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.
REPRESENTATIVE CLIENTS & MATTERS
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: 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, and HIV protease inhibitors. 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).
Professional & Civic Activities
- Lieutenant Commander United States Navy (1969-1976)
- Member, United States Office of Technology Assessment, Advisory Panel, "The Human Genome Project and Patenting Human DNA Sequences” (1993-94)
- Panel of Arbitrators, American Arbitration Association
Honors & Awards
- LMG Life Sciences: Hall of Fame (2015)
- PLC Global Counsel's Top 10 Patent Lawyers Worldwide (2002)
- Antares Pharma, Inc. v. Medac (2015), LMG Patent Impact Case of the Year
- The Best Lawyers in America (since inception)
- Chambers USA: America's Leading Lawyers in Business (2005-2017)
- New York Super Lawyers (2006-2018)
- Euromoney's Guide to the World’s Leading Patent Law Experts (since inception)
- Chambers Global: The World's Leading Lawyers in Business (2006-2015)
- IAM Patent 1000 – The World's Leading Patent Practitioners (2013-2018)
- LMG Life Sciences: “Life Sciences Star” (2013, 2016, 2018)
- PLC Which Lawyer
- International Who’s Who of Patent Lawyers (2006-2017)
- International Who’s Who of Life Sciences (2007-2017)
- IAM Life Sciences (2010-2018)
- Legal 500 (2016)
- Who's Who Legal: Life Science (2014-2018)
- Global Counsel: Life Sciences Industry Report - Leading Lawyer in Life
- Science - Intellectual Property
- Global Counsel Life Sciences Specialist 500 – The Super League
Memberships & Affiliations
- American Intellectual Property Law Association
- New York Intellectual Property Law Association
Published Work (Most Recent)
- Co-author, United States, in International Patent Litigation, Global Law and Business, 1st edition (2011), 2nd edition in press.
- Presenter, Building Up the Biosimilar’s Marketplace: Adjusting Current Life Sciences Patent Strategies to Keep Up with the Evolving Landscape, ACI Advanced Summit on Life Sciences Patents (February 2017).
- Co-author, “From Clones to Claims,” An Encyclopedia of the European Patent Office’s Case Law on the Patentability of Biotechnological Inventions with a Comparison to the United States and Japanese Practice, Heymanns Intellectual Property, 6th edition (2016) (and the earlier 5th, 4th, 3rd, and 2nd editions).
- Co-author, “Lessons Learned from IPR Proceedings in the Life Sciences,” Bloomberg BNA Patent, Trademark & Copyright Journal (January 30, 2015).
- Quoted, “Biosimilars – Blood on the Patent Dance Floor,” Managing Intellectual Property (December 9, 2014).
- Quoted, “Original-Patent Rule Dooms Drug Injection Complaint,” Law360 (November 17, 2014)
- Mentioned, “Appeals court won't stop Medac from selling injectable drug,” Reuters Legal (November 17, 2014).
- Quoted, “Pharma Sector Takes a Dose of Post Grant Patent Review,” Corporate Counsel (September 9, 2014).
- Quoted, “Sanofi-Aventis loses isolated DNA sequence appeal,” Intellectual Property Magazine (November 7, 2013).
- Quoted, “Pfizer wins IL-13 priority over Sanofi,” Life Sciences Intellectual Property Review (November 6, 2013).
- Quoted, “Pfizer Beat Sanofi To Isolated DNA Patent, Fed. Circ. Says,” Law360 (November 5, 2013).
- Quoted, “Stem Cell Patent Case Will Be Early Test of Myriad's Reach," Law360 (June 10, 2013).