Indian pharma firms seem to be in an upbeat mood as far as strengthening their presence in the US via the patent litigation route is concerned. This year, from January 2010 till date, Indian pharma majors, such as Lupin, Sun Pharma and Aurobindo, have entered into about 11 litigations with various patent-holding MNCs. Lupin leads the league with as many as six litigations.

Lupin’s cumulative ANDA (abbreviated new drug applications) filings in the US have risen to 111, with the company having received 40 approvals till date. The company is awaiting nod for close to 65 filings in the US and one-third of its filings would be Para IV opportunities, addressing a market size of over $40 billion.

Lupin president (finance & planning) & CFO S Ramesh told FE, ?Lupin R&D and the Intellectual Property Management group has always had a strategic focus on identifying and creating strong niches in various therapy areas. They have worked for a value-based product pipeline with a strong accent on controlled release, exclusive and unique first-to-file and niche filings, one of the main reasons why we have done so evidently well in the US in such a short period of time of less than six years. Lupin continues to invest 6-8% of our global revenues in R&D.?

Lupin witnessed the first litigation this year following paragraph IV ANDA submission for Teva Women?s Health?s LoSeasonique, an oral contraception. Teva filed a suit on January 6, in the district court of New Jersey. Later, Ortho-McNeil-Janssen Pharmaceuticals challenged Lupin on January 15 in the district court of New Jersey, after Lupin sought the marketing approval for Ortho-McNeil?s drug for oral contraception. Purdue Pharma filed a suit against Lupin on January 21 in the district court of Delaware after Lupin sought FDA approval for the Purdue’s Ultram, a drug used to treat chronic pain.

Once the companies win the litigations, they will be allowed to sell the generic version of the patented drugs in the US market with 180-day exclusivity. A few of the drugs at stake have revenues worth $1 billion in the US. Once the generic drug manufacturers file paragraph IV ANDA with the USFDA seeking the marketing approval for their drug, which would be a copycat of the drug which is already protected by patent in the US, the patent holder files a litigation, alleging patent infringement by the generic firms.

In February, Merck, Sharp & Dohme Corp sued Lupin and AstraZeneca also sued Lupin after Lupin?s filing of an ANDA to manufacture a generic version of AstraZeneca?s Nexium. Recently, Cephalon Inc challenged Lupin following a Paragraph IV certification as part of Lupin’s filing of an ANDA to manufacture a generic version of Cephalon’s Nuvigil, used for sleep disorder. Bayer Schering Pharma also sued Lupin for Bayer?s Cipro Oral Suspension.

Sun Pharma and Aurobindo Pharma witnessed two litigations each in the US while Wockhardt has seen one patent litigation.