Law · Public Policy

The Novartis Debate

The judgment rendered by the Supreme Court has been applauded as a landmark one that will help provide millions of people around the world access to cheaper medicines and prevent pharmaceutical giants from “evergreening” their patents. The decision was delivered on a special leave petition preferred by Novartis challenging the decision of the Intellectual Property Appellate Board, which held that the drug that Novartis sought a patent for was hit by Section 3(d) of the Patents Act (“Section 3(d)”) and therefore was not an invention which could be patented under Indian law.

Historically, India only had limited patent protection on drugs and generic companies in the country made versions of many medicines. It was only when Indian firms began to make cheap copies of HIV drugs that it became possible more than a decade ago to contemplate the treatment of millions of people in impoverished countries of Africa, where the Aids epidemic was at its worst. But in 2005, India became compliant with World Trade Organisation rules on intellectual property and now grants patents on new drugs which show innovation.

In this case, the Supreme Court held that the beta crystalline form of Imatinib Mesylate being a polymorph of Imatinib Mesylate is directly covered under Section 3(d). Novartis contended that Section 3(d) was inserted in the Patents Act in its present form out of abundant caution and any invention that meets the threshold of novelty and inventive step under Section 2(1) of the Patents Act cannot fall within the restrictions of Section 3(d). The Supreme Court observed that Section 3(d) was amended to prevent abuse of product patents in medicines and agricultural products and to allay the fears of the opposition that product patents, especially in the pharmaceutical sector were capable of being abused by “evergreening”.

The court observed that in its opinion, the amended Section 3(d) is meant to especially cover pharmaceutical products and is meant to set up a second tier of qualifying standards for patenting pharmaceutical products. The court went on to specify that this case should not be interpreted to mean that Section 3(d) bars all incremental inventions. This is a very strong observation by the Supreme Court and clearly all pharmaceutical patents need to satisfy the Section 3(d) test. From a legal point of view, the Supreme Court judgment is both as much a landmark as KSR International Co. v. Teleflex, Inc.

The Supreme Court judgment has followed recent trends. Last year Pfizer Inc’s cancer drug Sutent and Roche Holding AG’s hepatitis C treatment Pegasys lost their patented status in India. Last September, a court in Chennai allowed the compulsory licensing of the Bayer cancer drug Nexavar, and a court in Delhi declared that Roche could not obtain a patent for its lung cancer drug Tarceva. It seems that this case is one in a long line which might affect the outcomes of future pharma patent disputes. The spirit imbuing all the recent patent cases in India has been to strike a balance between the returns to (inventors and investors) against the concerns of consumers in a country where the affordability of drugs is of paramount political and social concern. This is of course unavoidable if generic alternatives are available at one-tenth or even one-thirtieth the cost.

What remains to be seen now is how this decision will affect the position of the multinational pharma companies with respect to the country. It seems that Section 3(d) may be a subject of consternation with respect to the WTO patent regime. However, it is true that the judgement has strengthened the IPR regime in India. The decision will greatly strengthen the quest for access to affordable medicines in India. It affirms the idea that a patent regime loses its social relevance when a drug is priced beyond the reach of the vast majority of a country’s people. The court order should prompt producers of patented drugs to move towards liberal licensing and low cost manufacture in India, the pharmacy of the South.

About the Author

dsDamayanti Sen

Damayanti is presently pursuing a five year integrated law program. She is the founder-editor of her college newswire and also occasionally contributes as a feature writer to various newspapers and blogs. A believer in objectivism and keenly interested in international law and politics, she cares enough to want to make a difference. Deeply involved in contemporary social issues, Damayanti makes sure that the word is spread. A keen debater and participant in many national level conferences and MUNs, she aspires to bring out a change through her chosen field of work. Being passionate and dedicated she treats every new challenge with the utmost enthusiasm.

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