Jim has focused his practice on the worldwide procurement, defense and enforcement of patents in the biotechnology, biopharmaceutical, pharmaceutical and chemical industries. He has counseled biotechnology and biopharmaceutical clients since 1978 and drafted, prosecuted and defended some of the basic patents in recombinant DNA technologies. He has extensive experience in United States and worldwide patent prosecution and patent enforcement and defense in all areas of biotechnology and biopharmaceuticals.Prior to co-founding Haley Guiliano, Jim was a Senior Counsel and Partner of Ropes & Gray, where he was former co-head of the Intellectual Property Rights Management practice group, and a partner of Fish & Neave. At Fish & Neave, Jim established and led the firm’s Life Sciences Technical Advisor program and successfully mentored over seventy Ph.D.’s in the life sciences and organic chemistry as they transitioned from the laboratory, through law school, to attorneys at law, specializing in intellectual property procurement, counselling, defense and enforcement.
Jim has prosecuted and led the prosecution to issue of more than 700 United States patents and many thousands of related patents around the world. Among the technologies represented in these patents are new chemical entities, synthetic methods; methods of treatment, formulations, microorganisms and their uses, recombinant proteins and antibodies and their uses, viruses, vaccines, antigens, expression systems, DNA sequences and vectors, diagnostic kits, crystals, polymorphs, enzymes, prodrugs and methods of using them to treat disease, receptors and binding pockets, imaging modalities, transgenic plants and animals and their uses, polymers, and ion channels. See, in particular, U.S. Patent 4,563,423 (hepatitis B viral antigens and vaccines – recognized by IP Worldwide (2002) as among “10 Patents That Changed the World”), 4,530,901 (recombinant alpha interferon – first “hybridization” claim) and 5,756,466 (first pharmacophore claim).
Jim has led numerous United States and foreign patent litigations, European and other patent oppositions and United States interferences and other PTAB contested AIA proceedings in biotechnology and biopharmaceuticals.
Some of his representative patent infringement cases include: Trustees for Dartmouth College/ ChromaDex, Inc. v. Elysium Health (D. Del.), In the Matter of Certain L-Tryptophan, L-Tryptophan Products, And Their Methods of Production (U.S. International Trade Commission) (representing Petitioner C.J. Cheiljedang) (lead trial counsel) Regeneron Pharmaceuticals, Inc. v. Ablexis LLC (S.D.N.Y), Medac Pharma, Inc. et al v. Antares Pharma, Inc. et al (D.N.J.), Antares Pharma, Inc. v. Medac GmbH and Medac Pharma (D. Del), Genzyme v Anika Therapeutics (D. Mass.), Shelbyzyme v Genzyme (D. Del.), Genzyme v Seikagaku and Zimmer (D. Mass.), Genzyme v Medicis (D. Mass.), MEEI v. QLT/Novartis Ophthalmics (D. Mass), MEEI v. QLT (D. Mass) Amgen v. Aventis/TKT (D. Mass.), Oregon Health & Sciences University v. Vertex (D. Oregon), Pieczenik v. Dyax (D. Mass and S.D.N.Y.), Schering-Plough v. Sterling Winthrop (D. N.J.), Sheller Globe v. Milsco (D. Wisc.)), Square D v. 3M (N.D. Ill), PPG v. Celanese (E.D. P.A.), Chiron v. Vertex/Lilly (N.D. Cal.), Biogen/Harvard v. Pharmacia (D. Mass), Biogen v. Amgen (D. Mass), Biogen v. Berlex (D. Mass), Biogen v. Genentech/Roche (D. Mass), Schering v. Genentech (D. NJ), PPG v. Celanese (E.D. Pa), Case v. BASF (D. Mass) BASF v. United Carbide (S.D.N.Y.), Schering v. ISI/Busch Biotech (D. Del). Case v. BASF (D. Mass.), Amgen v. TKT/Aventis (UK), Biogen v. Boehringer Ingelheim (Germany, Austria, Poland), Boehringer Ingelheim v. Bioferon (Germany), Biogen v. Medeva (UK), Epix v. Bracco (France, Germany, Netherlands), Biogen v. Amgen (Japan), Biogen v. BTG (Israel), Biogen v. Scitech (Singapore), Biogen/Harvard University v. Sumitomo (Japan), Biogen/Harvard v. Pharmacia (Sweden).Jim's representative oppositions include: EPO (bonemorphogenetic protein), EPO (BAFF antibodies), EPO (IL-1 Inhibitor), EPO (phage display), EPO (expression vector), EPO (alpha interferon), EPO (hepatitis B viral antigens), EPO (gamma interferon), EPO (beta interferon), Germany (beta interferon), EPO (protein secretion), EPO (xenomice and antibodies), EPO (imaging agents), Australia (gamma interferon), Australia (antiviral compounds), Japan (beta interferon), Japan (protein secretion), Japan (alpha interferon), Japan (antiviral nucleosides).
Jim's representative interferences and contested proceedings before the PTAB (all as lead counsel) include: BAFF antibodies, BCR-ABL mutations in cancer diagnosis, Tweak proteins, IL-13 receptor, M-CSF antibodies, alpha interferon, hepatitis B viral antigens, protein secretion, leukocyte adhesion molecules, beta interferon, interleukin 1 converting enzyme inhibitors, and bone morphogenic proteins, CD40 counterreceptor antibodies, transgenic fibrinogen, single chain antibodies, methods of treating inflammatory disease with methotrexate, and feedback inhibition in tryptophan biosynthesis, YddG in tryptophan biosynthesis, HIV protease inhibitors, and swage mounts. See in particular, Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993); Velander v. Garner, 348 F. 3d 1359 (Fed. CIR. 2003); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Sanofi-Aventis v. Pfizer, Inc., 733 F.3d 1364 (Fed. Cir. 2013); and Koios Pharmaceuticals v. Medac GmbH, IPR2016-01370 (Final Decision, February 2018).