Lipitor Summary: Ranbaxy likely to prevail

February 4, 2005

In order for Ranbaxy to prevail at trial, the judge:

• Must interpret the ’883 patent as limited to “racemic” mixtures of the statin cholesterol inhibitor which would mean that the ‘833 patent does not cover atorvastatin: atorvastatin is the “enantiomeric” active ingredient in Lipitor.  Therefore Ranbaxy’s proposed generic ANDA product would not infringe. The evidence supporting this prediction is:
  • Pfizer internally referred to the ’883 patent as the “racemic” patent;
  • Pfizer distinguished it as such in the ’995 prosecution; and
  • Made clear in foreign patent applications of the ’883 patent counterparts that it covered only the racemic active ingredient; and
• Must  also determine that:
  • The ’995 patent  is invalid because it is obvious over the ’883 and other prior art; or
  • The ’995 patent is unenforceable because the inventor intentionally misled the patent office into granting the patent:
    • By using scientifically irrelevant doctored test results claiming unexpected (ten times the) benefits of the enatiomer over the racemate, when all internal documents showed the expected 2x benefits;  or
  • Ranbaxy’s ANDA product does not infringe the patent because it does not use the atorvastatin acid salt prescribed in the claim on which the asserted claim depends.

Verdict believes the probability that Ranbaxy will prevail on one of the previous theories is 80%.

In order for Pfizer to prevail, the trial judge:

• Must interpret the ’883 patent to cover the atorvastatin enantiomer in Lipitor and the ANDA product; or
• Must find the ’995 valid and non-obvious; or
  • Must find that it is such a close case on validity that the commercial success of Lipitor is a function of the patent and that is enough to hold for Pfizer on the validity issue; or
• Must find that the inventor had no specific intent to mislead the examiner and the Pfizer patent lawyers were careless not malicious in allowing him to do it; or
• Must find that the limitation of the dependent claim concerning the required atorvastatin acid salt:
  • Is ambiguous and a misinterpretation of the patent and  need not be met; or
  • Need not be met because of some alleged exception to the rule that Pfizer would have to credibly put forth on post trial briefing to be filed on February 14, 2005.