Novartis is appealing decision that a new formulation of the drug constitutes evergreening and isn’t patentable.

Novartis is defending itself against criticism that its challenge to India’s patent law will reduce access to medicine for that nation’s poor. At issue is India’s 2006 refusal to award Novartis a patent on Gleevec (imatinib), also known as Glivec, a drug designed to treat chronic myeloid leukemia and some other forms of cancer. Officials cited Section 3(d) of the Indian Patent Act, which states: The mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine, or apparatus unless such known process results in a new product or employs at least one new reactant,” does not warrant patent protection.

The Madras High Court and Indian Patent Appellate Board upheld an earlier ruling by India’s Patent Office that held that under Section 3(d) the beta-crystalline formulation of Gleevec allowing for greater absorption within the body was not novel enough to be patented. The appellate board acknowledged that Gleevec was novel in some respects but not novel enough to warrant a patent, concluding that the formulation was a “mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance.”

Not surprisingly, Novartis disagrees, and has appealed to India’s Supreme Court, which is set to hear the case on March 28. The case had been scheduled several times, most recently set for February 28 but was delayed in the most recent instance due to the Mumbai terror attack trial taking longer to adjudicate than planned, reported.

The humanitarian aid group Médecins sans Frontières recently urged Novartis to drop the court case, arguing that a court win for Novartis would severely limit access to affordable medicine across the developing world, Pharma Times World News reported.

Médecins sans Frontières (MSF) has its own stake in such a case: The group relies on purchases of generic drugs to accomplish its mission: According to its website, MSF buys more than 80% of the medicines it uses to treat 1.6 million people living with HIV/AIDS worldwide from lower-priced Indian makers of generic drugs.

As noted by the blog New Internationalist, Section 3(d) specifically prohibits the practice of “evergreening,” in which biopharma companies secure patent protection on minor variations of a previously patented medicine, which MSF points out Novartis and other multinational pharma giants regularly engage.

Since India became fully compliant with the World Trade Organization’s TRIPS (trade-related aspects of intellectual property rights) international agreement in 2005, Section 3(d) “helped to sustain the growth of India’s generics manufacturers, some of whom currently produce versions of Glivec for less than a tenth of the price,” New Internationalist writes. “By keeping foreign monopoly interests at bay, Section 3(d) plays an important role in enabling India to supply life-saving medicines used in poor countries the world over,” the blog adds.

But in a statement to Pharma Times World News, Novartis defended its litigation and denies engaging in evergreening or trying to limit access to medicines. “We disagree with assertions by a number of groups that access to medicines is threatened by our case. The basis of this argument is false and very misleading,” Novartis stated, adding that it maintained “confidence the Supreme Court will make the right decision based on the law of India.”

Novartis argues that Section 3(d) violates Article 14 of India’s Constitution, since “enhancement of known efficacy” and “differ significantly in properties with regard to efficacy” are not defined specifically enough. “We believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India’s patent law,” Novartis added. “We need to know if we can rely on patents in India and whether as a research-based organization we can continue to invest in the development of better medicines for India.”

The case is believed to have significance beyond the biopharma world, as blog India Patents concluded last December: “The case is being closely watched as it is speculated that the Court would define the true scope of Section 3(d) amidst other matters.”

To read the story from Pharma Times World News, click here.
To read the story from, click here.
To read the story from New Internationalist, click here.
To read the blog from India Patents, click here.

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