Of Evergreening and Efficacy: the Glivec Patent Case

An important case  was decided this month that may have a significant impact on access to medicines for patients in developing countries. India'€™s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its anti-cancer drug Glivec.
In the aftermath of this case, it is more likely other countries will follow India's lead.


 Of Evergreening and Efficacy: the Glivec Patent Case


by Ryan Abbott*

   Associate Professor of  Law at Southwestern Law School, Los Angeles


An important case [1]  was decided this month that may have a significant impact on access to medicines for patients in developing countries. India’€™s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its anti-cancer drug Glivec.

Judging by recent public comments, this will be a landmark case. On the Novartis website [2], where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “€œdecision discourages innovative drug discovery essential to advancing medical science for patients.”€ Eric Althoff, a Novartis spokesman said, if “€œinnovation is rewarded, there is a clear business case to move forward. If it isn’€™t rewarded and protected, there isn’€™t.”€ On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “€œa historic judgment”€ that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “€œdebate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘€˜aberration’€™ under our constitutional scheme) at a minimum.”€

Despite the controversy, this case won’€™t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’€™s patent system to understand.

At the time of India’€™s independence in 1947, the country’€™s patent regime permitted patents for pharmaceutical products. However, there was a sentiment that pharmaceutical product patents catered to multinational corporations (MNCs) at the expense of domestic companies. For example, one study found that only 10 percent of Indian patents were held by Indians or Indian companies. As a result, a series of amendments to India’€™s Patent Act gradually eroded patent protections for pharmaceutical products. This culminated in the passage of a new patents act which expressly excluded product patents for medicines (the Patents Act, 1970, which came into force in 1972 and replaced the Patents and Designs Act, 1911).

The rise of the domestic Indian pharmaceutical industry has been partially attributed to this scaling back of patent protection. In 1970, MNCs enjoyed a 68% market share of the Indian pharmaceutical market. In 2003, Indian companies collectively commanded a 77% market share. Moreover, this has occurred in a growing market. The domestic Indian pharmaceutical market has been projected to reach $49-€“74 billion by 2020. India is already the largest exporter of generic drugs in the world, and as the Supreme Court noted, India has become the “€œpharmacy of the world.”€ For instance, it supplies over 80% of HIV/AIDS medicines for the 8 million HIV-positive patents in low- and middle-income countries. India does not only export to the developing world; India’€™s largest export recipient is the United States.

India’€™s patent regime was profoundly impacted by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came into force on January 1, 1995. TRIPS is a comprehensive multilateral agreement that establishes minimum levels of intellectual property protection for all members of the World Trade Organization (WTO), including India. It requires that patent protection be made available for pharmaceutical products.

India, along with a number of other developing nations, was afforded a transition period to amend its patent system to comply with the requirements of TRIPS. Specifically, India was permitted to delay application of TRIPS provisions for five years until 2000, with an additional five year delay permitted for pharmaceutical product patents. However, Article 70.8 of the TRIPS Agreement required India to adopt an arrangement called “€œthe mailbox procedure.”€ This allowed applicants to file product patents that would lie dormant until the expiration of the transition period. Under this system, a product patent could not be granted on a pharmaceutical product filed before 1995, while patents could be granted for applications filed from 1995-€“2005 that would become effective after 2005.

That is one reason why the Glivec product case is unusual; Glivec was invented during a transitional time for the Indian patent system. Novartis filed an initial patent application in the U.S. for the drug “€œimatinib”€ (in free base form) in 1992. If that drug would have been invented today, it would have enjoyed a twenty-year period of patent-based market exclusivity in India.

Cases involving the transition period are going to be less relevant in the future. Most of the countries that have domestic production capability are now committed to TRIPS, or even TRIPS-plus, patent protection. While the 2001 WTO Ministerial Declaration on the TRIPS Agreement and Public Health adopted in Doha (the Doha Declaration) extended the period for compliance with pharmaceutical provisions to 2016, this only applies to least developed countries (LDCs). LDCs generally lack significant pharmaceutical manufacturing capability.

The primary legal issue in the case, however, went beyond issues specific to the transition period and involved challenges to Section 3(d) of India’€™s patent act, which stipulates that “€œthe mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance”€ is not eligible for patent protection. It is designed to prevent evergreening, a term used to label practices where a small change is made to an existing product and claimed as a new invention. When Section 3(d) was enacted in 2005, it was unique to India – €”there was no analogous provision in any other country.

Even if imatinib had been patented in India in 1992, that patent would have expired last year. (In point of fact, the U.S. patent did not expire last year – €”the patent term was extended for 586 days to “€œcompensate”€ for the delay necessitated due to Food and Drug Administration [FDA] review). That is why, in an effort to extend patent protection for Glivec, Novartis filed a second patent application in 1997. The second application was for a specific variation (the beta crystalline form [it can also exist in alpha form or in amorphous form]) of the salt of imatinib (imatinib mesylate). That patent is due to expire in the U.S. in 2019 (it also received an extension). In 2001, the U.S. Food and Drug Administration approved “€œimatinib mesylate”€ for marketing. While the active ingredient of Glivec is imatinib in its free base form, capsules contain imatinib mesylate because it has percent greater bioavailability.

In the Glivec patent case, one of the central questions before the court was whether the “€œnew”€ drug form qualified for a patent under Section 3(d). The court ruled that it did not.

To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.

On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.

Theoretically, I suspect a more holistic approach is justified. At the extreme end of the spectrum, a new drug could cure multiple sclerosis yet be so toxic it kills more patients than it helps. If a new form of the drug is discovered that is not better at treating multiple sclerosis but that doesn’€™t cause any side effects, it would be hard to argue that it isn’€™t a leap forward in efficacy.

The broader question is where in the development chain someone should be entitled to a patent. Not too long ago, the U.S. Patent and Trademark Office required significant evidence of clinical efficacy for pharmaceutical product patents to comply with the utility requirement. In re Brana (Fed. Cir. 1995) changed that, when the Court of Appeals for the Federal Circuit decided it would deter innovation to require FDA approval or even Phase II testing to find a compound useful within the meaning of the patent law. Amgen Inc. v. Hoechst Marion Roussel, Inc (Fed Cir 2006) went further and held that therapeutic utility is not dependent on a product having an effect in a living being, such as curing disease.

Now researchers try to patent compounds at the earliest available opportunity, a trend which is only going to intensify in the U.S. with last month’€™s transition from a first-to-invent system to a first-to-file system under the America Invents Act. For good reasons the pharmaceutical industry is involved in a competitive race, but there is no great philosophical reason that the finish line for patentability should be closer to the moment a new compound is generated. The proposition that a new form of a drug should be more effective to get a patent isn’€™t that radical.  It would mean researchers would spend less time racing to invent compounds, and more time discovering what compounds do.

On a doctrinal level, the Indian Court’s decision is consistent with U.S. Supreme Court decisions that set limits on patentability and intellectual property protection. For example, just last month in Kirtsaeng v. John Wiley & Sons the U.S. Supreme Court ruled that the first-sale doctrine applies to lawfully made works manufactured abroad and imported into the U.S.

Novartis had at one point tried to argue that Section 3(d) was unconstitutional under the Indian constitution and non-compliant with TRIPS, but those arguments were rejected by the High Court at Madras in 2007. Novartis did not appeal those decisions. The High Court rejected the TRIPS claim because in India private plaintiffs may not challenge a national law based on its compatibility with an international agreement. However, the court also referred to the Doha Declaration, which affirms that “€œthe TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’€™ right to protect public health and, in particular, to promote access to medicines for all.” This means that WTO members can set their own standards for patent protection within the bounds of TRIPS. Section 3(d) establishes a higher standard for an inventive step, which means that drugs patentable in other countries won’€™t necessarily be patentable in India.

Narrowly then, in India, there are a number of pre-grant opposition cases currently being appealed by pharmaceutical companies. If the Supreme Court had weakened the interpretation of Section 3(d), it could have allowed denied applications to be granted on appeal. Aside from that, it’€™s possible that this decision will have limited impact given that it involves issues fairly specific to India.

Yet some other countries, such as Argentina and the Philippines, have already incorporated provisions similar to Section 3(d). As a consultant for Health Research for Action in 2009, I coauthored a report [3] recommending to Caribbean nations that they adopt provisions like Section 3(d). In the aftermath of this case, it is more likely other countries will follow India’€™s lead.

More importantly, India’€™s victory in this case may be a signal regarding changing political attitudes toward the demands of MNCs. Historically, MNCs have taken a hard line against “€œlax”€ patent protection for pharmaceutical products. Even as recently at 2006 and 2007, Thailand faced retaliation after issuing compulsory licenses for two on-patent HIV/AIDS drugs and an antiplatelet drug. Abbott, the maker of one of the HIV/AIDS drugs, subsequently withdrew all applications to register medicines in Thailand. The United States Trade Representative (USTR) then placed Thailand on the 301 Report’€™s Priority Watch List and threatened to terminate Thailand’€™s export privileges.

India is becoming increasingly assertive with regards to IP protections. Last year, India’€™s Patent Office issued its first compulsory license to a generics manufacturer for an on-patent medicine. The Indian company Natco is now licensed to produce and sell a generic version of the Bayer anti-cancer drug Nexavar. India also revoked Pfizer’€™s patent for its anti-cancer drug Sutent. Both companies are appealing.

These actions may portend a shift in North-South dynamics if the pharmaceutical industry fails to significantly change its model. Glivec and Nexavar can both cost $70,000 a year in India, where the average person makes $1,500 annually. Those economics are simply unworkable, even though Novartis and Bayer both provide free distribution programs for certain cancer patients.

Roy Waldron, the Chief Intellectual Property Counsel for Pfizer, stated [4] last month that, “€œIndia has taken steps that call into question the sustainability of foreign investment and the ability of American companies to compete fairly. In fact, the Global Intellectual Property Center’€™s International Intellectual Property Index [the GIPC is part of the U.S. Chamber of Commerce], ranked India dead last in terms of overall protection of intellectual property. Despite being a member of the World Trade Organization, and an important global trading partner, India has systematically failed to interpret and apply its intellectual property laws in a manner consistent with recognized global standards.”€ He concluded the U.S. government should signal such actions are not condoned, and that the U.S. should pursue a robust trade agenda. MNCs and developed countries such as the U.S. continue to push for higher levels of intellectual property protection in bilateral and regional free trade agreements, and in multinational agreements like the Trans-€Pacific Partnership Agreement (TPP).

Still, there is no way MNCs will make good on threats to withdraw innovative medicines from India. First, because with the possible exception of certain biological drugs, Indian generics companies could domestically produce just about any drug MNCs fail to introduce. Second, India’€™s pharmaceutical sector is booming; the domestic market is expected to experience double-digit growth this year, and it is among the top five pharmaceutical emerging markets. India’€™s pharmaceutical sector attracted foreign direct investments worth $4.9 billion in 2000-€“2011. It is unlikely that anyone’€™s business model will call for exiting that market on the basis of a legitimate patent law interpretation.



* Ryan Abbott, M.D., J.D., M.T.O.M., is Associate Professor of Law at Southwestern Law School. He has served as a consultant on health care financing and regulation, intellectual property, and public health for international organizations, academic institutions and private enterprises including the World Health Organization, World Intellectual Property Organization and University of California, Los Angeles. Professor Abbott has published widely on issues associated with health care law and intellectual property protection in legal, medical, and scientific peer-reviewed journals.

Professor Abbott is a licensed physician, attorney, and acupuncturist. He is a graduate of the University of California, San Diego School of Medicine and the Yale Law School, as well as a Summa Cum Laude graduate from Emperor’s College (MTOM) and a Summa Cum Laude graduate from University of California, Los Angeles (BS). Professor Abbott has been the recipient of numerous research fellowships, scholarships and awards, and has served as Principal Investigator of biomedical research studies at University of California. He is a registered patent attorney with the U.S. Patent and Trademark Office and a member of the California and New York State Bars.


[1] http://www.scribd.com/doc/133343411/Novartis-patent-Judgement

[2] http://www.novartis.com/newsroom/product-related-info-center/glivec.shtml

[3] http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1909978

[4] http://waysandmeans.house.gov/uploadedfiles/pfizer_testimony31313.pdf

News Link n. 46


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 46

Report on global giving: a new era in philanthropy and investment in global health 

Beyond the BRICS 

BRICS bank: dream or reality 

Historic Goals to End Extreme Poverty Endorsed by World Bank Governors 

Impact of Conditional Cash Transfers on Maternal and Newborn Health

Measuring equity in utilization of emergency obstetric care at Wolisso Hospital in Oromiya, Ethiopia: a cross sectional study

Global Challenges and the Future of the WTO: Views from the Candidates Beyond the Hype of the DG Race

Building health systems from scratch in Somalia

European and African Union Commissions meet to pave the way for next Africa-EU Summit 

Oxfam urges Congress to support global anti-poverty programs and key reforms 

Enhancing aid cooperation – the Australia-China Development Cooperation Memorandum of Understanding

Financial Times Publishes Special Report On Malaria

Africa: Malaria – Keeping a Crafty Killer On the Run

Sanofi and DNDi celebrate six years of collaboration in fighting malaria by distributing 200 million treatments of ASAQ 

Anti-Counterfeiters Focus On Organised Crime, Softer Public Message

WIPO Committee Issues Revised Text On Traditional Knowledge Protection 

First Global Vaccine Summit Highlights Remarkable Progress Towards Vaccinating Every Child 

UK to protect up to 360 million children against polio

Eliminating Neglect and Neglected Tropical Diseases

South Africa seeks to close drug patent loophole




Investors’ IP Rights Unbound: The Danger of Investment Clauses to Access to Medicines

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


Investors’€™ IP Rights Unbound:  The Danger of Investment Clauses to Access to Medicines

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

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 “€œevergreening”€ 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 “€œdeterrent”€ 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 “€œinvestors”€ who have made “€œinvestments”€ 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 “€œminimum standards of treatment,”€ “€œindirect expropriation,”€ and “€œnational 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 “€œminimum 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 “€œpromise 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 “€œinvestments”€ 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).

[xii] Id.

[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.pdfSee 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 at http://italaw.com/sites/default/files/case-documents/italaw1172.pdfSee 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, “€œTreaty 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.


News Link n. 45


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 45

Editorials Address China’s Response To Emergence Of H7N9 Bird Flu Strain 

L’eredità della SARS: sorveglianza e controllo delle epidemie all’età della globalizzazione 

After the vote: Future of Italian aid still uncertain

UN experts urge World Bank to adopt human rights standards in its policies 

In My Place: Oxfam, Coldplay and you fight land grabs

Climate change: how a warming world is a threat to our food supplies

Health and Foreign Policy Bulletin: March 2013 issue 

Chagas: A silent killer

Mind the GAPPD: A Pivotal New Resource Offers Global and Local Strategies to Overcome Leading Child Killers

Change@WHO – April 2013 newsletter on WHO reform

La Tobin Tax è il primo passo per curare la finanza malata 

The Novartis Decision: A Tale Of Developing Countries, IP, And The Role Of The Judiciary 

Companies  work  t o  employ  India’s  poor:  Business  Call  to  Action  announces  new  initiatives during  G20  Inclusive  Business  Workshop  in  Mumbai

6 reasons companies fail to reach the bottom of the pyramid

President Obama’s Budget Request Signals Confidence In Global Fund

It’s Half-time at the Global Fund 

Greek Gene Bank’s Struggle Indicative Of Changing Times 

Measuring universities’ commitments to global health

Viral transmission linked to injecting illicit drugs: finding the best medicine 

Access to HIV meds secured for Pacific

Unwelcome side effects of mining in Mozambique 

Riflessioni intorno all’Emergenza Nord Africa









News Link n. 44


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 44

Race For WTO Director General Down To Five Candidates 

Reports: Obama’s Proposed 2014 Budget Favours Patent Office, Generic Drugs 

The Good, The Bad And The Budget: What Obama’s Plan Means For Foreign Aid 

Questions Follow Sharp Rise In Investor-State Disputes, Far-Reaching Cases 

Global Fund: A $15 Billion Target for a Transformative Effect

New Draft Traditional Knowledge Bill Published In South Africa

South Africa Announces Rollout Of New Single-Dose ARV Therapy

The BRICS Summit in Durban: too soon to write it off

BRICS agree development bank and science forum

Australia and China: New partners in aid

How Turkey is emerging as a development partner in Africa

‘Beyond MDGs and beyond aid’ 

Implementing the European Union  gender action plan 2010-2015: challenges and opportunities 

World Bank and IMF Spring Meetings – Nancy Birdsall and Todd Moss

Africa: Is the Bank’s Attitude Towards Participatory Development Changing? 

Health Research Colloquium Calls On Countries To Invest More In R&D

Movies, fashion and food: Halle Berry joins Michael Kors to fight hunger 

Why Chemotherapy That Costs $70,000 in the U.S. Costs $2,500 in India 

Cipla, The Human Care Company  

Climate Conversations – World Health Day 2013: Combating malnutrition and infection with forests

Healthcare cuts may have lasting effect on obesity: Think tank

Let’s end the two biggest child killer diseases

New SMS Tool To Report Non-Tariff Trade Barriers At African Borders









Publications: Archives





I. TPP Deal and access to medicines: prospects from Asia-Pacific Geopolitics 

II. Humanitarian Aid, Health: International Financing needs to reinvent itself 

III. Il gap Nord-Sud nell’accesso a farmaci di qualità: un problema di salute pubblica globale 

IV. Farmaci substandard e contraffatti: il mercato nei Paesi in Via di Sviluppo 

V. L’industria internazionale della contraffazione. Altolà alle “cattive medicine”: ma il generico è un altra cosa 

VI: Cina, contro l’AIDS occorrono più farmaci indiani 

VII. Irrevocable Johnson&Johnson’s “No” to the Medicines Patent Pool? 

VIII. MNC behaviour in the pharmaceutical industry in India after TRIPS 

IX. WHO / EU “Bad Medicine” Plans: Flaws, Coordination Gaps 

X. BRICS e salute globale: contributo montante 

XI. La farmacia India contro le multinazionali 

XII. HIV Medicine Alliance: Lip Service Move to Get Rid of the Medicines Patent Pool? 

XIII: Filling the gap: China’s fight agains HIV/AIDS 

XIV: Nigeria’s Public Health: Gains and Challenges 

XV: Fondo Globale: Più Performance dalla Ristrutturazione

XVI: The AIDS Story You May Not Have Heard

XVII: EU Health Cooperation: Room for Improvement

XVIII: Transnational Health Care and Medical Tourism

XIX: Fondi in Calo per le Malattie Neglette

XX: Access to Medicines and Quality of Medicines: always together!

XXI: Pending Cutback in EU Spending for Development Cooperation

XXII: 26 Years On: A Need for a Moral Revolution in Maternal Health Care

XXIII: Farmaci Essenziali e Malattie Trascurate


News Link n. 43


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.



From March Madness to April Anxiety: The WTO Leadership Contest Heats Up 

Who picks up the tab for development?

Global financial flows, aid and development 

Invest in health systems for a balanced approach

DNDi R&D Projects – 2013 Outlook 

What will the new pope mean for the development sector?

Balancing conservation and people’s access to land

The poorest countries are under renewed threat from WTO rules on access to medicines (and yes, this is 2013) 

Novartis Loses Patent Bid: Lessons From India’s 3(d) Experience

The Judgment In Novartis v. India: What The Supreme Court Of India Said 

India Dismisses Antitrust Complaint Against Gilead Sciences

Australian Pharmaceutical Patents Review’s New Report Critical Of Patent Extensions, R&D Funding 

The European Commission calls on EU Member States to fulfil their commitments towards the world’s poorest

Some OECD Nations’ Development Aid Spending Down 4% In 2012, Report Says 

Donors likely to cut down on HIV and Aids funds  

End of polio by 2018 a global win — WHO

US Trade Office Calls For Comments On Transatlantic Trade Deal

Banking on the BRICS for health?

Enter   the  Dragon  and  the  Elephant:  China’s  and  India’s  Participation  in  Global  Health  Governance   

Sizing Up China’s Role in Global Health Aid to Africa

Alcohol and alcohol-related harm in China: policy changes needed 

New apps transforming remote parts of Africa

Gene Patenting: Consequences for Global Health

Crisi finanziaria, austerità e salute in Europa







News Link n. 42


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 42

Obama After Meeting with African Leaders

Novartis Loses Patent Bid: Lessons From India’s 3(d) Experience

India Dismisses Antitrust Complaint Against Gilead Sciences

India pressured by U.S. Congressional committee, Pfizer, over drug patents  

Indonesia to override patents for live-saving medicines

East African Community Doubles Efforts To Boost Local Drug Production 

Shasun Signs Licence With MPP to Produce Low-Cost HIV Medicines 

 –Far diventare i farmaci evergreen, come alcune canzoni

The Lancet series: Health in Europe 

UN high-level panel highlights 5 areas of reform post-2015

UPOV 1991 Will Adversely Impact Farmers In Tanzania, Civil Society And Farmers Say 

Sahel crisis not over yet, WFP chief warns

Donate ฿99 To Provide School Meals For Girls In Asia For 2 Weeks (Thailand)

US food aid revolution: rumour or reality?  

A Growing Opportunity: Measuring Investments in African Agriculture

Inequality out of World Bank’s 2030 strategy?

World Bank live chat: Have your say on managing risk and opportunities  

Canada’s International Development Agency Is No Longer; Maybe That’s Not Such A Bad Thing 

‘Grand Challenges In Global Health’ Initiative Calls For Applications For The ‘Next Generation Of Condom’  

Innovation, IPR Cooperation Among Top Priorities For BRICS

BRICS development bank: ‘The devil is in the detail’ 

Callan, Blak and Thomas on China’s foreign aid and investment 

New VSO paper sets out how post-2015 process could put women’s empowerment at the heart of fighting poverty 

Biovision: Personalised Medicine, Climate Change, Sustainability Need Innovation 

Former US Congressman Howard Berman Joins Lobbying Firm

The USA and global health diplomacy: goals and challenges