Overview
Dr. James F. Haley, Jr. is a partner at Leason Ellis and a member of the Patent Practice and Litigation Practice Groups. He focuses his practice on the worldwide procurement, defense, and enforcement of patents in the biotechnology, biopharmaceutical, pharmaceutical, and chemical industries. He has counseled clients since 1975 and drafted, prosecuted, and defended foundational patents in recombinant DNA technologies. Jim has extensive experience in U.S. and international patent prosecution, patent enforcement, and contested proceedings.
Jim has prosecuted more than 900 U.S. patents and thousands of foreign patents across technologies including small molecules, biologics, recombinant proteins and antibodies, vaccines, viral vectors, diagnostic tools, CRISPR-related technologies, formulations, polymorphs, prodrugs, imaging modalities, and transgenic organisms. He has led numerous litigations, oppositions, interferences, and PTAB AIA proceedings worldwide, and his legal work includes several landmark patents and contested proceedings recognized as industry-defining achievements.
Industries
Credentials
- Brandeis University, Ph.D., Organic Chemistry, 1975
- Suffolk University Law School, J.D., magna cum laude, 1975
- University of Notre Dame, B.S., Chemistry, 1967
- New York
- Massachusetts
- Registered Patent Attorney: U.S. Patent and Trademark Office
- U.S. District Court for the Southern District of New York
- U.S. District Court for the Eastern District of New York
- U.S. District Court for the District of Colorado
- U.S. District Court for the Northern District of California
- U.S. Court of Appeals for the Federal Circuit
- Haley Guiliano
- Ropes & Gray
- Fish & Neave, Associate
- United States Navy, Ensign-Lieutenant Commander
- American Intellectual Property Law Association, Member
- New York Intellectual Property Law Association, Member
- American Arbitration Association, Panel of Arbitrators
- U.S. Office of Technology Assessment, Advisory Panel (Human Genome Project), 1993- 1994
Speaking Engagements
- ACI, IAM & Life Sciences IP Conferences on Patent Strategy, PTAB, Proceedings, Biosimilars and Biotechnology Patent Law, Presenter & Panelist, 2013- 2024
Selected Articles
- “A Closer Look at the Latest PTAB Estoppel Developments,” IAM Life Sciences, 2024
- “Recent Application of Patent Damages Law,” IAM Global Patent Litigation, 2022
- “Written Description: A Death Knell to Genus Claims in Biotechnology,” IAM Life Sciences, 2022
- “Drug Repurposing and Skinny Labels,” IAM Life Sciences, 2021
- “Q&A on United States Patent Litigation,” IAM Global Patent Litigation, 2021
- “United States in International Patent Litigation,” Global Law and Business, 1st, 2011, 2nd ed., 2018
- “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 (also contributed to 5th, 4th, 3rd and 2nd ed.,) 2016
- “Lessons Learned from IPR Proceedings in the Life Sciences,” Bloomberg BNA Patent, Trademark & Copyright Journal, January 30, 2015
Selected Cases
U.S. District Courts & ITC
- Ajinomoto Co. v. Cheiljedang (S.D.N.Y.)
- Cherokee Gray Eagle IP v. Sky Zone (M.D. Fla)
- Cherokee Gray Eagle IP v. CircusTrix (M.D. Fla)
- Cherokee Gray Eagle IP v. Rockin’ Jump (S.D. Fla)
- 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. ITC) — Lead trial counsel for Petitioner C.J. Cheiljedang
- 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.)
- Genzme v. Seikagaku and Zimmer (D. Mass)
- Genzyme v. Medicis (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. Pa.)
- 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.N.J.)
- 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.)
International Litigation
- 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)
Representative Oppositions (EPO, Japan, Australia, Germany)
European Patent Office (EPO)
- PTSD treatments
- Cyclobenzaprine eutectics
- Depression treatments
- Bone morphogenetic protein
- BAFF antibodies
- IL-1 inhibitor
- Phage display
- Expression vector
- Alpha interferon
- Hepatitis B viral antigens
- Gamma interferon
- Beta interferon
- Protein secretion
- Xenomice and antibodies
- Imaging agents
Germany
- Beta interferon
Australia
- Gamma interferon
- Antiviral compounds
Japan
- Beta interferon
- Protein secretion
- Alpha interferon
- Antiviral nucleosides
Representative Interferences & PTAB Proceedings (Lead Counsel)
- BAFF antibodies
- BCR-ABL mutations (cancer diagnostics)
- 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
- Bone morphogenic proteins
- CD40 counterreceptor antibodies
- Transgenic fibrinogen
- Single-chain antibodies
- Methods of treating inflammatory disease with methotrexate
- Feedback inhibition in tryptophan biosynthesis
- YddG in tryptophan biosynthesis
- HIV protease inhibitors
- Mounts for attaching a suspension assembly to an actuator arm in a hard disk drive
- Trampoline arena architecture
Select Landmark Decisions
- 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)
- Koios Pharmaceuticals v. Medac GmbH, IPR2016-01370 (Final Decision, Feb. 2018)
- NHK Spring Co. v. Intri-Plex Technologies, IPR2018-00752 (Non-Institution, Sept. 12, 2018) — one of the most important PTAB decisions of 2018
- Biogen’s Murray Hepatitis B Vaccine Patent, one of “10 Patent That Changed the World” IP Worldwide, 2002
