Sunday, June 29, 2008

Lipitor Settlement: What Lies Beneath? Part II

Strategically Lipitor settlement seems to be more favorable for Ranbaxy as this provides certainty for Ranbaxy to launch generic product in the United States without any patent hurdle and may allow recouping the expenses made in Lipitor litigation worldwide but what benefits Pfizer from settlement? Pfizer too avoided legal cost that would be spend further in litigation and importantly put an end to nightmarish litigation which witnessed the ‘995 patent going down.

What about 180-day market exclusivity?

Technically the 180-day market exclusivity will trigger soon after the expiration (March 2010) of the genus patent but Ranbaxy, under the terms of the agreement, would delay the launch until November 2011 which would possibly lead to forfeiture of Ranbaxy’s right to 180-day market exclusivity. 21 USC 355 (j)(5)(D) states that if the first applicant fails to market the generic product within 75 days from the date of FDA final approval of ANDA that will lead to forfeiture of 180-day exclusivity period. And in case of forfeiture, any later ANDA applicant may market its generic product upon receiving FDA final approval. Interestingly, if Ranbaxy forfeits its 180-day market exclusivity then the Lipitor generic space will open much earlier than the expected (that is before July 2010). However, it would still not be easy for any generic player to cross hurdles of Pfizer’s polymorphs and amorphous patents and step into Lipitor generic fortune. Pfizer not only litigated its patents strategically but possibly put an end to prized 180-day market exclusivity.

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