Generic drugmakers, including domestic companies like Sun Pharmaceutical and Aurobindo will gain, as Eli Lilly has lost a US court case over its hyperactivity disorder drug, Strattera.
The District Court for New Jersy invalidated a patent on the medicine that would have prevented sales of copies until May 2017. The ruling would strengthen the chances of generic companies to launch low-cost versions of Strattera much before the patent’s normal expiry date.
Lilly said in a statement that it anticipated near-term entry of generic versions of the medicine. The company intends to appeal against the decision.
Global generic majors like Actavis, Apotex, Mylan, Sandoz and Teva are also eyeing at the opportunity to launch generic versions of Strattera in the world’s biggest drug market.
Lilly had sued all these generic players in 2007 after they applied for US Food and Drug Administration approval to sell the generic version of Strattera in the US.
The litigation had triggered a 30-month stay (till November 2010) on the introduction of generic Strattera in the US market. An adverse court decision prior to November 2010 would terminate the stay and enable one or more companies to launch the product.
“This is the second patent invalidation victory for Sun in the last 20 days. It indicates the quality of our intellectual property litigation strategy and the robustness of our product pipeline,” Uday Baldota, Sun Pharma spokesperson said.
Incidentally, the previous patent victory for Sun was also against Lilly, when a US Court of Appeals upheld a lower court decision to invalidate a patent for Gemzar, Lilly’s anti-cancer drug.
While Strattera had a sale of $100.4 million in the US during the three months ending June 30, Gemzar fetched Lilly $189.8 million during the same period.
