Who Took Away The Better Half? Lipitor Patent Battle VI

Validity of the ‘995 patent (1) Double-patenting: Ranbaxy asserted claims 12 and 14 of U.S. Patent # 5,003,080 (the ‘020 patent) against the validity of the ‘995 patent. With regard to claim 14 of the ‘080 patent, the Court concluded that claim 14 claims a process for producing a single compound atorvastatin lactone. Neither this process nor this compound are contemplated by claim 6 of the ‘995 patent, and Ranbaxy has not demonstrated by clear and convincing evidence that claim 6 of the ‘995 patent recites an obvious variation of that which is recited in claim 14 of the ‘080 patent. The Court further stated that the inventions described in claim 14 of the ‘080 patent and claim 6 of the ‘995 patent are patentably distinct, and therefore claim 6 of the ‘995 patent is not invalid for non-statutory double patenting in light of claim 14 of the ‘080 patent. As for claim 12 of the ‘080 patent, the Court likewise concluded that claim 12 presents an invention which is patentably distinct from that which is claimed in claim 6 of the ‘995 patent. Claim 12 of the ‘080 patent recites a process capable of making a variety of compounds, while claim 6 of the ‘995 patent is directed to a single compound, atorvastatin calcium.

(2) Obviousness: Ranbaxy asserted the ‘893 patent as the relevant prior to be considered in the analysis of whether the ‘995 patent is obvious. Before making analysis, the Court first identified the level of person skilled in the art and the relevant prior art, and then consider the differences between the prior art and the claimed subject-matter. After carefully analyzing, the Court concluded that Ranbaxy has not demonstrated that claim 6 of the ‘995 patent is obvious in light of the ‘893 patent as there was no motivation in the prior art to select the species compound of atorvastatin calcium from the genus of compounds identified in the ‘893 patent, and absent such a motivation, the Court cannot conclude that the ‘893 genus patent renders the ‘995 species patent obvious. Accordingly, the Court concluded that Ranbaxy has not demonstrated by clear and convincing evidence that claim 6 of the ‘995 patent is obvious.

(3) Anticipation: Ranbaxy contended that claim 6 of the ‘995 patent is anticipated by the ‘893 patent. Ranbaxy also pointed out that the ‘893 patent discloses calcium as one of the seven listed pharmaceutically acceptable salts. In response, Pfizer contended that prior art disclosure of a racemate does not anticipate either of its individual isomers. Pfizer also contended that the earlier disclosure of a genus does not anticipate an undisclosed species member of the genus. After applying the legal principles of anticipation, the Court, however, concluded that Ranbaxy has not established that the species compound claimed in the ‘995 patent is anticipated by the genus of compounds claimed in the ‘893 patent. To be continued …