Tuesday, March 11, 2014

Janssen Targets Lupin over Generic Prezista

Case Filed: Mar 04, 2014

Court: New Jersey District Court

Case Summary:

Janssen, a company which produces and markets mental health prescription pharmaceutical products claimed violation of their patent covering the drug Prezista used in the treatment of human immunodeficiency virus (HIV-1) infection. The lawsuit attempts to block the release of generic Prezista tablets in the US. The patent at issue is: US8518987 entitled ‘Pseudopolymorphic forms of a HIV protease inhibitor’, duly issued by United States Patent & Trademark Office on Aug 27, 2013. The patent is set to expire[i] by May 16, 2022 and is currently assigned[ii] to Janssen (source: MaxVal’s Assignment Database).

The complaint alleges that Lupin infringed claims of the ‘987 patent by filing Abbreviated New Drug Application (ANDA) seeking approval to sell generic versions of Janssen’s highly successful Prezista® (darunavir) 75 mg, 150 mg, 300 mg, 400 mg, 600 mg, and 800 mg products prior to the expiration of the '987 patent, the complaint said. It added further that if approved and marketed, the generic would infringe the ‘987 patent.

Janssen is the current holder[iii] of approved New Drug Application (NDA) No. 21-976 for Prezista® (source: Patent Marker). On or about November 4, 2013, plaintiff received a letter from Lupinstating the submission of ANDA No. 202-073 seeking approval for Lupin's generic tablets, asserting that the claims of the '987 patent are invalid and/or will not be infringed by the commercial manufacture of the generic tablets.

Plaintiff requested Court to order that the effective date of approval of Lupin’s ANDA be a date that is not earlier than the expiration of the ‘987’s patent term.

See 2:14-cv-01370 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

Max-Insight enables you to access all of our patent tools such as Patent Term Estimator, Patent Family Tree, Has This Patent Been Litigated, etc. in one location. Max-Insight is available in 4 different subscriptions: FreeBronzeSilver and Gold with varying usage levels. To learn more about Max-Insight, click here. 

[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents. 
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

No comments:

Post a Comment