Federal Circuit
CAFC Affirms Invalidation of Patents for MS Drug Copaxone
Written October 19, 2018
The Federal Circuit on October 12, 2018, affirmed a district court decision invalidating Teva’s patents for Copaxone, its best-selling multiple sclerosis drug. Teva Pharm. USA, Inc. v. Sandoz Inc., Fed. Cir., 10/12/18.
On appeal, Teva contended that the district court erred in finding the patents’ claimed 40mg 3x/week dosing regimen obvious, arguing that the district court relied on hindsight and an improper “obvious to try” analysis. The Federal Circuit noted that there are two situations where the “obvious to try” analysis would run afoul of the Supreme Court’s decision in KSR and § 103 – the first when a POSITA would need to experiment with all the variables to arrive at the patented invention, and the second where the prior research only gives general guidance about the technology in the patented invention. Teva’s patents don’t fall into either situation, the Federal Circuit said.
On appeal, Teva contended that the district court erred in finding the patents’ claimed 40mg 3x/week dosing regimen obvious, arguing that the district court relied on hindsight and an improper “obvious to try” analysis. The Federal Circuit noted that there are two situations where the “obvious to try” analysis would run afoul of the Supreme Court’s decision in KSR and § 103 – the first when a POSITA would need to experiment with all the variables to arrive at the patented invention, and the second where the prior research only gives general guidance about the technology in the patented invention. Teva’s patents don’t fall into either situation, the Federal Circuit said.