Gemini attorneys are among the most experienced and successful at helping manufacturers of biopharma products navigate IP barriers to access the U.S. market. Gemini has particular expertise in patent strategy and litigation relating to biosimilar, biobetter, generic and 505(b)(2) products, as well as collateral issues concerning the Hatch Waxman and BPCIA regulatory schemes. Gemini is also very experienced in counseling early-stage biotech companies to optimize patent portfolios and mitigate the risk posed by competitors’ IP, as well as IP issues related to licensing and development transactions. Gemini offers “end to end” counseling on IP issues in support of biopharma product development and launch in the U.S., including:
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