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Patent disputes in the health care industry generally have billions of investment and sales dollars at stake. Generic drug and biosimilar patent challenges under the Hatch Waxman Act and Biologics Price Competition Act warrant unique strategic considerations as compared to traditional patent litigation. Specifically, litigation under these Acts generally arises before the alleged infringer markets its product. Additionally, defendants may also elect to pursue their challenges at the PTAB in addition to (or in lieu of) district courts. The presenters will cover a summary of key considerations and related decisions which help clarify these unduly complex and vague statutes and their applications.
- Venue options post TC Heartland
- Considerations during concurrent IPRs and district court litigation
- Practice tips for successfully navigating complexities based on recent Federal Circuit and PTAB decisions