Proving Prior Invention Does Not Require That The Prior Inventor Appreciated The Subject Matter Using The Same Words Of The Claim

Judges: Rader, Dyk, Linn (author)

[Appealed from E.D. Pa., Judge Yohn]

In Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP, No. 11-1091 (Fed. Cir. Dec. 1, 2011), the Federal Circuit affirmed the district court's grant of SJ of invalidity of certain claims of Teva Pharmaceutical Industries Ltd.'s ("Teva") U.S. Patent No. RE39,502 ("the '502 patent") based on AstraZeneca Pharmaceuticals LP's ("AstraZeneca") prior invention under 35 U.S.C. § 102(g)(2).

AstraZeneca manufactures and sells the drug CRESTOR®, which is a statin (rosuvastatin calcium) formulation for the treatment of dyslipidemia. Because statins are inherently unstable compounds, they must be manufactured in stabilized formulations. Therefore, AstraZeneca designed the CRESTOR® composition with the stabilizer tribasic calcium phosphate. CRESTOR® also contains crospovidone, which AstraZeneca included as a disintegrant.

Teva sued AstraZeneca for infringing several claims of the '502 patent by manufacturing and selling CRESTOR®. The asserted claims are directed to statin formulations stabilized exclusively by an amido-group containing polymeric compound ("AGCP compound") or by an amino-group containing polymeric compound. Teva asserted that it had conceived and reduced to practice its claimed invention by December 1, 1999.

It was uncontested that AstraZeneca intended to use tribasic calcium phosphate, which is not an AGCP compound, as the stabilizer in its formulation, and it did not appreciate, prior to December 1, 1999, the alleged stabilizing effect of crospovidone, an AGCP compound, in CRESTOR®. It was also undisputed that AstraZeneca manufactured multiple batches of rosuvastatin calcium with the same ingredients in substantially the same amounts as its CRESTOR® composition beginning in mid-1999 and publicly disclosed the ingredients and quantities for its rosuvastatin formulation.

Based on these facts, AstraZeneca moved for SJ of invalidity under 35 U.S.C. § 102(g)(2), alleging prior invention of the subject matter of Teva's asserted claims. For the limited purpose of advancing its SJ motion, AstraZeneca conceded infringement of Teva's claims. The district court granted AstraZeneca's motion and held the asserted claims invalid in light of AstraZeneca's prior invention. Teva appealed.

The Federal Circuit noted that it was undisputed for purposes of the appeal that the CRESTOR® composition fell within the scope of the asserted claims because AstraZeneca...