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Novartis Defeat Revives Debate Over Patents' Life Span
When India's Supreme Court ruled this week that Novartis AG's cancer drug Gleevec was not sufficiently innovative to merit a patent, public health advocates lauded the decision, which they said would give more people access to needed drugs, and Big Pharma condemned it, saying it would stifle innovation.
The court's decision, however, was not about encouraging innovation or access. It revolved around a practice the pharmaceutical industry refers to as "life-cycle management" and which public health advocates call "evergreening."
That practice, which is common in the United States, involves pharmaceutical companies periodically making small changes to a patented drug, enabling them to apply for a new patent on the modified drug. This strategy essentially extends the term of a drug's patent, prolonging the time in which patent protection can ensure exclusive rights and keep out competition from generic drug manufacturers.
This strategy has long come under criticism by generic drug makers and public health advocateseven in the U.S., where it has been cited as one reason healthcare costs are so high. But as long as the drug is shown to have utility and to be novel and non-obvious, it can receive a patent.
"There have been cases in which the courts have ruled against a company's secondary patent, but the Federal Circuit has made it clear that if a company writes its claims carefully, the new patent can stand," said Srividhya Ragava, a professor at the University of Oklahoma's College of Law who has followed the Novartis case.
The standard for patentability in India, however, is much higher. "It's a more rigorous standard than in the U.S. but it's not contrary to the rules of the World Trade Organization," said Janice Mueller, a former patent law professor who offers legal seminars and consulting services to law firms and has followed the "evergreening" controversy.
A statute in India's law known as Section 3(d) that is now well known in the pharmaceutical world says in part that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not patentable. In the pharmaceutical world, that can mean changing the form of a drug to a salt, ester, polymorph, or anything else cannot by itself result in a new patent.
"In other words, if it's the same compound but in a new form, it will be deemed the same as the original drug unless the applicant can prove clear therapeutic efficacy," Ragava said, adding that the rule is "a tough bar" for drug companies to clear.
And Novartis did not, according to the Indian court, clear it in this case. The patent for the original compound on which Gleevec is basedimatinib mesylatewas filed in the U.S. in 1993. India only began implementing patents in 1995, but compounds that predated India's patent system were not eligible for patent protection in India. That meant Novartis could only apply for a patent on the newer secondary cancer drug, said Bhaven Sampat, a professor at Columbia University's Mailman School of Public Health who is also affiliated with Columbia Law School.
The courts in India found that the basis for the newer form was anticipated by the earlier Novartis U.S. patentthat it was a new form of a known substance. And it denied the patent, saying there was no proof of "enhanced efficacy" as required by India's law.
"No one questions the value of the drug, and if Novartis could have filed a patent application in India for the original drug, it would have been granted," Sampat said. "Gleevec was a victim of timing."
Even in the U.S., a generic challenge has been asserted against the secondary drug, according to Sampat. Generic drug makers often try to be the first challenger of a patent, because the move can give them 180 days of exclusivity when the patent expires. But in many instances, a brand owner, when notified of such a challenge, will sue the generic drug maker in federal court to show its patent is valid. Novartis, however, has not done so. "Novartis doesn't seem to be pursuing it," Sampat said. "Perhaps it knows even in the U.S. its patent wouldn't hold up."
In fact, Sampat and Columbia Law School professor Scott Hemphill conducted a study in which they found that generics almost always win in U.S. courts when the challenge is litigated to completion.
But back in India, where Big Pharma is also facing compulsory licensing rulings that allow generic drug makers to pay a royalty to produce drugs still under patent protection, the repercussions of the Supreme Court ruling are still unclear. Some say Big Pharma will stop investing in research and development facilities in India. Others say the decision paves the way for a booming generic drug industry in India, a country that is already dubbed "the world's pharmacy."
"We don't know what will happen, but the rest of the world is watching," said Mueller. "Other countries already have some anti-evergreening provisions in place, and more are likely to follow India's lead."