From first-hand experience, members of our Pharmaceutical Group understand the importance of patents, trademarks and trade secrets to pharmaceutical companies. Group members have conducted research at and represented pharmaceutical giants and startups alike. This means we understand the interaction of patents with a range of FDA issues such as patent term extensions, non-patent exclusivities, Orange Book listing requirements, Hatch-Waxman issues and ANDA (Abbreviated New Drug Application) litigation.

OUR CLIENTS

Our clients include global and emerging pharmaceutical companies such as Takeda, Vertex Pharmaceuticals and Viamet Pharmaceuticals, as well as prestigious academic and research institutions such as Harvard Medical School and Dana Farber Cancer Institute. They appreciate our depth of experience as well as our attention to client service.

INDUSTRY EXPERIENCE

Members of our group have extensive experience in the pharma industry, having worked at such companies as Johnson & Johnson, Novartis and GlaxoSmithKline. We have worked as in-house legal counsel at companies including Cubist Pharmaceuticals and Amgen. As a result, we have an intimate understanding of the challenges in-house counsel face.

STRATEGIC APPROACH

Working closely with our clients, we customize IP infrastructures that coordinate with and complement existing in-house protocols and systems. We create strategic plans for portfolios and adjust as IP and business needs dictate. We are forward-looking and proactive about filing strategies, always keeping in mind potential collaboration and licensing opportunities as well as future R&D efforts.

• A new client thought it had a dominant IP position based on patents filed years earlier. We were asked to do diligence and a freedom-to-operate opinion respecting a lead product. We uncovered a series of prior art documents that would have undermined the client’s position in the eyes of an investor. The client bought the competitor’s IP, took a new position in-line with the discovered prior art, yielding a strong valuation and investment.
• We conducted multiple patent due diligence projects for a clinical-stage, biopharmaceutical company related to both small-molecule and antibody therapeutics, including analyzing strengths of granted and pending patent claims and possible hurdles to overcome, focusing on large business markets such as the U.S. and Europe.  
• A large hedge fund client sought our advice to help it decide whether to invest in a small pharmaceutical company whose patent portfolio might prevent a large pharmaceutical company from making and selling a blockbuster drug. We performed due diligence to determine the strengths of the patent portfolios of the pharmaceutical companies, the likelihood of success of the small pharmaceutical company in a potential interference proceeding against the large pharmaceutical company in the U.S., and the likelihood of success of the pharmaceutical companies in various opposition proceedings in Europe. Based on our due diligence report, our client invested heavily in the small pharmaceutical company.
• For a small bio-medical device company with foundational IP encompassing non-invasive methods of treating various ophthalmologic conditions, we battled for two years with the USPTO over the scope of claims, finally succeeding in submitting key data and arguments which garnered allowance without jeopardizing claim scope. The issuance of two additional U.S. patents covering related methods quickly followed, and our world-wide strategy produced similar results.
• A global biotechnology company asked us to conduct IP due diligence on a technology it wanted to acquire. In less than two weeks, we evaluated over 200 U.S. patents and pending U.S. and international applications, mapped out a timeline of the IP landscape in relevant antisense technology over the past 25 years, and provided our opinion regarding freedom to operate with the technology to be acquired.
• A major research university asked us to evaluate one of its U.S. patents in preparation for litigation to enforce patent rights. The claims of the patent were being allegedly infringed by the sale of a recently approved drug with over $2 billion in annual sales. We reviewed each claim, term by term, to provide systematic support for claim construction and provided our client with an opinion on enforceability against the infringing product.
• We developed an Orange Book listing strategy successfully used to block generic competition via ANDA litigation.

Representative Clients

• Agency for Science, Technology and Research (A*STAR) - public sector agency in Singapore that develops innovative technologies and supports R&D aligned to areas of competitive advantage and national needs
• Boehringer Ingelheim - concentrates on developing innovative therapies that can extend patients’ lives
• Broad Institute - a biomedical and genomic research center with researchers in medicine, biology, chemistry, computation, engineering, and mathematics from MIT, Harvard and Harvard-affiliated hospitals
• Dana-Farber Cancer Institute, Inc. - cancer treatment hospital and research center
• Epizyme - biopharmaceutical company focused on treatments for blood cancer and tumors
• Greenlight Biosciences, Inc. - biotechnology company focused on the sustainable production of chemicals and fuels from renewable, non-petroleum based resources
• Harvard University & Medical School - Harvard's Office of Technology Development is responsible for managing its intellectual property assets for the public good
• H. Lundbeck A/S - a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders
• Innocrin Pharmaceuticals, Inc. - discovers and develops novel, best-in-class oral selective inhibitors of CYP17 lyase, a validated target for the treatment of advanced breast and prostate cancer
• Lantheus Medical Imaging, Inc. - provider of medical imaging solutions
• Massachusetts General Hospital - biomedical research facility and teaching hospital of Harvard Medical School
• Massachusetts Institute of Technology - education and research institute managing commercial investment in and licensing of inventions and discoveries from research at MIT and Lincoln Laboratory
• Takeda - biopharmaceutical company focused on developing and marketing specialty medicines
• Stanford University - Stanford's Office of Technology Licensing transfers technologies developed at Stanford from the laboratories to industry
• Swedish Orphan Biovitrum AB (publ) - an international specialty healthcare company dedicated to rare diseases
• University of Florida Research Foundation, Inc. - supports research activities of UF faculty, staff, and students
• University of South Florida Research Foundation, Inc. - supports research activities of USF faculty, staff, and students
• Vertex Pharmaceuticals - discovers, develops, manufactures and commercializes medicines for serious diseases
• Viamet Pharmaceutical Holdings, LLC - discovers and develops small molecule inhibitors via an enzyme-binding approach for the treatment of various diseases
• Vision Medicines, Inc. - clinical-stage biopharmaceutical company developing therapies for patients suffering from blinding ocular diseases
• Whitehead Institute for Biomedical Research - biomedical research institution
• Xcovery, Inc. - a biopharmaceutical company with the aim to improve the lives of cancer patients by discovering and developing innovative medicines to fight advanced tumors 

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