Indian Court Deals Sharp Blow To Roche’s Local Tarceva Patent; Allows Generics On Market
This article was originally published in PharmAsia News
Executive Summary
After a four year spat, an Indian court hands down a verdict that may alter the Swiss firm’s market outlook. Local generic drug makers on the other hand are rejoicing.
MUMBAI – The $45 billion Swiss drug maker Roche suffered perhaps its biggest setback in India as the Delhi High Court favored drug maker Cipla Ltd. in its four-year long patent row over lung cancer brand Tarceva (erlotinib). In 2008, Cipla stunned the Indian market and launched a cut-price generic version of the drug under the brand name Erlocip, prompting Roche to appeal for an injunction and, after many court tussles that ensued, the issue finally landed at the Delhi High Court.
Judge Manmohan Singh, in a 280-page ruling seen by lawyers, said that Roche’s Indian Patent IN196774 was valid but found that its polymorphic forms were not violated by the Indian company. (See Delhi Tarceva decision.) In essence, the judge viewed Cipla’s marketed drug different from those claimed as patented by Roche (Also see "India Court Nixes Roche Patent-Infringement Suits Against Matrix, Intas" - Scrip, 14 Dec, 2011.).
A copy of the ruling, dated Sept. 7, has not been gazetted, but the verdict announced has already stirred up the country’s legal fraternity with those representing Indian generic companies terming the verdict as historic and validating Cipla’s audacious move to launch the product even when Roche had the local patents. Lawyers working for multinational drug companies said the judiciary had taken a lopsided view on the scope for innovation on a patented drug.
Both sides, however, agreed that Cipla’s erlotinib win may also clear the way for a slew of other Indian companies to make similar challenges, and add to growing concern over intellectual property protection in the country and the ability to use the patent exclusivity window to offset major development costs and competition (Also see "Exclusive: As Sweeping Policy Framework Takes Shape, MNCs May Be Forced To Slash Prices Of Patented Drugs In India" - Scrip, 16 Aug, 2012.).
“Like Cipla, others like Natco Pharma Ltd., Glenmark Pharmaceuticals Ltd., Dr. Reddy's Laboratories Ltd. can keep the product in the market,” a top Cipla official told PharmAsia News as Roche has argued on the same grounds against other companies. A Roche India official was non-committal on the future legal steps, including an appeal. But observers indicated that Roche may contemplate more legal steps to press for its patent rights.
Swiss-based Roche did not respond to requests for comment by deadline.
Pricing Issue
Cipla makes around $1 million a year from Erlocip with a price of $16 per tablet, compared to $75 per tablet charged by the Swiss firm. However, the judgment delivered by the court was said by lawyers who saw the order to have steered clear of issues of affordability.
That contrasts with another high profile case of Bayer AG’s kidney cancer drug Nexavar (sorafenib) whereby the Controller of Patents granted a compulsory license in March to Natco Pharma, primarily leaning on issues of sufficient supplies and pricing (Also see "India Grants First Compulsory License To Natco For Bayer’s Nexavar; Disappointed, Bayer May Challenge Decision" - Scrip, 11 Mar, 2012.).
Cipla’s lawyers, in their argument, stated that compared to the granted patent, marketed Tarceva is a polymorph form B and therefore Roche had no authority to sue Cipla. In the same breath, Cipla argued that polymorphs of a compound are not patentable and stand as a mere incremental innovation under the provisions of Section 3(d) of the Indian Patents Act (Also see "Cipla Questions Patentability Of Roche’s Tarceva In Ongoing Dispute" - Scrip, 7 Aug, 2008.).
In 2009, a division of the Delhi High Court upheld that claim and penalized Roche by ordering it to pay 500,000 Indian rupees ($9,046) to Cipla for allegedly making false claims.
Lung cancer is the leading cause of cancer deaths in both men and women worldwide, according to the World Health Organization, with Indian cases rising sharply due to smoking and air pollution.