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: 

• 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