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| Edited By: KV Ramana |Source: DNA |Updated: Mar 17, 2018, 05:34 AM IST
Eli Lilly, the US pharma giant, has sued Dr Reddy’s Laboratories over an alleged patent infringement involving Gemzar.
The drug, an injection, is used in treatment for non-small cell lung cancer, pancreatic cancer, breast cancer and ovarian cancer and is estimated to have a market of about $700 million.
According to Eli Lilly’s petition in the US district court of Indiana, the global pharma major was issued the patent on Gemzar on November 7, 1995, and it is due to expire on November 7, 2012 followed by a six-month period of market exclusivity granted by the US Food and Drug Administration.
Dr Reddy’s had filed an abbreviated new drug application (Anda) to manufacture and market gemcitabine hydrochloride, which is branded as Gemzar by Eli Lilly.
Dr Reddy’s had on August 13, 2010, also notified Eli Lilly about its Anda for generic Gemzar in 200 mg base/vial and 1 gm base/vial.
According to Eli Lilly’s petition, Dr Reddy’s said the patent was invalid under the doctrine of obviousness-type double patenting and the application would also not amount to infringement.
“Dr Reddy’s knows that physicians prescribing or using their gemcitabine hydrochloride for injection drug products according to the indications sought by Dr Reddy’s will be using them in a manner that will infringe one or more claims of the patent. Lilly will be substantially and irreparably harmed by Dr Reddy’s infringing activities unless those activities are enjoined by this court. Lilly has no adequate remedy at law,” it said.
Another domestic giant, Sun Phama, was also engaged in a legal tussle with Eli Lilly on Gemzar. Lilly has petitioned for rehearing and a mandate has not been issued from the federal circuit. Sun and Lilly are currently awaiting the court’s decision.
