Pharma patent war brings India's healthcare sector in focus

The pharmacy of the world - the sobriquet India has earned for its ability to supply cheap drugs to poor countries globally - is in for a churn. The landmark decision of the patent office to break the monopoly of Bayer in kidney and liver cancer drugs recently is already having a rippling effect.

Close on the move to invoke 'compulsory licensing' in Bayer's case, Roche has announced plans to sell cheaper variants of its breast and blood cancer drugs in Indian markets soon.

The patent office had felt that Bayer had failed to price the anit-cancer drug Nexavar at a level that could be accessed and was affordable. Besides, the firm was unable to ensure that the drug was available in sufficient quantities in the country.

SPECIAL:India's confused search for cheap drugs

Now, on the block is future of another cancer drug Glivec, of Swiss drug major Novartis, which is locked in a long-drawn patent battle with India. This week, the Supreme Court is likely to begin final hearing in the case that observes feel will impact not only multinationals like Novartis but also the future of India as destination for cheap drugs.

Novartis first challenged the government in 2006 after its patent application for Glivec (imatinib mesylate) was rejected. The 2005 Indian patent law amendment allows product patents but not for drugs which are mere modifications of already existing drugs.

COSTLY CANCER DRUGS Bayer’s drug sorafenib tosylate for kidney and liver cancer costs $5,500 per month. Price of generic version $175 per month Roche’s drug Herceptin for breast cancer and MabThera for cancers of the blood and lymphatic system cost between $3,000 and $4,500 per patient per month Novartis’ drug Glivec for leukemia costs $2,500 per patient per month. Generic versions sell for $160 to $200 per patient per month NOVARTIS TRYST WITH PATENTS ACT January 2006: Novartis’ patent application for Glivec is rejected in India on several grounds, including Section 3(d) May 2006: Novartis challenges the rejection in the Madras High Court saying it is contrary to TRIPS and the Constitution August 2007: HC rejects Novartis plea, says 'efficacy’ under Section 3(d) will require Novartis to prove increase in therapeutic efficacy June 2009: The Intellectual Property Appellate Board rejects Novartis’ appeal and confirms Glivec does not deserve a patent August 2009: Novartis approaches SC seeking to challenge interpretation and application of Section 3(d) by Indian courts and patent offices

Besides, the drug firm questioned validity of the law itself, particularly Section 3(d) under which patents can be granted only when there is 'significant enhancement of efficacy in terms of treating human disease'. Companies seek patents even for minor improvements in existing drugs in terms of bioavailability, solubility or stability just to retain their monopoly over a particular drug class. This is known as 'evergreening'.

If such a practice is allowed, experts fear it will open floodgates of patents on trivial changes to existing medicines across the board.

"The implications of this case will be far beyond India and his particular cancer drug," said Leena Menghaney of Médecins Sans Frontières.

"A victory for Novartis would lead to patents on modifications to drugs which would otherwise remain off-patent in India," said Yoginder Kumar Sapru of Cancer Patient Aid Association, which was the first to take on Novartis.

Currently, Indian generic drug companies supply anti-HIV and TB drugs at affordable prices to many African countries because they are able to make copies of patented drugs with minor changes. If minor changes also become patentable, as argued by Novartis, Indian generic companies could go out of business.

Industry lobbies such as the Organisation of Pharmaceutical Producers of India, however, feel that particle size, combinations and derivatives of known substances should be patentable as long as they meet classic criteria of patentability such as novelty, non-obviousness and commercial applicability.

Courtesy: Mail Today