India's trade-related aspects of Intellectual Property Rights (TRIPS) compliant Patent (Amendment) Act 2005 saw the transformation of its laws from a process patent regime to a product patent regime. The amendments have had a direct impact on India's generic drugs manufacturing sector, which was developed through the process patent regime introduced under the 1970 Act. The knock-on effect will soon be felt both domestically and globally, as a number of developing countries have come to rely strongly on Indian generics. This article seeks to study the effectiveness of the Act of 2005, and if it can be seen as an instance of success of the TRIPS provisions in Articles 7 and 8 read along with the Doha Declaration. It will be queried if developing countries in the World Trade Organization can possibly benefit from the model set-up by India for the issuance of compulsory licenses, and to check the practice of ‘evergreening’ by pharmaceutical patent holders. Recent decisions from the Indian judiciary and the qu...

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India's trade-related aspects of Intellectual Property Rights compliant pharmaceutical patent laws: what lessons for India and other developing countries?

This paper considers the impact of the new Indian patent regime on the important issue of access to affordable drugs. Access is dependent, in part, on the ability of generic manufacturers to produce cheap generic drugs. Working with the bird flu patent example, this paper will demonstrate that far from abetting 'genericide', the new regime provides adequate legal windows to aid the continued production of affordable generics. However, the mere existence of such windows/flexibilities is not enough - generic manufacturers will only exploit such windows when it is economically and politically viable to do so.

India's New Patent Regime: Aiding 'Access' or Abetting 'Genericide'?

On April 1, 2013, the Supreme Court in India handed down its decision to dismiss Swiss drug maker Novartis AG's attempt to win patent protection for its cancer drug Glivec. In doing so, the Supreme Court held that incremental improvements or modifications to an existing drug are not patentable under Indiaâ€™s patent laws. While the ruling may have allowed India to maintain its ability to manufacture generic drugs, the ruling has increased the challenges that pharmaceutical and biotechnology companies face in obtaining patent protection in India. In the long term, these challenges may prove to have far greater implications for the biotechnology industry that go beyond merely the patentability of one drug product. In view of this recent decision, pharmaceutical and biotechnology companies are undoubtedly re-evaluating their foreign patent strategies.

Evergreening patents: The Indian Supreme Court rejects patenting of incremental improvements


 
 
 Rising Research and Development (R&D) activity has led to dramatic growth in India’s pharmaceutical market in the last decade. This increase in R&D was occurring at a time of significant changes in the sector, notably in the intellectual property rights (IPR) system and the sector’s increased focus on biopharmaceuticals. The objective of this study is to examine the impact of these structural changes along with the traditional drivers of R&D activity to better understand the transformation in India’s pharmaceutical sector during this period and shed light on its future trajectory.
 
 
 
 We extend the traditional model to estimate the determinants of R&D by incorporating the changes in India’s pharmaceutical sector during this period. With pooled data for the top 16 pharmaceutical firms during the last decade, this model is estimated using feasible generalised least squares.
 
 
 
 Our results show that R&D is affected by firm size, global reach, and profitability. Experience, particularly successful patent experience, is important. However, at some point, R&D activity resulting from longevity succumbs to diminishing returns. Also, the IPR environment and firm investment in biopharmaceutical treatment are important drivers of R&D.
 
 
 
 Promoting R&D activity is vital to keep India’s pharmaceutical sector on its growth trajectory. Policies supporting the sector’s shift from imitation to innovation and promotion of biopharmaceutical treatment will ensure its continued success.


How structural changes are driving R&D activity in India’s pharmaceutical sector

In 2005, India amended its Patent Law to bring the country into compliance with the WTO TRIPS Agreement. Criticisms have arisen over a flexibility in the law, Section 3(d), which attempts to reduce evergreening by granting patents to only those inventions that enhance the drug’s known efficacy. The lack of a clear definition in the law has raised worldwide concerns over its misuse which was exacerbated by the 2013 Supreme Court denial of Novartis’s Appeal of Section 3(d)based patent rejection for the cancer treatment drug, Glivec. To analyze the importance of Section 3(d) and this ruling on patent decisions in India, a database of 500 pharmaceutical patent cases between 2005 and 2016 was created. The determinants of patent decisions were estimated using a binomial logit regression and conducted a statistical analysis to identify their confounding factors. The results show that if a patent application has Section 3(d) objection, the odds of the case being rejected and/or abandoned more than double. Also, although the odds of patent rejections have fallen since the 2013 Supreme Court ruling, this result is driven by non-Section 3(d) cases. Thus, it was concluded that Section 3(d) will play an increasingly important role in patent rejections.

http://nopr.niscair.res.in/bitstream/123456789/55114/1/JIPR%2025%283-4%29%2065-73.pdf

Kaitlyn Maloney

Papers

Section 3(d) and Pharmaceutical Patents in India