Abstract

THE 3D EFFECT: EXPANDING THE INTERPRETATIVE FRAMEWORK OF INVENTIVENESS FOR PHARMACEUTICAL PATENTS

Rajshree Chandra

Volume: 8 Issue: 1 2018

Abstract:

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) regime has brought about definitive changes in the dynamics of drug trade, and research and has had a far-reaching impact on drug access, availability, research, prices, disease control, and much else. Until recently, providing patent protection for pharmaceuticals was a choice made by individual governments, in accordance with their development levels. Today, pharmaceutical patents are globalized through the World Trade Organization's (WTO) Agreement on TRIPS, and then further reinforced through bilateral and regional arrangements. 1 Medical patents constitute an important case study within the broader field of intellectual property rights (IPRs) because this constitutes an area where the industry is highly dependent on patents. One of the perceived advantages of medical patents is that they provide incentive to the private sector to undertake research and innovation of medicines and pharmaceutical products. However, the utility of intellectual property protection - even if that were to be its most powerful defense - cannot be judged solely in terms of the innovation generated. It is important to view patents as a “social contract” 2 between the patent owner and society and that societal health forms the other end of the stakeholder chain. At stake, therefore, is not just the inventive potential of manufactures

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References

• See, for instance, J. Replogle, ‘Central American Trade Pact May Limit Access to Generics,’ Lancet 363, 2004, pp. 1612–1613. Also, for instance, the Free Trade Agreements (FTAs) and TRIPS plus agreements. The FTA process has become the principal process through which the IPR-based industries are able to ensure that the standards of protection and enforcement keep pace with new developments. See, ITAC 15, The U.S.-Colombia Trade Promotion Agreement (TPA) The Intellectual Property Provisions, September 20, 2006. For details on FTA and IP protection see, World Bank Group Trade note, Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements February 7, 2005 http://www.cptech.org/ip/health/trade/worldbank02072005.pdf
• A term used by Carlos Correa in ‘Guidelines for the Examination of the Pharmaceutical Patents: Developing a public Health Perspective’, WHO - ICTSD – UNCTAD Working Paper, Jan., 2007. Available at http://www.iprsonline.org/resources/docs/Correa_Patentability%20Guidelines.pdf . (Accessed 11Aug. 08)
• Refer for instance, Adam B. Jaffe & Josh Lerner, Innovation and Its Discontents: How Our Broken Patent System is Endangering Innovation and Progress, and What to Do About It, Princeton University Press, 2004; Michele Boldrin and David K. Levine, “The Case against Intellectual Property,” American Economic Review, Vol. 92(2) (2002); Sunil Kanwar and Robert Evenson, Does Intellectual Property Protection Spur Technological Change? Center Discussion Paper No. 83, Economic Growth Center: Yale University, June 2001.
• See, UNDP, Human Development Report 2003, New York: OUP, 2003
• Because patents are the primary rewards that provide research incentives it logically follows that the patent system stimulates innovation only where industry sees the opportunity for increasing sales and market share. This is one of the prime reasons why there has been a significant growth in the research and development of lifestyle drugs as there is a strong monetary demand for them. Consider this: Anti-baldness drugs generated $180 million in sales in 1998, the anti-wrinkle drug Botox earned $90 million in sales in 1997, and Viagra’s sales approached $800 million in its first year. ‘Discretionary Drug Dollars,’ Journal of Business Strategy Publication, 1Jul, 02 .http://www.accessmylibrary.com/coms2/summary_0286-25645998_ITM (Accessed June 26, 2007)
• ion, 1Jul, 02 .http://www.accessmylibrary.com/coms2/summary_0286-25645998_ITM (Accessed June 26, 2007) 6 Global Forum Health 10/90 Report on Health Research 2003-2004. http://www.globalforumhealth.org/Site/002__What%20we%20do/005__Publications/001__10%2090%20reports.php. Also see, Developing New Health Products; (Drugs, Diagnostics, and Vaccines) To Control The Ancient Afflictions of Stigma and Poverty,” The George Washington University Neglected Tropical Diseases Initiative http://gstudynet.org/docs/The%20GWU%20Neglected%20Tropical%20Diseases%20Initiative.doc Accessed July 13, 2007
• Declaration on the TRIPS Agreement and Public Health, WTO 14 November 2001. Available at http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
• A compulsory license (in the field of health) is an exception to the patent law that is usually justified as an attempt by the government to correct a market failure or negotiate a situation of national health emergency. If patented drugs cost too much, the government authorities can take measures such as issuing a compulsory license to an agency or company to manufacture or import a generic version of that patented drug, which can then be made more available to patients more cheaply. The Doha agreement effectively permits a distribution and use license in countries experiencing a public health emergency and a manufacturing-for-export license in countries possessing appropriate manufacturing capacity. explain compulsory licensing. Some instances of Compulsory licensing being used to address health emergencies are: Thailand for ARV Efavirenz in Nov.2006 and Kaletra in Feb.2007; Indonesia for manufacture of generic Lamivudine and Nevirapine in October 2004; Malaysia for import from India for ARVs dd1, AZT and Combivir; Taiwan in Nov.2005 for manufacture of Tamiflu
• Decision of the General Council, WTO, 30 August 2003. WT/L/540 and Corr.1
• Mogha Kamal Smith of Oxfam said that the space given to developing countries by the August 2003 agreement is being taken away by bilateral and regional FTAs with developed countries, especially the United States. For details refer, Martin Khor, Patents, Compulsory License and Access to Medicines: Some Recent Experiences, TWN, 2007; Sangeeta Shashikant, ‘More Countries Use Compulsory License, But New Problems Emerge,’ TWN Info Service on Health Issues No. 4 Geneva, 19 May 2005.
• For an exposition of this position see, Martin Khor, ibid.
• There is considerable debate on both counts, most of which centers around the ambiguity of various criteria listed and the subjective interpretations and increased litigational impact that they will generate.
• For a view that the definition of inventiveness definition dilutes the requirements of an inventive step and broadens the existing provision to the benefit of patent holders, See, e.g., K.M. Gopakumar & Tahir Amin, Patents (Amendment) Bill 2005: A Critique,40(15) Economic & Political Weekly. 1503, 1504 (Apr. 9, 2005)
• he mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant’.
• Unlike what Novartis alleged in its application for the Glivec patent in Chennai Patent Office. Refer hearing held on Oct.14, Available at http://www.scribd.com/doc/416824/Patent-office-Order-India-Glivec (Accessed 21 Oct. 2006)
• Article 10(2) (b) of Directive 2004/27/EC of the European Parliament states that: ‘The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.
• For a discussion refer, Catherine Colston and Kristy Middleton, Modern IP Law, London: Cavendish Publishing Ltd., 2005. pp163-4
• It does not, therefore, apply to a case where the new form is found to have a completely different use (and not just an increased efficacy vis-à-vis the known use), which are entertained as “Swiss Claims”.
• See for instance, Trevor M Jones, India: Innovation at Crossroads. CIEC Working Paper, GWU, May 2007
• CIPIH Report, ‘Public Health, Innovation and Intellectual Property Rights,’ Geneva, April 2006.
• For instance India where right to health is interpreted as a derivative right of the right to life enshrined in Art. 21 of the constitution (for court interpretations refer Bandhua Mukti Morcha case (AIR 1984 SC 802), Surjeet Singh v. the State of Punjab (1966-2- SCC-366), Paschim Bengal Khet Mazdoor Society v. State of West Bengal( AIR 1996 SC 2426); For a similar interpretation of courts see the Venezuela case of Cruz Bermudez et al v. MSAS, 1999; the Ecuarorian case of Mendoza & Ors v. Minister of Public Health and the Director of the Nationsl AIDS-HIV-STI Programme. Case references from COHRE’s Litigating Economic, Social and Cultural Rights: Legal Practitioners’ Dossier, 2006. http://www.cohre.org/store/attachments/COHRE%20Legal%20Practitioners%20Dossier.pdf
• In South Africa for instance. S.Afr.Const. 1996, Art. 27; See also Art. 24.
• Available at http://164.100.47.133/debate14/debtext.asp?slno=1866&ser=WTO&smode=t . (Accessed 10 Aug. 2008)
• Novartis Files Case in India Challenging Patent Controller’s Order and Patent Law. Berne Declaration. Available at http://www.evb.ch/en/p25011414.html#note1#note1.
• India amended her regime in 1999 to provide for exclusive marketing rights. See Chapter IVA of The Patents (Amendment) Act 1999 (India).
• CPAA also contested the fact that there were only around 7000 CML patients, 99% of who were covered by Novartis GIPAP and provided Glivec free of charge. According to CPAA there are 30,000 CML patients detected every year most of who are not covered by Novartis drug donation program. Quoted from Times of India, Sunday Mailbox, April 22, 2007
• As did Cipla, Natco Pharma, Sun Pharmaceuticals and Ranbaxy in their own right. Natco Pharma, which launched a generic version of Gleevac under the brand `Veenat', had also challenged the grant of EMRs to Novartis.
• Text of the Writ petition No. 24759 OF 2006 in The High Court of Judicature at Madras. Clause16, p.12
• Invention of the base compound, called as imatinib had already been disclosed in the European Patent publication no. EP-A056409, published on October 6, 1993, and its equivalent US Patent no. 5521184, etc. [IP-health]... The patent term extension certificate granted by US Patent Office for the 1993 Patent explicitly mentions imatinib mesylate (Glveevec R)as the product. For details see Text of Indian Decisions on Glivec Patent Application http://lists.essential.org/pipermail/ip-health/2006- March/009200.html
• Technical challenges were submitted to the Controller about the enhanced efficacy of the new compound by Natco Pharma Ltd. C.R. Sukumar, ‘Novartis Loses Patent Claim On Cancer Drug — Patents Controller upholds Natco contention’, Financial Daily, The Hindu, Jan 26, 2006
• Writ Petition No. 24759 0f 2006 in the High Court of Madras
• Refer, Novartis petition at The High Court of Judicature at Madras (Special Original Jurisdiction) w.p.no.24759 of 2006
• Quoted from Praful Bidwai, High Stakes in Attack on Indian Patent Law, One World, http://www.commondreams.org/headlines07/0202-08.htm (Accessed 12-11-2007)
• There have been very few cases where Section 3(d) of the Patent Act, 2005 has been used as the basis for the rejection of a patent application. After the Glivec case, Delhi patent office rejected the claim for an anti HIV Nevirapine composition, as falling short of satisfying the increased efficacy hurdle under section 3(d). Details available at http://www.lawyerscollective.org/sites/default/files/Patent%20Decision%20-Pg%208-14.pdf. A recent court case, where the Delhi High Court declined to grant a temporary injunction to Roche, who sued CIPLA for infringement of its patent covering its anticancer drug, Tarceva. CIPLA counterclaimed invalidity, citing section 3(d) as one of the grounds. See F. Hoffman-La Roche Ltd. & Anr. v Cipla Ltd., CS(OS) 89/2008, Delhi High Court.