has cited the failure of the Indian patent office to comply with the patent law and remanded the matter back to the Patent Controller.
The judgment was delivered on a petition filed by civil society groups IndianNetwork for People Living with HIV/AIDS (INP+) and Tamil Nadu Networking People with HIV/AIDS (TNNP+), who had challenged the Indian Patent Offices decision to grant a patent without hearing the pre-grant opposition filed by them.

In July 2006, INP+ and TNNP+ had filed a pre-grant opposition before theChennai Patent Office objecting to the grant of patent to Roche andrequested for a hearing. Under the Indian law, if an opponent requests a hearing, the patent office is required to provide the opponent an opportunity to be heard. However, this was not done.

At Roche's maximum retail price of over Rs 1000 per tablet, a patient whohas to take a treatment course of approximately four months for CMVretinitis in India would have to pay over Rs 2.5 lakh. This puts thetreatment unafforable for those who need them.

The grant of patent to Roche allowed it to continue charging exorbitant prices and also prevented the entry of generic versions of valganciclovir.
However, in May this year, Cipla launched the generic valganciclovir in thedomestic market at a price of Rs 245 for a tablet. Under law, a generic producer can challenge the patent by taking the risk of launching a generic version after obtaining marketing approval. In response, Roche filed an infringement suit against Cipla in the Bombay High Court in September seeking an injunction, which is till pending.
The dispute between the companies hinges on "patentability'' of the drug. The validity of the patent is in question under the country's patent laws that do not allow patents on new forms of old drugs, also known as Section 3(d). Experts pointed out that valganciclovir is a hydrochloride salt of an olddrug `ganciclovir' and hence not patentable.

The generic producers of the drug, Matrix, Ranbaxy and Cipla have also filed post grant oppositions.

While the opportunity to oppose the application is only granted to the patient groups, it is likely that Roche's injunction proceedings against Cipla for launching the generic version will no longer have a legal basis as the patent is now revoked.
Whether the Mumbai court will keep the infringement proceedings pending remains to be seen, legal experts say.
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http://www.ip-watch.org/weblog/index.php?p=1344

Brazilian Draft Law Would Curb Expanded Patents On Pharmaceuticals


By Claudia Jurberg


Intellectual Property Watch


December 2, 2008


RIO DE JANEIRO - Brazil’s lower house of Congress held a recent hearing to discuss proposed changes to rules on pharmaceutical patents that would limit patents on two types of pharmaceuticals.


Under proposed legislation, patent rights would not be permitted in two modalities: second-use drugs and polymorphs.


A second-use drug patent refers to when another function is discovered in a drug for which the pharmaceutical industry holds the patent on a substance. The situation could be explained as a positive side effect.


In the case of polymorph patents, the substance is made with the same material and shows the same effects as the medicines protected by a patent, according to legislation author Deputy Paulo Teixeira. It is like a substance with the same crystalline forms.


The authors of the legislation are congressional deputies Teixeira and Dr. Rosinha (Florisvaldo Fier) of the Workers Party, the same political party as the Brazilian president.


According to Luis Carlos Wanderley Lima, coordinator of intellectual property at the Brazilian National Health Surveillance Agency (Anvisa), both cases lack novelty - one of the principles required to issue a patent.


Wanderley Lima said that applying patents to polymorphs has been identified as a pharmaceutical industry strategy to expand patents and gain a monopoly on some substances important to the commercial market. In his view, it could be valid to developed countries but it could prejudice developing countries such as Brazil because it causes a delay of generic drugs’ entrance in the market.


The president of the Brazil Patent Office (INPI), Jorge Avila, said during the 31 October hearing that in his view “there is space for an [positive] environment for business initiatives in the country while at the same time it is possible to promote the strengthening of production of generics and encourage Brazilian research in the pharmaceutical area.”


Researcher Claudia Chamas, representative of the Health Ministry, said “there is a profound difference in understanding between the INPI’s guidelines and the opinion of the deputies.” According to her, the project of the deputies is better, because it incentivises the innovation and curb the excesses.

In general, the acceptance of pharmaceutical patents in Brazil should be very carefully done, said Wanderley Lima, as patents can limit the access to drugs.


The attention to protection of drug patents is significant because it could have implications for public health. Access to medications by governments and consumers can be restricted to a single producer who monopolises production and could choose to charge high prices, thereby causing a problem to the public health system, according to Wanderly Lima.


[HOWEVER, THE MERE ACT OF DEVELOPING AN INNOVATIVE LANDMARK DRUG FOR WHICH A PATENT HAS BEEN GRANTED IN A DEVELOPED COUNTRY OR AT THE WIPO, DOES NOT, BY ITSELF, WITHOUT MORE, INDICATE THAT ILLEGAL MONOPOLISTIC PRACTICES HAVE OCCURRED, ARE OCCURRING OR WILL OCCUR IN THE FUTURE. THESE BRAZILIAN BUREAUCRATS AND LEGISLATORS ARE TRYING TO CREATE A LEGAL FICTION - A FALSE PRESUMPTION OF ILLEGALITY (MONOPOLISTIC PRACTICES) - i.e., THAT MARKET LEADERS IN THE PHARMACEUTICAL INDUSTRY HOLDING VALUABLE DRUG PATENTS & TRADE SECRET KNOW-HOW ARE, BY VIRTUE OF THEIR OWNERSHIP OF SUCH RIGHTS, EXPLOITING OR PLANNING TO EXPLOIT SOCIETY FOR PECUNIARY GAIN. THESE PIECES OF LEGISLATION ARE NOTHING MORE THAN A COORDINATED EFFORT AT LEGITIMIZING THE PLANNED EXPROPRIATION OF FOREIGN DRUG PATENTS!!]


Every nation has the right to define patent concession criteria for pharmaceutical companies, he said, adding that public health can be adversely affected by broad application of patent rights, such as in the case of second-use drugs.


[WHILE THIS IS TRUE, IT IS ANOTHER MATTER ENTIRELY TO REDEFINE THE INTERNATIONAL STANDARD FOR 'NOVELTY' AS AN ELEMENT OF 'PATENTABILITY'. THIS IS NOT SANCTIONED BY THE WTO TRIPS AGREEMENT, NOTWITHSTANDING WHAT THE LEFT-LEANING BRAZILIAN, U.S., & EUROPEAN 'INTELLECTUALS' SAY.]

According to him, “It is important that the INPI discusses the organisational guidelines and the examination of patents, but it is fundamental that they do not forget the interests of society.”

This subject should be resolved quickly by an Intellectual Property Interministerial Group, Chamas said. For her, patents such as on second-use drugs and polymorphs do not have support in Brazilian law, which provides rights only for patents on products and processes with novelty, inventive activity and industrial application.




“These undue monopolies could cause an increase in medicine prices and bring obstacles to development assistance programmes and to the pharmaceutical industry in general,” Chamas told Intellectual Property Watch. “It is a barrier to free competition, plus an unjustified monopoly.”


Prior Informed Consent



A further discussion regarding patents is occurring between Anvisa and INPI on prior informed consent. For approval of the right of a drug patent in Brazil, both Anvisa and INPI give their opinion.



Anvisa has established stiff rules on obtaining this kind of privilege and the agency showed this position to INPI. The agency says it understands the importance of the patent system to pharmaceutical companies, but believes that this protection of patent could be given only to drugs that meet the basic requirements and not just for any kind of patent. The concern is that there are a lot of made-up situations that do not bring any benefit to the country and prejudice the public interest.






[ACTUALLY, THE GRANT OF A PATENT IS A RIGHT, NOT A PRIVILEGE, PROVIDED THE STATUTORY REQUIREMENTS ARE SATISFIED. BUT, THIS DOES NOT VEST GOVERNMENTS WITH THE UNFETTERED DISCRETION TO DEPART FROM LONG-ACCEPTED LEGAL PRINCIPLES TO EFFECTIVELY CONVERT WHAT IS INTERNATIONALLY RECOGNIZED AS A 'PRIVATE PROPERTY RIGHT' INTO A 'PUBLIC INTEREST' RIGHT, & CONSEQUENTLY, A GOVERNMENT PRIVILEGE].




On the other hand, there are many critics of prior informed consent, many arguing that the mechanism delays the patent processing system. For this reason, at the lower house of Congress there is proposed legislation from Deputy Rafael Guerra that would eliminate the prior informed consent mechanism realised by Anvisa. If the legislation were approved, the agency would no longer analyse all patent requirements.





[THE 'INFORMED CONSENT' REQUIREMENT, IF ADOPTED, WOULD EFFECTIVELY INJECT OTHER THAN LEGAL & ECONOMIC PATENTABILITY CRITERIA (i.e., HUMAN & SOCIAL RIGHTS THEORIES), INTO THE PATENT REVIEW PROCESS, & THUS, RESULT IN THE LOSS OF VALUABLE PRIVATE PROPERTY RIGHTS & THE 'EXACTING OF RENTS' FROM FOREIGN PATENT HOLDERS & BRAZILIAN PATENT APPLICANTS BY GREEDY BRAZILIAN GOVERNMENT BUREAUCRATS. AFTER ALL, AS NUMEROUS MEDIA REPORTS REFLECT, BRAZILIAN GOVERNMENT BUREAUCRATS & LEGISLATORS ARE NO STRANGERS TO CORRUPTION!!].






Wanderly Lima said that the Anvisa had created a special coordination with professionals to perform this task, and the period of analysis is about 120 days. After this period, if the patent is granted, the holder shall have the exclusive rights to exploit the object protected by the period of 20 years. Therefore, he said there is a need for a careful review because they are giving a monopoly, and must take into account that this implies a lack of competition and, consequently, the final price of the product to the public and for Health Ministry programs.






According to him, 1002 applications were sent for analysis by Anvisa from 2001 to 2007, and 752, or 68 percent, were approved. Around 30 percent stumbled on requirements before being granted permission, which he said proves the accuracy of the mechanism.






[THIS REASONING HAS NO VALIDITY SINCE IT IS A TAUTOLOGY - CIRCULAR REASONING - WHEREIN 'THE ENDS JUSTIFY THE MEANS' AND 'THE MEANS JUSTIFY THE ENDS'.]






About 5 percent of the applications were denied permission due to purely legal aspects, such as the lack of novelty or inventive activity. This shows that the prior informed consent process is aimed at granting the patent according to Brazilian law while preventing the suffering of society by undue restrictions on drugs, such as high prices.






If this initiative of the Deputy Guerra advances, it will change one of the most important articles of the patent system and weaken the Brazilian system, said Wanderley Lima. If approved, he added, it could cause a serious drop in the quality of the examination of pharmaceuticals patents, generating worrisome economic and social consequences to society.






Claudia Jurberg may be reached at info@ip-watch.ch.

Tuesday, February 19, 2008

Brookings Analyst Criticizes USG For Ensuring That Foreign Governments Protect US Constitutionally Recognized Private IP Rights Abroad

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/17/EDR1V0LCD.DTL


U.S. expanding the law - domestic and foreign - to benefit corporations


By Ben Klemens


Sunday, February 17, 2008


As a U.S. taxpayer, you may be contributing to fewer cheap drugs on international shelves. Public dollars support the Office of the U.S. Trade Representative, the trade agency with authority to pressure foreign governments to change their domestic intellectual property laws. As such, the agency actively presses for laws that would keep generic drugs out of markets worldwide.


[IS THIS COMMENTATOR SUGGESTING THAT THE US TRADE REPRESENTATIVE INSIST THAT FOREIGN GOVERNMENTS WEAKEN THEIR DOMESTIC INTELLECTUAL PROPERTY LAWS SO THAT THEY ARE ABLE TO ‘TAKE’ U.S. HELD PATENTS, COPYRIGHTS AND TRADE SECRETS WITHOUT PAYING ADEQUATE AND FULL COMPENSATION FOR THEM, CONTRARY TO THE FIFTH AMENDMENT OF THE BILL OF RIGHTS TO THE U.S. CONSTITUTION?? IS THIS COMMENTATOR ADVOCATING THE GIVE-AWAY OF U.S.-OWNED INTELLECTUAL PROPERTY RIGHTS AS A FORM OF TECHNOLOGY TRANSFER IN ORDER TO IMPROVE AMERICA’S IMAGE ABROAD??]


Congress is considering legislation to create a separate executive branch office dedicated to using government resources for lobbying other countries to change their laws, sometimes exclusively to benefit certain U.S. companies.


That's a bad idea for patients here and abroad, because it would give the U.S. government more power in an area where it should instead have less.


[DOES THIS COMMENTATOR FAVOR THE EXERCISE OF MORE GOVERNMENT POWER TO DETERMINE HOW DRUGS SHOULD BE MADE, HOW THEY SHOULD BE PRICED, HOW MUCH PROFITS DRUG COMPANIES SHOULD MAKE, JUST AS THEY DO IT IN EUROPE, CANADA, BRAZIL AND OTHER SOCIALIST COUNTRIES??? DOES THIS COMMENTATOR ADVOCATE IN FAVOR OF SOCIALIZED MEDICINE AND UNIVERSAL HEALTHCARE FOR ALL AT THE EXPENSE OF NEW HEALTHCARE RESEARCH & DISCOVERIES AND PRODUCT INNOVATIONS??]


The international intellectual property system is based on an ingenious 1994 international treaty: Rather than establishing an unwieldy international copyright and patent office, the agreement merely stipulates that every signatory country must have domestic copyright and patent systems that meet certain basic requirements.


[THIS COMMENTATOR IS OBVIOUSLY UNAWARE OF THE CONSTITUTIONAL OBLIGATION OF BOTH THE U.S. CONGRESS AND THE PRESIDENT TO PROTECT THE PRIVATE PROPERTY RIGHTS OF U.S. CITIZENS, WHETHER TANGIBLE OR INTANGIBLE, NO MATTER WHERE THEY ARE LOCATED. HE ALSO IS UNAWARE THAT THE WTO TRIPS AGREEMENT INCORPORATES AND FURTHER ENHANCES THE PROTECTION OF INTELLECTUAL PROPERTY (PATENTS & COPYRIGHTS) ALREADY RECOGNIZED AND PROTECTED UNDER THE TERMS OF TWO WORLD INTELLECTUAL PROPERTY ORGANIZATION (WIPO) AGREEMENTS, SO THAT SUCH PROTECTIONS ARE MORE CLOSELY ALIGNED WITH THOSE PROVIDED FOR UNDER U.S. DOMESTIC LAW. THE DECISION NOT TO ESTABLISH A SUPRANATIONAL WORLD INTERNATIONAL COPYRIGHT AND PATENT OFFICE, WHICH THIS COMMENTATOR FAVORS, WAS CERTAINLY A PRUDENT ONE, IN ORDER TO MAINTAIN U.S. SOVEREIGNTY.]


The trade agency's interpretation of what other countries' domestic laws need to cover expands beyond the broadest definitions within U.S. law. To give one example, data gathered during clinical trials of new drugs are not protected by copyright, patent or trademark in the United States. But as a rule of bureaucratic procedure, the Food and Drug Administration restricts use of test results finding that a brand-name drug is safe when considering the safety of identical generic drugs. Even though it is hard to argue that this FDA rule is an intellectual property law, the trade representative is using its authority to press for comparable rules restricting the approval process for generic drugs in other countries.


[THIS COMMENTATOR OBVIOUSLY IS UNAWARE OF THE COMMON LAW NOTION OF TRADE SECRETS WHICH CONSTITUTE A RECOGNIZED AND ENFORCEABLE PRIVATE PROPERTY RIGHT UNDER THE LAWS OF MANY U.S. STATES. THUS, THE USTR AND FDA ARE MERELY PROTECTING THESE SAME INTANGIBLE PROPERTY RIGHTS HELD BY U.S. CITIZENS FROM UNJUSTIFIED FOREIGN GOVERNMENTAL INTRUSION AND EXPLOITATION AND ‘TAKINGS’, CONSISTENT WITH THE PROVISIONS OF THE WTO TRIPS AGREEMENT, IN MUCH THE SAME WAY THAT SUCH RIGHTS WOULD BE PROTECTED AGAINST U.S. GOVERNMENTAL ACTION UNDER U.S. CIVIL AND CONSTITUTIONAL LAW. INDEED, THE FDA RULES PROSCRIBE THE TAKING OF TRADE SECRETS AND ACTUALLY IMPOSE CIVIL AND CRIMINAL PENALTIES ON GOVERNMENT EMPLOYEES FOR VIOLATING TRADE SECRETS. THUS, THE USTR AND FDA ARE NOT ACTING BEYOND THEIR LEGAL AUTHORITY BY ENSURING THAT FOREIGN GOVERNMENTS DO NOT VIOLATE U.S. CONSTITUTIONALLY PROTECTED PRIVATE PROPERTY RIGHTS.]


It doesn't take much sleuthing to follow the money back to the U.S. pharmaceutical manufacturers on the trade agency's advisory panel, who can maintain monopolist profits while a generic drug is blocked from the market in Guatemala, Malaysia or any of the dozen other countries that the trade agency is pressuring to adopt U.S.-style restrictions on generic drug approval.


[THIS COMMENTATOR IS ALSO ABLE TO TRACE NEW DRUG AND MEDICAL DEVICE DISCOVERIES AND INNOVATIONS BACK TO THE LIFE SCIENCES COMPANIES THAT INVESTED THE $$ AND EFFORT TO INVENT THEM AND SEE THAT THEY RECEIVE THE NECESSARY FEDERAL REGULATORY APPROVALS TO MAKE IT TO MARKET. PATENTS AND TRADE SECRETS ARE BY DEFINITION EXCLUSIVE PRIVATE PROPERTY RIGHTS OF TEMPORARY DURATION].


Proselytizing U.S. intellectual property law would be easier if we knew exactly what U.S. intellectual property law is, but many debates still rage in the courts and in the law journals. Is software patentable? Justice Breyer, Justice Stevens and the U.S. Patent and Trademark Office's semi-judicial board of appeals have clearly expressed that it is not. Yet the trade representative thinks it is, which is why a 2000 agreement with Jordan required that country to change its domestic laws to better accommodate the patenting of software, and its nonbinding reports find fault with countries whose patent systems do not allow software patents.


[THIS COMMENTATOR OBVIOUSLY WISHES TO PORTRAY THE U.S. AND GLOBAL INTELLECTUAL PROPERTY SYSTEM AS UNCERTAIN, UNCLEAR AND BROKEN INORDER TO RECOMMEND AN ALTERNATIVE TO THE PRESENT MARKET-BASED SYSTEM. THAT ALTERNATIVE WOULD ENTAIL CENTRALIZED GOVERNMENT SANCTIONED TOP-DOWN ESTABLISHMENT OF A HEALTH CARE MARKET SYSTEM THAT DETERMINES FOR INDUSTRY AND PATIENTS ALIKE WHAT IS NEEDED, HOW IT IS TO BE DEVELOPED, HOW IT IS TO BE ADMINISTERED AND HOW MUCH THEY SHOULD CHARGE/PAY FOR IT. THIS SOUNDS AN AWFUL LOT LIKE THE SOCIALIZED MEDICAL SYSTEMS CURRENTLY OPERATING IN EUROPE AND CANADA AND IN BRAZIL.]


The U.S. Trade Representative's treaties bind all parties to rewrite their domestic laws accordingly. That is, the agency can dictate how Congress is to write domestic law, and how federal courts interpret it, via its international treaties. We all want intellectual property law to evolve with the times, but every new treaty by the trade agency makes evolution a little more difficult.


[THIS COMMENTATOR OBVIOUSLY IS UNAWARE OF THE RELATIVE ROLES (BALANCE OF CONSTITUTIONAL POWERS AND OBLIGATIONS) BETWEEN THE LEGISLATIVE AND EXECUTIVE BRANCHES AS CONCERNS INTERNATIONAL TREATY NEGOTIATION, RATIFICATION AND ENFORCEMENT. IF THE U.S. CONSTITUTION RECOGNIZES AND PROTECTS U.S. DEVELOPED AND HELD PRIVATE INTELLECTUAL PROPERTY RIGHTS, BOTH WITHIN AND WITHOUT THE TERRITORIAL U.S., THEN EVERY NEW TREATY ENTERED INTO BY THE UNITED STATES MUST CONTINUE TO ENSURE THAT THESE CONSTITUTIONALLY PROTECTED PRIVATE PROPERTY RIGHTS ARE UPHELD ABROAD. ACTUALLY, THE INTERNATIONAL LAW OF INTELLECTUAL PROPERTY RIGHTS IS EVOLVING FOR THE BETTER UNDER SUCH PRINCIPLES, AND NOT FOR WORSE.]


HR4279, now pending in the House Judiciary Committee, would establish an Office of the U.S. Intellectual Property Enforcement Representative, spinning off intellectual property from the trade representative's portfolio into its own office, without repealing the agency's authority to negotiate other countries' intellectual property laws. The new office would have authority to define the scope of intellectual property as it sees fit, and it would have expanded ability to use the resources of other departments (the Department of Justice, the State Department, Homeland Security, state and local governments, and many others) in pressuring other countries to change their domestic laws accordingly.


[H.R. 4279, ENTITLED, THE “PRIORITIZING RESOURCES AND ORGANIZATION FOR INTELLECTUAL PROPERTY ACT OF 2007 – ‘THE PRO-IP ACT’”, IS INTENDED TO STRENGHTEN COPYRIGHT AND TRADEMARK PROTECTION AGAINST FOREIGN & DOMESTIC PIRACY. HOWEVER, IT MAY ACTUALLY GO BEYOND THE TENOR AND SCOPE OF CURRENT IP LAW TO PENALIZE NOT ONLY COMMERCIAL INFRINGERS BUT ALSO ORDINARY CONSUMERS WHO MERELY COPY ALREADY PURCHASED MUSIC CDS AND MOVIE DVDS FOR THEIR OWN PERSONAL USE, AT NO ECONOMIC LOSS TO THE COMPANIES.]


SEE, e.g.,: Paul Devinsky and Rita Siamas, “United States: House Proposes Creation Of An IP Enforcement Czar, Seeks Stronger Trademark And Copyright Enforcement”, McDermott, Will & Emery (Jan. 15, 2008) at: http://www.mondaq.com/article.asp?articleid=55962


The 1994 treaty on trade-related international property defines a simple base for copyright, patent and trademark, and it makes sense for the trade agency to hold countries to the basic framework. But our trade representative has gone well beyond that, to simply interpreting intellectual property as its corporate advisory boards wish, and then using the muscle of the U.S. government and the resources of U.S. taxpayers to press other countries into changing their laws to suit that interpretation. Congress needs to restrict the trade representative's expansive tendencies, instead of releasing what little rein is left.


[H.R. 4279 ARGUABLY REFLECTS THE CONCERNS OF THE MUSIC & ENTERTAINMENT INDUSTRY AND ITS FAILURE TO DEVELOP A NEW BUSINESS MODEL THAT CAN RESPOND AND HARNESS THE EVOLVING DOMESTIC MARKETPLACE. FOREIGN COPYRIGHT & TRADEMARK PIRACY, HOWEVER, POSES A SIGNIFICANT PROBLEM AND CERTAINLY RISKS FUTURE INDUSTRY REVENUES. BUT DOES THIS BILL PROVIDE THE BEST SOLUTION?]


Ben Klemens is a guest scholar in Economic Studies at the Brookings Institution. Brookings is a private nonprofit organization devoted to independent research and innovative policy solutions.


[WHILE AT BROOKINGS, MR. KLEMENS HAS ADVOCATED IN FAVOR OF OPEN SOURCE SOFTWARE, AMONG OTHER THINGS]


http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/17/EDR1V0LCD.DTL

This article appeared on page E - 5 of the San Francisco Chronicle

Thursday, February 7, 2008

EU Supports Flexible Compulsory Licenses for Healthcare, But None for Entertainment or Information Technologies; Is This a TRIPS Double Standard?

http://www.ip-watch.org/weblog/index.php?p=907


EU Threatens Taiwan With WTO Case Over Law On Compulsory Licences


31 January 2008


By David Cronin


Intellectual Property WatchBRUSSELS -


The European Union has demanded that Taiwan change its intellectual property law within two months following a probe into how the East Asian island overruled patents on recordable CDs (CD-Rs).


Philips, the Dutch electronics giant which holds patents for the core technologies used in CD-Rs, filed a complaint with the EU in early 2007 over the activities of a Taiwan-based company Gigastorage.


Since the 1990s, Philips had given licences to use technology for which it held patent rights to several companies in Taiwan. These firms went on to supply about 80 percent of the global market in CD-Rs by the early part of this decade.


While Gigastorage was one of the firms with which Philips had a licence agreement, this accord was scrapped in 2001. Gigastorage subsequently asked the Taiwanese national authorities to enable it to continue making the discs by issuing a compulsory licence. Its request was granted in 2004.


After investigating Philips’ complaint, the EU’s executive, the European Commission, warned on 30 January that it could start dispute proceedings against Taiwan in the World Trade Organization unless its patent law is swiftly amended.


http://ec.europa.eu/trade/issues/respectrules/tbr/pr300108_en.htm



The Commission has objected to a provision in the Taiwanese law allowing national authorities to grant a compulsory licence if a rights-holder has refused a voluntary one.


...According to the EU Commission the provision of the [Taiwanese] Patent Act dealing with compulsory licences was inconsistent with Article 28 of the TRIPs Agreement, because it allows the grant of the such licences where there is no more than a refusal to deal on the part of the patent owner. Further, the Commission services concluded that the interpretation of various procedural requirements relating to the grant of compulsory licences in the decisions of the authorities of Chinese Taipei were inconsistent with Article 31 of the TRIPs Agreement. The Commission services also found that Chinese Taipei had failed to respect the obligation to ensure that the compulsory licences were not used to produce for export, and that in fact they had been predominantly used to produce for export."


[THE EUROPEAN COMMISSION'S OBJECTION TO COMPULSORY LICENSES FOR WHAT ESSENTIALLY AMOUNTS TO A 'FAILURE TO WORK'/ REFUSAL TO DEAL' IS QUITE HUMOROUS GIVEN THAT EUROPE HAS TAKEN THIS POSITION WITH RESPECT TO U.S. PHARMACEUTICAL AND SOFTWARE PRODUCTS SOLD IN EUROPE, AND BRAZIL & THAILAND HAVE DONE THE SAME THING AS TAIWAN WITH RESPECT TO U.S. HIV/AIDS DRUG PATENTS].


...“The EU fully supports the use of compulsory licensing in specific circumstances, in particular to facilitate access to medicines,” said Peter Mandelson, the European commissioner for trade.


“However, we cannot accept the abuse of this system. I hope that the Taiwanese authorities will move quickly to bring their law and practice into line with WTO rules. I cannot rule out seeking WTO dispute settlement if they do not.”


The Commission said that it is challenging Taiwan’s patent law as part of its overall efforts to remove barriers to trade encountered by European firms doing business abroad. In a 2006 strategy paper titled Global Europe, the Commission argued that the protection of European patent rights outside the EU’s borders is essential to guarantee the competitiveness of European industry.


A report prepared by EU officials who examined the Philips’ complaint concludes that “circumstantial evidence” has been found to suggest the Taiwanese authorities are willing to use compulsory licensing as an industrial policy instrument, rather than as a limited exception to patent rights.


[THIS PRACTICE IS OTHERWISE REFERRED TO AS 'IP OPPORTUNISM']


It suggests that a compulsory licence was issued in this case to pressurise Philips into lowering the royalty rates it charged to all CD-R manufacturers in Taiwan. None of the other CD-R manufacturers in Taiwan opposed the advantages given to Gigastorage, it noted.


According to the Commission, the case sets a “terribly dangerous precedent of an industrial policy built on violation of the TRIPS agreement.”


A Taiwanese diplomat familiar with the case said that producers on the island had encountered a “dramatic change” because the international price of CD-Rs has fallen considerably in recent years. Although the Taiwanese authorities had asked Philips to reassess the royalty rates it was charging to reflect this situation, the Dutch firm declined to do so, the diplomat said.


[THIS SOUNDS AWFULLY SIMILAR TO THE BRAZILIAN GOVERNMENT'S ARGUMENT THAT BRAZIL HAS ENCOUNTERED A 'DRAMATIC CHANGE' BECAUSE THE INTERNATIONAL PRICE OF ITS NATIONAL 'UNIVERSAL ACCESS TO HEALTHCARE' PROGRAM HAVE INCREASED CONSIDERABLY IN RECENT YEARS.]


“It might seem odd that the Commission wants us to change the law within two months,” the diplomat continued. “Maybe it just wants to send out a signal not just to Taiwan but to others that it will vigorously safeguard Europe’s intellectual property concerns.”


Despite the Commission’s warning, a preliminary settlement was reached between Philips and Gigastorage in October 2007. The settlement followed a ruling in Philips’ favour, delivered by the US International Trade Commission earlier in the year. The Commission said its aim is a change to Taiwanese law.


http://www.usitc.gov/secretary/fed_reg_notices/337/337-TA-474.Notice.1170697224.pdf


The amount of compensation being paid as a result of the settlement has not been disclosed.


[THE PRIOR SITUATION DESCRIBING THE EUROPEAN UNION'S GROWING DISPUTE WITH TAIWAN OVER THE LATTER'S ISSUANCE OF A COMPULSORY LICENSE AGAINST EUROPEAN COMPANY (PHILIPS) INFORMATION / ENTERTAINMENT TECHNOLOGIES FOR THE PURPOSE OF SECURING A BETTER PRICE MUST BE READ IN LIGHT OF TAIWAN'S PREVIOUS ISSUANCE IN 2005 OF A COMPULSORY LICENSE FOR EUROPEAN COMPANY (ROCHE) MEDICINES:


'Taiwan’s Adventures With Tamiflu’


“In November 2005, Taiwan's government issued a license to allow local companies to manufacture generic versions of Tamiflu -- the only drug in the world considered effective in combatting the effects of bird flu. To date, Taiwan has recorded no cases of bird flu, but according to health authorities, it lies squarely in the path of migrating birds from China...At the time, Taiwan's health authorities stated very clearly that the purpose of the compulsory license was only to stockpile enough Tamiflu to protect against an outbreak of bird flu. But...Taiwan[] [subsequently]...amend[ed] [its] patent laws to allow the export of its generics to other nations


...‘The new provision will relax regulations on drug exportation, so that upon the request of poorer countries, local drug companies may manufacture and export drugs to those countries without the consent of the patent holders...As such, these medicines would be available at a much cheaper price than their authorized versions...


This amendment seems custom-designed to allow companies which are making generic Tamiflu for Taiwan's DOH under compulsory license conditions to make extra money from their participation in the project. And it seems to contradict the DOH's earlier statement made when it was enacting compulsory licensing conditions in November 2005, when it said that any Taiwan-made generic Tamiflu was strictly for local use only and would not be exported to any other country’... [W]hatever gains Taiwan generates with developing nations, it will lose with the developed world...” (Andrew Leonard - Salon 2006)


¨The following compulsory licensing conditions were agreed upon between Taiwan’s DOH and the patent-holder, during negotiations:

§“Taiwan must use Tamiflu supplied by Roche before resorting to using any supply produced under the compulsory license”;

§“The compulsory license could be cancelled if TDOH obtained a voluntary license from Roche during the compulsory period”;

§“The products produced under the compulsory license would be limited to domestic prevention”;

§“Taiwan’s Dept. of Health would provide adequate remuneration to Roche” (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP)