Finland-based Orion Corporation has filed a patent infringement lawsuit in the US against Sun Pharma Global, Inc, after Sun sought marketing approval for a generic version of Orion's drug Comtan, for treating Parkinson's disease, in the US.
Orion had filed a similar suit against Wockhardt, another Indian company that sought regulatory approval for marketing the low-cost version of Comtan in the world's largest drug market.
Comtan contains entacapone, a product developed by Orion and marketed in the US by its exclusive licensee, Novartis.
Orion filed a similar suit against Sun last year over
the generic version of Orion's another medicine, Stalevo.
Sun's application had challenged the validity of two patents Orion has on Stalevo.
According to the US laws, any suit filed against such applications for drug marketing approvals (called Para IV challenges) within 45 days, will automatically trigger a 30-month stay on such approvals.
Only an earlier court decision adverse to Orion's patent rights can now allow Sun or Wockhardt to get an early marketing approval for the medicine in the US.
Such suits, meant to delay the entry of generic medicines, are common in the US.
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