India Partly Revokes Roche Patents For Herceptin Breast Cancer Drug
Once again, the Indian government has decided to revoke patents on a medicine sold by a global drugmaker. The latest episode involves patents for the Herceptin breast cancer treatment by Roche, which last year agreed to lower the price of the drug and made plans to undertake local manufacturing.
In explaining its decision, however, the Kolkata Patent Office maintained that the drugmaker failed to follow appropriate procedures for filing applications, and that the move was not related to pricing. We asked Roche for comment and a spokeswoman writes us to say that the drugmaker Is "considering the further course of action... We recognize that access to healthcare is a major challenge in many countries, including India." Roche is now assessing the impact of its pricing program.
Last month, the Indian health ministry moved to revoke the patents in the public interest, a highly unusual step that has been taken only twice in the past. The followed a decision by the Department of Industrial Policy and Promotion to reject a plea for a compulsory license by patient advocates to make the medicine more affordable.
By emphasizing that the decision was not based on pricing, the patent office may be attempting to thwart more of the blistering criticism has been directed at Indian officials by the pharmaceutical industry and some US lawmakers in recent months over intellectual property concerns. The issue was the subject of a recent Congressional hearing, for instance.
The example regularly cited was a decision made last year by the Indian government to award a compulsory license to a generic drugmaker to produce a lower-cost version of a Bayer cancer, a step that was regarded as a landmark decision at the time. After the license was issued, the monthly treatment cost reportedly dropped by about 95 percent. Bayer appealed, but lost.
Three months ago, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication. The court sided with patient advocates who charged the drugmaker sought the extension based on minor changes, which would inhibit access to the treatment and since generic drugmakers would be prevented from making lower-cost copycat versions (see this).
Late last week, India’s Intellectual Property Appellate Board revoked two patents granted to GlaxoSmithKline for the Tykerb breast cancer drug. One revocation was cited because the drugmaker attempted to use small changes to make a variation of the medicine, a process that is criticized by patient advocates as evergreening.
These decisions have created a climate that global drugmakers have derided as not only hostile to medical research, but threatening to their intellectual property in still other countries that are considering issuing compulsory licenses for high-priced medicines. The cost of prescription drugs, for instance, is a key point to be debated in the Trans-Pacific Partnership trade talks that just began.
STORY ENDS HERE
In explaining its decision, however, the Kolkata Patent Office maintained that the drugmaker failed to follow appropriate procedures for filing applications, and that the move was not related to pricing. We asked Roche for comment and a spokeswoman writes us to say that the drugmaker Is "considering the further course of action... We recognize that access to healthcare is a major challenge in many countries, including India." Roche is now assessing the impact of its pricing program.
Last month, the Indian health ministry moved to revoke the patents in the public interest, a highly unusual step that has been taken only twice in the past. The followed a decision by the Department of Industrial Policy and Promotion to reject a plea for a compulsory license by patient advocates to make the medicine more affordable.
By emphasizing that the decision was not based on pricing, the patent office may be attempting to thwart more of the blistering criticism has been directed at Indian officials by the pharmaceutical industry and some US lawmakers in recent months over intellectual property concerns. The issue was the subject of a recent Congressional hearing, for instance.
The example regularly cited was a decision made last year by the Indian government to award a compulsory license to a generic drugmaker to produce a lower-cost version of a Bayer cancer, a step that was regarded as a landmark decision at the time. After the license was issued, the monthly treatment cost reportedly dropped by about 95 percent. Bayer appealed, but lost.
Three months ago, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication. The court sided with patient advocates who charged the drugmaker sought the extension based on minor changes, which would inhibit access to the treatment and since generic drugmakers would be prevented from making lower-cost copycat versions (see this).
Late last week, India’s Intellectual Property Appellate Board revoked two patents granted to GlaxoSmithKline for the Tykerb breast cancer drug. One revocation was cited because the drugmaker attempted to use small changes to make a variation of the medicine, a process that is criticized by patient advocates as evergreening.
These decisions have created a climate that global drugmakers have derided as not only hostile to medical research, but threatening to their intellectual property in still other countries that are considering issuing compulsory licenses for high-priced medicines. The cost of prescription drugs, for instance, is a key point to be debated in the Trans-Pacific Partnership trade talks that just began.
STORY ENDS HERE
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