Novartis insists that Glivec meets the criteria for patentability. Like the other drug companies, it argues that allowing generic drug makers to sell copies of its patented drugs will discourage innovation. "We strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients without options," says Novartis spokeswoman Julie Masow.
Novartis appealed the patent office's decision, and the case has wended its way through the courts. India's Supreme Court heard the case in September, and it could issue a ruling before the end of the year.
International aid organizations fear that a ruling for the drug company would represent a big setback for the public. Says Rehman: "At the end of the day, it's the patients who suffer."
Since the Novartis fight began six years ago, other drug companies have lost big battles in India over top-selling and life-saving drugs. In 2009 India's patent authority rejected applications filed by Gilead Sciences for Viread, a widely prescribed drug used to treat HIV. In 2010 it revoked the local patent held by Roche on its antiviral drug Valcyte, which is used to treat HIV-AIDS patients and to prevent infection in patients who have received an organ transplant.
In response to the chorus of complaints, international aid groups say that the drugmakers are blowing the issue out of proportion by focusing on these losses. They point out that the majority of patent applications in India are not rejected, and the companies are profiting from their patents.
But Big Pharma has another concern. The recent compulsory licensing order in India sparked fears that other nations would follow its lead. Multilateral agreements have given poorer countries the right to order compulsory licenses when public health is at stake. And countries like Malaysia have made use of them in the past.
Subsequent developments suggest that these fears were not unfounded. In June, China overhauled its IP laws. The changes allow the Chinese government to issue compulsory licenses to local companies to produce generic versions of patented drugs during states of emergency or unusual circumstances, or when the public interest is at stake.
Three months later, the companies' worst fears were realized. The government of Indonesia overrode the patents on seven hepatitis and HIV drugs. The companies affected were Merck & Co., GlaxoSmithKline plc, Bristol-Myers Squibb Company, Abbott Laboratories, and Gilead. An estimated 310,000 people are living with HIV in Indonesia. The country justified its actions by citing the need to improve patient access. Now Big Pharma and international aid organizations are watching and waiting to see who fires next in this escalating intellectual property war.
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