IP Disputes in Medicine

Sunday, January 28, 2007


by Brook Baker

Professor Brook K. Baker
Northeastern U. School of Law, Program on Human Rights and the Global Economy;
Health GAP (January 26, 2007)

The Mashelkar Committee in India was tasked with determining “whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substances to new chemical entity or to new medical entity involving one or more inventive steps.” In its recently released report, “Report of the Technical Expert Group on Patent Law Issues (Dec. 2006)” [Mashelkar Report], not only did the Expert Committee misinterpret India’s flexibility under international law to limit patents of pharmaceutical products to new chemical entities, it exceeded its mandate to critique section 3(d) of the India Patents (Amendment) Bill, 2005. The errors in the Report include:

1. The Mashekar Report asserts without argumentation that “[g]ranting patents to only NCEs or NMEs and thereby excluding other categories of pharmaceutical inventions is likely to contravene the mandate under Article 27 to grant patents to all ‘inventions’.” (¶ 5.6.) In ¶5.7, it goes even further and concludes that such a limitation “is not consistent with the TRIPS Agreement.” In doing so, the Report erroneously concludes that the definition of invention (newness, inventive step, and industrial capacity) contained in Article 27.1 has any particular and definite meaning within the WTO TRIPS Agreement. In particular, the Report ignores (does not even address) the flexibility that countries like India have under Article 1.1 of the TRIPS Agreement, which states that “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” (Emphasis added.)

Although Members must “give effect to the provisions of [the TRIPS] Agreement,” Article 1.1, they have considerable flexibility in doing so, especially with regard to the Agreement’s under-determinate language, including that governing scope of patentability. In essence Article 1.1 of TRIPS devolves interpretive authority and discretion to sovereign nations to balance national interests within a minimally constraining international intellectual property system. Rather than seeking harmonization at any particular level of intellectual property protection, the GATT negotiators agreed to core of minimum standards only. Moreover, even in setting minimum standards, the negotiators left some implementation flexibility. Especially, where governments elected to adopt more general rules rather than very specific rules, as they did with respect to the definition of “invention,” there is necessarily broader discretion left to Members to determine the strictness of their definitions of newness, inventive step [1] and industrial applicability. Although these terms are not infinitely elastic, they are flexible enough to accommodate India’s current choice in Section 3(d) and arguably even a more stringent standard limiting pharmaceutical patents to new chemical entities involving an inventive step. The existence of this reservoir of flexibility is particularly apparent given the wide variability of patentability standards and exceptions among the many Member countries.[2]

2. The Mashelkar Report does not directly claim that limiting pharmaceutical patents to new chemical entities involving an inventive step would constitute prohibited discrimination against a field of technology and thus be prohibited by Article 27. However, over-eager reading between the lines of the Report might infer to such a claim. To the contrary, the TRIPS Agreement clearly permits differentiation between fields of technology, even though it does not permit out-and-out discriminatory exclusion of patents for a particular field of technology. Such differentiation is implicit in the many diverse forms of Article 30-related exceptions to patent rights such as: private and non-commercial use, experimental use, teaching, prior use, pharmacy preparations, foreign vessels, international civil aviation, regulatory review (Bolar), and exhaustion regimes.[3] Additional, express exceptions to patentability are set forth in Article 27.2 (protection of ordre public) and in Article 27.3 (diagnostic, therapeutic and surgical methods; and plants and animal). Moreover, courts and patent offices routinely come up with patent standards specific to particular fields of technology. India has simply chosen to clarify standards of patentability for pharmaceutical products in section 3(d) of it Patent (Amendment) Act of 2005, and in doing so has neither unfairly discriminated against a field of technology nor created an erroneous exception to patentability.

3. The Mashelkar Report asserts, without argument, that neither Articles 7 and 8 of the TRIPS Agreement nor the Doha Declaration on the TRIPS Agreement and Public Health can be used to derogate from the specific mandates of Article 27. (¶ 5.6.) To the contrary, the Doha Declaration in particular was adopted as a specific clarification that the 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.” (¶ 4, emphasis added.) Furthermore, the Doha Declaration states that “each provision of the TRIPS Agreement shall be read in light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.” (¶ 5(a).) Article 7 of the TRIPS Agreement is part of the basic principles of the Agreement, and it provides for “the mutual advantage of producers and users” and for “social and economic welfare” broadly construed. (Emphasis added.) Article 8 is also part of the basic principles of the Agreement, and it provides that “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health ... provided such measures are consistent with the provisions of this Agreement.” The Doha Declaration and Articles 7 and 8 of the TRIPS Agreement tilt the balance in favor of defining scope of patentability to maximize access to medicines. This maximization would support both the existing provisions of section 3(d) of the Patents (Amendments) Bill, 2005, but also the adoption of the more stringent NCE-only standard.

4. The Mashelkar went far beyond its terms of reference to indirectly challenge the legality of Section 3(d) of the Patents (Amendments) Bill, 2005: “There is a perception that even the current provisions in the Patents Act could be held to be TRIPS non-compliant.” (¶5.11.) The Expert Committee was not asked to assess the legality of the Patents Bill nor has it provided any analysis whatsoever of alleged defects. This unwarranted and unprofessional excursion into areas beyond its mandate is particularly unfortunate given the pending lawsuit in India by Novartis challenging the TRIPS compliance of Section 3(d).

5. The Mashelkar Report makes no mention whatsoever of India’s obligations under binding human rights law. The Universal Declaration of Human Rights (UDHR),[4] the founding document of the international human rights regime, recognizes that every person has a right to a standard of living adequate for his or her health and medical care (Article 25), the right to share in scientific achievements (Article 27), and the right to a social and international order in which the Declaration’s rights can be fully realized (Article 28). The skeletal framework of a human right to health, articulated in the UDHR, has been further specified in the International Covenant on Economic, Social & Cultural Rights (ICESCR),[5] a legally binding treaty signed by India.

In Article 12, the ICESCR guarantees the right of everyone worldwide to "the highest attainable standard of physical and mental health" and requires State Parties to take steps necessary for “the prevention, treatment and control of epidemic, endemic, occupational and other diseases” and to provide “conditions which would assure to all medical services and medical attention in the case of sickness.” This skeletal right to health provision received further clarification when the Committee on Economic, Social and Cultural Rights (CESCR) issued General Comment No. 14 which concluded that there is a basic obligation to ensure a sufficient quantity of essential medicines (¶ 12(a)) and that these medicines must be affordable (¶¶ 12(b), 17). In sum, universal access to essential medicines is a core, non-derogable duty of all member States as is preventing, treating, and controlling epidemic and endemic diseases. (¶ 43(d) and ¶ 44(c)).

6. The Mashelkar Report creates a legally incoherent differentiation between what it calls “incremental innovation,” meaning “sequential developments,” and “ever-greening,” meaning trivial and inconsequential changes to an existing patented product. In doing so, it provides no litmus test by which such categorization might be made. How small a change must there be to be inconsequential instead of incremental? Where minor modifications to existing molecular structures in now routine in low-standard countries, like the U.S., or where obvious new doses or new combinations of existing products are likewise patentable, how would Indian patent examiners make the alleged distinctions?

7. In addition to misapplying governing legal standards, the Mashelkar Report incorrectly assesses and references the national interests of India, of its medicines consumers, and even of its pharmaceutical industry by:

• Ignoring public-health and access-to-medicines needs in their entirety;
• Confusing the practice of Indian producers in filing new use and new form patents in low-standard, high-income countries with the issue of setting proper TRIPS-compliant standards of patentability in India;
• Failing to acknowledge that Indian pharmaceutical companies can simultaneously earn high returns in U.S., European, and Japanese markets for off-patent medicines and for medicines patented under those countries’ lower patent standard, and still earn money and serve the needs of much poorer Indian and developing country consumers who rely on India for expanding and affordable access to newer life-saving and life-enhancing medicines that are not patentable under strict, but lawful, standards of patentability;
• Misunderstanding India’s role as an international leader and defender of developing-country interests and flexibilities on intellectual property-related issues to advance public health and to ensure access to medicines for all.

8. The Mashelkar Report fails to even acknowledge the input of civil society groups, including those from local and international intellectual property experts, that supported India’s flexibility to adopt a NCE standard of patentability for pharmaceutical products. In contrast, it included summaries of submissions by multiple industry stakeholders and of patent-attorney stakeholders.

9. The Mashelkar Report is a betrayal of the interests of people suffering from life-threatening diseases worldwide, especially people living with HIV/AIDS, and a capitulation to the interests of the multinational drug companies and a narrow spectrum of India manufacturers that subverted the process and stand to benefit from increased rights to charge unconscionable prices and to extract monopoly profits at the cost of denied access and millions of lives in India and abroad.


1 Footnote 5 to the TRIPS Agreement gave Members flexibility to deem “inventive step” as synonymous with “non-obvious” and “capable of industrial application” to be synonymous with “useful.” However, the footnote does not restrict Members to that less strict standard, suggesting that they have flexibility to adopt much more rigorous tests.

2 Different standards concerning patentability of computer programs is but one example of this variability. Another testament to the degree of flexibility is efforts within WIPO to enact a new Substantive Patent Law Treaty.

3 See, Christopher Garrison, Exceptions to Patent Rights in Developing Countries (UNCTAD-ICTSD 2006).

4 U.N. Gen. Assembly Res. 217A, U.N. GAOR, 3d Sess., at 71, U.N. Doc. A/810 (1948).

5 International Covenant on Economic, Social and Cultural Rights, Dec. 16, 1966, 993 U.N.T.S. 3, 6 I.L.M. 360 (1966) (entered into force Jan. 3, 1976). The ICESCR has been ratified by 152 U.N. Member states, and another seven, including the U.S., have signed, signaling their intent to become legally bound.


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