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Background

S. Peter Ludwig is a Principal in the New York office of Fish & Richardson. Mr. Ludwig’s practice is focused on domestic and foreign patent prosecution, litigation, licensing, interference and counseling issues, particularly in representing high-tech start-up companies and academic institutions. His technical expertise includes biotechnology (vaccines, functional genomics, pharmacogenomics, high throughput screening, stem cell technology, autoimmune diseases, gene therapy), pharmaceuticals (neuroleptic drugs, drug delivery systems, anti-metabolites, natural pharmaceuticals, anti-tumor agents, anti-viral agents), medical devices, photo-chemistry, paper chemistry, medical rubber products, aluminum processing and diagnostic products.

Mr. Ludwig has spoken on intellectual property issues for numerous professional associations, including the American Chemical Society, Pharmaceutical Research and Manufacturers of America, the New York Biotechnology Association, the Association of the Bar of the City of New York, the Biotechnology Industry Association, the Genetics Policy Institute, The American Conference Institute and the New York Intellectual Property Law Association.

Under an Ampart grant from the United States State Department, Mr. Ludwig lectured and advised government authorities and industry representatives in Brazil on strengthening intellectual property rights for biotechnology and pharmaceuticals.

From 2001 to 2005, Mr. Ludwig served as a speaker and as the chair or co-chair of the annual Biotechnology and Pharmaceutical Law and Business Program sponsored by the Practising Law Institute in New York and San Francisco. Mr. Ludwig was the Chair of the New York Intellectual Property Law Association’s Patentable Subject Matter Committee for the 2009-2010 term.

Education

LL.M., New York University 1972
Trade Regulation


J.D., St. John's University School of Law 1968


M.S., New York University 1965
Biochemistry


B.A., New York University 1964
Biology

Admissions

  • U.S. Patent and Trademark Office 1970
  • New York 1969
  • Supreme Court of the United States
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. District Court for the Eastern District of New York
  • U.S. District Court for the Southern District of New York

Other Distinctions

Selected by Super Lawyers New York (2016).

Recognized as a 2013 Top Rated – AV® PreeminentTM Lawyers in Intellectual Property Law.

Selected Publications
Life Sciences Update – Spring 2012” (S. Peter Ludwig, et al.)

“Stem Cell Law, Regulation and Intellectual Property: A Fundamental Pillar of Success” World Stem Cell Report 2009 (S. Peter Ludwig, Samuel Woodley, Ph.D.)

“Potholes & Roadblocks on the Road to Patent Protection” Medical Innovations & Business, pp. 12-19, October 2009 (S. Peter Ludwig, Andrew K. Holmes, Ph.D.)

“Generic Drug-Approval Process: Hatch-Waxman Update” Chapter in The Pharmaceutical Regulatory Process Second Edition, I. Berry, Editor (2008) (S. Peter Ludwig, Marc Gross)

Biotechnology and Pharmaceutical Patents: Law and Practice, 2008, Aspen Publishers (Marc Gross, S. Peter Ludwig, Robert Sullivan)

Biotechnology and Pharmaceutical Patents, Law and Practice, 2007, Aspen Publishers (S. Peter Ludwig, Robert C. Sullivan, Marc Gross)

“Hatch-Waxman in the Federal Courts: From 1994-2004″ Drug Development and Industrial Pharmacy, 31(2): 15-22, (2005) (S. Peter Ludwig, Kristin B. Kosinski)

“Generic Drug Approval Process: Post 1984: Hatch-Waxman Reform” Chapter in Introduction to the Pharmaceutical Regulatory Process, I. Berry, Editor (2005) (S. Peter Ludwig, Marc Gross, Atul Singh, Kristin B. Kosinski)

“Patents and Polymorphs” Chapter in Biotechnology and Pharmaceutical Law 2004:  Patents and Business Strategies, Practising Law Institute Intellectual Property Course Handbook Series (S. Peter Ludwig, Kristin B. Kosinski)

“Patenting Life Forms” Chapter in Biotechnology Law 2003:  Biotechnology Patents & Business Strategies, Practising Law Institute Intellectual Property Course Handbook Series (S. Peter Ludwig, Samuel Woodley, Ph.D., Sandra Lee)

“No room for experiment: The Federal Circuit’s Narrow Construction of the  Experimental Use Defense”  Nature Biotechnology 21:453, April 2003 (S. Peter Ludwig, Jason C. Chumney)

“Preparing Legal Opinions for Biotechnology Patents” Biotechbology Law 2002:  Biotechnology Patent & Business Strategies (S. Peter Ludwig, John Todaro, Sandra Lee)

“Life After Eli Lilly: Planning for Compliance with the Written Description Requirement” Chapter in Biotechnology Law 2001:  Biotechnology Patents & Business Strategies in the New Millennium, Practising Law Institute Intellectual Property Course Handbook Series (S. Peter Ludwig, Samuel Woodley, Ph.D.)

“Inadvertent Disclosure of Privileged Information” New York Law Journal, October 18, 1999, pp. 6, 14-15 (S. Peter Ludwig, Patricia J. Clarke, T. David Bomzer)

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