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Life Sciences

Fish attorneys have served as leading advisors to pioneers in the pharmaceutical, biotechnology, and life sciences fields for more than a century. For three consecutive years, we have been named the top US law firm for life sciences and biotechnology IP work by Managing Intellectual Property magazine. Clients choose Fish because of the technical and scientific expertise of our internationally recognized attorneys.

Large and small companies, along with academic and research institutions, turn to Fish's team to protect their most valuable innovations. We offer biotechnology and pharmaceutical clients services that include:

Patent portfolio planning, strategic advice, opinions, and prosecution
Patent reexamination advice
Litigation services, including representation in Hatch-Waxman cases
FDA expertise
Counsel on licensing and other transactions

We have a rapidly expanding practice representing branded pharmaceutical companies in Hatch-Waxman litigation. Biotechnology and pharmaceutical companies trust Fish's litigation team to handle these complicated, high-stakes cases because we are the world's most experienced patent litigators.

Examples of our biotechnology and pharmaceutical work include:

Representing dozens of biotechnology and pharmaceutical clients in patent infringement litigation
Successfully litigating ANDA cases on behalf of branded pharmaceuticals
Obtaining patents for therapeutic agents and methods currently in clinical trials, including tumor-specific agents such as oncolytics viruses and humanized antibodies and methods for treating strokes
Patenting groundbreaking tissue engineering patents on breakthroughs that show promise in treating spinal cord injuries
Obtaining the first patent on a genetically engineered animal
Gaining FDA approvals for small molecule drugs and biologics, including gene and cell therapies, antibiotics, immunologics, and anti-anxiety medications
Conducting intellectual property due diligence on thousands of licensing agreements for the merger of two large pharmaceuticals companies in just a few months' time

Allergan, Inc., et al v. Apotex Corp., et al.
Represented plaintiffs in Hatch-Waxman action over ANDAs for eyelash drug LATISSE®. Judgment entered against generic defendants.

Prometheus Laboratories Inc. v. Mayo Collaborative Services, et al.
Fish defended Mayo in an action for patent infringement over metabolite assays for 6-mercaptopurine drugs. We argued and obtained summary judgment of invalidity for the client. Appealed to the Supreme Court, which ruled unanimously in favor of Mayo, finding the Prometheus patents described a law of nature, not patentable under Section 101 of U.S. patent law.

Hoffman-La Roche Inc. v. Roxane Laboratories Inc., et al.
Representing plaintiff Roche in Hatch-Waxman litigation relating to its XELODA® (capecitabine) product, an oral chemotherapy for metastatic breast and colorectal cancer and Dukes' C Stage III colon cancer.

In re Brimonidine
Represented Allergan in multi-district litigation regarding multiple ANDAs for Allergan's glaucoma drugs ALPHAGAN® P 0.15% and ALPHAGAN® P 0.1%. Verdict of infringement, validity and enforceability on all five patents-in-suit.

Perlan Therapeutics v. NexBio, Inc.
Defended biopharmaceutical company in trade secret, unfair competition, patent and Lanham Act case. Obtained judgment for defendants after motion to dismiss in clients' favor.

Allergan Inc., et al. v. Watson Laboratories Inc.
Representing Allergan, Endo Pharmaceuticals, and Supernus Pharmaceuticals relating to SANCTURA XR®, treatment for overactive bladder.

Eurand Inc., et al. v. Anchen Pharmaceuticals Inc., et al.
Representing plaintiffs Eurand, Cephalon, and Anesta in Hatch-Waxman litigation over skeletal muscle relaxant AMRIX®.

Allergan Inc. v. Hi-Tech Pharmacal Co. Inc.
Representing Allergan in Hatch-Waxman litigation relating to its glaucoma drug COMBIGAN®.

Allergan Inc. v. Barr Laboratories Inc.
Representing Allergan in Hatch-Waxman litigation relating to is glaucoma drug LUMIGAN®.

Eurand Inc., et al. v. Impax Laboratories Inc.
Representing plaintiffs Eurand, Cephalon, and Anesta in Hatch-Waxman litigation over skeletal muscle relaxant AMRIX®.

Allergan Inc. v. Sandoz Inc.
Representing plaintiff in patent action over ANDA for glaucoma treatment COMBIGAN®.

Hoffman-La Roche Inc. v. Mylan Inc., et al.
Representing Roche in Hatch-Waxman litigation involving XELODA®, the first oral chemotherapy drug approved in the US for treatment of breast and colorectal cancer and Dukes’ C Stage III colon cancer.

Cephalon Inc., et al. v. Barr Pharmaceuticals, et al.
Representing plaintiffs Cephalon and CIMA in Hatch-Waxman patent litigation pertaining to the drug FENTORA®, fentanyl citrate buccal tablets, used in the treatment of opioid tolerant patients suffering from breakthrough cancer pain.

Cephalon Inc. v. Watson Pharmaceuticals Inc., et al.
Representing plaintiff Cephalon for fentanyl citrate buccal tablets.

Eurand Inc., et al. v. Mylan Pharmaceuticals Inc., et al.
Representing plaintiffs in Hatch-Waxman action over ANDAs for Cephalon's skeletal muscle relaxant AMRIX®.

Cephalon Inc., et al. v. Watson Pharmaceuticals Inc., et al.
Representing plaintiffs Cephalon and CIMA in Hatch-Waxman patent litigation pertaining to the drug FENTORA®, fentanyl citrate buccal tablets, used in the treatment of opioid tolerant patients suffering from breakthrough cancer pain.

Exela Pharmsci Inc. v. Allergan Inc.
Represented Allergan for glaucoma drugs ALPHAGAN® P 0.15% and ALPHAGAN® P 0.1%.

Allergan Inc. v. Exela Pharmsci Inc., et al.
Represented Allergan for glaucoma drug ALPHAGAN® P 0.15%.

Sciele Pharma Inc., et al. v. Mylan Pharmaceuticals Inc., et al.
Represented plaintiffs in Hatch-Waxman action over ANDA for Sciele’s blood-pressure drug, SULAR®. Case successfully resolved upon patent expiration.

Alzheimer’s Institute of America v. Mayo Clinic, et al.
Represented 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.

Repligen and MIT v. ImClone Systems Inc.
Represented plaintiffs in patent infringement litigation relating to mammalian cells genetically engineered with patented expression vectors. Case settled on the morning of trial for $65,000,000.

National Starch and Chemical Investment Holding Corporation, et al v. Cargill Inc., et al
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.

Allergan Inc., et al. v. Alcon Laboratories, et al.
Counsel for Allergan in series of cases regarding ANDAs and 505(b)(2) NDAs for Allergan’s glaucoma drugs, ALPHAGAN® and ALPHAGAN® P 0.15%. Cases involving ALPHAGAN® resulted in landmark rulings on the permissible assertion of method-of use patents under the Hatch-Waxman Act. Case involving ALPHAGAN® P 0.15.% resulted in settlement on the morning of opening statements with defendant agreeing not to launch competitive drug for several years and to pay royalty on release.

Whatman PLC v. Schuell Inc.
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.

Immtech International, Inc. v. Neurochem, Inc.
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.

TriStrata Technology v. Cardinal Health Inc., et al
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.

Allergan Inc., et al. v. Alcon Laboratories, et al.
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.

Stratagene v. Takara Holdings, Inc, et al
Represented Takara Bio, Inc., in patent infringement litigation in the U.S. District Court for the District of Maryland related to DNA polymers.

Allergan Inc., et al. v. Alcon Laboratories, et al.
Asserted several of Allergan’s patents related to treatment of glaucoma with Brimonidine Tartrate against Alcon in Abbreviated New Drug Application (ANDA) litigation. Case favorably settled shortly before trial.

PolyMASC Pharmaceuticals v. Alza Corporation
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.

Genzyme Corporation v. Genentech Inc.
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.

Glaxo Welcome, Inc. v. 3M
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.

Elan Pharmaceuticals, et al v. Mayo Foundation For Medical Education and Research
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.

Great Lakes Chemical v. Archimica SpA, et al
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.

Invitrogen Corp. v. Clontech Laboratories, Inc.
Represented Clontech, taking over long-standing litigation between the parties after appeal to the Federal Circuit. Conducted trial focused on inventorship of RNase H minus reverse transcriptase and potential damages. The case settled during trial on business terms that were mutually acceptable to both parties.

New England Medical Center, et al v. Peprotech, Inc.
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.

Cargill, Incorporated v. Canbra Foods, Ltd.
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.

Life Sciences

2012 Winter Update

Life Sciences

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