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The Life Sciences group at Fish & Richardson focuses on the intellectual property and business needs of clients in the life sciences and pharmaceutical industries. Our attorneys have been leading advisors to pioneers in the life sciences fields since the 1980s. Large and small companies, along with academic and research institutions, all turn to our firm to protect their most valuable innovations. A 2008 survey by Managing Intellectual Property magazine named Fish the top U.S. law firm for life sciences and biotechnology work.
Clients choose us because we are internationally known for the depth and breadth of our technical and scientific expertise. There are more than 100 attorneys in our life sciences group, including more than 80 PhD’s, located in each of our ten offices in the United States and in our office in Munich, Germany. We offer the resources of a global IP powerhouse, the expertise of a boutique, and the personal service that comes with a local presence.
Strategic patent advice
Intellectual property protection must be part of each client’s overall business strategy. In addition to patent prosecution, our Life Sciences group provides patent portfolio planning and analysis, advice on strategic planning, and opinions - including freedom-to-use, infringement, validity, and patentability opinions. We also offer patent-related analysis of competitive and other third-party positions, and patent portfolio analysis in connection with financing, evaluation, and acquisition of technology.
Patent re-examination, historically used primarily to bolster patent validity or clear patents in light of newly-disclosed art, is increasingly becoming a strategic defensive weapon in patent litigation. With the increased awareness of patent quality issues, the United States Patent and Trademark Office (PTO) has stepped up its efforts and is taking a bite out of issued patents. Our re-examination practice is fully integrated with our litigation and prosecution practices. No firm matches us for re-exam experience, particularly no firm with substantial patent litigation and prosecution groups.
Transactional work
Attorneys in our Corporate and Securities group have significant experience working with life
sciences companies. The Corporate and Securities group provides advice and guidance for licensing, development, joint venture, and technology transfer agreements. Our attorneys help life sciences companies with capital structuring and financing, public equity and debt offerings, and a broad range of corporate transactions.
Regulatory work
In addition to our intellectual property practice, Fish has an FDA regulatory practice, which includes attorneys with experience and expertise in Hatch-Waxman matters. Regulatory and patent attorneys work closely together on the various Hatch-Waxman issues that surface with drug, biologic, and medical device approvals. Our attorneys advise clients on the marketing exclusivities which are available for new drugs and “first filer” generics, and on Orange Book issues involving patented drug products. Clients come to us for counseling and representation on “safe harbor” exemptions from patent infringement for FDA-related activities and for assistance in securing their patent term extensions for drugs, biologics, and Class III medical devices. The attorneys also counsel clients on Orphan Drug approvals and pediatric exclusivity rights.
Using technology to boost efficiency
We believe in using technology to serve clients better. Ninety-five percent of the 5,400 U.S. patent applications we file each year are electronically filed using the Patent Office’s EFS-WEB online system. Our firm implemented an electronic workflow and file system that gives us greater agility in responding to client needs and allows us to offer our clients real-time, round-the-clock access to matter information through FishLink®, our secure extranet site.
Litigation
Fish is ranked among the top firms for patent litigation and our victories have consistently been named to the National Law Journal biggest winners list for more than a decade. IP Law & Business has ranked us as the most active patent litigation firm in the United States for six out of seven years since 2000. The magazine also ranks us at the top of its lists for handling patent cases at the International Trade Commission.
We handle both plaintiff and defense cases, giving us the ability to understand patent litigation strategy from both an offensive and defensive perspective. Our attorneys litigate patent disputes involving a wide variety of life sciences, pharmaceutical, and chemical patents.
Representative life sciences litigation
Amyloid precursor protein mutations: Defended Mayo Clinic and Myriad Pharmaceuticals against Alzheimer’s Institute of America before the American Arbitration Association in a patent dispute over genetic sequences related to Alzheimer’s Disease.
Crohn’s disease treatments: Defended Mayo Medical Ventures against Prometheus Laboratories Inc., in patent litigation relating to methods for optimizing drug therapy of immune-mediated gastrointestinal disorders by measuring selected drug metabolites during drug treatment.
Recombinant protein production technology: Represented Repligen Corporation and the Massachusetts Institute of Technology against ImClone Systems, Inc., in the U.S. District Court for the District of Massachusetts in a patent infringement case involving the manufacture of the highly publicized cancer drug, ERBITUX.
Brimonidine (reduced allergy glaucoma drugs): Represented Allergan against Alcon Laboratories in litigation pending in the U.S. District Court for the District of Delaware. Allergan sued Alcon for patent infringement after Alcon filed a Section 505(b)(2) application to market a bioequivalent of Allergan’s ALPHAGAN P glaucoma medication, an improved version of its ALPHAGAN medication.
Expression vectors: Represented Repligen and the Massachusetts Institute of Technology
in the U.S. District Court for the District of Massachusetts in a patent infringement case against ImClone Systems, Inc. The patents cover expression vectors that, when inserted into a mammalian cell, cause the cell to make abundant amounts of the gene of interest.
Anti-amyloid benzamidine drugs: Represented Immtech International, the University of
North Carolina, and Georgia State University in an inventorship/ownership dispute against Neurochem, Inc., at the International Chamber of Commerce. The disputed patents covered the use of benzamidine compounds for treatment of amyloid diseases.
Chromatin transfer methods: Represented the University of Massachusetts in a dispute in Massachusetts State Court regarding ownership of inventions for chromatin transfer methods of mammalian cloning.
DNA polymers: Represented Takara Bio, Inc., in patent infringement litigation in the U.S. District Court for the District of Maryland.
Canola oils: Represented Cargill in a patent infringement case against Dow and Canbra in
the U.S. District Court for the District of Oregon. Cargill holds patents on canola oils with increased oxidative stability, reduced sulfur content, improved flavor and odor characteristics, and reduced trans fats.
Specialty corn products: Defended Cargill in a patent infringement case brought by National Starch in the U.S. District Court for the District of Delaware, involving a patent on corn with an increased amylose content and starch derived from the corn.
Brimonidine (neuroprotective glaucoma drugs): Represented Allergan against Alcon Laboratories in a series of cases in the U.S. District Court for the Central District of California and in the Federal Circuit. Allergan sued Alcon for patent infringement after Alcon filed an Abbreviated New Drug Application seeking FDA approval to market a generic equivalent of Allergan’s ALPHAGAN ocular medication. The cases made new law by establishing the scope of pioneer and generic pharmaceutical manufacturers’ rights to assert method-of-use patents under the Hatch- Waxman Act and the appropriate scope of method-of-use patents that may be listed in the Orange Book.
CFC-free metered-dose inhaler formulations: Represented 3M Company in multiple patent infringement actions in the U.S. District Court for the Middle District of North Carolina and
the District of Minnesota. The patents covered CFC- free pharmaceutical preparations used in metered-dose inhalers.
Topical alpha hydroxy: Defended A.P. Pharma in an action brought in the U.S. District Court for the District of Delaware by TriStrata Technology, Inc., alleging the infringement of patents related to alpha hydroxy skin treatments.
DNA storage matrices: Defended Schleicher & Schuell BioScience in an action brought in the U.S. District Court for the District of Delaware by Whatman PLC alleging the infringement of patents related to chemically treated paper matrices used to store and preserve DNA samples.
Pegylated liposomes: Represented PolyMasc, part of Valentis, against Alza, part of Johnson & Johnson, regarding PolyMasc’s patent on pegylated liposomes as a drug delivery system to make drugs longer acting, in the U.S. District Court for the District of Delaware. The accused product is Alza’s Doxil brand of the chemotherapy drug doxorubicin.
TNKase brand of t-PA: Represented Genzyme Corporation in a patent infringement suit against Genentech, Inc. in the U.S. District Court for the District of Delaware. Genzyme’s patent covered a longer-acting tissue plasminogen activator, a clot-buster used to treat strokes.
Pharmaceuticals — tic-d: Defended Clariant Life Science Molecules SpA in a patent infringement case brought by Great Lakes Chemical Company in the U.S. District Court for the District of Delaware. The patent covered a process to make tic-d, an important ingredient in AIDS drugs.
Transgenic mice: Defended the Mayo Foundation for Medical Education and Research in a patent infringement action brought by Elan Pharmaceuticals in the U.S. District Court for the Northern District of California. Elan accused Mayo of infringing two transgenic mouse patents covering a method of creating a mouse used in Alzheimer’s research.
Interleukin-1ß: Represented New England Medical Center Hospitals, Inc., Wellesley College, Tufts University, MIT, and Cistron Biotechnology Corporation against Peprotech, Inc., in the U.S. District Court for the District of New Jersey in an action to enforce a patent related to use of recombinant DNA technology for the production of interleukin-lß.
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Life Sciences