Enter to open, tab to navigate, enter to select
Federal Circuit Confirms Invalidity of Teva Patent Based on Prior Invention by AstraZeneca
Practical Law Legal Update 1-515-6991 (Approx. 3 pages)
Federal Circuit Confirms Invalidity of Teva Patent Based on Prior Invention by AstraZeneca
by PLC Intellectual Property & Technology
| Published on 08 Dec 2011 • USA (National/Federal) |
The US Court of Appeals for the Federal Circuit ruled in Teva Pharmaceuticals v. AstraZeneca Pharmaceuticals that an alleged patent infringer claiming invalidity of the asserted patent based on prior invention by another need only show that the earlier inventor understood the contents of its invention. The earlier inventor does not have to fully appreciate how the invention worked.
Key Litigated Issues
On December 1, 2011, the US Court of Appeals for the Federal Circuit issued an opinion in Teva Pharmaceutical v. AstraZeneca Pharmaceutical. The key litigated issue was whether a party must prove its understanding of how or why a prior invention worked to prove invalidity on the basis of prior inventorship by another under 35 U.S.C. § 102(g)(2).
Background
Teva sued AstraZeneca for infringing Teva's patent for a statin drug formulation stabilized by certain compounds used to treat high cholesterol. AstraZeneca filed a motion for summary judgment of patent invalidity based on its prior invention of a statin drug formulation that included the claimed stabilizing compound.
It was uncontested that AstraZeneca:
- Created its version of the drug before Teva.
- Included crospovidone, a stabilizing compound in the same family as Teva's claimed stabilizer, in its formulation.
- Did not understand that crospovidone acted as a stabilizer in its formulation.
The district court granted summary judgment for AstraZeneca, finding that AstraZeneca had previously invented and made batches of a product having the same formulation as the AstraZeneca product Teva later accused of infringement.
On appeal, Teva claims that the trial court erred in granting summary judgment because it did not require AstraZeneca to prove that it appreciated the stabilizing effect of crospovidone in its original formulation.
AstraZeneca argues that 35 U.S.C. § 102(g)(2) does not require it to understand how or why its invention worked. The only requirement, which AstraZeneca satisfied, was to understand the contents of its formulation.
Outcome
The Federal Circuit upheld the district court's summary judgment decision. Applying its earlier case law, the Federal Circuit held that a prior inventor does not need to know everything about how or why its invention worked for the invention to serve as invalidating prior art.
AstraZeneca was aware of the contents of its formulation, which included an amount of crospovidone, and that the compound was stable. The Court found this to be enough to satisfy the prior invention requirements under 35 U.S.C. § 102(g)(2). AstraZeneca was not required to appreciate which component was responsible for the stabilization.
Practical Implications
The Federal Circuit's holding interprets prior invention by another under 35 U.S.C. § 102(g)(2). An earlier inventor does not have to fully understand how every aspect of the invention works. The mere understanding of what is included in the invention is sufficient.
However, under the new first-inventor-to-file system created by the Leahy-Smith America Invents Act prior art defenses based on prior invention like the one made here by AstraZeneca will not be available for patents having an effective filing date on or after March 16, 2013.
For more information on the America Invents Act, see Practice Note, Leahy-Smith America Invents Act: Overview and Leahy-Smith America Invents Act Key Effective Dates Chart
For more information on patent infringement generally, see Practice Note, Patent Infringement Claims and Defenses.