UK Government Must Heed Dutch Audit Court Warning Prior To Implementing 'Open' IT Procurement Action

http://www.mondaq.com/article.asp?articleid=131628
UK Government Must Heed Dutch Audit Court Warning Prior To Implementing 'Open' IT Procurement Action

In the recent Guardian article entitled, Government Takes Action on Open Technology,¹ OpenForumEurope (OFE) president Graham Taylor revels in the UK Government's issuance of a January 2011 Procurement Policy Note that effectively reinstated, at least for the UK, the initial version of the European Interoperability Framework (EIFv1.0), despite its having been roundly rejected by the European Commission and Council of the European Union during December 2010 in favor of technology and business model neutrality.

OFE's IGOR

In alleging that the UK action had "shamed some other European countries", Mr. Taylor, however, shamelessly misrepresented how the UK Government hadn't been "open to lobbying pressure". This is a quite remarkable claim given the New York Times' revelation reported last year that the Brussels-based OFE has long served as a "lobbying front"/mask for U.S.-based industry members IBM, Google, Oracle and Red Hat - a/k/a/ 'IGOR' – which quietly but unsuccessfully endeavored to shape the European Commission's EIF project to suit their own interests. It rings all the more hollow considering the OFE's effective lobbying thereafter of the UK coalition government which was reported to have quickly warmed to its FOSS-centric ideas.² Indeed, given the size of the UK government procurement market (£16.9bn spend) and its growing influence over privatemarket behavior, it is no wonder that OFE's IGOR had worked diligently under cover of night within the UK Government's policy laboratory to align the parties' respective interests for purposes of ensuring that the UK government openly endorsed and expressed a clear preference for royalty-freeopen source software-based eGovernment platforms...

UK’s Promotion of Royalty-Free Government Procurement Standards - NOT AS REPORTED

http://www.mondaq.com/article.asp?articleid=129510

United Kingdom: UK’s Promotion of Royalty-Free Government Procurement Standards Not as Reported

April 14, 2011

By Lawrence A. Kogan

FOSS pundits have made much ballyhoo of the recent Procurement Policy Action Note issued by the UK Cabinet Office of Government Commerce (OGC) during January 2011 that defines 'open standards' as including only those which "have intellectual property made irrevocably available on a royalty-free basis" (emphasis added).¹

As an example, U.S. attorney Andy Updegrove, author of one recent article on the subject entitled,United Kingdom: U.K. Comes out for Royalty-Free Standards for Government Procurement,² waxed poetically about the UK government document's noteworthiness. To paraphrase the author's four main points, the UK government Procurement Policy Note is noteworthy because: 1) it includes informal regional as well as national standards consortia among the internationally recognized specification or standards organizations whose 'open' standards can and should be considered by the UK for government procurement purposes;2) its definition of 'open' standards constitutes a legally acceptable "repudiation" (allegedly consistent with the policy space afforded EU Member State governments vis-à-vis the European regional lawmaking institutions) of and permissible derogation from the final, binding European Interoperability Framework adopted by the European Commission during December 2010, following many years of thoughtful deliberation and contentious debate;3) it emulates and embraces a robust definition of 'open' standards that is very similar to that contained within the national interoperability framework adopted during November 2010 by the Indian Government; and 4) it proves that corporate lobbying and forum shopping undertaken at the EU Member State governmental level on behalf of the 'penguin' (open source) and 'software-as-a-service' (SaaS) industry communities can be successful, at least temporarily.

A closer examination of the UK Procurement Policy Action Note reveals that its ostensible noteworthiness and the author's observations relating to the legal and policy issues surrounding it are more nuanced than they have been depicted...

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].

The Thai 'Takings' Trap

http://online.wsj.com/article/SB120515886199824251.html?mod=3Dgooglenews_wsj

Thai Ministry to Recommend Ignoring Patents on Cancer Drugs

By NICHOLAS ZAMISKA


The Wall Street Journal


March 10, 2008 2:42 p.m.


HONG KONG -- Thailand's new health minister announced Monday that he would urge the Thai government to continue to ignore patents on several cancer drugs, disappointing big pharmaceutical companies that had hoped Bangkok might roll back a policy of overriding patents in the name of public health.


The drugs' makers include Roche Holding AG and Novartis of Switzerland and Sanofi-Aventis of France.


Suphan Srithamma, a spokesman for the Thai health ministry, said that Minister Chaiya Sasomsup has decided to support the previous government's decision to ignore four cancer drug patents in a bid to cut the cost of medicines for the Thai people. The health ministry will make its recommendation to the Thai cabinet Tuesday, according to Dr. Suphan.


Thailand's previous health minister, Mongkol na Songkhla, decided in early January to issue compulsory licenses for four drugs: Novartis's imatinib, also known as Gleevec; Novartis's breast cancer drug letrozole, whose brand name is Femara; Sanofi-Aventis's docetaxel, marketed as Taxotere and used to fight lung and breast cancer; and Roche's erlotinib, whose trade name is Tarceva.


Novartis proposed that same month to offer Gleevec free of charge to poor Thai patients, possibly making a compulsory license unnecessary, according to the ministry of health. A Novartis spokeswoman wasn't available for comment.


Martina Rupp, a spokeswoman for Roche, based in Basel, said the Swiss company's Thai subsidiary is currently in talks with the government "to support greater access to medicines for Thai patients." Ms. Rupp added that Roche "has been, and always will be, open to discussion and dialogue with the appropriate authorities."


Jean-Marc Podvin, a spokesman for Sanofi-Aventis in Paris, said that his company hasn't yet received definitive word from the Thai government, but that "we still remain optimistic" about the negotiations. Mr. Podvin added that Sanofi has "some concerns about the quality of the generic" version of docetaxel, which had world-wide sales of 801.87 billion in 2007, that would be used to replace Sanofi's drug in Thailand.


[SHORT-SIGHTED EUROPEAN DRUG COMPANIES THAT CONCEDE THEIR PATENT RIGHTS TO THE THAI GOVERNMENT, AS AN OPPORTUNITY FOR PHILANTHROPY AND POSITIVE PUBLIC RELATIONS, JEOPARDIZE THE PRIVATE PROPERTY BASIS FOR PATENTS, AND HARM THE OVERALL PURPOSE OF INTELLECTUAL PROPERTY INTERNATIONALLY]


[ALTERNATIVELY, DUE TO THE PRESSURES OF EUROPE'S CULTURE OF CORPORATISM, WHEREIN COMPANIES SET INDUSTRIAL & TECHNOLOGY POLICY WITH GOVERNMENT, THESE EUROPEAN DRUG COMPANIES MAY ACTUALLY BE ASSISTING SOME WITHIN THE EU COMMISSION TO DIMINISH THE VALUE OF PATENTS, FOR POLITICAL PURPOSES. THIS SOUNDS FANTASTIC, BUT IT IS NOT OUT OF THE QUESTION].


Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association --the multinational drug industry's trade group in Bangkok, which counts among its members the three European drug companies whose patents are at stake--condemned the Thai health minister's move.


"This is not good for the country. The image of Thailand will drop further," he said. "They should bring back the image of Thailand as a country that respects" intellectual-property rights.


Ever since a bloodless military coup in Thailand in September 2006, the military-installed government had been battling big pharmaceutical companies, threatening to sidestep their patents on drugs for AIDS and other diseases if they didn't drop the price of their medications. The Thai government argued that since the country's poor population couldn't afford the lifesaving drugs, and the government didn't have sufficient funds to cover their cost, drug companies should put public health before profit and cut the cost of the medications.


The drug companies argued that they had already made price concessions and needed to profit from their inventions to maintain the incentive to innovate. After the country's democratic elections last December, which ushered in a new government, hopes were raised that the new officials would soften the country's hardball tactics, which some within the international drug industry had feared might encourage other developing nations to follow suit and ignore drug patents.


Although members of Thailand's new government worried that the country could face harsh action from the U.S. government unless they rescinded the compulsory licenses, U.S. officials familiar with the situation say there wasn't any plan to retaliate against Thailand.


--James Hookway in Bangkok contributed to this article.

Improve Europe's Business Climate Plus Adopt Regional Patents: This Will Spur Company R&D Investment!!

Improving the Business Climate Will Spur European Company R&D Investments



By Lawrence A. Kogan





March 10, 2008




The synopsis provided by Bruno van Pottelsberghe in his recent Financial Times Leaders & Letters article “Europe must use its head on academic research” (3-7-08) is true concerning the unrealized potential of Europe’s antiquated R&D framework and the lag that it places upon the region’s technological and economic growth, inconsistent with the stated political goals of the Lisbon Agenda.
[SEE: http://www.ft.com/cms/s/0/85f21278-eb97-11dc-9493-0000779fd2ac.html ].


Professor van Pottlesberghe is most correct when he states, “the bottom line is that the EU needs now to adopt a common European patent - under discussion for 30 frustrating years- and spend more, and more wisely, on academic research...” I previously drew a similar conclusion in my article (“European universities learn importance of technology transfer” 9-29-06) in explaining why North American universities’ technology transfer offices had realised ‘a sixfold return’ in R&D spending, far greater than those realized in Europe.



Apart from the monies dedicated to R&D, I then stated that “Due credit must be given to the underlying US common law legal system, which recognises and protects temporary but exclusive private intellectual property right ownership in the know-how that underlies and is reflected in such research. Private intellectual property (e.g. a patent) is important precisely because knowledge is an intangible good that is not readily susceptible to valuation.”
[SEE: http://www.ft.com/cms/s/0/6b48c96c-4f99-11db-9d85-0000779e2340.html ].


However, that is the reality in North America, not Europe. The present ‘free movement of knowledge / ‘fifth freedom’ movement which increasingly pervades European public consciousness is likely to derail the enactment of region-wide patent legislation, just as it already impairs new thinking on how to spur the growth of innovative companies to carry that R&D to market.



I would thus add to my earlier conclusions the observation that government R&D spending and protection of patents alone cannot provide the necessary stimulus for business-driven innovation. What is also essential is the enactment of laws that facilitate entrepreneurship; i.e., the taking of economic risks, such as business formation and expansion, and incentives to reinvest company earnings.



In other words, apart from political rhetoric, European governments must create an actual economic enabling environment that promotes ‘doing business’ in Europe and then get out of the way. Unfortunately European countries, apart from Denmark, Ireland and the UK, which have reduced government funding of R&D, have not been too skilled in this endeavor.



If the 2007 World Bank’s Doing Business Report is any indication, it is only these countries that made it into the ‘top 10’ rankings. Indeed, a review of the report will show that, with respect to each of the following key metrics, most EU member states were laggards - the costs of: starting a business, dealing with licenses, workers, property rights, obtaining credit, protecting investors, paying taxes, cross-border trade, enforcing contracts, and closing a business. http://www.doingbusiness.org/EconomyRankings/Default.aspx?direction=desc&sort=1



To be more specific, only three EU member states besides those mentioned above made it into the ‘top 20’ - Finland (13), Sweden (14) and Estonia (17), while most of the remainder made it into the ‘top 50’ - Latvia (22), France (31), Slovakia (32), Portugal (37), Spain (38), Luxembourg (42), Hungary (45), Bulgaria (46), Romania (48) – with some even falling into the ‘top 100’ - Italy (53), Czech Republic (56), Poland (74) and Greece (100)!



Arguably, this report strongly suggests that the inability of EU member state governments to promote business-friendly enabling environments may correlate positively with EU business’ relatively low investment in research. Therefore, before the participants at this week's grandiose EU summit commence their obsessive over-thinking about the European R&D model, they should also consider how to improve the climate for business. Perhaps, this may provide the true answer to the principal question posed by Professor van Pottelsberghe: “What, then, should the EU and governments do to get business to invest more in research?”

Thai Health Activists Are Misled To Believe Their Government is 'Licensed' to Steal Private Drug Patents From Foreign Investors Pursuant To WTO Law!!

Letter to Editor from Thai Network of People Living with HIV/AIDS, concerning "Bangkok's Drug War, Round Two"


Thu, 6 Mar 2008


Dear Editor,


I am one of the 'packhounds' that you accuse of spreading scare stories in your editorial (Bangkok's Drug War, Round Two) of 27 February 2008. My organization, which consists of people living with HIV/AIDS in Thailand, supports access to necessary drugs for all Thais, not just the rich minority that can pay the prices charged by pharmaceutical companies enjoying monopoly patents.


[THE THAI GOVERNMENT HAS THE LEGAL & POLITICAL RIGHT TO DEVELOP AN HIV/AIDS UNIVERSAL ACCESS TO MEDICINES PROGRAM AT ITS OWN EXPENSE. BUT IT DOES NOT HAVE THE RIGHT TO DEMAND FINANCIAL SUPPORT FROM FOREIGN INVESTORS; OTHERWISE IT RISKS TRIGGERING CAPITAL FLIGHT].


Your article is sadly misinformed. What you call the 'loophole' of compulsory licensing (which is what has kept some of my friends alive) is in fact a piece of international law that was heavily negotiated and agreed by all member countries of the WTO.


[THIS IS NOT TRUE. THERE WAS NEVER A CONSENSUS ON THE SCOPE OF THE COMPULSORY LICENSING PROVISIONS WHICH HAS BEEN EXPLOITED BY FOREIGN GOVERNMENTS AT THE INSISTENCE AND ENCOURAGEMENT OF ACADEMICIANS AND NGOS].


The Thai government did not 'seize' patents; it used the same legal right that many other countries have used, including the United States, whose threats of trade sanctions so worry the new Thai Minister of Public Health.


[WHEN HAS THE UNITED STATES ACTUALLY ISSUED A DE JURE COMPULSORY LICENSE?? PLEASE DO NOT RELY ON THE MISLEADING INFORMATION PROVIDED BY KEI'S JAMIE LOVE].


You claim that the need for access to life-saving HIV, heart disease and cancer drugs is not a clear emergency in Thailand. Cancel the free distribution of drugs made possible through compulsory licences and thousands of Thai will be dead in weeks. The emergency is clear enough to them.


[WITH THIS RATIONALE, ANY DISEASE THAT INFLICTS A SUBPORTION OF A POPULATION WILL BE DESIGNATED AS AN 'EPIDEMIC' UNDER THE EVOLVING WORLD HEALTH ORGANIZATION STANDARDS AND THEN DECLARED A 'HEALTH EMERGENCY' FOR PURPOSES OF TRIPS!!]


And you claim that 'the other side of the argument' is 'missing'. Given the intense lobbying of the new Minister by what you call 'Big Pharma', supported by the US government and enjoying far richer resources than my organization can muster, this is hard to swallow.


[PHARMA COMPANIES HAVE LEGAL ECONOMIC RIGHTS TO DEFEND THEIR EXCLUSIVE PRIVATE PROPERTY, AN ECONOMIC ASSET AGAINST GOVERNMENT EXPROPRIATION. WHY IS IT WRONG FOR THEM TO PROTECT THEIR PRIVATE INTERESTS???]


It took my organization and our allies (in the government, the media, and academia, as well as in other NGOs) a long, long time to get our government to exercise its legal right to compulsory licensing.


Please do not misrepresent our case, bully our government or call us names.


Virat Purahong,
The chairperson of Thai Network of People Living with HIV/AIDS (TNP+)
494 Soi Nakornthai 11
Ladproa 101 Road,
Klongjan, Bangkapi
Bangkok, Thailand 10240
Tel (66)2377-5065 Fax (66) 2377-9719
E-mail : tnpth@thaiplus.net

A One-Side Argument Will NOT Ensure the Health of the Thai People

http://online.wsj.com/article/SB120406606358794697.html?mod=opinion_main_europe_asia


Bangkok's Drug War, Round Two



THE WALL STREET JOURNAL ASIA


February 27, 2008



Thailand's military government may be gone, but its war on drug patents is still very much alive. Just ask the new Health Minister, Chaiya Sasomsup, who is thinking about restoring intellectual property rights to their rightful owners -- the pharmaceutical companies.


Mr. Chaiya, who took office this month, is trying to clean up the mess bequeathed by his predecessor, Mongkol na Songkhla. Citing a World Trade Organization loophole, Dr. Mongkol seized patents on Merck's HIV/AIDS drug Efavirenz in 2006. In 2007, he took another HIV/AIDS patent -- Abbott Laboratory's Kaletra -- and Sanofi-Aventis's patent for a heart drug, Plavix. His last act before leaving office last month was to sign an order to seize four cancer drug patents: two from Novartis, one from Sanofi-Aventis, and one from Roche.


Mr. Chaiya is worried both about Thai patients' access to new drugs and trade sanctions against Thailand for seizing patents. Fair enough: The WTO provision Dr. Mongkol used specifies patent seizures are allowed only after "efforts to obtain authorization from the right holder on reasonable commercial terms and conditions," or in cases of "national emergency." It's unclear that Thailand's actions fit either circumstance.

But woe be to Mr. Chaiya to utter such heresy in Thailand, where nonprofit groups such as Oxfam and Doctors Without Borders have inculcated the public with scare stories about how Big Pharma has it in for Thai consumers. The NGO packhounds immediately flooded the Thai media with scare stories about Mr. Chaiya's proposal, forcing him to do a political backstep last week and say compulsory licensing policy has been "maintained." The matter is still under review.


What's missing here is the other side of the argument.


Many drug companies tier their pricing, charging developed countries more and developing countries such as Thailand, less. Thailand also faces a range of delivery problems that raise the ultimate cost of drugs to consumers, including high taxes on imports. Not least, seizing patents also puts patients at risk of importing nonbranded, lower-quality drugs.



Mr. Chaiya's job is to look after the health of the Thai people, not the political motivations of NGOs. It's clear what serves Thais best: drug companies that are incentivized, through the profit motive, to research and develop new drugs.

Thai Government Commissions Two-Week 'Study' To Find Country-Wide Cancer Health Emergency: Seeks To Justify Compulsory Licenses

http://nationmultimedia.com/2008/03/03/national/national_30067110.php


No cancellation of CL for cancer drugs : Chaiya


by Pongphon Sarnsamak


The Nation.


March 3, 2008

The Public Health Ministry will not revoke the recent enforcement of compulsory licensing for cancer drugs and will retain it as a key mechanism to negotiate with drug firms to reduce product prices, said Public Health Minister Chaiya Sasomsab Monday.

"The use of compulsory licensing must be continued alongside the negotiation with pharmaceutical companies to reduce the price of drug products," he said.


The Health Ministry has to retain compulsory licensing as an important tool to help give patients access to livesaving drugs. But the drugs, upon which compulsory licensing was imposed by his predecessor, Dr Mongkol Na Songkla, had not yet been approved by the previous Cabinet, he said.


Moreover, the Ministry of Commerce had informed him that the compulsory licensing of cancer drugs would affect Thailand's international trade, particularly with the United States, which may designate a country as a "Priority Foreign Country" if it has an adverse impact on relevant US products.


This was the reason why the Health Ministry earlier announced a revision of the compulsory licensing enforcement for cancer drugs.


The drugs for which compulsory licensing was imposed on January 4 are docetaxel, sold as Taxotere by Sanofi Aventis; erlotinib, sold as Tarceva by Roche; and letrozole, sold as Femara by Novartis. All are expensive and the poor could not afford for treatment.


"Some information and the process of the recent imposition of compulsory licensing for cancer drugs was not legal because it was not imposed by Cabinet resolution," he said.


To implement compulsory licensing and not affect international trade, Chaiya had assigned the National Health Security Office, the National Cancer Institute and health experts to calculate the total number of patients suffering from leukaemia and breast, lung and gastric cancer, which would help the ministry estimate the budget for imported drugs.


A study is now in process and is expected to conclude in the next two weeks. The results will then be submitted to the Cabinet for a decision on this controversial issue.


However, he said it is the duty of the Minister of Commerce to make the decision to revoke or retain compulsory licensing.


Government Pharmaceutical Organisation chairman, Vichai Chokewiwat said the recent imposition of compulsory licensing for cancer drugs could not be revoked by the Ministry of Commerce because the 1992 Patent Law's Article 51 allows any Ministry to announce compulsory licensing for the noncommercial use without approval by the Ministry of Commerce.


He said if the government makes a decision to cancel the recent compulsory licensing it would violate the constitution and the National Health Security Office Act, which appoints the government to provide cheap drugs and effective treatment for patients.

KEI Encourages Thai Taking of Private Drug Patents For Government's Own Public Use: Misleads About Law of Compulsory Licenses

http://www.keionline.org/index.php?option=com_content&task=view&id=168


His Excellency
Mr. Samak Sundaravej
Prime Minister
Government House
Nakornpratom Rd.
Dusit, Bangkok
Thailand 10300


His Excellency
Mr. Chaiya Sasomsap
Minister of Public Health
Tiwanont Rd.
Talad Kwan District
Nontaburi Province 11000
Thailand


March 4, 2008


Re: Thailand Compulsory Licenses and public health


Dear Prime Minister Sundaravej and Minister of Public Health Chaiya Sasomsap:


We are writing to address an issue of the utmost importance. Specifically, we urge the Thailand government to support its earlier decision to use TRIPS flexibilities and issue compulsory licenses on medicine patents.


Knowledge Ecology International (KEI) is a not-for-profit organization based in Washington, DC and with offices in Geneva and London, with extensive experience in providing technical assistance to governments and international organizations in the promotion of public health and advocating for the protection of patient interests.


Every sovereign government that grants patents on inventions also provides mechanisms for compulsory licenses. While the grounds for issuing a compulsory license differs from country to country, there is widespread agreement that such licenses are consistent with international law, particularly in, but not limited to, cases involving public health.


We are attaching a report on the use of compulsory licenses by other countries. It not only reports on compulsory licenses on medicines in developing countries, but also on the granting of compulsory licenses in high income countries, such as three recent compulsory licenses on medicines issued in Italy, and dozens of compulsory licenses issued in other fields of technology, such as software, digital television receivers, and automatic transmissions.


[KEI''S VAUNTED REPORT IS INACCURATELY PORTRAYS WHAT A COMPULSORY LICENSE IS AND IS NOT. MR. LOVE CONTINUES TO CONFUSE de jure COMPULSORY LICENSES WITH de facto COMPULSORY LICENSE, AND THEN EXAGGERATES ACTIONS THAT DO NOT CONSTITUTE de facto COMPULSORY LICENSES. HE ALSO MISLED THE THAI GOVERNMENT TO BELIEVE THAT COMPULSORY LICENSES ARE PERFECTLY LEGAL ANYTIME A GOVERNMENT SUBJECTIVELY DETERMINES THERE TO EXIST A PUBLIC INTEREST. THE WTO TRIPS AGREEMENT DOES NOT SAY THIS]


The United States will soon have a new president. All three of the leading candidates, Senators McCain, Obama and Clinton, are critics of the pharmaceutical industry. All three candidates care about access to medicine, and all three candidates are looking to repair and enhance the standing of the United States in the world community. Thailand should not assume that it will suffer if it stands by its earlier decision to issue compulsory licenses.


[BEG TO DIFFER: NOT ALL THREE OF THE CANDIDATES ARE WILLING TO FORCE U.S. CITIZENS TO GIVE AWAY THEIR PRIVATELY OWNED PROPERTY - DRUG PATENTS - TO SUIT THE NEEDS OF A THIRD COUNTRY, AND THEREBY ENDANGER U.S. DRUG INNOVATION PIPELINES. THOUGH, WE ARE WILLING TO BET WHICH TWO OF THE CANDIDATES WOULD BE WILLING TO DO SO!!]


On the other hand, if Thailand now backs down and cancels the compulsory licenses, it will be perceived as an acknowledgment that Thailand did something wrong earlier. It will make it much more difficult to issue compulsory licenses in the future, and it will undermine the relationship between Thailand and suppliers of generic medicines. If Thailand reverses its position, other developing countries will be deterred from using compulsory licenses, and Thailand will be seen as aligning itself with large pharmaceutical companies, against the interests of the poor.


[WELL, IF THE SHOE FITS, WEAR IT! YES THAT IS EXACTLY THE POINT - THE THAI GOVERNMENT WOULD VIOLATE INTERNATIONAL LAW (THE TRIPS AGREEMENT) BY ISSUING THOSE COMPULSORY LICENSES. THE TRUE QUESTION IS WHETHER THE GOVERNMENTS OF THE PATENT HOLDERS HAVE WHAT IT TAKES TO DEFEND THEIR CITIZENS' INTERESTS.]


Members of the U.S. Congress are monitoring the USTR and the Department of State to ensure that the US government respects the 2001 Doha Declaration on TRIPS and Public Health, and does not bully Thailand on this issue. Many public health and development organizations, including KEI, are supportive of the use of compulsory licenses to increase access to medicines in developing countries. Thailand has much to gain by supporting it's earlier decision, and very much to lose by repudiating that decision.


[YES, THAT IS TRUE. MEMBERS OF THE 110TH CONGRESSIONAL MAJORITY HAVE INTRODUCED LEGISLATION THAT WOULD CHANGE U.S. LAW TO PERMIT THE U.S. GOVERNMENT TO DECLARE COMPULSORY LICENSES THAT 'TAKE' U.S. DRUG PATENTS (EXCLUSIVE PRIVATE PROPERTY) AWAY FROM THEIR PRIVATE OWNERS FOR THE BENEFIT OF THIRD COUNTRIES SUCH AS THAILAND, THEREBY ENDANGERING THE U.S. INNOVATION PIPELINE!!]


Sincerely,


James Love
Knowledge Ecology International

Indian Pharma Company Refuses to Register Drug in Thailand Due to Risk of Patent Compulsory License

http://www.bangkokpost.com/breaking_news/breakingnews.php?id=126289


Chaiya favours CL on cancer drugs - for now


Bangkok Post.com


March 3, 2008


Public Health Minister Chaiya Sasomsap insisted on Monday that he intends to persevere with the policy of issuing compulsory licences (CL) for key cancer drugs - but the government may still decide to cancel the patent-busting measure.

Mr Chaiya, who has ordered a review of CL policies on drugs for heart disease, spoke on Monday with representatives from the labour union of the Government Pharmaceutical Organisation (GPO), which is theoretically to break patents and manufacture generic copies of expensive drugs eventually.


He said the issue will be finalised within two weeks, and insisted he will not withdraw the CL ordered on cancer drugs for poor patients.


He said, however, that the final decision on the issue rests with the Commerce Ministry. The public must await the results from the commerce ministry.


Rawai Phupaka, chairman of the GPO Labour Union said that an Indian drug company postponed drug registration in Thailand for another 25 months pending the public health ministry's final decision on the CL.

[EVEN THE INDIAN PHARMA COMPANIES ARE RELUCTANT TO REGISTER THEIR DRUG PRODUCTS IN THAILAND DUE TO THE LACK OF RESPECT FOR PRIVATE PROPERTY-BASED PATENTS. THE IMPRUDENT THAI GOVERNMENT POLICY WILL THUS HARM THE WELFARE OF THAI CITIZENS!]


The postponement, he pointed out, might cause the GPO substantial monetary damages. Until it is able to manufacture the drugs itself, the GPO is to import and resell Indian-made copies of the drugs. (TNA)

In the Thais' Eyes, Drug Patent Holders Must Fund Governments' Political Healthcare Promises

http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php


Head of Thailand's Food and Drug Administration resigns after one week


The Associated Press


Monday, March 3, 2008


BANGKOK, Thailand: The recently appointed head of Thailand's Food and Drug Administration resigned Monday amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs.

Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.


Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and groundless," without elaborating.


Chatree's predecessor, Siriwat Thiptharadon, was transferred to an inactive post last Tuesday by the new government of Prime Minister Samak Sundaravej. Siriwat called his transfer unfair, charging it was because he supported compulsory licensing of drug patents.


Compulsory licensing is intended to make some drugs more affordable by taking away the patent holder's ability to control the drug's price, a benefit of being a drug's exclusive supplier. International trade rules allow a government to issue a compulsory license to manufacture a generic version of a drug only in case of a national public health emergency.




[APPARENTLY UNDER THAI LAW, AS CALLED FOR BY HEALTH ACTIVISTS WHO LOBBIED TO REMOVE THE NEW FDA ADMINISTRATOR, DRUG INNOVATORS THAT DARE TO EXERCISE THEIR PATENT RIGHTS IN THAILAND ARE AUTOMATICALLY DEEMED ILLEGAL MONOPOLISTS. IN OTHER WORDS, A PATENT HOLDER'S EXERCISE OF THE EXCLUSIVE RIGHT TO SELL, DISTRIBUTE AND IMPORT A NEWLY PATENTED DRUG THAT HAS NO COMPETITOR IN THE MARKETPLACE, PROVIDES AMPLE BASIS FOR THE THAI GOVERNMENT TO DECLARE THAT A 'PUBLIC INTEREST' HAS BEEN VIOLATED. CONSEQUENTLY, THE THAI GOVERNMENT, PROMPTED BY ACTIVISTS BELIEVES IT IS PERMITTED TO 'TAKE' IT AWAY FROM THE PATENT OWNER VIA ISSUANCE OF A COMPULSORY LICENSE !!]




Siriwat was the architect of the government's policy leading to the issuing of compulsory licenses on Jan. 4 for four cancer-fighting drugs.


In the past two years, the Thai government has also issued compulsory licenses for several drugs used to treat AIDS and heart disease, drawing criticism from companies holding patents on the drugs.


The drug companies dispute whether the circumstances in Thailand qualify for such licenses.


Newly appointed Public Health Minister Chaiya Sasomsup said Monday the ministry will review the licensing policy on the cancer-fighting drugs, while ensuring patients have affordable access to the medicines.


[AT WHOSE COST, THAT OF THE DRUG COMPANIES?? ARE PATENT HOLDERS, AS A MATTER OF INTERNATIONAL POLICY, NOW RESPONSIBLE FOR FUNDING GOVERNMENTS' PUBLIC HEALTH CARE PROMISES??? WHY DOESN'T THE GOVERNMENT JUST TAKE OVER THE PHARMACEUTICAL BUSINESS & ELIMINATE FREE ENTERPRISE ALTOGETHER??]



He said that if negotiations fail to get drug companies to lower their prices, compulsory licensing would be maintained.


Chaiya earlier said the government planned to review the drug licensing policy because U.S. drug manufacturers might ask Washington to apply trade sanctions against Thailand.


The four drugs issued compulsory licenses on Jan. 4 are Novartis' Imatinib and Letrozole, Sanofi-Aventis' Docetaxel, and Roche's Erlotinib.


Novartis AG and Roche Holding AG are Swiss, and Sanofi-Aventis SA is French.

Health Activists Out to Destroy US Patent System & Give Away US Drug Technologies to the UN: Candidate Hillary Clinton Approves

http://www.huffingtonpost.com/james-love/access-to-medicine-in-dev_b_89151.html




Access to medicine in developing countries -- hoping for 'change'


Posted February 29, 2008 09:53 AM (EST)


For his first seven years, Bill Clinton pursued an aggressive policy of imposing tough intellectual property rules for developing countries, most importantly in the area of new medicines, which were seen as an important U.S. export. In 1994, I began a long effort to address the flaws in this policy, working first with (Huffpo blogger) Rob Weissman, Ralph Nader, and soon a few global public health groups, like Health Action International and MSF, and local public health groups in Thailand and South Africa. In 1998, through 1999, a global campaign advocating the use of compulsory licenses on medicines was launched. By June of 1999, a small but very motivated and informed group of U.S. AIDS activists began a campaign to disrupt the Gore campaign for President, to protest Gore's direct involvement in bullying South Africa over proposed changes in its patent laws.


With very few exceptions,* the U.S. new media had largely ignored this issue, until it became an unexpected but real problem for Al Gore. For the first time, the U.S. public had some information about why the U.S. is resented around the world, on this topic. The United States Trade Representative and the U.S. Department of State, directed by President Clinton and Vice President Gore, were forcing developing countries to impose tough and costly monopolies on medicines, and directly reducing access to medicines needed to prevent death and suffering. As an aside, it was through this issue that I met Arianna Huffington. Although she was then known mostly as a right wing allay of Newt Gingrich, she began writing about the dispute over drug patents in Africa, and more generally about the nature of corporate power, and her columns on this topic helped change U.S. trade policy.


Both Gore and Clinton responded to the pressure from AIDS activists (people like Paul Davis, Asia Russell, Mark Milano, Eric Sawyer, Bob Lederer and many other brave and selfless persons whose names I am ungratefully neglecting) and groups like ours, and by 1999, U.S. trade policy was significantly modified, most dramatically in a well received speech delivered by Bill Clinton on December 1, 1999, on world AIDS day, at a chaotic WTO meeting in Seattle. Gore flipped too, and made peace with the AIDS activists, who then supported his run against George W. Bush.


The changes in Trade policy announced by Bill Clinton in December 1, 1999 began a moderation of a very bad trade policy, but only partly. For example, in January 2001, in his last ten days in office, Bill Clinton authorized a WTO case against Brazil, in order to stop Brazil from issuing compulsory licenses on patents for the AIDS drug efavirenz, an action dubbed "the Merck case" by USTR.


George W. Bush's election was initially not a disaster on the access to medicines issue. Bob Zoellick, then the head of USTR, initially retained the Clinton changes in trade policy, and to make a very long story short, in November 2001, agreed to the Doha Declaration on TRIPS and Public Health, which called for implementing patent laws in manner to promote "access to medicine for all." Unfortunately, drug company CEOs then began meeting directly with Karl Rove, and a much reigned in USTR began a long pro-big-pharma drift that now features regular bullying of developing countries on the drug patent issue.


Looking back, on his worst days, George W. Bush has had a better trade policy on medicine patents than Bill Clinton did on his worst days. But looking forward, it is quite important that the next president make some big 'changes', and allow countries like India, Brazil, Thailand and others to issue compulsory licenses on drug patents.





[ARE THESE THIS THE TYPE OF 'CHANGE' PROMOTED BY THE 'GREAT OBAMA' - GIVING AWAY FUTURE AMERICAN INGENUITY??]





More important, we need to create a new global trade policy based upon public health needs, looking to treaties on research and development, rather than the ever tougher intellectual property rules. Resolutions that would support these changes included Senate Resolution 241, and House Resolution 525.






[SENATE RES. 241 - SPONSORED BY DEMOCRATIC SENATOR SHERROD BROWN (OH): A resolution expressing the sense of the Senate that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=sr110-241]







[HOUSE RES. 525 - SPONSORED BY DEMOCRATIC CONGRESSMAN THOMAS ALLEN (ME): Expressing the sense of the House of Representatives that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=hr110-525 .]







[***THIS IS ACTUALLY A POLICY OF GIVING AWAY AMERICA'S FUTURE TECHNOLOGICAL INNOVATION & ECONOMIC GROWTH TO THIRD COUNTRIES WHICH WILL HOBBLE U.S. LIFE SCIENCES COMPANIES AND RESULT IN ADDITIONAL LOSS OF AMERICAN JOBS AND LOWER STANDARDS OF LIVING***]




We now have three leading candidates for President, and none of them have agreed to co-sponsor Senate Resolution 241. But we have "hope" for good things.






[THIS IS MOST LIKELY BECAUSE THEY DON'T WISH TO BE CRITICIZED, ONE WAY OR THE OTHER, DUE TO ACTIVIST CAMPAIGNS LAUNCHED BY BOTH THE 'EXTREME' DEMOCRATS & THE 'EXTREME' REPUBLICANS].



Hillary has clearly been influenced by a combination of her own sensitivities to the health issue, and the increasingly deep commitment of Bill Clinton, as an ex-president, to address concerns about access to medicine in developing countries. Like many liberal Congressional Democrats, Bill Clinton has often embraced a policy of AIDS exceptionalism on these issues, which focuses on the needs to AIDS patients, but does not necessarily extend this concern to other health problems, such as the need for developing countries to have access to new treatments for cancer or heart diseases.


But many activists believe that Hillary will be very good on this issue if she becomes president. My own 16 year old son actually talked directly to Hillary about this topic, during a February 7 visit she made at an Arlington High School. Senator Clinton took a moment to personally express her support for poor patients having access to new medicines, and she endorsed the use of compulsory licensing of patents to make this possible.




[***BY FAVORING THE ISSUANCE OF COMPULSORY LICENSES AS OFFICIAL U.S. POLICY, FOR THE BENEFIT OF NON-U.S. CITIZENS ABROAD, MRS. CLINTON IS NOW ON RECORD FOR PROMOTING THE DEMISE OF U.S. CONSTITUTIONALLY PROTECTED PRIVATE PROPERTY RIGHTS IN INDIVIDUAL DISCOVERIES & INVENTIONS QUALIFYING FOR CIVIL RIGHT PROTECTION UNDER THE U.S. PATENT LAWS, AS AMENDED, SINCE THE FOUNDING OF OUR NATION. IN OTHER WORDS, SHE HAS DECLARED, CONTRARY TO U.S. HISTORY & SUPREME COURT JURISPRUDENCE, THAT PATENTS ARE NOT PROTECTABLE PRIVATE PROPERTY UNDER THE 'TAKINGS' CLAUSE OF THE 5TH AMENDMENT TO THE U.S. CONSTITUTION.***]



AIDS activists have had some luck in getting Obama to offer some encouraging words on this topic, as it relates at least to AIDS, and his very bright Senate staff has given meetings on the topic, and seem sympathetic.


For both Hillary and Obama, I should emphasize that huge efforts have so far have failed to get either candidate to co-sponsor Senate Resolution 241. This is not entirely encouraging. But we have hope.


John McCain has shown a lot of independence from big pharma on domestic issues, like parallel trade in medicines (importing cheaper brand name drugs from Canada or Europe to benefit U.S. consumers). But he has yet to directly address the trade issue in a constructive way, and the best that can be said is that his unhelpful statements reflect a lack of understanding. But, we hope that if he becomes president, he will do the right thing.


This is a very important issue. Thailand is today being pressured by the U.S. Department of State and the USTR to abandon compulsory licenses it had earlier issued on patents on drugs for AIDS, heart disease and cancer. Brazil is being pressured to not issue a compulsory license for the Gilead drug tenofovir. Chile has been pressured over it's efforts to import generic versions of an expensive leukemia drug. The USTR is pressuring dozens of Latin American countries to abandon a pro-public health position in a far ranging negotiation on public health, innovation and intellectual property at the World Health Organization. The U.S. government is trying to stop the World Health Organization from offering useful technical assistance on patent issues to poor countries, and opposes many measures that would promote greater access to safe generic medicines.


These issues don't directly concern U.S. voters, but they are extremely important. We are creating new global norms that will last several decades, and impact billions of persons throughout the world. For people who don't follow this issue very closely, this is what is at stake. People who live in developing countries typically have average incomes of anywhere from 1 to 20 percent of the US. And, within developing countries, unskilled workers are far below the average. With monopolies, drug companies typically choose prices that are only affordable for the richest 1 to 20 percent of the populations. With generic competition prices fall a lot (More than 95 percent for many important drugs), and access is much better.



[NO. WHAT IS AT STAKE IS AMERICA'S FUTURE INNOVATION & COMPETITIVENESS, BECAUSE ACTIVIST GROUPS LIKE THE ONE JAMIE LOVE OPERATES ARE CALLING FOR U.S. LIFE SCIENCES COMPANIES TO GIVE AWAY THEIR NEW DRUG DISCOVERIES & INVENTIONS TO THIRD COUNTRIES AND WILL HAVE INADEQUATE PROFITS TO REINVEST INTO FUTURE DRUG RESEARCH & DEVELOPMENT. ALSO, U.S. TAXPAYERS WILL BE DIRECTLY AFFECTED, BECAUSE THESE COMPANIES WILL BE FORCED TO RAISE THE COSTS OF THEIR NEW DRUGS IN THE U.S. TO COMPENSATE FOR THE LOSS OF THEIR PRIVATE PROPERTY ABROAD. IN OTHER WORDS, AMERICANS WILL BE CALLED TO SUBSIDIZE THE ENTIRE WORLD'S HEALTH NEEDS BASED ON GENERAL COMMUNITARIAN PRINCIPLES OF PUBLIC INTEREST. SO MUCH FOR THE QUALITY OF LIFE AMERICANS WILL NEED TO SACRIFICE UNDER SUCH PROPOSALS...]


In the global battle over access to medicines, what side are these candidates on? And what changes will they made if elected?


[APPARENTLY, ACTIVISTS, HILLARY CLINTON & BARACK OBAMA ARE AGAINST THE INTERESTS OF AMERICA'S SMALL AS WELL AS LARGE INVENTORS]

********************************************************
Journalists who wrote about US trade disputes before the 1999 Gore Zaps February 29th, 2008 James Love
-------------

In a blog posted today on the Huffington Post, I could have, should have, elaborated a bit on the few U.S. journalists who had written about the trade disputes involving patents on medicines, before AIDS activists began their zaps of Gore's presidential campaign in June of 1999.

I can recall (help me if I am forgetting someone) four journalists who were ahead of the curve. Each had to sell their institutions on the news value of the stories, and have continued excellent reporting on these issues.

* March 29, 1998, Donald McNeil, for the New York Times, "South Africa=E2=80=99s Bitter Pill for World's Drug Makers." A long (more than 2,= 900
words) and informative article about the dispute over parallel trade, written more than one year before others wrote about the dispute.

* April 11, 1999, Lisa Richwine for Reuters, "Groups say U.S. Hurts World Access to AIDS Drugs." The first U.S. wire service article on the trade dispute, Lisa addressed a wide range of technical issues and topics, including even Donna Shalala's refusal to allow Thailand to use the NIH owned patent on ddI.

* April 28, 1999, Merrill Goozner in the Chicago Tribune, "Third World Battles for AIDS Drugs." This long article ran on page one above the fold, with a photo, and was the winner of a Washington Monthly journalism award. The Goozner article was reportedly read by President Clinton on Airforce One, causing him to use the White House staff to immediately track down Sandy Thurman (who was taking a bath in a Hotel) to talk about the issue. Interesting fact: It was in this article that Goozners mentioned the TRIPS provision on national emergencies, leading to thousands of subsequent news stories which implied incorrectly that compulsory licensing could only be done in cases of national emergencies.

* May 24, 1999, Sabin Russell, in the San Francisco Chronicle, "New Crusade to Lower AIDS Drug Costs: Africa's needs at odds with firms' profit motive." A front page story by a knowledgeable reporter on AIDS and other health issues.

KEI Activists Try to Promote Anti-Patent Populism to Prod Politically-Motivated Patent Reforms Reminiscent of Prior Poor Policy Proposals

The following 1886 New York Times Op-Ed was disseminated by James Love of the George Soros-Funded Activist Organization, Knowledge Ecology International (KEI), in an Effort to Persuade US Policymakers & Congressional Representatives How the US Patent System is Broken and Needs to Be Replaced. Sadly, This Effort is Not Only Misguided But also Dangerous to Future U.S. Global Economic & Technological Competitiveness.


The article below is actually demonstrative of the historical ebbs and flows of U.S. patent policy during the late 19th and 20th centuries, as is reflected in additional information provided by the ITSSD following this article.


In the 19th Century, the New York Times on a number of occasions reported and editorialized on various proposals at radical reform of patent laws, including this automatic licensing [COMPULSORY LICENSING] proposal in 1886.


"PATENT LAW AMENDMENTS." The New York Times, February 11, 1886.


Representative Dunn, of Arkansas, introduced in the House on Monday a bill to prevent the establishment of monopolies under the patent laws of the United States. Section 4,884 of the Revised Statutes gives the inventor a complete monopoly of his invention. It provides that, in addition to a description of the invention, every patent shall contain "a grant to the patentee, his heirs or assigns, for the term of seventeen years, of the exclusive right to make, use and vend the invention or discovery throughout the United States and the Territories thereof." Mr. Dunn's bill amends this section by declaring that the grant to the inventor shall be, as now, for seventeen years, but instead of an exclusive and entire property in the invention, it shall cover "a royalty of 10 per centum of all gross sales of the right to make, use, and vend the same throughout the United States." Any person, it is further provided, shall have the right to make, use, and vend the patented article upon payment of the 10 per cent royalty to the patentee or his heirs or assigns.


The principle of Mr. Dunn's bill is sound and its purpose is commendable. It is obvious that some amendment of the bill would be necessary, for patented inventions vary so widely in respect to their cost of construction, the extent of the public demand for them, and the expense of putting them on the market, that a 10 per cent royalty would in many cases be a very insufficient return to the patentee for his expenditures of time, labor, money, and brains. The effect of such a law would be to discourage invention, and that would be a worse evil than the tendency to monopoly which the bill aims to check. The problem is too complicated to be solved in that simple way, but there is not the slightest doubt that a just and workable amendment to the patent laws can be drawn up which would prevent the use of the grants of the Patent Office as a foundation for greedy and oppressive monopolies.


It is high time that the interests of the people as against those of patentees received some consideration and protection. The spirit of the time is hostile to monopolies, and justly so. It is hard enough for the public to bear the exactions of corporate monopolies which have no other warrant than a charter granted under State laws and no protection save that accorded them by bribed legislators and lenient Judges. But that the great seal of the United States should be allowed to confer a license for unlimited extortion is a monstrous wrong. The doctrine that a corporation may demand "what the traffic will bear" is held to be outrageous and wicked. Yet letters patent of the United States at present grant to patentees an absolutely unrestricted right to apply this doctrine to the sale and use of their inventions. Surely there is somewhere a just limit to the profit which a patentee may be permitted to exact from the public under his grant from the Government, a limit which would yield him the due reward of his genius and insure him a full and generous return for his toil and outlay, and yet would protect the people to whom his devices were a necessity from that boundless avarice which experience has shown is often fostered in the favoring and secure shelter of a patent. Such a restriction would not discourage inventors, and it would have the salutary effect of making useful inventions more widely available.


There is one form of extortion under the patent laws, and it is the most common one which ought to be made impossible. The best example of this kind of legalized pillage is furnished by the Bell Telephone Company. That company, protected by a patent whose validity is strenuously disputed, exacts and annual rent of $14 from the local companies for telephone instruments which cost $3.42. That is the whole case in a nutshell of robbery by royalty. As a consequence of this 350 per cent profit and of its great revenues from the local companies, whose stock it holds to the face value of $22,000,000, the capital stock of the Bell Company, according to the statement of Boston newspapers, has been "watered" to seven times its original amount, and still the dividends are 17 per cent upon the enormously inflated capital. No such monopoly as that ought to exist by the sanction of the Government.


There should be most assuredly a well defined limit to extortion in the form of rent or royalty upon patented machines and devices. And the privilege of exacting royalties is one which should never be accorded save with reasonable safeguards. It ought not to be possible for a patentee to exact his own price with no alternative to the user. The latter should have the option of purchase outright in lieu of royalty or rent paid at stated periods; and the permissible royalty or rent would naturally become the basis of the purchase price. A patentee ought to be content to sell his machine or device at a fair price, and the user ought to have the right of absolute ownership in it if he chooses to remunerate the patentee in that way.


James Love, Knowledge Ecology International (KEI)


**********************************************************************************
It is no surprise that U.S. government treatment of patents, copyrights & trade secrets has long been influenced by concerns and fears about economic downturns.


“A Brief History of the Patent Law of the United States”


According to at least legal commentator,


“[D]ifferent attitudes...have prevailed at [] different times and...have had...effects on...the...development of [] patent law...In the last two decades of the nineteenth century there was a period of economic depression and increasing concern about the power of "big business" leading to the passage of the Sherman Antitrust Act in 1890. This climate was reflected in the patent field by an increasing tendency of the courts to hold patents invalid. By the late 1890's the depression had run its course and patents came back into favor with the reviving economy. In general the twentieth century has seen a dynamic interrelationship between the patent system and the application of antitrust laws. Although the first antitrust law, the Sherman Act, was enacted in 1890, the courts did not start to give it teeth until Theodore Roosevelt’s administration (1901-1909). It was not until the 1930's that the patent system started to come under attack, being viewed as assisting in the maintenance of monopolies that were seen as being at least a contributing factor to the economic misery of the thirties. This skepticism about the patent system survived World War II and blossomed again in the depressed economic conditions of the 1970's, a period of strong anti-trust enforcement...In the early 1980's, the thinking of the Chicago School of economists came to the fore and with the election of President Reagan enthusiasm for antitrust enforcement went out of fashion.” (Ladas & Perry, LLP – 2003)



Source: Rediscovering the Value of Intellectual Property Rights, Presented at The 20th Liberty Forum Of Instituto de Estudos Empresariais - iee “Property Rights and Development”, ‘IP in the 21st Century: Challenges & Concerns’, in Porto Alegre, Brazil
April 17, 2007, accessible at: http://www.itssd.org/ppt/IPinthe21stCentury.ppt .

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