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 Shire, Vertex Pharmaceuticals and Viamet Pharmaceuticals, as well as prestigious academic and research institutions such as Harvard Medical School, Dana Farber Cancer Institute and Sloan Kettering. 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

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 Shire, Vertex Pharmaceuticals and Viamet Pharmaceuticals, as well as prestigious academic and research institutions such as Harvard Medical School, Dana Farber Cancer Institute and Sloan Kettering. 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