Generic firms to gain strength from US order

A recent court ruling in the US on allowing the declaratory judgment provision in the US patent law has come as a boost to Indian pharmaceutical companies such as Ranbaxy, Dr Reddy's, Sun Pharma and Lupin.

The declaratory judgment provision allows generic companies to use the US Medicare Modernization Act, 2003, to "obtain patent certainty". The generic firms can get a judgment on whether they infringed the patent of the innovator or not, if innovators spare them from litigation on related patents when challenging the main patents.

In a recent case involving Teva Pharmaceuticals and Novartis, the United States Court of Appeals for the Federal Circuit, Washington, upheld a petition from generic drug maker Teva demanding declaratory judgement. The decision will help generic companies plan their launches as it will eliminate uncertainities to a large extent.

Further, there will be a surge in the number of lawsuits from generic drug companies seeking declarations of patent invalidity or non-infringement, experts say.

Sources said Teva had filed an ANDA to market a generic version of Famvir (famciclovir), an antiviral medication. Novartis sued Teva for infringing the main patent, but chose not to sue the company on the other four patents on methods of manufacturing.

Teva demanded a declaratory judgment action on the remaining method patents. Though the district court dismissed Teva's complaint, the Federal Circuit reversed the dismissal, to set a precedence.

Gopakumar G Nair, managing director and CEO, GNA Patent Gurkul, a company into educating professionals on patents, noted that a few years ago, the US district court for New Jersey had dismissed a Dr Reddy's Labs suit that sought a declaratory judgment that its Sertraline product did not infringe Pfizer's '699 patent. In a recent case, Sun Pharmaceutical's US subsidiary Caraco Pharmaceuticals filed a case with the US district court for Michigan against pharmaceutical majors Forest Laboratories Inc of US and Lundbeck A of Denmark, demanding declaratory judgment on anxiety and depression drug Lexapro's patent. Though Caraco faced infringement suit with respect to the main '712 patent on Lexapro (escitalopram oxalate), Forest and Lundbeck did not sue Caraco for infringing the '941 patent on crystalline particles of escitalopram oxalate. Caraco's submission is to get a declaratory judgment on the US '941 patent. Experts said as per the amended US rules, an ANDA applicant can demand for declaratory judgment against the innovator companies, if the patent holder fails to initiate legal action within 45 days of publication of the ANDA.

This provision is to help the generic companies speed up launch of products and clear up any 'bottleneck in the market' created by another applicant's 180-days exclusivity, by becoming the first to file ANDA of the generic version.

About 14 Indian companies had received over 80 ANDA approval from US FDA in 2006 alone, and many more ANDAs are pending. Several of these are patent challenges with Para IV certifications. It is estimated that more than US $ 50 billion drugs are going off-patent by 2015 in the US market.