India has regularly been pulling the rug out from under Western drugmakers' intellectual property and has done it again, this time dealing a big blow to GlaxoSmithKline ($GSK). The news is another distraction for the company, which is sorting out serious bribery charges against employees in China.
India's Intellectual Property Appellate Board (IPAB) has pulled the patent that GSK had for its breast cancer drug Tykerb, a salt form of lapatinib, while upholding the patent on the original API, according to Reuters. But instead of the challenge coming from one of the home-grown Indian companies, this one came from the Indian unit of Fresenius Kabi, the German drugmaker, Reuters reported.
"This decision is just like the landmark Glivec ruling," Dominic Alvares, a lawyer for Fresenius Kabi, told Reuters. "The IPAB has said that the salt version of lapatinib cannot hold a patent." Alvares was referring to the closely watched case several months ago in which the Supreme Court did not grant Novartis' ($NVS) patent on its cancer drug Glivec, allowing copies to come onto the market.
GSK said it is considering other legal options, but Indian officials have not been very receptive to the pleas of Western drugmakers and have increasingly been stripping patent protection from Big Pharma's products. There's the Natco Pharma compulsory license on Bayer's Nexavar, which opened up the market to cheap copies of the on-patent cancer drug. It has also pulled the patents on Pfizer's ($PFE) Sutent and Roche's ($RHHBY) hepatitis C drug Pegasys, among others. And the Indian government is now considering a compulsory license application on Roche's Herceptin.
The government argues that prices are too high for life-saving drugs and innovations too limited for patents to be upheld. Drugmakers have been looking for ways to lower prices in hopes of keeping their patents in place, often offering the drugs at deep discounts. As Reuters points out, Glaxo had been using a flexible pricing plan that reduced Tykerb prices by more than 30%. And Roche has cut the price of Herceptin in India by 30%.
This is one more difficult issues for Glaxo CEO Andrew Witty. The drugmaker has nearly two dozen employees detained in China as the government investigates allegations that GSK folk were paying bribes and offering sexual favors to health officials in an effort to sell more drugs. Witty has called the allegations "shameful" and "deeply disappointing." The probe is now spreading to other drugmakers in China.
- read the Reuters story