Historical patent litigation between world’s largest drug manufacturer Pfizer and world’s most aggressive generic company Ranbaxy over biggest ever blockbuster drug Lipitor has finally ended in unexpected climax with both Pfizer and Ranbaxy settling all their patent litigations worldwide. Under the agreement, Pfizer voluntarily licensed Ranbaxy to sell generic versions of Lipitor in the
Pfizer’s Strategy was Ranbaxy’s Dilemma
It all triggered when Ranbaxy filed an abbreviated new drug application (ANDA) with the United States Food and Drug Administration seeking marketing approval for generic equivalent of Lipitor before the expiration of Orange Book listed patents. Pfizer sued Ranbaxy within statutory timelines (45 days) and filed civil action for alleged infringement in the District Court. During the course of litigation proceedings, Ranbaxy strongly challenged the validity of the
Patent Circle believes that Pfizer strategically litigated Lipitor against Ranbaxy and kept polymorph and amorphous patents out of Para IV litigation so that Pfizer may unfold them in separate litigations. Pfizer not only used patents against Ranbaxy but also in parallel strategically filed a citizen petition with the United States FDA regarding amorphous atorvastatin. In its petition, Pfizer concerned about higher levels of impurities and inferior stability of other polymorphs and amorphous forms that may be used by generic companies. Pfizer also stated that the pending application for a generic version is in an amorphous form (though not mentioned the name of company but was possibly referring to Ranbaxy ANDA). In March 2008, Pfizer extended its strategy by filing fresh infringement suit against Ranbaxy for infringement of two non-orange book listed patents – US 6,087,511 and US 6,274,740 both covering processes for the preparation of amorphous Atorvastatin which suggest that Ranbaxy possibly used amorphous atorvastatin calcium for their proposed ANDA. The process patents are due to expire in July 2016 and would mean that if Pfizer succeeds in wining the litigation that would delay Ranbaxy’s generic product till 2016. This litigation put Ranbaxy in dilemma whether to launch generic soon after the expiration of genus patent with a possible risk of treble damages or wait till litigation get over but that may possibly risk of running out 180-days market exclusivity without even launching the generic product for which Ranbaxy played such a risky game. Pfizer’s Strategy was Ranbaxy’s Dilemma.
To be continued …