Several newspaper editorials and columns devoted considerable attention to the Novartis decision and analysts have considered the future implications of the judgment. In a leading article contributed to The Hindu., an Indian daily, Feroz Ali suggests that
property7cat200003 doc644952378.html .
31 Sarah Hiddleston, ‘The Madras High Court rejects pharma major Novartis’ petition against a provision of the Indian patent law’, Frontline, 24:16, August 11-24, 2007,
http://frontlineonnet.com/n2416/stories/20070824503410500.htm.
Is Amelia Gentleman, ‘Setback for Novartis in India Over Drug Patent’, The New York Times, August 7,
2007,
hup://www.nytimcs.com/2007/08/07/busincss/worklbusincss/07drug.html?cx=l 187409600&cn=958c444 fcae7d0b6&ci—5070.
U.S.-India Business Council; USIBC Encourages Medical Innovation, Science Letter, k, 21 August 2007 through http://global.factiva.eom/ha/default.aspx.
the decision should be understood in an overall context by knowing what it permits and what it prohibits. He considers that section 3(d) is a trendsetter provision and nowhere in the world can such a provision be found in the patent legislation.320 It seems an overstatement as developing countries are increasingly following model patent laws developed by different NGOs which contain provisions similar to the Indian patent law. Feroz Ali further writes: ‘What section 3(d) actually does is to allow genuine improvements and at the same time bar frivolous “tweakings” which are passed under the garb of incremental innovation.’321
A commentator in The Economic Times criticised that some NGOs had given misleading statements after the decision and an impression has been given that the weakening intellectual property rights (IPRs) would magically give the poor the best drugs available. The authors noted: ‘This “patients not patents” campaign has a simplistic appeal but it undermines growth and it distracts attention from the real causes o f ill health, delaying difficult reform where it is most needed.’322 The author argues that the patent debate had diverted attention from the barriers to access to healthcare such as health infrastructure, doctors and nurses and the patients are suffering from the current fixation with patents and prices.
,2tl Feroz Ali, ‘Novartis: do Indian patent laws stifle research?’, The Hind„ August 9, 2007, http://vvwvv.hindu.coni/seta/2007/08/09/stories/2007080950161500.htm.
321 Ibid.
■l22 IP fixation is bad for health, The Economic Times, 13 August 2007,
http://economictimes.indiatinies.com/Cjuest Writcr/lP fixation is bad for health/articleshovv/2276398.c ms.
The New York Times approached the decision with a caption: ‘Setback for Novartis in India over Drug Patent.’323 It has noted that now Indian companies will be free to manufacture cheaper generic versions of patented medicines.
An editorial in The Wall Street Journal Asia criticised the patent policy of the Indian government which allowed the incorporation of some last minute loopholes in the patent law in 2005, which later provided the basis for the rejection of the Novartis patent application. The editorial noted that Indian patients and the drug manufacturers will be the losers in the wake of the High Court judgment. It further stated that: ‘There’s a good reason why major pharmaceutical companies have set up shop in Singapore and China rather than on the Subcontinent.’324
Praful Bidwai writing for the Inter Press Service revealed that, despite the Court’s verdict, the Indian government was planning to amend the patent law to encourage
incremental innovation by pharmaceutical drug companies.325 In an article for The
Economic Times Sanjeev Choudhary also confirmed this report when he stated: ‘We are looking for ways to award patents for discovery of a new form of a known substance which results in the enhancement of the known efficacy of that substance.’326
323 Amelia Gentleman, ‘Setback for Novartis in India Over Drug Patent’, The New York Times, August 7, 2007,
littp://vv\vvv.nvtimes.eom/2007/08/07/business/worldbusiness/07dru«z.htmr.)ex=l 187409600&cn=958e444 Icac7d0b6&ci=5070.
'^4 Editorial, ‘Drug Patents in India’, The Wall Street Journal Asia, 14 August 2007, http://aw s j. c o m. h k/ lac t i v a - n s.
325 Praful Bidwai, ‘Health-India: Novartis Patents Case Far From Dead’, Inter Press Service (IPS), August 9 http://ipsnews,net/news.asp?idnews=38840
3-6 Sanjeev Choudhary , ‘Novartis to divert India investment after patent case The Economic Times- India’, The Economic Times, August 9, 2007.
VII. Conclusion
The judgment of the Madras High Court not only establishes the validity of Section 3(d) of the Patent Act 1970 (India) but also sets the tone of judicial response to the question of interpretation of patentability criteria in India. The case has been an influential precedent. The Kolkata patent office has rejected Eli Lilly’s patent application for Forteo, an osteoporosis drug after hearings on a pre-grant opposition filed by the domestic drug manufacturer USV Ltd. The application was rejected on the grounds of prior knowledge, incremental innovation and the failure to establish enhancement of known efficacy.327 Abbott Laboratories also faced opposition proceedings on the same grounds for its application to patent Aluvia, a ’heat stable’ form of an antiretroviral drug, consisting of Lopinavir and Ritonavir.328 The High Court has appropriately suggested that the meaning of the terms ‘efficacy’ and the ‘enhancement of known efficacy’ could be judged in light of the therapeutic effect of the new form. So, the burden of proof is on the applicant to show the enhanced efficacy. This may help in reducing the possibility of evergreening but the patent office should develop some guidelines to sustain its practices in future by setting aside the possibilities of any misuse of powers under the relevant clauses.
On the issue of international law compliance and the jurisdiction of national courts, the judgment highlights the need to adopt a proactive engagement strategy to interpret the law cohesively in the light of treaty obligations and national policy objectives. The
TRIPS Agreement 1994 assumes a critical role in the national courts for the enforcement of obligations under the agreement, and the courts should respond to this duty by
327 C.H. Unnikrishnan, ‘India turns down Eli Lilly’s patent plea’, The Wall Steet Journal, August 29 2007, http://wwvv.livemint.com/2007/08/29000400/lndia-tuins-dovvn-Eli-Lilly82.html.
328 I-MAK Summary of Patent Challenges on Lopinavir/Ritonavir tablet in Europe and India (accessed on 12 July 2009) at http://wwvv.i-mak.onz/lopinavirritonavir/ .
devising appropriate interpretations. Nonetheless, the judgment will assist in maintaining the current flow of Indian drugs exports to poor patients in many developing countries across the world.