India High Court Temporarily Halts Sovaldi Competition

The Delhi high court on set aside a government order rejecting Gilead’s patent for hepatitis C treatment Sovaldi, saying the Office of Patents Designs and Trademark had made procedural errors in issuing its decision.

The ruling is a setback for generics makers hoping to cash in on Sovaldi (sofosbuvir), which retails for $1,000 per pill and $84,000 for a full, three-month treatment.

The patent office initially rejected Gilead’s patent two weeks ago, siding with a challenge by Indian generics manufacturer Natco Pharma and the U.S.-based nonprofit Initiative for Medicines, Access & Knowledge.

Tahir Amin, co-founder of I-MAK, says the ruling does not refute the government’s ruling that Gilead’s product is not patent worthy; it simply means procedural problems need to be corrected in the way it reached its decision.

Simon Elliott, an attorney with Foley & Lardner, however, welcomed the ruling, saying the government’s decision to end Sovaldi’s exclusivity was poorly thought out and not based on patent law.

The court ruling gives drugmakers some assurance that India’s intellectual property policy is relatively predictable and that the law is not being rewritten on the fly to favor political constituencies, Elliott says.

Gilead declined to comment on the high court’s decision. — Jonathon Shacat