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prescription and OTC products can directly compete; many non-FDCA-based claims survive

43(B)log

Sanofi-Aventis U.S. 5, 2021) Scilex sells an FDA-approved, prescription-strength topical analgesic self-adhesive patch, ZTlido (lidocaine), which is allegedly often prescribed off-label, including for general neuropathic pain (e.g., Scilex Pharmaceuticals Inc. LLC, 2021 WL 3417590, F.Supp.3d 3d -, 2021 WL 3417590, No.

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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

The letter discusses the BPCIA and the Hatch-Waxman Act frameworks (for small molecule drugs) and sets forth several topics for USPTO’s consideration and further discussion: engagement between FDA and USPTO to increase efficiencies, possible misuse of the patent system (e.g., Sanofi, Aventisub LLC , 987 F.3d Rezvoglar ™. Eli Lilly).