Pharmacy of the “Developing World”: The Novartis Case

 [highlight]-Geetashree S. Kurup, National Law University and Judicial Academy, Assam[/highlight]

Ever greening of patent refers to the attempts by the patent-holders and especially pharma companies to try and extend the life of the patent by obtaining patents on different aspect of the same drug to extend their monopoly. Due to such ever greening, a single drug can end up having multiple patents leading to patent thickets. This prevents introduction of generic versions of drugs even after the expiry of the original patents.

In order to prevent frivolous patenting and ever greening Section 3 of the Patents Act, 1970 defined which kinds of inventions are not patentable. The amended 2005 act under section 3(d) declares that any substance is not patentable when it is: “the mere discovery of a new form of a known substance which does not result in the enhancement of the new efficacy of that substance or mere discovery of a new property, new use of that property or any known substance or mere use of known process unless such known process results in a new product or involves new reactant.”

The said section from the very beginning is seen as an obstacle by several [1]MNCs and the pharmaceutical companies to capture the Indian market with their new products and have been contesting every word of section 3(d)- like efficacy, enhancement and significant etc.  The major case post 2005 seeking to redefine and interpret section 3(d) has been the famous [2]Gleevec case (gleevec is the brand name of an anti cancer drug). In 1998, the Swiss Pharmaceutical company Novartis filed an application for a product patent on the beta crystalline form of [3]imatinib mesylate, the original molecule having been discovered in early [4]1990s and patented by Novartis in the United States and other developed countries in 1993.

As a result in 2006, the Chennai Patent Office refused Novartis’ patent on the ground that it was not innovative which again followed in the year 2009 by the Intellectual Property Appellate Board rejected Novartis’ appeal against Section 3(d) and Novartis approached the Supreme Court in 2009 which finally was rejected its this year. The [5]Supreme Court held that Glivec is not new, not innovative and failed to fulfill the section 3(d) criteria which states that inventions that are a mere “discovery” of a “new form” of a “known substance” do not result in increased efficacy of that substance and are not patentable. [quote]The judgment was unanimously agreed by people as it prohibits global pharma firms from repeatedly claiming a patent on the same drug by making minor changes to it. That allows domestic companies to come out with cheaper generic versions, making lifesaving drugs affordable to a large section of patients in a developing country like India with a population of low level income families.[/quote]

Innovation or Affordability?

There is little doubt that India’s approach is based upon a public health perspective, namely the concern that absent such provision, the law would allow ever greening or an extension of a patent protection through multiple patents on the same invention.

[highlight]Some have argued that section 3 d. is acceptable under TRIPS[6] through recognition in the Doha Declaration. However it is unclear why, in the light of changes to the laws to provide patent protection, section 3 (d) is necessary if the patent is to promote the access to medicine? In other words inclusion of this provision raises questions as to purpose of limiting the scope of property rights particularly considering other measures available in the patent law to us property if public health issue arises. Ultimately in constructing section 3(d) the parliament effectively limited the ability to obtain property rights in incremental pharmaceutical innovations, where currently the bulk of research and development occurs, including medicines that may be more and more effective in tropical climates. Therefore attempt to define invention violates the obligation to make patents in all fields of inventions, consequently, further debate on the role of directives on the state policy with respect to protection of property under the Indian Constitution.[/highlight]