Future Implications of India's Gleevec Ruling

Differences in patent extension terms in the United States and India have led to a ruling that may affect future drug innovation overseas.

Differences in patent extension terms in the United States and India have led to a ruling that may affect future drug innovation overseas.

Earlier this month, the Indian Supreme Court ruled that Novartis cannot retain the rights to the patent for Gleevec (imatinib mesylate), a drug used to treat chronic myeloid leukemia. Because of a rule established in 2005 in Indian intellectual property (IP) law, drugs are not allowed to be protected by patents unless they were discovered after 1995. Novartis first patented a version of Gleevec in 1993. Even though the company ultimately abandoned development of that particular version, the Indian judges deemed the newer and older versions too similar to merit a separate patent for each. As a result, generic drug companies in India are free to continue making generic versions of the drug.

This decision may seem like a great victory for those supporting increased access to affordable versions of expensive branded drugs and a significant blow to branded manufacturers, who argue that protecting their intellectual property allows them to stay in business and fund future drug discovery ventures.

In the United States, drug companies that seek to extend the patent of a branded drug may do so by submitting a compound for review that is slightly altered. A single enantiomer difference in the inactive component in a drug salt, or a change in the specific hydrate form of the drug salt, for instance, can usually make the compound eligible for an extension. Under Indian patent law, however, minor changes in the formulation of a compound alone are not enough to warrant an extension. Instead, according to an article in The Economic Times, the Indian Patents Act of 2005 requires new forms of known molecular entities to offer “enhanced therapeutic efficacy” as a prerequisite for receiving a patent extension.

The Indian Patents Act of 2005 also tries to discourage “attempts at repetitive patenting or extension of the patent terms on frivolous grounds.” In other words, the Indian approach is to erect safeguards against the practice of evergreening, or the extension of a drug manufacturer’s patent rights past their normal expiration date. This practice is commonly employed in the United States to maximize the manufacturer’s revenue for as long as possible.

The practice of evergreening, used primarily as a tool to prevent competition from manufacturers, will likely continue as patents for specialty pharmaceuticals expire. Further biosimilar pathway development will also likely propel the topic of evergreening back into the headlines as drug developers scramble to find ways to maintain the return on their investments.

Some critics of the Indian court’s decision worry that it could drive innovation out of India, as companies may decide not to develop drugs there for fear their research will not be protected by the country’s intellectual property laws. “In my opinion, the Supreme Court’s decision was not a patent ruling, but a domestic economic policy decision,” Peter Pitts, president and cofounder of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA, told NDTV. Pitts said that while a beta crystal reformulation may not always change a drug’s efficacy, the science required to make such a change represents “incremental innovation” and should be recognized by the Indian courts.

Others argue that extending patents on drugs without proving that the alteration improves patient outcomes is a frivolous practice and contributes to the “monopoly protection” of certain blockbuster brands. Novartis countered that the reformulation it submitted for review was 30% easier for patients to absorb than earlier versions, an argument that the Indian court felt was not supported with enough evidence.

A representative from Novartis and an IP attorney supporting the United States pharmaceutical industry weighed in last Friday in separate letters to the editor of The New York Times. Paul Herring, chairman of the board, Novartis Institute for Tropical Diseases, wrote that although the original Gleevec compound was first created in the early 1990’s, this version was not “medically viable,” and Novartis “never introduced an earlier version of Gleevec in any country, including India.”

Lisa A. Kilday, the IP lawyer, who opposes the Novartis decision, wrote that the efficacy requirement in the Indian Patent Act of 2005 is a “protectionist” measure benefiting India’s $26 billion generic drug industry. “India’s generic drug industry has made billions by ignoring laws when exporting drugs that may be under patent protection in another country,” Kilday noted in her letter. “The intellectual property community should focus on a balanced patent protection system that is in compliance with international agreements, encourages the use of compulsory licensing for least developed countries, and negotiates trade agreements that bar parallel imports of discounted drugs.”