Patrick H. Higgins
Patrick Higgins has over 25 years’ experience in the Industry building, preserving, and extending market exclusivity related to therapeutic entities. Patrick’s practice focuses on both Pharma and Biopharma assets under the current authoritative judicial interpretation of the statutory requirements for patentability under Title 35 USC, as well as the Biologics Price Competition and Innovation Act (BPCIA) (Biosimilars Act) (PHS Act §351(k)), Hatch Waxman Act, as well as FDA regulatory and data exclusivity under the FD&C Act (Title 21 USC; 21 CFR).
Patrick closely monitors biologics as well as relevant drug substance facts, freedom to operate, patent exclusivity, relevant scope, term, jurisdiction, ownership, validity, enforceability, as well as risk and antitrust exposure.
Prior to joining Eckert Seamans, Patrick was a partner at an international law firm in Princeton. He previously served as senior patent counsel for a major pharmaceutical company, where he was responsible for strategic portfolio development, risk evaluation, and due diligence matters. Patrick was awarded the annual Global Director of Research Award as a Patent Attorney. Before entering law school, he worked as a research scientist at a major pharmaceutical company.
- Biopharma diligence, guidance, opinion work, and portfolio development.
- Small molecule compound therapeutics diligence, guidance, and opinion work.
- Advised a global biopharmaceutical company in the IP diligence of its potentially $800 million strategic alliance with a German biotechnology company. Client received worldwide rights to a fully human antibody directed against a therapeutic target for the treatment of multiple myeloma (MM) and certain leukemias.
- Advised a global biopharmaceutical company in the IP diligence of its $2.9 billion acquisition of another global biopharmaceutical company and its injectable formulation of paclitaxel, a mitotic inhibitor drug used in the treatment of breast cancer, lung cancer, and pancreatic cancer.
- Represented a global healthcare company based in Switzerland in an appeal concerning an iron chelation therapy for the management of chronic iron overload due to blood transfusions (over $1 billion formulation annual commercial sales).
- Advised global biopharmaceutical company in the IP diligence of its $2.9 billion acquisition of company that produces a treatment for myelodysplastic syndrome.
- Advised a global biopharmaceutical company in the IP diligence of the potentially $500 million strategic alliance with a public biopharmaceutical company headquartered in Louisville, Colorado, focusing on cancer immunotherapy.
- Advised a global biopharmaceutical company in the IP diligence of the potentially $500 million strategic alliance with a public clinical stage biopharmaceutical company with a focus on anemia drug development.
- Advised a global biopharmaceutical company in the IP diligence of its up to $640 million acquisition of a privately held biotech company, including an injection treatment for certain types of cancer called cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).
- Advised a global biopharmaceutical company in the IP diligence of a potentially $400 million collaboration and license agreement with a clinical stage biopharmaceutical company creating personalized therapeutics for patients with genetically defined cancers.
- Advised a global biopharmaceutical company in the IP diligence of a potentially $500 million option and license agreement toward an antibody drug candidate with a biologic immunotherapeutic.
- Advised a global biopharmaceutical company in the IP diligence of a potentially $500 million strategic alliance toward antibody constructs with a private biopharmaceutical company headquartered in South San Francisco.
- Philadelphia Intellectual Property Law Association
- New Jersey Intellectual Property Law Association
- Biotechnology Council of New Jersey
- American Intellectual Property Association
News and Insights
- “Following the Factors that Have Impacted Biopharma Cos.,” Law360, February 2015.
- “Chemical Compounds and Biologics Developing Issues Relevant to Market Exclusivity,” Intellectual Property Today, August 2011.
- “Patent (IP) Exclusivity – Small Molecule Compounds and Biologics” Intellectual Property Today, August 2011.
- “Market Exclusivity—Paramount in Evaluating Target Companies,” Genetic Engineering and Biotechnology News, September 2009.
- “Build, Maintain, and Enforce Strategic Market Exclusivity,” a chapter appearing in Essential Strategies for Protecting and Defending IP (Aspatore Books, May 2007).
- “Tipping the Balance Back Towards Patent Owners,” New Jersey Law Journal, Vol.CLXXXIII-No.11-Index.907, March 2006.
- “Calculated Words are Often Required to Preserve an Exclusive Market for Next-Generation Therapeutics,” Intellectual Property Today, Vol.12, No.7, July 2005.
- “Current Prospects for a Generic Biopharmaceutical Industry,” The Metropolitan Corporate Counsel, Vol.12, No.12, December 2004.
- “Decisions Related to Discovery Assets in the Pharmaceutical Industry,” Intellectual Property Today, Vol.11, No.4., April 2004.
- “Patents: Lifeblood of Biotech or a Cancer to Innovation?” BioWorld Financial Watch, May 25, 2009.
- “Chemical Compounds and Biologic: Developing Issues Relevant to Market Exclusivity,” GlaxoSmithKline, Novartis Pharmaceuticals, Purdue and Johnson & Johnson, October 2012.
- “Tools to Maintain Market Exclusivity in the Pharmaceutical Industry: Discovery, Development, FDA approval, Manufacturing and Sale of Therapeutic Entities, Legislative and Judicial Reform, Legal and Regulatory Tools, MMA Amendments and Antitrust Issues,” CLE, January 2008.
- “Leveraging the Value of Discovery Assets in the Pharmaceutical Industry,” American Chemical Society, Chemical Consultants Network, April 2005.
- “Strategic Role of Intellectual Property in Drug-Discovery Industry Transactions,” New Jersey Institute for Continuing Legal Education Intellectual Property Law Summit 2004, December 2004.