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Compulsory Licensing in the Context of India’s March 2012 Nexavar® Decision

A research paper for HNRS 302-001 Legal Issues in Globalization. It addresses the history of international intellectual property rights protection, the extension of that protection to pharmaceutical products, and the justifiable compulsory license issued by India for Nexavar® in March 2012. Written 17 April 2012.

I. Introduction

On March 9, 2012 the Indian Controller of Patents and Designs issued the country’s first compulsory license, in the case of Natco Pharma Ltd. v. Bayer Corp. (hereafter “the Case”), to the domestic pharmaceuticals manufacturer Natco Pharma for a pharmaceutical patent filed by the German manufacturer Bayer Corporation[1]. The patent concerned the Bayer drug marketed under the name Nexavar®, or Sorafenib Tosylate in chemical nomenclature, which is used to treat Renal Cell Carcinoma-RCC, a form of kidney cancer; and Heptacellular Carcinoma-HCC, a form of liver cancer. Although it was the first compulsory license issued by India, it follows earlier such actions by Thailand, for several cancer and AIDS drugs in 2007 and 2008, and Brazil, for an AIDS drug in 2007.[2],[3] As was the case with those licenses, the Nexavar® decision has garnered criticism from multinational pharmaceutical corporations as well as from the countries that host those corporations. The outcry raises questions as to whether developed nations are ignoring their commitment to international intellectual property rights agreements that specifically permit compulsory licenses or whether developing nations are abusing the original intent of those agreements to circumvent patent protection. That debate among legal scholars and public health experts will be presented later in this analysis.

Relevant international agreements include the Paris Convention for the Protection of Industrial Property of 1883, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994, and the WTO Declaration on the TRIPS Agreement and Public Health of 2001. Among those, TRIPS is noteworthy for making explicit that international patent protection extends to pharmaceutical products as they “shall be available for any invention, whether products or processes, in all fields of technology” (emphasis added).[4] That extension brought the concern of governments to promote innovation through patent rights into conflict with the public health needs of their citizenry. To ameliorate that conflict, compulsory licenses have existed in international law to permit the use of patented processes or products by another manufacturer or firm. To incorporate the requirements of international patent laws, India approved the Patents Act of 1970. An amendment to the Act in 2005 updated it for the requirements of TRIPS. The history of compulsory licensing, the aspects of international agreements that relate to the patenting of pharmaceutical products, and the implementation of TRIPS through the Indian patent law will be addressed later in this analysis. Before continuing that discussion, this analysis turns to a definition of key terms.

Three terms that will be referred to throughout this paper are intellectual property right, patent, and compulsory license. Intellectual property rights relate to intangible assets, and grant exclusive control over the use and/or sale of those assets to the holder. As relates patents and the Case, the particular combination of chemical components are considered intellectual property and were patented. A patent is an intellectual property right that is awarded to an inventor by a government for a non-obvious product or process. It is an exclusive right for the inventor to license, to manufacture, and/or to sell the product or process. In exchange for that right, the patentee is able to enjoy the monopoly profits associated with restricted competition, while concurrently society is argued to benefit from the commercialization of the innovation and the later the release of the design of the product or process into the public domain following a period of 20 years. In effect, it is a government-sanctioned monopoly, which is argued to spur innovation by providing an incentive for developers to release their designs into the public domain – by enjoying monopoly profits. Others may then expand on those designs, while the profits afforded to the inventors can cover the expenses associated with inventing new products and processes.

A mechanism for superseding the exclusivity associated with patents and intellectual property rights is compulsory licensing. Under the terms of a compulsory license, a government can force a patentee to license the manufacture of its product or process to a third party, often as a result of access or availability issues that negate the public benefit presumed to come despite the monopoly right of the patent. As noted by the Indian Controller of Patents and Designs in the Case, it is an “involuntary contract between a willing buyer and an unwilling seller.”[5] The licensee is still required to pay royalties for the use of the patent, and the compulsory license is often scheduled to sunset once the conditions that led to its issuance are resolved. The rationale is that the licensee is able to sell the product at a steep discount, given its lack of investment in its research and development costs, thereby improving public access. It is the issuance of a compulsory license by the Indian government that is the impetus for this paper, but the international law framework for the patenting and licensing of pharmaceutical drugs will be addressed first.

II. International Law on Pharmaceutical Patents and Compulsory Licenses

Although international patent regimes are relatively new, the right has existed in domestic law for more than 500 years. Patents were first used in Renaissance Italy in the Republic of Venice to attract engineers to the city – to engage in the clear societal benefit of preventing its collapse into the sea. Those first patents were 10-year monopoly rights, and were developed because the “moral interest of the inventors and the wider societal benefits were treated as complementary.”[6] Centuries later, the prevalence of international trade as well as the explosion of inventions and innovation capacity following the industrial revolution led to the 1873 Patent Congress in Vienna, which first devised compulsory licenses as a “strategic compromise” between innovation and access, while requiring that licensees pay patentees “reasonable compensation” for use of the patent.[7] Following that Congress, a binding international patent agreement, which included compulsory licensing, was adopted at the 1883 Paris Convention for the Protection of Industrial Property. Although the agreement launched with only 11 contracting parties, it was novel for creating an oversight and enforcement body – the United International Bureaux for the Protection of Intellectual Property (BIRPI).

BIRPI has since been absorbed by the United Nations World Intellectual Property Organization (WIPO), which was founded in 1967. The Paris Convention too has changed, with its current version dating to 1979. However, even as the document has been amended, the key provisions relating to compulsory licensing have persisted. It notes that parties to the convention are entitled to develop a framework for issuing compulsory licenses “to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work.”[8] The fear that patentees would violate the social contract embodied by the patent is evident by the specific mention of “failure to work” as a cause for issuing a compulsory license. There can be no societal benefit if a government issues a monopoly right to produce a life-saving vaccine, but the company refuses to manufacture it – knowing that it may be more profitable to treat the symptoms of the disease with its current line of pharmaceutical products. Still, the Convention recognizes that working a patent may not occur immediately – given the demands of capacity-building and supply chain development, and so it prevents governments from issuing licenses “before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last.”[9] From its limited beginnings, the Convention now has 174 contracting parties. That is more than the WTO, even as that 157-member organization approved TRIPS to explicitly incorporate the Convention in its appendices.

The TRIPS Agreement is one of three foundational prongs of the WTO. The other two are the General Agreement on Tariffs and Trade (GATT) and the General Agreement on Trade in Service (GATS). TRIPS was developed with GATS toward the end of the Uruguay Round, and came into force on January 1, 1995.[10] Although the widespread adoption of the Paris Convention indicated that the then negotiating GATT countries had already accepted international standards for patent protection, TRIPS was novel for requiring patent protection for pharmaceuticals – a right that drug manufacturers did not enjoy in all countries, particularly those low- and middle-income countries (LMICs).[11] In those countries, there were separate legal and regulatory systems for drugs, with governments treating the public health benefits ascribed to pharmaceutical products as distinct from those derived from other inventions.[12] As such, the concessions of LMICs in adopting the TRIPS Agreement should be considered nothing short of dramatic, even when considering the other trade benefits associated with GATS and GATT. For that reason, the implementation of TRIPS was phased in concurrent to a country’s economic standing. Developed countries were required to implement trips in 1995, developing countries – such as India, in 2005; and least developed countries in 2016.[13]

Several provisions of TRIPS concern the right of countries to issue compulsory licenses. As previously stated, Article 27 mandates that patent protection be made available for all “products and processes, in all fields of technology,” it further states that “patents shall be available and patent rights enjoyable without discrimination as to the place of the invention, the field of technology, and whether products are imported or locally produced.”[14] Those qualifications enable developers to patent their products in foreign markets without differing requirements from local inventors. Of particular concern is the specification that products which are “imported” should not be discriminated against, a matter that will be discussed later as related to the Indian controller’s decision. The rights are noted to cover “a period of twenty years counted from the filing date.”[15] Still, as previously noted, that right is not absolute. Although, TRIPS does not use the term compulsory license, it states that “members may provide limited exceptions to the exclusive rights conferred by a patent” so long as they do not “unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner.”[16] Presumably, an abnormal exploitation of the patent and illegitimate interests of the patentee would be grounds to provide a limited exception – or compulsory license, but the Agreement is vague as to the actions or interests that would meet those requirements. Still, TRIPS provides detailed procedures for the issuance of such exceptions following such abnormality or illegitimacy.

TRIPS details 12 conditions that are to be met when using a patent “without the authorization of the right holder.[17] Even if a holder is abusing the rights of the patent, a government is not empowered to simply issue a license. Rather, it must have “made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions” for a “reasonable period of time.”[18] Notwithstanding the lack of clarity regarding reasonable, the Agreement continues by providing for a waiver of that condition during a “national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.”[19] As with the ambiguity surrounding “reasonable,” there is little guidance as to what constitutes an “emergency.” When issued, a compulsory license is to be “terminated if and when the circumstances which led to it cease to exist and are unlikely to recur.”[20] The patentee is to be paid “adequate remuneration,” – which in practice is more than a “reasonable royalty” but less than the “lost profits” of the otherwise monopoly pricing.[21],[22] In addition, disputes involving TRIPS are appealable to the WTO dispute settlement mechanism. However, member states are required to develop independent reviews for all decisions on the issuance of a compulsory license and on the level of remuneration.[23] Although it was evident from TRIPS that compulsory licenses could be issued by member states for patented pharmaceutical products, the lack of clarity regarding the circumstances for issuance led to the Declaration on the TRIPS Agreement and Public Health.

That Declaration came during the WTO Doha Round and elaborated on the compulsory licensing requirements as related to TRIPS provisions about public health. The first of those provisions comes in the TRIPS preamble. Although it does not have substantial legal effect, the preamble emphasizes that developing countries be given “maximum flexibility” in implementing the subsequent provisions. Later in the Agreement, it states that members may “adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development.”[24] In accord with those provisions, during the Doha Round member states affirmed that TRIPS “does not and should not prevent Members from taking measures to protect public health,” and that it “can and should be interpreted and implemented in a manner supportive” of that “right to protect public health” and “to promote access to medicines for all.”[25]

The principle of member state flexibility was too upheld. The Declaration stated that “each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.”[26] To underscore that point, it noted that “each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency.”[27] Instead of clarifying the TRIPS Agreement with a detailed list of specific circumstances that would enable a country to issue a compulsory license, it clarified its intent by granting broad powers to member states to identify abuses of patent rights and to set the conditions for waiving the requirement to first negotiate with a patentee. As such, it would appear that LMICs have significant latitude to develop both their compulsory licensing laws and to supersede patent rights in matters of public health. However, given the continued resistance of developed nations to compulsory licenses, the cynical view that the Declaration was motivated by embarrassment concerning access to AIDS medications would appear to have some merit.[28] Nevertheless, having detailed the core international law provisions about pharmaceutical patents and compulsory licensing, this analysis turns to the debate over both practices.

III. Debating Pharmaceutical Patents and the Compulsory License Escape Clause

The arguments for and against compulsory licensing can be reduced to two apiece. Those favoring the mechanism argue that there is an innate right to health that supersedes patent laws, and that promoting lower drug prices in LMICs will not significantly impact the research and development strategy of multinational pharmaceutical corporations. Those who caution against using compulsory licenses argue that they will stifle drug innovation – thereby harming the beneficiaries of today’s action in the long-run, and that they are susceptible to improper use – thereby unnecessarily aggravating the negative impact on innovation. The nature of each argument will be considered, as well as possible alternatives to the pharmaceutical patent and compulsory licensing framework. First, the arguably lofty right to health will be discussed.

Although the right to health might appear to lack legal force, it is found in the United Nations International Covenant on Economic, Social and Cultural Rights (ICESCR) of 1966, an agreement which boasts 160 parties. Those parties are held to “recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” and include both India and Germany.[29] It has been argued that the ICESCR creates an obligation on contracting parties to “protect the enjoyment of accessibility and affordability” of medications and to ensure that the “privatization of the health sector does not constitute a threat” to such accessibility and availability.[30] As such, if “pricing practices” were found to have “impaired or reduced access to medications” then compulsory licenses would be justifiable.[31] However, even if, as others have said, that “governments have moral obligations to put the lives of their citizens before the commercial interests of foreign companies,” then the issuance of a compulsory license does not necessarily achieve the “highest attainable standards” of health, as access issues beyond price may be prevalent in LMICs.[32] Successful efforts to distribute “cheap medicines” for tuberculosis, malaria, and AIDS have not solved the problem of those diseases.[33] Indeed, with 65% of Indians noted for lacking access to modern health care facilities, the value of licensed kidney and liver cancer drug could be called into question.[34] Even so, the need for additional healthcare infrastructure to make a wider impact need not preclude the deployment of affordable medicines – so long as their deployment does not stifle innovation.

Even though the marginal cost of producing an additional dosage of a drug is relatively miniscule, there are substantial costs associated with the research and development that produces the successful drug. It is estimated to cost a pharmaceutical company $1 billion on average to develop a new drug, with the majority of the costs linked to expensive clinical trials and a success rate for each new compound of only five percent.[35] Without a health emergency driving the need for the compulsory license, research and development spending is argued to be at risk of decreasing due to the erosion of property rights.[36] If drug companies are unable to recoup the $1 billion investment, they will arguably limit their investments in new drugs as their financial resources decline. However, it too is argued that the risk of stifling innovation is exaggerated given that many drugs are funded by government grants and special tax breaks. Considering those provisions, pharmaceutical companies are argued to spend 75% less on the development of new drugs then they claim.[37] Any dependence on LMICs to recoup the development expenditures can be questioned too, as they are arguably an ancillary market for the company for “global drugs” – or those that treat conditions affecting wealthy and developing countries alike. [38] Furthermore, according to World Health Organization estimates, only 4.3% of pharmaceutical company research and development spending is on health problems that primarily affect LMICs.[39],[40]  

The research and development spending discrepancy may be a symptom of the regulatory environment in LMICs rather than an argument for issuing compulsory licenses. If multinational corporations believe that it is likely for an LMIC to issue a compulsory license for its pharmaceutical product, then it may refrain from investing in those products for which its revenue stream would be primarily linked to those countries. For those products, the LMIC is the market, not the ancillary market. A study of six compulsory licenses issued in the United States could support that conclusion. Even as it found that there was no measurable decline in the rate of innovation for the given therapeutic area in five of the cases – as measured by pre- and post-patent counts, it noted that in case of the decline the issuance of the license was predictable and was a significant market for the company.[41] Still, it is difficult to draw too many conclusions from that study as it is anecdotal in nature and relates to a developed nation. At the same time, a study that utilized game theory to measure the impact of compulsory licenses on foreign direct investment (FDI), found that if countries could coordinate, that issuing compulsory licenses would have no effect on FDI.  However, given the incentive to undercut other countries to maximize FDI, countries would not opt to issue compulsory licenses as the country viewed to have the strongest patent and other intellectual property rights protections would garner the most investment.[42]  Perhaps for that reason, only three developing countries have issued compulsory licenses since they joined the WTO framework in 2005. That relative dearth of licenses would be then likely to persist as the framework is extended to least developed countries, as they may be particularly reliant on FDI.

The risk of losing FDI and of discouraging pharmaceutical companies from deploying future products into developing markets puts governments in an uneasy bind – they can either act to help save lives now or hope that at-present unquantifiable lives saved later justifies inaction. At the same time, those who lack access to live-saving medication may be small in number, as generics are largely available “in nearly every therapeutic class to treat diseases with substantial morbidity.”[43] Indeed all of the World Health Organization listed “essential drugs” are off patent.[44] However, that is little solace to those who, if even in the minority, are left to die due to the lack of access to existing treatments. If patents are truly designed to balance the needs of the inventor against the benefits of the public, then the deployment of a drug without making it truly available to those who would most benefit, would appear to upend that balance. In addition, if the legal principle guiding compulsory licenses distinguished between diseases, then the claimed universal right to health would be discriminated “by the size of the patient pool.”[45] That discrimination could then violate a government’s responsibility to its citizenry, in particular as regards India, as its Supreme Court has established a right to health in the country’s Constitution.[46] Nevertheless, the effects on FDI and research and development may require a different framework then the current patent system provides. Alternatives include Equitable Access Licenses for drugs developed in universities and provided at low cost to LMICs, Generic Open Licenses that are immediately available, and the respective governments issuing lump payments to pharmaceutical companies to help recoup research and development costs while then enabling them to issue production licenses.[47],[48] Without those alternatives available, India issued a compulsory license for Nexavar® and it is to the Case concerning that issuance that this paper now turns.

IV. Indian Patent Law and the Nexavar® Compulsory License

The case of Natco Pharma Ltd. v. Bayer Corporation concerned the decision by Bayer to sell a monthly dosage of Nexavar® for 280,000 rupees (INR) (approx. $5,500). The drug was patented first in the United States on January 13, 1999; and granted a patent in India on March 3, 2008.[49] In its submission to the Indian Controller of Patents and Designs for a compulsory license, Natco Pharma noted that the lowest-paid government employee would need to work three and a half years to afford a supply for a single month.[50] In order to remedy that access issue, Natco proposed producing and selling the drug at 8,800 INR (approx. $170) per month) – a 97% price reduction.[51] There was no apparent emergency or epidemic of liver and kidney cancer at the time Natco filed for the license on July 29, 2011, and by the estimates of Bayer and Natco only approximately 11,000 or 23,000 Indians could benefit from the drug, respectively.[52] In addition, the drug is primarily life-extending rather than life-saving as it extends the lives of those suffering from kidney cancer four to five years and liver cancer only six to eight months.[53] Given those factors, the case tested the Controller’s willingness to weigh the limited public health benefits of the drug against its exorbitant cost. To evaluate whether a compulsory license would be granted, the Controller examined the requirements of the Indian Patent Act of 1970 as amended to incorporate TRIPS in 2005.

When first enacted, the Indian Patents Act was in line with other developing nations by precluding the patenting of pharmaceutical products. It noted that for “substances intended for use, or capable of being used, as food or medicine or drug… no patent shall be granted in respect of the claims for the substances themselves.”[54] Further, it granted an automatic “license of right” or compulsory license to any such products developed outside of India three years following the filing for the patent.[55] However, the 2005 Amendment to the Act stripped those provisions and enabled pharmaceutical companies both within and outside of India to submit patents for drugs. However, it retained the provisions relating to patent applications and to compulsory licensing. The Act dictates that recipients of patents must ensure that “inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practical,” they are noted for not being “granted merely to enable patentees to enjoy a monopoly for the importation of the patented article.”[56] In contrast to the Paris Convention, the Act enables the issuance of compulsory licenses three years after the patent was filed if the circumstances meet any of three conditions: 1) “that the reasonable requirements of public health… have not been satisfied,” 2) that it “is not available to the public at a reasonable price,” and that it “is not being worked in India on a commercial scale to an adequate extent.”[57],[58] In the Case, Natco argued that Bayer met all three of those requirements.

As noted earlier, the Controller issued his 62-page decision in mid-March 2012. It is appealable first to the Intellectual Property Appellate Board (IPAB) of India and then to the Supreme Court of India.[59] If Bayer remains unsatisfied with the outcome and would like to pursue the case beyond those channels, then it could petition the German government to espouse the case to the dispute settlement mechanism of the WTO. For its part, the Controller ruled against Bayer on all three questions. In regards to meeting the requirements of public health, the Controller noted that Bayer supplied the drug to only 200 patients in 2011 or little more than 2% of the eligible patients under even its lower estimate, such that “the supply in India was not anywhere near the requirement.”[60] As for the reasonable price requirement, Bayer argued that it needed to account for research and development costs. Nevertheless, the Controller held that the price must be “construed predominantly with reference to the public” and noted that the assessment by Natco of the cost to a government employee indicated it was unreasonable.

For the final point, the Controller needed to define “worked in India.” For its part, Bayer contended that in order to take advantage of economies of scale – such that a plant in every country would be inefficient, it could not be required to produce in India to meet that standard. The Controller evaluated the Paris Convention’s provision that “importation of patented articles by the patentee shall not entail forfeiture of the patent” and held that a compulsory license is inherently limited and as such is “something less” than a “forfeiture.” Further, the Controller held the Patent Act of 1970 specifies that patentees are “obliged to contribute towards the transfer and dissemination of technology” through “either manufacturing the product in India or by granting a license.” As mentioned before, patents are not to be granted for the sole purpose of allowing the patentee to import the product into India. From those provisions, the Controller held that Bayer’s reliance on manufacturing Nexavar® outside of India did not meet the “worked” requirement, regardless of its availability in local medical facilities. Having held that all three circumstances were present, the Controller ruled against Bayer and granted a license to Natco Pharma provided that it paid Bayer a 6% annual royalty of net sales.

V. Conclusions

The result of the Case should not be discounted. To those who advocate a cautious approach to compulsory licensing and favor more stringent patent rights, it marks a dramatic application of TRIPS and the Paris Convention through Indian patent law. Even though Bayer sold Nexavar® at what is arguably an exorbitant price for ordinary Indians, its public health impact was limited. With a population of nearly 1.2 billion individuals, the issuance of a compulsory license to treat from 11-23,000 persons may set the standard too low for granting licenses and in effect eliminate the ability of pharmaceutical companies to earn monopoly profits – thereby removing a key incentive found in patent law.  Nonetheless, Natco noted that Bayer earned $934 million worldwide in 2010 from sales of the single drug, such that it virtually met the cost of its research and development in a single year.[61] Surely, 19 other years of patent exclusivity at monopoly prices would not be necessary to recoup the remaining costs or to amass sufficient funds to develop new drugs. Even as the patent system should retain its foundations of exclusivity to spur further innovation, this case should serve as a warning to pharmaceutical companies that just because exclusivity permits the price to be charged, it need not be charged. As one Indian attorney remarked, it should “make them look at the market more realistically” and to “put in place a proper pricing, supply and manufacturing policy to the mutual benefit of all concerned.”[62] Whether higher Indian courts or even the WTO agrees with the decision is an open question, but given the history of international patent law, flexibilities for public health, and the circumstances of the case, it should be upheld.

Works Consulted

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Aaron S. Kesselheim. Think Globally, Prescribe Locally: How Rational Pharmaceutical Policy in the U.S. Can Improve Global Access to Essential Medicines. 34 AM. J. L. AND MED. 125, 2008.

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[1] Natco Pharma Ltd. v. Bayer Corp., C.L.A.No.1 of 2011 (ICPD 2012)

[2] Ged Kenslea and Lori Yeghiayan. Drug Patent Decision “A Victory for the Thai People,” says AIDS Healthcare Foundation. Business Wire. 14 March 2008.

[3] Vivian Sequera. Brazil bypasses patent on U.S. AIDS drug. USA Today. 5 April 2007.

[4] World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, part 2(5) art. 27(1), 15 April 1994, http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm.

[5] Natco Pharma Ltd. v. Bayer Corp., 2012

[6] Graham Dutfield. Delivering Drugs to the Poor: Will the TRIPS Amendment Help? 34 AM. J. L. AND MED. 107, 2008.

[7] Colleen Chien. Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation? 18 BERKLEY TECH. L.J. 853, 2003.

[8]World Intellectual Property Organization Paris Convention for the Protection of Industrial Property, art. 5(a)2, 20 March 1883 as amended 28 September 1979, http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html.

[9] Paris Convention, art. 5(A)4

[10] Erin M. Anderson. Unnecessary Deaths and Unnecessary Costs: Getting Patented Drugs to Patients most in Need. 29 B.C. THIRD WORLD L.J. 85, 2009

[11] Anderson. Unnecessary Deaths, 2009

[12] Aaron S. Kesselheim. Think Globally, Prescribe Locally: How Rational Pharmaceutical Policy in the U.S. Can Improve Global Access to Essential Medicines. 34 AM. J. L. AND MED. 125, 2008.

[13] Subramanya Sirish Tamvada. Human Rights: Law, Policy, and Implementation: TRIPS and Human Rights: The Case of India. 2 JINDAL GLOBAL L. REV. 131, 2010.

[14] TRIPS, part 2(5) art. 27(1), 1994

[15] TRIPS, part 2(5) art. 33, 1994

[16] TRIPS, part 2(5) art. 30

[17] TRIPS, part 2(5) art. 31, 1994

[18] TRIPS, part 2(5) art. 31(B), 1994

[19] TRIPS, part 2(5) art. 31(B), 1994

[20] TRIPS, part 2(5) art. 31(G), 1994

[21] TRIPS, part 2(5) art. 31(H), 1994

[22] Chien, Cheap Drugs, 2003

[23] TRIPS, part 2(5) art. 31 (I, J), 1994

[24] TRIPS, part 1 art. 8(1), 1994

[25] World Trade Organization Deeclaration on the TRIPS Agreement and Public Health, sec. 4, 14 November 2001, http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.

[26] Declaration on TRIPS, sec. 5(B), 2001

[27] Declaration on TRIPS, sec. 5(C), 2001

[28] Peggy B. Sherman and Ellwood F. Oakley, III. Pandemics and Panaceas: The World Trade Organization’s Efforts to Balance Pharmaceutical Patents and Access to AIDS Drugs. 41 AM. BUS. L. J. 353, 2004.

[29] United Nations International Convenant on Economic, Social and Cultural Rights, art. 12(1), 16 December 1966, http://www2.ohchr.org/english/law/cescr.htm.

[30] Alicia Ely Yamin. Not Just a Tragedy: Access to Medications as a Right under International Law. 21 B.U. INT’L L.J. 325, 2003.

[31] Yamin, Not Just a Tragedy, 2003

[32] Dutfield, Delivering Drugs to the Poor, 2008

[33] Sherman and Oakley, Pandemics and Panaceas, 2004

[34] Ranjit Shahani, Mortgaging the Future of Healthcare in India, in Viveka Roychowdhury, Compulsory licensing Patients vs. Patents? Express Pharma. 1 April 2012.

[35] Ben Hirschler. Insight: Chasing cheaper cancer drugs. Reuters. 1 April 2012.

[36] Ranjit Shahani, Mortgaging the Future, 2012

[37] Anderson, Unnecessary Deaths, 2009

[38] Frederick M. Abbott. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health. 99 A.J.I.L. 317, 2005.

[39] Chien, Cheap Drugs, 2003

[40] Dutfield, Delivering Drugs to the Poor, 2008

[41] Chien, Cheap Drugs, 2003

[42] Robert Bird and Daniel R. Cahoy. The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach. 45 AM. BUS. L.J. 283, 2008.

[43] Kesselheim. Think Globally, Prescribe Locally, 2008

[44] Ranjit Shahani, Mortgaging the Future, 2012

[45] Rajeshwari. The proposition that CL be reserved for a certain type of disease or a class of patients would legally not be maintainable, in Viveka Roychowdhury. Compulsory licensing Patients vs. Patents? Express Pharma. 1 April 2012.

[46] Subramanya Sirish Tamvada. Human Rights: Law, Policy, and Implementation: TRIPS and Human Rights: The Case of India. 2 JINDAL GLOBAL L. REV. 131, 2010.

[47] Kesselheim. Think Globally, Prescribe Locally, 2008

[48] Hirschler. Chasing Cheaper Cancer Drugs, 2012

[49] Natco Pharma Ltd. v. Bayer Corp., 2012

[50] Natco Pharma Ltd. v. Bayer Corp., 2012

[51] Rupali Mukherjee. Natco Pharma’s invoking of compulsory licensing could trigger cheaper drug production. The Economic Times. 14 March 2012.

[52] Natco Pharma Ltd. v. Bayer Corp., 2012

[53] Natco Pharma Ltd. v. Bayer Corp., 2012

[54] Indian Patents Act of 1970, Ch. 2(5)a, 19 September 1970, http://www.wipo.int/wipolex/en/details.jsp?id=2393.

[55] Indian Patents Act of 1970, Ch. 16(1)

[56] Indian Patents Act of 1970, Ch. 16(83)a,b

[57] Indian Patents Act of 1970, Ch. 16(84)

[58] Indian Patents Act of 1970, Ch. 16(84)c

[59] Rahul Dhote and Mita Sheikh. Natco win: Deterrent for FDI? MoneyControl.com CNBC TV-18. 20 March 2012.

[60] Natco Pharma Ltd. v. Bayer Corp., 2012

[61] Natco Pharma Ltd. v. Bayer Corp., 2012

[62] Anuradha Salhotra. The Judgment should not discourage MNCs but make them look at the market more realistically, in Viveka Roychowdhury. Compulsory licensing Patients vs. Patents? Express Pharma. 1 April 2012.

Prozac photograph provided courtesy of Tom Varco via Wikimedia Commons

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