On November 5, 2020, the Federal Circuit issued a precedential decision, Vaeleant Pharmaceuticals v. Mylan Pharmaceuticals, that is likely to have a significant impact on the litigation of Hatch-Waxman cases—including the possible development of “generic-friendly” districts. In short, if this decision stands, the future of patent pharma litigation against multiple generics for the same drug will likely be spread out, difficult to consolidate, subject to multiple forums determining in parallel common issues related to infringement and invalidity. Costs for brands are likely to go up along with settlement leverage for generics. Although, exactly who wins and who loses from this decision remains to be seen.
Read MoreThe PTAB has issued its first post-AIT decision, Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC. In Realtime, the Patent Owner sought to defeat institution by arguing that Unified has run afoul of the AIT decision by failing to identify all RPIs, namely, its members. The PTAB disagreed and instituted Unified’s IPR. (The institution decision was entered in October, but the redacted decision issued on November 27, 2018). How do we square the AIT decision with the Realtime decision? Will third-party filers, such as Unified and RPX, no longer face RPI issues?
Read MoreA recent precedential case by the Federal Circuit, Maxchief Investments, Ltd. v. Wok & Pan, Ind., Inc., shows that the risk of a DJ action resulting from a pre-suit notice letter may be less troubling for a different reason than the one that preceded TC Heartland—namely, personal jurisdiction.
Read MoreMylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®. Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland. What are the implications of TC Heartland governing venue in all Hatch-Waxman cases? Will it lead to “generic friendly” judicial districts?
Read MoreVenue arguments unsupported by a plausible claim that defendant has a physical place of business in the district (in a district where defendant is not incorporated) are likely losers -- and may not even open the door to jurisdictional discovery.
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