PTAB Litigation 2016 Part 11 – Bio/Pharma Issues 1

Impact of IPR on Hatch-Waxman IPR perceived as easier for generics to invalidate Orange Book patents— i.e., easier for generic to “win” and enter the market. Eliminates protection of 30-month stay if claims are deemed patentable and the district court litigation was stayed. Faster speed of IPRs threatens to extinguish 30-month stay earlier than expected if claims are deemed unpatentable. Potential to render district court decisions moot. Might trigger forfeiture of 180-day exclusivity. 2

Eliminates Protection of 30-month Stay 30-month stay is intended to permit judicial resolution of infringement and invalidity issues prior to FDA approval, thus eliminating unlawful generic products from entering the market. When litigation is resumed, the 30-month stay will end before completion of the district court proceeding. 3 Generic files ANDA Brand files infringement suit Generic files IPR petition Suit stayed Board determines claims are valid

Eliminates Protection of 30-month Stay Faster speed of IPRs threatens to extinguish 30-month stay earlier than expected if claims are deemed unpatentable. 4 Generic files ANDA Brand files infringement suit Generic files IPR petition Suit stayed Board determines claims are invalid

Renders District Court Decisions Moot This result renders the district court decision moot and judicial resources wasted on duplicative efforts. 5 Generic files ANDA Brand files infringement suit Generic files IPR petition Board invalidates claims and Fed. Cir. affirms Stay denied, litigation proceeds to conclusion

IPR Might Trigger Forfeiture Provisions IPR might provide basis for a later generic filer to trigger forfeiture of 180-day exclusivity of the first filer. Here, “A” may be forced to launch quickly, otherwise lose exclusivity (where a final court decision triggers the 75 day clock). Potential to trigger acceleration clauses in Brand-Generic settlements. 6 Generic “A” files ANDA (180 day exclusivity) Generic “B” files ANDA Generic “B” files IPR petition Board invalidates the claims and Fed. Cir. affirms