Transfer Pricing Associates

Set back in India for IP protection

post Thursday September 19, 2013

Tags: glaxosmithkline, gsk, india, indian patent board, ip protection, ipb


In a move that is in stark to contrast to positive progress in the protection of intellectual property, the Indian Patent Board revoked a local patent that had been granted to GlaxoSmithKline (GSK) for a pioneering version of a prominent breast cancer drug.

India is home to a sizeable $13 billion dollar medicine market, but has been at the center of intellectual property controversy for quite some time. The move to revoke GlaxoSmithKline’s patent for Tykreb, one of the most often prescribed breast cancer treatments in the country, is a critical decision made by the Indian Patent Board(IPB). The IPB claims that the patent for Tykreb should be invalid because Tykreb is, “an incremental improvement of the original compound and not sufficiently innovative to warrant a patent.”

The ruling to overturn the patent underscores the strong stance that India takes on protecting intellectual property, especially in the pharmaceuticals and biopharmaceuticals industry. GSK has not commented on potential responses to this overturning of the protection of their IP.

India’s decision to revoke the patent for Tykreb is in line with recent decisions that have been made by the leaders of the Indian government regarding IP and how IP should be protected. The revocation of Tykreb follows a major precedent that was established by the Indian Supreme Court in April when the court revoked patent updates from the prominent Swiss pharmaceutical company Novartis. Novartis had requested updates and new patents for their blockbuster drug Gilvec, which is used to treat advanced and deadly forms of leukemia.

One positive that GSK can take away from the ruling is that the original patent for the basic lapatinib compound was not revoked by the Intellectual Property Appellate Board. The patent for lapatinib is scheduled to expire in 2019, while the patent that was overturned for Tykreb was scheduled to expire in 2021.

The $13 billion dollar medicinal market located in India is of great potential value for U.S. medical companies.  As long as the Indian government does not maintain a climate of protecting intellectual property rights, there will be great risk to approaching the market that could create a long term negative impact for the country.

Source: Industry Week

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