Expertise

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

Litigation risk mitigation and avoidance

Patent & trade secret design-around strategies

Patent portfolio optimization

Biosimilar (BPCIA) litigation & regulatory strategy

Hatch Waxman litigation & regulatory strategy

“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

Patent landscaping and freedom-to-operate opinions

IP-related licensing, development & manufacturing transactions

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