India generics giant wins cancer drug patent case

Indian generics giant Cipla says it has scored a "landmark" court win in a patent challenge launched by Switzerland's Roche Holding over the Mumbai firm's version of a lung-cancer drug.

Delhi High Court Justice Manmohan Singh on Friday ruled that Cipla's drug, Erlocip, did not violate the Roche patent on its anti- medication Tarceva due to its different molecular make-up.

"It's a landmark judgment in a patent case," Pratibha Singh, a patent lawyer who represented Cipla, told Mint newspaper. "The court has taken all efforts to analyse claims of both parties in terms of legality and scientific evidence."

No further details of the judgment were available.

The Cipla court case was being watched worldwide as it involved interpretation of stricter drug patent protection rules introduced by India in 2005 to comply with regulations.

India is the world's leading exporter and manufacturer of non-branded medicines and medical charities have expressed concern that compliance with WTO trade rules could reduce the country's role as a supplier of cheap medicines.

Roche's Tarceva is priced at 140,000 rupees ($2,533) for a month's supply, though it has discount schemes to make the drug more affordable for poorer people, the newspaper said, while Cipla's version is priced at 25,000 rupees.

It was not immediately known whether Roche would appeal the ruling.

The decision could act as a precedent for a string of other Indian generic firms also facing patent challenges from Roche over their versions of Tarceva.

The Delhi ruling came ahead of a high-profile battle expected to start Tuesday in India's Supreme Court over a bid from Swiss firm Novartis for for its top-selling drug Glivec.

The Novartis case could have significant implications for multinational drug firms, determining how much protection they will receive under India's from cheaper generic rivals.

Novartis filed in 2006 a in India for Glivec, used to treat blood and gastrointestinal cancer but a lower court rejected the request, saying the drug was a new formulation of an existing product.

The Novartis' challenge goes to the heart of India's patent act, which says a patent cannot be granted for an old drug unless changes make it significantly more effective.

add to favorites email to friend print save as pdf

Related Stories

Bayer challenges India cancer drug ruling

May 06, 2012

German pharmaceutical giant Bayer AG has challenged a ground-breaking Indian ruling that allowed a local firm to produce a vastly cheaper copy of its patented drug for kidney and liver cancer.

Novartis fights patent rejection in Indian court

Sep 06, 2011

(AP) -- In a case that could affect India's role as drug provider to the developing world, the Supreme Court began hearing arguments Tuesday over whether the government had the right to deny a patent to Swiss drugmaker Novartis ...

Recommended for you

Ebola vaccine not before late 2016: GSK researcher

Oct 17, 2014

An Ebola vaccine by British pharmaceuticals giant GlaxoSmithKline may not be ready for commercial use until late 2016 and should therefore not be seen as the "primary answer" to the current outbreak, a company researcher ...

Chimerix gets FDA OK to test drug for Ebola

Oct 17, 2014

(AP)—A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration.

Esbriet, ofev approved to treat deadly lung disease

Oct 16, 2014

(HealthDay)—Two new drugs have been approved by the U.S. Food and Drug Administration to treat progressive lung scarring from an uncertain cause, medically called idiopathic pulmonary fibrosis (IPF).

FDA weighs removing bolded warning from Chantix

Oct 14, 2014

(AP)—The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not ...

Drug-coated balloon catheter approved

Oct 13, 2014

(HealthDay)—The first drug-coated balloon catheter designed to clear narrowed or blocked arteries in the thigh and knee has been approved by the U.S. Food and Drug Administration.

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

ThanderMAX
not rated yet Sep 08, 2012
Good news for cancer patients !
SRJ
not rated yet Sep 09, 2012
'heart of India's patent act, which says a patent cannot be granted for an old drug unless changes make it significantly more effective'
India should charge for every patent being processed even if it is not granted and especially more for such behavior from drug companies.