Expertise

Gemini offers “end to end” counseling on IP issues in support of biopharma product development and launch in the U.S.

Patent prosecution & portfolio optimization

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Virtual in-house counsel services

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Hatch Waxman litigation & regulatory strategy
Biosimilar (BPCIA) litigation & regulatory strategy
Patent & trade secret design-around strategies

“Biobetter” & “fast follow-on” product litigation & regulatory strategy

Pharmaceutical device-related litigation & regulatory strategy

IP & regulatory issues concerning healthcare AI
CREATES Act requests & litigation

Section 1782 discovery requests for use in foreign litigation

Global coordination of litigation strategy concerning biosimilar, generic and biobetter products

Litigation risk mitigation and avoidance

Patent landscape analysis and freedom-to-operate opinions

Lobbying and legislative initiatives relating to the BPCIA and Hatch Waxman laws