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Posted on Categories Featured 116 Comments on Dark days befall health Rights advocates in Uganda

Dark days befall health Rights advocates in Uganda

On Tuesday 5th  June, 2012, Health rights activists filled the constitutional court to get news of a declaration they had sought from Court to interpret Acts and Omissions done by government health workers in Public health facilities as a violation of their rights to life and health respectively.

Their bid to secure a declaration against violation of reproductive health rights was frustrated as it dawned on them that court could not listen to their grievances as it called them “political questions” which should be left to the Executive and the legislature.

“This Court has no power to determine or enforce its jurisdiction on matters that require analysis of the health sector government policies, make a review of some and let on, their implementation. If this court determines the issues raised in the petition it will be substituting its discretion for that of the Executive granted to it by law.” the Judgement reads.

Angry activists walk out of court
Every opinion outside court was freely expressed
Every opinion outside court was freely expressed
Posted on Categories Featured, News 67 Comments on Advocates Reject Constitutional Court’s Ruling that it has no Competence to Address the Crisis of Preventable Maternal Mortality in Uganda: Appeal to Supreme Court Planned

Advocates Reject Constitutional Court’s Ruling that it has no Competence to Address the Crisis of Preventable Maternal Mortality in Uganda: Appeal to Supreme Court Planned

(June 5 2012) Advocates have sharply criticised the ruling by Constitutional Court on whether or not the Court has standing to hear Petition Number 16 of 2011, a landmark case on preventable maternal mortality, the rights of women, the right to health and the right to life.

Justices ruled that the case, Petition Number 16 of 2011, must be dismissed, they believe that they have no competency to hear a case regarding realization and protection of these human rights.

“We are deeply disappointed that Constitutional Court has ruled that it has no standing to address a life and death issue affecting all Ugandans. We feel this is a grave mistake,” said Nakibuuka Noor Musisi of CEHURD and the Coalition to Stop Maternal Mortality. “This ruling means the Court wants the status quo to continue. They are standing in the way of constructive solutions to a crisis.”

“We did not receive the ruling we sought today. However, we are confident that in the near future, the Judiciary will realize its role in addressing the crisis of preventable maternal mortality in this country. We will not be deterred,” said Lillian Mworeko of the International Community of Women Living with HIV/AIDS East Africa. The advocates called for an appeal of the ruling to the Supreme Court. The ruling was in response to a preliminary objection raised by government on 26th October 2011.

The Petition was filed on 3rd March 2011, highlighting the cases of Sylvia Nalubowa and Jennifer Anguko, both of whom died unnecessarily in childbirth. It seeks a declaration that non-provision of essential maternal health commodities and services in government health facilities leading to the death of expectant mothers is an infringement on their rights to life and health.

While this case has delayed, many more preventable maternal deaths continue unchecked—Cecilia Nambozo, Nanteza Irene, Sanyu Kassaga and Sarah Nalukwago and many more. These people died as a result of failed maternal health care system in Uganda.
80% of maternal deaths are caused by severe bleeding, infections, unsafe abortion, high blood pressure and obstructed labor. Lack of access to life-saving HIV treatment is another major contributor to maternal deaths—and results in high rates of mother to child transmission of HIV.

In Uganda, untreated HIV contributes to about one in four maternal deaths—and triple-combination HIV treatment for all pregnant women would substantially reduce maternal mortality (See: Trends in Maternal Mortality, 1990-2008. WHO, UNICEF, UNFPA and the World Bank. 2010). Petition Number 16 of 2011 argues if the government does not provide essential medical commodities and health services to pregnant mothers, it is a violation of the Constitutional rights of Ugandans, including the right to health, and the rights of women.

Posted on Categories Featured, General News 49 Comments on WHO will set generics apart from counterfeits

WHO will set generics apart from counterfeits

By Vineeta Pandey

World Health Organisation (WHO) has adopted a resolution to clearly define counterfeit medical products (CMP) so as to set them apart from genuine generic drugs.

The resolution follows intense lobbying by India at the World Health Assembly (WHA) last week and is seen as a major diplomatic win. The country has worked through back-channel ways at the inter-governmental level for almost two years to pressurise the international organisation.

This also means WHO will limit its role to public health issues and not get into the debate of intellectual property rights (IPR) raised by multi-national companies to block generic drugs from India and other countries from getting into international markets.
Generic drug shipments from India have often been seized at European Union ports on charges of infringing IPR and therefore qualifying as counterfaeit or spurious products.

Sources said innovator pharma companies have used multiple routes, including raising IPR issue with WHO through its arm International Medical Products Anti-Counterfeiting Taskforce, to stop generic drug consignments from India.
In 2009, for instance, a Brazil-bound consignment from India was stopped at Amsterdam.

“The authorities applied definition of CMP for these generic drugs as the history of such drugs showed patents in EU. Hence, they termed it as infringement of their IPR and seized them,” said a Union health and family welfare ministry official.

Such seizures forced India and some other countries to aggressively take up the matter at WHA. Expressing concern over the involvement of WHO’s Western Pacific Regional Organisation in the enforcement activities relating to combating CMPs, India strongly argued that WHO was mixing up issues of public health and private IPR in the context of defining counterfeit drugs.

The Indian delegation, backed by Brazil, Thailand and other BRICS and SEARO nations, sought to limit WHO’s role only to public health and said it should concentrate on affordability and accessibility of drugs rather than be engaged in IPR enforcement issues.

WHO now appears to have put in place a new mechanism with the consensus of all member states to clearly define CMP as “substandard, spurious, falsely-labelled, falsified” drugs to bring uniformity for better global acceptance of these definitions without interrupting the supply of genuine generic medical products in the world.

India is now pressurising WHO to give more funds to strengthen the national regulatory authority for drugs.

Source: http://www.dnaindia.com/money/report_who-will-set-generics-apart-from-counterfeits_1697759

Posted on Categories Featured, News 278 Comments on What’s a counterfeit? And how many counterfeit drugs are there?

What’s a counterfeit? And how many counterfeit drugs are there?

Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: “Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease.” A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html

Unless I missed something, the web based version of the story does not seem to accept comments, but I wanted to make a few comments, hence, this blog.
First, when Donald said:

“About a third of the drug samples from both continents failed. Some were clearly criminal counterfeits, some were expired drugs that had been repackaged and some were poorly made with too little active ingredient”

I was immediately interested in how many were actually counterfeit, as opposed to having false information on the label, or being of low quality. For political reasons, PhRMA and the Chamber plays up the counterfeit angle quite a bit, to justify a very broad intellectual property right enforcement agenda, by mixing together the counterfeit, falsified, substandard or fake drug categories.

The NYT article was reporting on a new study published in the June issue of Lancet Infectious Diseases (Volume 12, Issue 6, Pages 488 – 496, June 2012, doi:10.1016/S1473-3099(12)70064-6). The article is available, for free, here, with the title “Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa.” The authors are Gaurvika ML Nayyar, Joel G. Breman, Paul N. Newton, and James Herrington. According to the study:

Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified. In 21 surveys of drugs from six classes from 21 countries in sub-Saharan Africa, 796 (35%) of 2297 failed chemical analysis, 28 (36%) of 77 failed packaging analysis, and 79 (20%) of 389 were classified as falsified.

The term counterfeit appears 9 times in the body of the article, and 22 times in the 83 footnotes. However, what the authors mean as counterfeit is a broader category of falsified drugs, including cases where any information about the drug is false, including such items as the expiration date or ingredients, wholly independent of any perceived infringements of trademarks or any other intellectual property rights. From the article:

Definitions of drug quality
We obtained data for samples in two categories: drugs failing chemical assay analysis and drugs failing package testing; these categories were not mutually exclusive. No universally accepted definitions exist for the different types of poor-quality drugs and national terminologies are diverse. Some nations, and some of those involved in intellectual property law, are concerned that the word counterfeit could wrongly lead to the classification of some legitimate generic drugs as such, thus creating much debate about terminology.16 WHO’s executive board documents use the undefined and unwieldy term spurious/falsely-labelled/falsified/counterfeit medical products.17 As a simplified and neutral term, we use falsified as a synonym for counterfeit, devoid of considerations of intellectual property. We classify poor-quality drugs into three main types: falsified (fraudulently manufactured with fake packaging and usually no or a wrong active pharmaceutical ingredient); substandard (products resulting from poor manufacturing with no intent to deceive, usually with inadequate or too much active pharmaceutical ingredient); and degraded (good-quality drugs that are degraded by poor storage after leaving the factory).

The authors consider the WHO term of “spurious/falsely-labelled/falsified/counterfeit medical products” to be “undefined and unwieldy,” and assert that it is “simplified and neutral” to “use falsified as a synonym for counterfeit, devoid of considerations of intellectual property.” The authors also endorse a plethora of possible remedies to address the problems of counterfeit, falsified and poor quality drugs.

Given the research on the topic, I am surprised the authors did not appear to appreciate the context of the WHO struggles to develop workable definitions of the various problem drugs, or to appreciate why the term counterfeit is so controversial, when used loosely in news reports and policy debates. While there are many definitions of counterfeits, the term often has a specific meaning in the context of intellectual property laws, typically as an act to deceive the buyer that the product is authorized by the owner of a well known trademark. Probably the most common type of counterfeit drugs these days are those that present themselves as Viagra, Pfizer’s brand of sildenafil citrate, complete with the unauthorized use of the Pfizer and Viagra trademarks. In addition to anything else that may be a problem, such acts are considered criminal violations of Pfizer’s trademark. In the United States, such violations are punishable for anywhere from ten years to life in prison (see below).

While there are undoubtedly cases of both high quality and low quality counterfeit drugs, and a need for governments to pursue such acts, it is not clear how common is the problem of counterfeiting to the more general case of dangerous and low quality drugs, and what should be the focus of government interventions.

The pharmaceutical industry has painted a picture of counterfeiting that in some news reports would include a huge percentage of all drug sales in developing countries, and this is used to justify all sorts of remedies that have certain predictable impacts on legitimate trade in generic drugs, including greater surveillance of the markets for unbranded and unpatented chemicals used to manufacture generic drugs, more onerous border enforcement of alleged intellectual property infringements, and greater third party liability for sales of chemicals or generic products that are alledged to have infringed both trademarks and patents. These intellectual property debates are important by themselves, and should be informed by better empirical data regarding the nature and extend of true counterfeiting.

The problem of falsified and low quality drugs is much broader than counterfeits, and, KEI assumes, involves a much larger share of the problem drugs. There are also other issues, such as the suppression or falsification of information about drug safety and efficacy, and the selling of legitimate products in ways that are illegal and unethical. These problems are common in all levels of the drug business, as one can easily verify by using such Google search terms as: pfizer violation (780,000 hits), Merck criminal sanction (2,060,000 hits), or FDA fines GSK (905,000 results), to mention a few. For Malaria drugs in Asia and Africa, a huge part of the problem comes from persons selling low quality drugs under brands that are not famous, and using the names of companies that may not even exist.

These are not trademark counterfeiting problems, but rather quality regulation problems.
If the regulatory shortcomings are the leading cause of health risks, why has the policy focus been on the intellectual property issues, such as the new Anti-counterfeiting Trade Agreement (ACTA), or the intellectual property chapter of the Trans Pacific Partnership Agreement, or the USPTO training programs? Why has the WHO pre-qualification program been so weakly funded? Why don’t global and local actors focus on measures to restore confidence in legitimate generic drugs?

The recent article in Lancet is another in a series of papers that sheds little light on the extent of the true counterfeit problem, by describing counterfeits as a synonym for falsified drugs, as if the distinctions don’t matter to anyone. In any case, the authors don’t shy away from discussing causes and remedies for falsified/counterfeit products.
Consumption of falsified antimalarial drugs is related to self-treatment through the unregulated private sector, the cost and inaccessibility of good-quality antimalarial drugs, the scarcity of drug regulation, and the absence of punitive measures for counterfeiters.

The economic incentives for criminals of drug falsification surpass the risks involved in their production and sale. Free trade zones with lax regulation promote increased access to drugs and could be pathways for informal agreements, illegal trade, corruption, and covert practices.20, 53, 54 Legal approaches to combat falsified drugs, where they exist, are only applicable nationally, which makes penalising of international trade in falsified drugs even more challenging. No universal jurisdiction allows prosecution of international traders in falsified drugs.

The complaint about the lack of international jurisdiction for “legal approaches” strikes us as odd, in that nearly all civil and criminal sanctions are based upon national laws, and like other illegal acts, there are a variety of ways that governments cooperate and resolve these jurisdictional issues, including via extradition for criminal prosecution, or enforcement of foreign judgments in civil matters. This current approach certainly has its flaws in terms of civil and criminal law enforcement objectives, but this is hardly limited to counterfeit or falsified drugs. Also, the Lancet article seems poorly informed as regards global norms on both civil and criminal sanctions against at least counterfeit products.

Interestingly, the authors make no mention at all of the new Anti-Counterfeiting Trade Agreement (ACTA). Perhaps more importantly, the WTO Agreement on Trade Related Aspects of Intellectual Property Rights already offers requirements as regards both civil and criminal sanctions. For example, consider Article 61 of the TRIPS:

SECTION 5: CRIMINAL PROCEDURES
Article 61

Members shall provide for criminal procedures and penalties to be applied at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale. Remedies available shall include imprisonment and/or monetary fines sufficient to provide a deterrent, consistently with the level of penalties applied for crimes of a corresponding gravity. In appropriate cases, remedies available shall also include the seizure, forfeiture and destruction of the infringing goods and of any materials and implements the predominant use of which has been in the commission of the offence. Members may provide for criminal procedures and penalties to be applied in other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale.

Note that the TRIPS makes it mandatory (“shall provide”) to provide for “imprisonment and/or monetary fines sufficient to provide a deterrent,” for “wilful trademark counterfeiting . . . on a commercial scale.” If it is true that any of the 155 WTO members are not in compliance, the US government, which is highly focused on counterfeits these days, has the opportunity to file a WTO case. Why hasn’t this happened in the context of counterfeits? Perhaps because the lack of official legal sanctions is not as is implied in the Lancet article. It is possible, and indeed likely, that the problem is not so much the lack of a legal basis for sanctions, but the lack of resources devoted to enforcement of existing laws.

In developing countries, that lack of enforcement of civil and criminal sanctions is a problem, not only for falsified drugs, but for all sorts of other issues, including basic security and protection from acts of violence against individuals, white collar crime, etc. To mobilize significant resources and extraordinary global legal regimes to counter an apparent emergency in terms of falsified and counterfeit products, it would have been helpful to have unpacked the data a bit more, and recognized that remedies for dealing with counterfeits of trademarks on a commercial scale (what many call “true counterfeits) is a different problem than other issues about “falsified” products. It is also important to appreciate the dual motivies of the pharmaceutical industry in pursuing this agenda, at this time.
A number of corporate intellectual property right holders, not only in the medicines area, are lobbying governments for stronger IPR enforcement measures. These lobby groups present dangerous drugs as the core motivating factor for legislation that has little to do with solving the bulk of the substandard and dangerous drug problem, and they also seek to introduce measures the undermine the trade in high quality legitimate generic products. One risk is that the various anti-counterfeit drug initiatives will be used to further undermine legal parallel trade in branded drugs. Another is that surveillance of trade in unpatented and unbranded chemicals will be used to further expand monopoly power. To appreciate the risks, consider three recent cases.

When Thailand started manufacturing its own version of the AIDS drug ddI, Bristol-Myers Squibb put pressure on its supplier of unpatented APIs. BMS was a bigger customer of APIs than the Thai government, and the Thai government had to find a new supplier — one that BMS would not pressure. When Roche faced exploding demand for generic Tamiflu, a drug off patent in many developing countries, it also used its market power in the API market to cut off generic producers. A similar strategy was used by BMS in the markets for generic version of the unpatented cancer drug paclitaxol.

Many of the efforts to address the security of the supply chain for medicines are motivated by public health concerns, but to ignore the other motivations is to ignore a lot. If authors systematically see the problem in ways consistent with drug company lobbyists, they are not seeing the whole picture.

WHO to convene meeting in Buenos Aires, Argentina

The 65th World Health Assembly (WHA) of the World Health Organization (WHO) recently adopted the text of resolution (EB130.R13) on substandard/spurious/falsely-labelled/falsified/counterfeit medical products. The resolution establishes a member state mechanism “for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding “substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products” .

The first meeting of this WHO member state mechanism will take place in Buenos Aires, Argentina on November 19, 2012.
US sanctions for trafficking in counterfeit goods.

18 USC § 2320 – TRAFFICKING IN COUNTERFEIT GOODS OR SERVICES
(b) Penalties.—
(1) In general.— Whoever commits an offense under subsection (a)—
(A) if an individual, shall be fined not more than $2,000,000 or imprisoned not more than 10 years, or both, and, if a person other than an individual, shall be fined not more than $5,000,000; and
(B) for a second or subsequent offense under subsection (a), if an individual, shall be fined not more than $5,000,000 or imprisoned not more than 20 years, or both, and if other than an individual, shall be fined not more than $15,000,000.
(2) Serious bodily injury or death.—
(A) Serious bodily injury.— Whoever knowingly or recklessly causes or attempts to cause serious bodily injury from conduct in violation of subsection (a), if an individual, shall be fined not more than $5,000,000 or imprisoned for not more than 20 years, or both, and if other than an individual, shall be fined not more than $15,000,000.
(B) Death.— Whoever knowingly or recklessly causes or attempts to cause death from conduct in violation of subsection (a), if an individual, shall be fined not more than $5,000,000 or imprisoned for any term of years or for life, or both, and if other than an individual, shall be fined not more than $15,000,000.
(3) Counterfeit military goods or services.— Whoever commits an offense under subsection (a) involving a counterfeit military good or service—
(A) if an individual, shall be fined not more than $5,000,000, imprisoned not more than 20 years, or both, and if other than an individual, be fined not more than $15,000,000; and
(B) for a second or subsequent offense, if an individual, shall be fined not more than $15,000,000, imprisoned not more than 30 years, or both, and if other than an individual, shall be fined not more than $30,000,000.

Source: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html?_r=1

Posted on Categories Featured

Open Letter to Patent Office, on Its War Against the Global Poor

On Wednesday, on behalf of the U.S. government, the U.S. Patent and Trademark Office delivered a blistering attack on developing countries use of compulsory licenses for medical patents (Copy of U.S. statement available here.) This what we thought of the USPTO statement:

Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and health
May 25, 2012

To each and everyone who worked on the SCP submission:

This letter outlines our concerns to the May 23, 2012 statement to the 18th Session of the World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents (SCP), on the agenda for patents and health.

In its opening, the USPTO said the following:

“Some of the public health issues facing developing and least developed countries (DC/LDCs) include neglected diseases, the spread of TB, malaria and HIV/AIDS, and availability of medicines to treat these and other ailments. There is no easy solution to these problems. Reducing patent protection is not likely to solve these thorny issues. Furthermore, the notion that all developing countries face identical challenges and should apply the options that exist under international agreements in a single way – or that access to medicines would be enhanced by such an approach — has been rejected by many WIPO member states, including developing nations.”
Are you trying to say that reducing patent protection for AIDS drugs in developing countries did not enhance access to medicines? If so, where have you been the past 15 years? DHHS says the PEPFAR program pays on average 37 cents per day for ARV drugs to treat HIV/AIDS. Were you aware that by 2001, some 24 countries in Saharan Africa had granted patents on nevirapine and more than 30 had granted patents on 3TC, and that South Africa had patented d4T, and the brand name price for an ARV regime of these products was priced at more than $10k, in South Africa? Did you know that most patients in the PEPFAR program were using fixed dose combinations of these drugs, manufactured by generic drug manufacturers that benefited from compulsory licenses in South Africa and in many Subsharan Africa countries, including the LDC countries in Africa that used paragraph 7 of the Doha Declaration on TRIPS and Public Health to ignore patents on these products? Do you know how many people in Africa and other developing countries were receiving AIDS drugs in 2001 and how many are receiving AIDS drugs today?

Did you know that Mitch Daniels said, when serving as director of the Office of Budget and Management, that PEPFAR would not have been set up if the U.S. had to pay the brand name prices for patented AIDS drugs, and the possibility of using cheap India generic drugs made the PEPFAR program possible?

Is it your conclusion that Thailand did not expand access to patented medicines for AIDS, heart disease and cancer when it granted compulsory licenses on the patents for these products?

Is it true, in other words, that “reducing patent protection is not likely” to enhance access? Or is this a blatant falsehood, which the USPTO has expressed during the WIPO session on patents and health?

Is it true, as USPTO asserts, that:

“Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care, because many other factors other than patents more directly affect the availability of medicines.”
In the case of HIV/AIDS drugs, is this true? Is this true for cancer drugs in the developing world? We mean, is it really “not a productive approach to improving availability” of care? And even if other factors are also important, as they surely are, is your point is that poor countries should ignore high prices, and focus all of their attention on solving every problem but high prices?

How much access to herceptin, the patented biologic drug for breast cancer, exists in developing counties? How many patients in India received access to Bayer’s version of the patented cancer drug Nexavar? Is it really, as USPTO claims, “not a productive approach” to override strong patent protection when cancer drugs are priced at $50k to $70k per year in a developing country? Do you have evidence that these drugs can be made accessible in developing countries at these high prices? Or, does the USPTO believe that people in developing countries do not need treatments for cancer, either because they somehow never develop cancer during their lifetimes, or their lives are not worth the cost of receiving the medicines?

We don’t want to be repetitive, but its hard not to when addressing repetitive assertions that strong patent rights do not present problems for access that are contained throughout the 1,200-word USPTO statement on patents and health.

We were surprised that the USPTO continues to raise the paucity of patented medicines on the World Health Organization’s List of Essential Medicines, as evidence that patents do not harm access to medicines, because “their availability in many markets is still limited.” Yes, it is true. In countries where incomes are low, there are all sorts of problems, and not only a lack of access to essential drugs, but sometimes not enough food, or decent shelter, or education opportunities. But as indebted as we are to this brilliant insight, you of course leave out the more important insight, which is that the lack of patented drugs on the WHO list of essential medicines is not an accident, but rather a direct consequence of the impact of the patents on the prices for these medicines. Thus, as you know from our previous conversations and formal communications to WIPO on this topic, the most recent cancer drug on the WHO model list is an off-patent drug registered with the FDA in 1996. Does the USPTO appreciate or even care what it means when the global health authorities tell poor people that none of the cancer drugs developed since 1996 are “essential,” because they are too expensive to be cost effective when treating poor people? Is this what the Obama Administration endorses, a system of extremely unequal access to cancer drugs?

Does the USPTO believe that “Conducting a study on the positive impact of patent systems in providing lifesaving medicines to developing countries” is anything more that defending the indefensible, and using the power of the Obama Administration against the developing countries who have tried to fight the pharmaceutical company’s most egregious abuses in terms of pricing and anti-competitive practices?

As regards the USPTO objections to compulsory licenses, and your advice to developing countries to avoid their use, can you explain why the Obama Administration supported a mandatory compulsory licensing provision in the U.S. biologics pathway legislation passed as part of the health reform legislation, and if the Obama Administration expressed any opposition to these six compulsory licenses on medical technologies that were granted by courts in the United States?

2006: Voda v. Cordis Corporation

2007: Innogenetics, N.V. v. Abbott Labs

2009: Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates

2009: Medtronic Somafor Danek USA, Inc. v. Globus Med., Inc.

2010: Johnson & Johnson Vision Care, Inc., v. Ciba Vision Corp., 712 F. Supp. 2d 1285 (M.D. Florida 2010)

2011: Edwards Lifesciences AG and Edwards Lifesciences LLC, Plaintiffs, v. CoreValve, Inc. and, Medtronic CoreValve, LLC, Defendants. C.A. No. 08-91-GMS. United States District Court, D. Delaware., February 7, 2011.
Since the USPTO and apparently the rest of the Obama Administration is in complete denial of the harsh consequences tough IPR protections on medicines, allow me to point out that the George W. Bush Administration:

Embraced President Clinton’s executive order protecting the right of sub-Saharan Africa countries to grant compulsory licenses and use other TRIPS flexibilities to protect access to medicines (Executive Order 13155),
Negotiated the 2001 WTO Doha Declaration on TRIPS and Public Health,
endorsed a new amendment to the TRIPS agreement to expand the ability to use compulsory licenses to export medicines,
Set a system for the FDA to approve the registration of generic medicines to treat AIDS that were produced under compulsory licenses,
Set up the PEPAR program and allowed it to become the world’s largest consumer of products manufactured under compulsory licenses,
Agreed, on May 10, 2007, to introduce public heath safeguards in the intellectual property chapters for developing country FTA agreements (a policy recently abandoned in the TPPA negotiation), and
Negotiated and agreed to the 2008 World Health Organization Global Strategy on Public Health, Innovation and Intellectual Property.
As pleased as we all are that Barack Obama is now president, the Administration seems to be leading a march backwards as regards policies for the poorest and most vulnerable people on earth. At WIPO this week, the USPTO is lending its considerable power and prestige to launch new attacks on the welfare of poor people in developing countries.

All governments are huge institutions, and the U.S. government is particularly large. Often decisions are made by groups of officials, each operating under somewhat different mandates and motivations. When there is a moral vacuum at the top, as is the case for the White House on matters concerning intellectual property and access to health care in developing countries, there is a risk that your own efforts will contribute to an outcome that you cannot in good conscience justify to your neighbors or families. Given the raw nature of corruption in the way that political campaigns are financed these days, it is not surprising that an agency like the USPTO has become an enemy of moral values and basic decency — abandoning even the more compassionate values embraced by conservative political figures like George W. Bush. But as individuals, you have to make some choices. When you fail to object to offensive statements such as the one delivered to the SCP on Wednesday, you become part of a large failure — the failure of ordinary people to recognize and resist the worst and most brutal acts by the powerful against the weak. You can do better.

Sincerely,

James Love, Knowledge Ecology International
Thiru Balasubramaniam, Knowledge Ecology International

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