Robert Smyth, Ph.D., advises on biotechnology, pharmaceutical, and chemical patent prosecution in the United States and around the world. He advises on post-grant and opposition proceedings in the United States, Europe, Asia, and South America. He also focuses on patent infringement, validity, and freedom to operate analyses. Bob offers litigation support and analysis, drafts licensing agreements, and conducts intellectual property due diligence analysis for mergers and acquisitions. With a background in pharmacology, immunology, virology, and molecular biology, Bob advises companies on the development and commercialization of pharmaceutical, biological, and diagnostic products.
Bob has prepared and prosecuted thousands of patent applications in the life sciences sector, including complex matters under appeal before the Patent Trial and Appeal Board (PTAB) at the US Patent & Trademark Office (USPTO). He advises on post-grant proceedings in the USPTO including inter partes review, reexamination and reissue applications for pharmaceutical, biological, and diagnostic products. He provides strategic counseling on the creation and development of patent portfolios for branded pharmaceuticals to address issues arising during ANDA litigations. Bob also has expertise in analyzing and preparing Orange Book listings and patent term extensions for branded pharmaceuticals. He also counsels clients in patent matters relating to biosimilars as governed by the Biologics Price Competition and Innovation Act.
In addition, Bob advises on patent due diligence matters in mergers, acquisitions, venture capital financing, and public offerings involving pharmaceutical, biotechnology, and medical device companies. He regularly advises on intellectual property licenses and patent purchase agreements in the life sciences sector.
Prior to joining Morgan Lewis, Bob was a patent agent at a pharmaceutical company where he was responsible for managing the prosecution of patent applications for pharmaceutical and biological products. Bob received his B.S. in biology with a concentration in immunology from Syracuse University. He later received his Ph.D. in pharmacology from Temple University School of Medicine. His doctoral research focused on the use of monoclonal antibodies to drug receptor subtypes to assess their role in cancer cell proliferation. His doctoral research was published in the Journal of Pharmacology & Experimental Therapeutics. He completed his post-doctoral fellowship in virology at the University of Pennsylvania School of Medicine. His post-doctoral research focused on HIV cofactor utilization using HIV subtype chimeras and monoclonal antibodies specific to HIV cofactors. His post-doctoral research was the subject of multiple publications in the scientific journals Nature and Cell.
Acerta Pharma B.V. in patent litigation against Pharmacyclics involving tyrosine kinase inhibitors
Jazz Pharmaceuticals in its license of PASylation technology from XL-Protein GmbH to develop long acting Asparaginase products
Prosecution of Orange Book listed patents for Calquence
Acerta Pharma B.V. in its acquisition by AstraZeneca
Optimer Pharmaceuticals in its acquisition by Cubist Pharmaceuticals
EUSA Pharma in its acquisition by Jazz Pharmaceuticals
Optimer Pharmaceuticals in its license of European and Japanese commercialization rights for Dificid to Astellas
Prosecution of Orange Book listed patents for Dificid
Prosecution of Orange Book listed patents for Entresto
Carnegie Institution for Science in prosecution of patents for Nobel Prize in Medicine relating to RNA interference
Eli Lilly & Company in patent litigation against Genentech involving antibody production
EUSA Pharma in settlement of litigation relating to patent false marking
EUSA Pharma in its license of Asparec for acute lymphoblastic leukemia from Alize Pharma
EUSA Pharma in its acquisition of Collatamp G Implant product
Profectus BioSciences in the worldwide acquisition of Wyeth's therapeutic and prophylactic DNA and vectored vaccine programs for HIV
Barrier Therapeutics in patent term extension for Vusion
Barrier Therapeutics in its acquisition by Stiefel Laboratories
Cytogen in its acquisition by EUSA Pharma
Cytogen in settlement of patent litigation against Eastern Virginia Medical School related to PSMA monoclonal antibodies
Cytogen in its acquisition of Caphosol for oral mucositis from Inpharma AS
Cytogen in the sale of its joint venture interest in conjugated antibody technology to Progenics
Apollo Management on its acquisition of Ondeo Nalco from Suez S.A.
Enzon in its acquisition of the rights to Abelcet for infections related to cancer treatment
Syracuse University, 1989, B.S.
Temple University, 1995, Ph.D.
Temple University, Beasley School of Law, 1999, J.D.
University of Pennsylvania, 1997, P.D.F.
District of Columbia
US Court of Appeals for the Federal Circuit
US Patent and Trademark Office
Awards and Affiliations
Recommended, Intellectual property: Patents: prosecution (including re-examination and post-grant proceedings), The Legal 500 US (2019)
Recognized, IAM Patent 1000: The World’s Leading Patent Professionals (2017–2019)
Member, American Bar Association, Intellectual Property Section
Member, American Intellectual Property Law Association, Biotechnology Committee
Member, Intellectual Property Owners Association, International Patent Practice Committee