Prior Conception and Reduction to Practice Defeats Invention

Addressing whether limitations claimed in a patent need to have been appreciated by a prior developer of the invention in order to qualify as prior art under § 102(g)(2), the U.S. Court of Appeals for the Federal Circuit affirmed a decision on summary judgment, finding that the defendant’s earlier development of the infringing formulation invalidated the patent, even though the defendant had not appreciated that it had achieved the claimed invention.   Teva Pharmaceuticals Industries Ltd. v. AstraZeneca Pharmaceuticals LP, Case No. 11-1091 (Fed. Cir., Dec. 1, 2011) (Linn, J.). 

Teva asserted its patent covering statin formulations stabilized exclusively by an amido-group containing polymeric compound (AGCP) against AstraZeneca, alleging infringement by AstraZeneca’s manufacture and sale of CRESTOR®. In the district court, it was undisputed that less than one year prior to the filing of Teva’s patent, AstraZeneca made statin formulations with the same ingredients, in substantially the same amounts, as the allegedly infringing commercial product. AstraZeneca’s formulations did contain, as required in Teva’s claims, an AGCP stabilizer.   However, at the time, AstraZeneca did not appreciate that this component was a stabilizer.  In fact, AstraZeneca believed another component provided stabilizing activity.

AstraZeneca stipulated to infringement for the limited purpose of advancing a motion for summary judgment of invalidity based on § 102(g)(2) prior art. Since it was undisputed that AstraZeneca had made the infringing formulations before Teva conceived and reduced to practice its patented invention, the only issue in dispute was the legal issue of whether AstraZeneca had to appreciate that its AGCP compound was acting as a stabilizer in order for its formulations to qualify as prior art under § 102(g)(2). The district court held that such an appreciation was not required and granted AstraZeneca’s motion for summary judgment.  Teva appealed.

The Federal Circuit affirmed, finding that AstraZeneca did not need to appreciate what component in its formulation was responsible for stabilization in order for its formulation to be prior art under § 102(g)(2). Rather, the Court held that AstraZeneca simply needed to appreciate that the compound it asserted as its invention was stable and what the components of its formulation were. Citing interference case law (which falls under a related provision, § 102(g)(1)), the Court explained that the invention is not just the literal language of the claims but, rather, the subject matter thereby defined. The Court also indicated that it did not need to consider how the doctrine of inherency applied to § 102(g) because there was no dispute about whether or not the asserted prior art included, either expressly or inherently, particular claim limitations.

Practice Note:   Under the America Invents Act (AIA), the United States will move from a “first to invent” to a “first to file” system in March 2013. Under the new system, §102(g)(2) would not have been available to AstraZeneca to invalidate Teva’s patent. Additionally, as the AIA’s prior commercial use defense to infringement requires that the use must have been more than one year prior to the effective filing date, this defense would not have been available to AstraZeneca either.