Pharma majors face fresh cases in US

In a fresh round of patent battle over the launch of generic drugs in the US market, domestic pharmaceutical majors Orchid, Sun Pharma and Ranbaxy Laboratories have been sued by Cima Labs, Otsuka Pharmaceutical Co and Abbott Laboratories, respectively, in separate litigations in the courts there.

Cima Labs sued the Chennai-based Orchid Chemicals and Pharmaceuticals in the US district court of New Jersey for infringing patent on Desloratidine, a blockbuster allergy drug marketed exclusively by Schering Plough Corporation as Clarinex Redi-Tabs since 2003. The case was slapped after Orchid filed an abbreviated new drug application (ANDA) with the US FDA seeking approval for a generic version of Desloratidine in 2.5 mg and 5 mg strengths.

In its petition, Cima Labs alleges that the ANDA of Orchid infringes its '697 US patent on "taste masking particles for oral dosage forms". Orchid is believed to be the first to file ANDA status on Clarinex, which will help the company to get a 180-day marketing exclusivity in the US, in the event of successful patent challenge as per the rules there.

In another litigation, Japanese pharma major Otsuka Pharmaceuticals sued Sun Pharmaceutical Industries, Mumbai, in the same court for challenging its patent on aripiprazole, a billion-dollar schizophrenia drug marketed in the US as Abilify. The drug had US sales worth about $1.9 billion during the last year. In addition to schizophrenia, Abilify is also prescribed as a treatment for symptoms of bipolar disorder. Otsuka's '528 US patent, which Sun Pharma challenged, is valid until October 20, 2014. Otsuka is also fighting legal battle with generic majors such as Teva and Barr, apart from Sun Pharma over the aripiprazole patent, sources said.

As reported few days ago, Eli Lilly and Company also had sued Sun Pharma in the US, for challenging the patent on Gemzar, a blockbuster cancer drug. "Sun Pharma is confident in our approach to challenge that patent with Para IV certification. We hope to win the litigation and launch the product in the US market" Uday Baldota, vice president, international relations, Sun Pharma had said.

Meanwhile, a Bloomberg report said Abbott Laboratories has sued Ranbaxy, Teva Pharmaceutical Industries Ltd and Sandoz of Novartis AG to block regulatory approval of a generic version of the antibiotic Omnicef to treat ear, sinus, throat and skin infections.

In its complaint filed on March 28 in the federal court in Chicago, Abbott and its Tokyo-based partner Astellas Pharma Inc said the generic versions infringe on Astellas patent on a crystalline form of cefdinir, the drug's active ingredient.

Omnicef had sales of US $637 million in the last year. Its patent expires in 2011.

Malvinder Mohan Singh, managing director and CEO of Ranbaxy had told Business Standard in Mumbai two days ago, that Ranbaxy has 19 first to file ANDAs in the US and that augurs a big generic opportunity for Ranbaxy in the US market.

Blockbuster drugs worth over US $ 50 billion are going off-patent in the US market by 2015.