Access to Life-Saving Medication: The Struggle Between Innovation and Efficacy

Posted By Megha Bhatt, JILP Member, Apr 24, 2013

Innovation of new, life-saving drugs is partly influenced by how a particular country defines “innovation” and how receptive the country’s laws are to innovation. The Swiss pharmaceutical giant, Novartis, was denied a product patent application from the India Patent Office (IPO) for a specific compound, the beta crystalline form of imatinib mesylate.[1] The drug, Gleevec, is a cancer drug used to treat chronic myeloid leukemia and some gastrointestinal cancers.[2] On April 1, 2013 in Novartis v. India, the Supreme Court of India (“Court”) rendered a verdict against Novartis and affirmed the IPO’s rejection of the patent.[3]

 

In reaching its decision, the Court considered the 2005 India Patents Act. The Section 3(d) amendment of the Patents Act requires that patents for new forms of known substances should be granted only if they show “significant enhancement in known efficacy.”[4] The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows great flexibility in the adoption of patenting standards.[5] The Court interpreted “known efficacy” in Section 3(d) as “enhanced therapeutic efficacy,” meaning that Novartis had to prove that the beta crystalline form of imatinib mesylate resulted in actual improved therapeutic results for patients when compared to the old salt form.

 

The Court noted that Novartis’ evidence failed to compare the old salt to the new salt, the beta crystalline form.[6] Rather, the evidence compared the new salt with the non-soluble, “free base” form of the drug. It would be interesting to note how India’s standards for efficacy and their application of the TRIPS agreement compare to other countries. Will more countries in the developing world follow India’s lead in this landmark case? If the future market of availability of drugs depends on emerging markets in developing countries, this case may be setting the stage for a larger trend.

 

The Court has upheld the rule that there must be evidence proving that a new drug has increased efficacy in order for a new patent to be approved in India. India’s standards are harder to meet than countries like the United States or the United Kingdom. As a result, the focus for patents in India shifts to improving end results rather than spurring innovation. After 1995 in the United States, for example, patents with very minor modifications were approved in a practice called “ever-greening.”[7] This allows pharmaceutical companies to charge patients higher amounts for a patent-protected version of their popular drug. This practice encourages “innovation” in a very broad sense but fails to recognize that an important purpose of manufacturing life-saving drugs is to actually see measurable improvements in patients.

 

The Court’s ruling in Novartis v. India took the position that improved modifications are more important than promoting modifications in drug patents. If a particular country shifts the focus from drug marketing to drug efficacy, there could be a major shift in the way international patent law is interpreted and implemented.



[1] Frederick Abbott, The Judgment In Novartis v. India: What The Supreme Court Of India Said, Intellectual Prop. Watch (Apr. 5, 2013, 9:30 PM), http://www.ip-watch.org/2013/04/04/the-judgment-in-novartis-v-india-what-the-supreme-court-of-india-said/.

[2]Cancer Drugs to Remain Affordable as Novartis Loses Indian Patent Battle, IBN Live (Apr. 5, 2013 10:05 PM), http://ibnlive.in.com/news/sc-denies-patent-to-novartiss-glivec-cancer-drugs-to-remain-cheaper/382394-17.html [hereinafter Cancer Drugs].

[3] Abbott, supra note 1.

[4] Id.

[5] Id.

[6] Id.

[7] Cancer Drugs, supra note 2.