WE NEED YOUR HELP TO PROTECT AND EXPAND FUNDING FOR HIV/AIDS, TB AND MALARIA!
In the next week, both the U.S. House of Congress and the Senate will be taking action on the section of the budget that allocates money to fight global AIDS, TB and Malaria. The subcommittees for State and Foreign Operations will be voting on their specific appropriations bill, before it moves up to a vote in the full House and Senate. The House is scheduled to vote on THIS FRIDAY, JULY 19TH, while the Senate is likely to vote next week, as early as TUESDAY, JULY 23RD. The full committee mark-up will take place on July 25th.
In the next few days, we need all hands on deck to remind the appropriators on the State and Foreign Operations Subcommitees that funding for HIV/AIDS and global health is crucial to saving lives across the world.
CALL THE CONGRESS MEMBERS AND SENATORS ON THE STATE AND FOREIGN OPERATIONS SUBCOMITEES TODAY!
Do you live in the district of any of the legislators below? GLOBAL HEALTH JUSTICE GOLD STAR AWARD If you can make phone calls, AND set up an in-person meeting with the staff of your legislator either in district or in DC.
CALL IN SCRIPT:
First, ask to speak to the person in the office who works on "foreign operations appropriations and global health issues". Record the name of the person you speak with, and jot down their answer.
"My name is __________ and I am calling from ( town, state ) and am a member of (your organization, school chapter, church or service provider group). As you've seen previously, science has shown us that increasing the number of people on HIV treatment will turn the corner and bring an end to the global AIDS epidemic, stop HIV infections and give a normal productive life to people already living with the virus. We need you to stand up and lead the effort to finish the bipartisan work started by President Bush and continued by President Obama, by fully funding PEPFAR and the Global Fund during the upcoming [House/Senate] Foreign Operations Appropriation votes. Will you propose or at least vote for $4.58 Billion for PEPFAR and $1.65 Billion for the Global Fund in committee? Will you and [the member of congress] meet with us during the August recess to discuss this further? Creating an AIDS-free generation is a big priority for the US around the world, and for us here back home."
After you call, email us to let us know! Email this or any questions or comments to Paul Davis at firstname.lastname@example.org
Below is a list of important legislators. These are the most important targets to call right now. Call Congressional Representatives today FIRST, then move on to the Senators! The most important targets are in bold.
HOUSE OF REPRESENTATIVES:
State, Foreign Operations, and Related Programs Subcommittee Members to Call
• Kay Granger, Texas, Chairwoman: TOP PRIORITY - (202) 225-5071 | (817( 338-0909
State, Foreign Operations, and Related Programs Subcommittee Members to Call
• Senator Dick Durbin (IL) - (202) 224-2152 | (312) 353- 4952
• Senator Mary Landrieu (LA) - (202) 224-5824 | (337) 436-6650
• Senator Jeanne Shaheen (NH) - (202) 224-2841 | (603) 647-7500
• Senator Mark Begich (AK) - (202) 224-3004 | (907) 271-5915
• Senator Chris Coons (DE) - (202) 224-5042 | (302) 573-6345
• Senator Lindsey Graham (Ranking) (SC): TOP PRIORITY (202) 224-5972 | (864) 250-1417
• Senator Mark Kirk (IL): (202) 224-2854
Congressional Letter Challenging Indian IP Policy Falsely Condemns Protectionism While Trouble-Shooting for Big Pharma
by Professor Brook K. Baker, Health GAP Senior Policy Advisor
On June 18, 2013, 170 Members of Congress wrote to President Obama complaining about Indian trade policy and more particularly India's intellectual property "climate." Under the umbrella of claiming that policies of the Government of India favor domestic producers over U.S. Exporters – in other words, that India is protectionist – the Members of Congress claimed that "the intellectual property (IP) climate has become increasingly challenging in India."
In particular, the letter complained about IP issues affecting pharmaceuticals: "For example, last year several biopharmaceutical companies inappropriately had their patents revoked or their appeals denied by the India courts to market a variety of life-saving drugs in India. Additionally, the Indian Government issued its first compulsory license (CL) on a stage three liver and kidney cancer drug. It has been reported that additional drugs may be subject to CLs imminently and that the decisions related to these CLs are being improperly driven by an interest in growing the pharmaceutical market in India. These actions by the Indian Government greatly concern us because innovation and the protection of intellectual property are significant driving engines of the U.S. economy."
Under the WTO TRIPS Agreement, India has every right to define standards of patentability so long as they satisfy minimum standards of patentability set forth in TRIPS, namely novelty, inventive step, and industrial activity. India has elected to define and apply standards of patentability rigorously. When this rigorous standard is applied in India, it prohibits patents on secondary patents involving new uses of existing medicines or minor modifications of existing medicines/active ingredients that do not significantly enhance therapeutic efficacy. Although Members of Congress and Big Pharma executives, including those from Novartis and Pfizer, condemn an Indian decision denying a patent on secondary form of the anti-cancer medicine Glivec, they neglect to acknowledge that both Novartis and Pfizer have received hundreds of patents on medicines in India in the past 8 years and that it is only the frivolous or unworthy patents that are being screened out. Moreover, rather than serving domestic producers, the Novartis decision in India would allow imports of Glivec from any of the other 160 countries in the world that also do not presently have patents on Glivec.
The U.S. is notorious with respect to the ease by which pharmaceutical companies extend their patent monopolies on medicines by seeking secondary or "evergreening" patents, what is euphemistically called patent lifestyle management in polite Pharma circles. These kinds of patents can add decades to the 20-year period of initial patent exclusivity. Yet even in the United States, the Supreme Court, academics, and other policy makers are beginning to question the wisdom of weak U.S. standards for patents and the impact of lax patent standards both on affordability and the ecology of innovation. Thus, the Supreme Court has recently tightened standards on inventive step, prohibited patenting of naturally occurring genes, and questioned the competitive impact of sweetheart deals that delay generic entry. Instead of trouble-shooting for Big Pharma, Congress should turn its attention to revising standards of patentability upward in the U.S., reducing patent thickets, and restricting patent trolls. Maybe then we could get some of our bloated healthcare costs under control and reduce the federal deficit and the pharmaceutical-tax on productivity.
Likewise, the WTO TRIPS Agreement allows India and any other country to issue compulsory licenses on any grounds they want to as long as certain procedural safeguards are followed. Using fully lawful compulsory licensing procedures, India did issue a compulsory license on an overpriced Bayer cancer medicine, citing three justifications in a 60-plus page decision: excessive pricing, failure to supply the market, and refusal to produce locally. As a result of this license, the cost of the cancer medicine has now fallen more than 97%, showing the excess mark-up that Bayer imposes on patients. Rather than acting arbitrarily, the legal system in India allows a court review of the compulsory license decision, which Bayer is now pursuing. Moreover, instead of acting protectionist in a trade sense, India is protecting public health, public resources, and common sense in the face of monopoly pricing.
Although Members of Congress and Big Pharma companies are complaining about the issuance of compulsory licenses, the U.S. has perhaps the easiest system in the world for issuing government use licenses (by any government official or federal contractor) and has used these rights on hundreds of occasions. Although there are not routine rights for compulsory licenses for all sectors of the economy on pharmaceuticals, there are CL provisions with respect to other technologies, and the U.S. maintains rights to march-in and grant licenses with respect to IP generated with federal resources.
It is deeply ironic when the world's biggest wolf cries wolf. Any objective examination of U.S. trade policy, including that represented in the current negotiations of the Trans-Pacific Partnership Agreement, would conclude that the U.S. is relentless in its pursuit of heightened standards of patentability, data protection, and enforcement in order to protect the interests of Big Pharma and other IP-intensive domestic industries. Over 600 industry representative sit on advisory committees to the U.S. Trade Representative having privileged access to otherwise secret trade agreement proposals. It's an affront to democracy that the first Member of Congress gained access to the text of just three sections of the proposed TPPA just this past week, while industry reps have been able to lobby U.S. trade negotiators constantly for three years to advance their monopoly interests. It's an insult to our collective intelligence when Members of Congress misleadingly condemn alleged "protectionism" in India while tolerating monopoly encroachment globally and doing so to protect "jobs and investments" in the United States.
We could only wish that more countries, including our own, would emulated India's IP policies. Maybe then we would have more affordable and equitable access to global public goods like medicines, maybe then Medicare would not be bankrupted, and maybe then the fruits of prosperity would not be siphoned off to IP rent-seekers who deliver so little in terms of innovation despite massive monopoly-based profits both here and abroad.
LDC and Civil Society Coalition Win a Partial Victory in Extending LDCs Freedom from Oppressive Intellectual Property Rights
LDCs stood together and won a partial victory at the World Trade Organization delaying the time within which they must become fully compliant with global minimums for protecting patents, copyrights, trademarks, and other forms of intellectual property. Although they committed to deliberate carefully, they won back policy space to reduce existing levels of intellectual property protection if appropriate in order to develop a viable technological base and to overcome severe and lingering capacity constraints. This same policy space will permit them to access more affordable medicines and medical technologies, educational resources, agricultural inputs, and green and climate control technologies.
Europe and the US, home of powerful intellectual property industries including pharmaceuticals, publishing, movie and recording, information technology and other, tried to force LDCs, the poorest countries in the world, to open their weak economies to monopoly protections for IP-based multinational corporations. At first the US and EU wanted to split up the LDCs coalition and speed up implementation of select IPRs, but LDCs held firm in demanding what they are fully entitled to under international law - an unconditional extension of the time period within which to become compliant with the WTO TRIPS Agreement until any particular country is no longer an LDC with no guarantee that they would maintain even existing levels of IP if it were not in their interest to do so.
At the same time that the US and EU were exerting massive backroom pressure on LDCs, often with the assistance of the TRIPS Council Chair, civil society organizations, health activists, academics, international organizations, and others rallied to support the LDCs. They exposed the intellectual dishonesty of the big powers' position and demonstrated global solidarity in support of poor people in the world's poorest countries.
In the end, the US and EU did enforce some compromises, including a duration of this extension for only 8 years (though LDCs will be entitled to further extensions in the future) and LDCs expressed their unenforceable "determination to preserve and continue progress towards implementation of the TRIPS Agreement." But 8 years is a victory in light of the US endgame insistence on only a 5 year extension, and the expression of "determination" is modified by a separate sentence entitling LDCs to make "full use of the flexibilities in the TRIPS Agreement to address their needs including to create a sound and viable technological base and to overcome their capacity constraints," which in this case would include the flexibility under Article 66.1 to rollback existing levels of TRIPS compliance.
Countries now have to use the policy space they have fought for and won. Many LDCs still need to enact IP reforms that allows unrestricted access to essential public goods. They can be selected, but they shouldn't simply maintain the colonial IP systems that they inherited, nor should the follow the siren song of WIPO and other IP fundamentalistic who claim that IP is good for you - just close your eyes and swallow. To the contrary, virtually all the theoretical and empirical evidence on this questions finds that IP impedes rather than helps the development project in low income countries.
In addition, LDCs and their allies will have to begin early to win an even better extension of the pharmaceutical product transition period which will expire in 2016. Here too the LDC should insist on an unconditional extension (like the one they won in 2002) and it should last as long as a WTO member is an LDC. The fight against HIV/AIDS, tuberculosis and malaria and the simultaneous fights against neglected tropical diseases and non-communicable diseases depends on affordable access to generic medicines of assured quality.
Leading members of the U.S. Congress today sent a letter to the Obama administration supporting the request by Least Developed Countries to continue their exemption from implementing TRIPS, which is set to expire at the end of next month, until they graduate from "least developed" status.
The letter was sent from the Ranking Members of the
- Energy and Commerce Committee
- Labor, Health, Human Services, and Education Appropriations Subcommittee and
- Africa, Global Health and Human Rights Subcommittee
- as well as the chair of the HIV/AIDS Caucus
Read more about the issue in our fact sheet.
by Prof. Brook K. Baker*, Policy Analyst Health GAP, Northeastern U. School of Law, Program on Human Rights and the Global Economy, Honorary Research Fellow, University of KwaZulu Natal
Invited Op Ed for Equilibri: A Simply New Perspective on Global Affairs
http://www.equilibri.net/nuovo/articolo/investors%E2%80%99-ip-rights-unbound-danger-investment-clauses-access-medicines (reprinted with permission of author)
April 20, 2013
Access-to-medicines activists have recently had much to celebrate. In India, the Supreme Court upheld India’s strict standards of patentability and rejected an “evergreening” patent on Glivec, an important cancer medicines that Novartis sells for $70,000 per year [i]. Earlier last year, the Indian Comptroller of Patents issued India’s first compulsory license on a Bayer cancer medicine, Nexavar, to Natco, thereby shaving the price by 97%. The Intellectual Property Appellate Board of India affirmed that decision which is now on appeal to the High Court [ii]. On the trade front, India health activists succeeded in convincing the Indian government to reject European demands in EU-India trade negotiations that would have imposed data monopolies and extended the length of patent monopolies [iii]. Fortunately, India is not acting alone; Indonesia also quietly issued compulsory licenses on seven hepatitis and HIV antiretroviral medicines last year [iv], and Argentina recently adopted proactive guidelines to restrain secondary patents on minor modifications to existing medicines[v]. Last summer, the over-reaching Anti-Counterfeiting Trade Agreement was rejected by the generally pro-IP European Parliament [vi] and Europe was forced to reconsider its draconian border measures that had resulted in the seizure of lawful in-transit medicines in the Netherlands and elsewhere [vii].Even the U.S. is reconsidering its willingness to patent isolated genes[viii] while Canada is accelerating its rejection of patents on medicines that fail to make required disclosures, e.g., Pfizer’s Viagra [ix].
We could wish that the tide was irreversibly turning against the excesses of patent and data monopolies on medicine that erect ever-higher and stronger exclusivity barriers that price poor people and poor countries from accessing life-saving public goods. But anyone who thinks that Big Pharma is sitting still and that their allies in European and US trade offices have found a new religion is dangerously wrong. We’ve know for a decade and a half that Big Pharma and its rich-country trade rep allies have been seeking to ratchet-up longer, stronger, and broader patent and data monopolies in a string of bilateral and plurilateral free trade agreements such as US-CAFTA and EU-Caricom [x]. Those efforts are intensifying in the TRIPS-plus demands that the US and EU are putting forth in current negotiations, e.g., the Trans-Pacific Partnership Agreement [xi] and the EU-India FTA. In these trade negotiations, the US and EU typically seek patent term extensions, eased standards of patentability, restrictions on patent opposition procedures and patent revocations, data exclusivity [xii], and greatly enhanced enforcement powers in terms of “deterrent” damages, mandatory injunctions, enhanced border enforcement, and expanded criminal enforcement [xiii]. This IP-maximalist agenda is pursued not only in secret free trade agreement negotiations, but through diplomatic pressure, threats of sanctions found in IP/trade assessments (like the U.S. Special 301 Watch List), biased technical assistance and training to IP examiners and judges, and a thorough-going disinformation campaign that casts intellectual property rights as irreducible and irreplaceable, as the only engine for innovation and creativity, and as the prime fount of foreign direct investment, technological advancement, and development more broadly [xiv].
Although access to medicines activists have been wise to focus our attention intently on convincing low- and middle-income countries to adopt and use all possible TRIPS-compliant flexibilities and to oppose the TRIPS-plus IP chapters in free trade agreements, we have neglected to interrogate another chapter in free trade agreements and bilateral investment treaties that perhaps pose an even greater threat to our collective access to medicines – investment chapters.
Under investment chapters, foreign IP investors, like Novartis and Bayer, are recognized as “investors” who have made “investments” involving expenditures and expectations of profit [xv]. Suddenly intellectual property rights, already hugely protected, are given another mantle of protection, namely protections as investments. In addition, investors are given rights to bring claims for private arbitration directly against governments whenever their expectations of IP-based profits are frustrated by government decisions and policies. Decisions of these private arbitral tribunals consisting of three international trade lawyers are not subject to judicial review, but are reducible into court judgments that can be levied against government property.
Using loose and imprecise standards addressing “minimum standards of treatment,” “indirect expropriation,” and “national treatment,” multinational pharmaceuticals might claim that denying patents, granting oppositions, revoking patents, issuing compulsory licenses, and registering generics while referencing clinical data or doing so before patent expiration all violate their legitimate expectations for profit. Although the “minimum standards of treatment” clause was originally designed to prevent grossly abusive and discriminatory courtroom adjudications totally outside the bounds of normative due process, it has morphed to decisions with a much more lenient standard that rewards investors even when they have been given a full panoply of due process safeguards. The expropriation standard, originally adopted to deter nationalization of businesses and seizures of real property has similarly morphed to prevent indirect expropriations, what we call regulatory takings in the U.S., where changes in government regulations – many designed to protect public health, environment, and other legitimate public interests – are challenged as having diluted the investor’s expectations of profit. Finally, the national treatment standard, though originally adopted to ensure that foreign investors are treated equivalently to domestic investors, is also morphing in new directions.
Threats like these with respect to pharmaceutical IPRs used to be theoretical, but the theoretical has now become real. In November of 2012, Eli Lilly sued the government of Canada for $100 million under NAFTA's investment chapter because Canada invalidated a Bayer patent on a medicine used to treatment attention deficit disorders [xvi]. Courts in Canada, including its Court of Appeals, reviewed the patent in depth as part of an invalidation case initiated by Teva. The patent was declared invalid pursuant to requirements in Canadian patent law that an applicant must satisfy its “promise of utility” (more commonly called industrial applicability) by disclosing evidence pointing to a claimed benefit as an inventive medicine. Eli Lilly objected because the promise doctrine had been developed judicially and that it had been clarified only after Bayer had filed its common patent application in the format authorized by the Patent Cooperation Treaty, of which Canada was a member.
Eli Lilly didn't like this ruling, so it is seeking to greatly expand the accepted meanings of minimum standards of treatment, indirect expropriation, and national treatment to argue that Canada should not be able to modify any of its patent standards or even to have a patent standard on utility and disclosure of utility that is any higher than that currently practiced in the US and EU. It argues further that it should not have to disclose information needed to satisfy patent requirements in Canada that is above and beyond what is required in patent applications filed pursuant to the Patent Cooperation Treaty, even thought the PCT clearly covers procedures for filing patent applications, not substantive requirements of patentability enforced as a sovereign rights by each country. It is important to note that Eli Lilly is pursuing a patent invalidation claim despite an express provision in the NAFTA investment chapter that purports to exclude NAFTA-compliant patent granting, revocation, and compulsory license decisions from investor dispute resolution [xvii].
If Eli Lilly can file this kind of expansive, topsy-turvy claim in Canada with respect to its decision to revoke a patent, what would prevent Novartis and Bayer from filing comparable claims against India because it too has adopted strong protections against evergreening in section 3(d) of its Patents Act and has allowed compulsory licensing in section 84? India has international investment agreements with 82 countries and has been subjected to 17 known investor-state claims [xviii]. Although no claims to date have been brought based on pharmaceutical IPRs, these are exactly the kinds of claims that a major international corporate law firm, Jones Day, is urging companies to file under existing investment clauses that India has ill-advisedly entered into [xix].
Novartis and Bayer, and the rest of Big Pharma, are relentless in their search for monopoly rights and monopoly profits. The right to sue governments directly when their unquenchable thirst for profits is thwarted is a dangerous escalation of corporate power. These kinds of investor cases are expensive to defend (average cost to governments over $8 million/case) and have cost taxpayers globally nearly $3 billion and counting. Five hundred and eighteen known investor-state cases have been filed, of which only 244 have been concluded [xx]. The pace of new cases is escalating (62 new cases filed in 2012 alone), as is the rate of investor wins (70% of investors claims decided on the merits in 2012 were favorable to claimants). When investors win, they can win a lot, like the $1.77 billion, plus compounded interest, costs, and attorney’s fees, awarded to Occidental in its claim against Ecuador. But even when they don’t win, investors can coerce settlements on favorable terms (approximately 27% of case are settled). Once the pharmaceutical floodgate is unlocked, the number of claims and taxpayer exposure will expand as well.
India and other trade negotiators should heed the entreaties of trade, IP, and health activists who are warning against the inclusion of an Investment Clause in the EU-India FTA [xxi], the Trans-Pacific Partnership Agreement, and in the many other trade agreements that are underway or soon-to-be initiated. Preferably, investment chapters will be rejected in their entirety, as they are becoming a corporate sword of Damocles that hangs over the head of rich and poor governments alike. At the very least, IP should be totally defined out of “investments” and no investor claims whatsoever should be available for alleged frustration of IP-based expectations. IP right holders already have multiple forms of enforcement including private lawsuits, border seizures, criminal prosecution, and state-state dispute resolution. Enough is enough. Expanded and unbound investment rights for Big Pharma under the cover of underscrutinized investment chapters is a grave threat – a threat with deadly consequences to millions of patients who rely on governments’ rights to regulate IPRs and to use any and all TRIPS-compliant flexibilities to ensure affordable access to medicines for all.
[i] Novartis cancer drug patent bid rejected by Indian court in landmark ruling, The Guardian (April 1, 2013).
[ii] Patent board rules in favour of Natco in cancer drug case; Bayer to challenge decision, CNN-IBN Live (March 5, 2013).
[iii] India-EU FTA won't hit generic drugs industry: EU envoy, Business Standard (April 13, 2013).
[iv] Indonesia to override patents for life-saving medicines, IRIN News (March 25, 2013).
[v] Argentina adopts new guidelines to examine patent applications for pharmaceuticals, Don’t trade our lives away (May 31, 2012).
[vi] European Parliament rejects ACTA piracy treaty, The Telegram (July 4, 2012).
[vii] India Ministry of Commerce and Industry, India EU Reach an Understanding on the Issue of Seizure of Indian Generic Medicines in Transit (July 28, 2011); see Brook K. Baker, Settlement of India/EU WTO Dispute re Seizures of In-Transit Medicines: Why the Proposed EU Border Regulation Isn't Good Enough, PIPIF Research Paper Series (2012).
[viii] Justices Consider Whether Patents on Genes are Valid, New York Times (April 14, 2013).
[ix] Canada’s Supreme Court strips Viagra Patent from Pfizer, Reuters (Nov. 8, 2012).
[x] Baker, B. and Avafia, T., (2011), The Evolution of IPRs from Humble Beginnings to the Modern Day TRIPS-plus Era: Implications for Treatment Access. Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011.
[xi] Sean M. Flynn, Brook Baker, Margot Kaminski & Jimmy Koo, The U.S. Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement, 28 Am. U. Int’l L. Rev. 105, 149-184 (2012).
[xiii] Id. at 183-200.
[xiv] Brook K. Baker, Debunking IP for Development: Africa Needs IP Space, Not IP Shackles (draft 2013).
[xv] Trans-Pacific Partnership, Intellectual Property Rights Chapter September 2011 Draft (Selected Provisions), available at http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificIP1.pdf. See Brook K. Baker, Corporate Power Unbound: Investor-State Arbitration of IP Monopolies – Eli Lilly and the TPP (draft 2013).
[xvi] The investor-state claim is Eli Lilly and Company v. The Government of Canada, Notice of Intent to Submit a Claim to Arbitration under NAFTA (Nov. 7, 2012), available athttp://italaw.com/sites/default/files/case-documents/italaw1172.pdf. See Public Citizen, U.S. Pharmaceutical Corporation Uses NAFTA Foreign Investor Privileges Regime to Attack Canada’s Patent Policy, Demand $100 Million for Invalidation of a Patent (2013).
[xvii] NAFTA, Article 1110(7).
[xviii] Biswajit Dhar, Reji Joseph & T.C. James, India’s Bilateral Investment Agreements: Time to Review, 52 Economic & Political Weekly 113-122 (2012).
[xix] Jones Day Commentary, “Treaty Protection for Global Patents: A Response to a Growing Problem for Multinational Pharmaceutical Companies,” 3 (October 2012).
[xx] UNCTAD, Recent Developments in Investor-State Dispute Resolution (2013).
[xxi] Does the EU/India free trade agreement spell the end of cheap drugs for poor countries?, The Guardian (February 10, 2013).
*Brook K. Baker is a law professor at Northeastern University School of Law (US) and an affiliate of its Program on Human Rights and the Global Economy. He is also an honorary research fellow at the University of KwaZulu Natal, Faculty of Law, South Africa. He is a policy analyst for Health GAP (Global Access Project) and writes frequently on IP, trade, and access to medicines issues.
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