Washington
T: 202.663.7950
F: 202-293-7860
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Practices
Biotechnology / Pharmaceutical
Chemical Patent
Nanotechnology
Litigation
Interference
Biosimilars
William J. Simmons, Ph.D.
Associate


Dr. William Simmons is an associate at Sughrue Mion and works out of the Washington office. Will’s practice focuses on worldwide procurement, defense and enforcement of patents in the biotechnology, chemical and nanotechnology industries. Will works in all areas of patent law, including interferences, reexaminations, oppositions and prosecution. Will prepares opinions regarding patentability and infringement and conducts freedom-to-operate analyses and advises clients regarding biosimilar (follow-on biologic) law.

Bars
District of Columbia
U.S. Patent and Trademark Office
U.S. Court of Appeals - District of Columbia, Federal Circuits
U.S. District Court - District of Columbia
Supreme Court of the United States

Education
National Institutes of Health at New York University (Extramural Post-doctoral Fellow  2006)
New York Law School (J.D.  2006)
Stanford University, Engineering & Science Institute (Certification Nanoscience and Nanotechnology, 2006)
The State University of New Jersey at University of Medicine & Dentistry of New Jersey (Ph.D. Biological & Biomedical Research Sciences, 2003)
New York University (M.S. Biological Sciences, 1999)
Long Island University (B.S. Molecular Biology, with honors 1995)

Other Distinctions
American Bar Association, Leadership, 2000-Present
Charter Facilitator, Peer to Patent Project, 2006-Present
Otto L. Walter Distinguished Writer & Scholar Award, 2006
National Research Service Award, Department of Health and Human Services, 2006
Excellence in Intellectual Property Law, American Bar Association & BNA, 2004
Stanley S. Bergen, Jr. Medal of Excellence, Top Graduating Research Scientist, 2003
Pre-doctoral Fellow, Governor and State Commission on Cancer Research, 2001-2003
Young Investigator Award, Chugai Pharmaceutical Company, 2001

Expertise
Will conducted primary scientific research for over a decade, including during a post-doctoral fellowship funded by the National Institutes of Health at New York University where he investigated mechanisms of immunity, oncology and, specifically, cell signaling by conducting differential studies on the proteomes of normal and aberrant cells. Will’s work included nucleic acid and protein engineering and mammalian genetic engineering. Will began his work at New York University in the laboratory originally founded by Nobel Laureate Dr. Baruj Benacerraf, a laboratory later maintained by Dr. Jeanette Thorbecke. Will has extensive experience in molecular biology and molecular immunology and was a member of various collaborations including pre-Phase I clinical trials. Will has reported his results in proceedings throughout the world.


Associations
American Intellectual Property Law Association
American Bar Association
American Society for Biochemistry and Molecular Biology
American Chemical Society
American Association of Immunologists
Member, Sigma Xi, 1997-Present

Publications and Teaching
The New U.S. Biosimilar Pathway: Rapid Developments in the U.S. and Europe, BNA's Pharmaceutical Law & Industry Report, March, 2011
In Person: A Career in Biotech Patent Law
Thioredoxin 1-Mediated Post-Translational Modifications: Reduction, Transnitrosylation, Denitrosylation, and Related Proteomics Methodologies
Bilski v. Kappos: the US Supreme Court broadens patent subject-matter eligibility, Nature, August 2010
Biosimilars Pathway: A Far Cry from Hatch-Waxman (as published in IPLaw 360, HealthLaw 360, Competition Law 360 and International Trade Law 360)
Bilski Blundering Biotechnology, Nature Biotechnology, March 2009
Nanopharmaceuticals: Patenting Issues and FDA Regulatory Challenges
 
  • Nanotechnology as a Nascent Technological Model for Immediate Substantive United States and Japan Patent Law Harmonization, Albany Law Journal, Vol. 17, No. 13 (2007).
  • Codes of the Unaccounted For: DNA As A Vital Tool for the International Criminal Court in Exposing Human Rights Violations, The SciTech Lawyer, Winter 2007.
  • New and old functions of STAT3: a pivotal target for individualized treatment of cancer.
    Cell Cycle. 2005 Sep;4(9):1131-3. Epub 2005 Sep 30.
  • Stat3 is required for ALK-mediated lymphomagenesis and provides a possible therapeutic target.
    Nat Med. 2005 Jun;11(6):623-9. Epub 2005 May 15.
  • Tim-3+ T-bet+ tumor-specific Th1 cells colocalize with and inhibit development and growth of murine neoplasms. J Immunol. 2005 Feb 1;174(3):1405-15.
  • Effecting a comprehensive intellectual property strategy using the Madrid Protocol. Nat Biotechnol. 2004 May;22(5):603-5.
  • Regulation of mouse mammary tumor virus env transcriptional activator initiated mammary tumor virus superantigen transcripts in lymphomas of SJL/J mice: role of Ikaros, demethylation, and chromatin structural change in the transcriptional activation of mammary tumor virus superantigen. J Immunol. 2003 Jan 1;170(1):218-27.
  • NPM-ALK transgenic mice spontaneously develop T-cell lymphomas and plasma cell tumors.
    Blood. 2003 Mar 1;101(5):1919-27. Epub 2002 Nov 7.
  • Interleukin-12-induced cytotoxicity against syngeneic B cell lymphomas of SJL/J mice. Leuk Res. 2002 Jun;26(6):577-90.
  • Appearance of Langerhans cells in the epidermis of Tgfb1(-/-) SCID mice: paracrine and autocrine effects of transforming growth factor-beta 1 and -beta 2(1). J Invest Dermatol. 2001 Dec;117(6):1574-80.
  • Induction of germinal centers by MMTV encoded superantigen on B cells. Dev Immunol. 2001;8(3-4):201-11.
  • META-controlled env-initiated transcripts encoding superantigens of murine Mtv29 and Mtv7 and their possible role in B cell lymphomagenesis. J Immunol. 2001 May 1;166(9):5422-9.
  • Modulation by cytokines of induction of oral tolerance to type II collagen. Arthritis Rheum. 1999 Jan;42(1):110-8.
  • Components essential for the generation of germinal centers. Dev Immunol. 1998;6(3-4):325-30.
  • Gene therapy in allergic encephalomyelitis using myelin basic protein-specific T cells engineered to express latent transforming growth factor-beta 1. Proc Natl Acad Sci U S A. 1998 Oct 13;95(21):12516-21.



Speeches
"Patenting Strategies and Biologic Product Patent Protection," Paris, France 2011

"Updates on Implementation of the U.S. Biosimilar Pathway and Strategies for Avoiding Patent Litigation Pitfalls," Bombay, India 2011

"Tips for Drafting Biotechnology and Pharmaceutical Patent Applications in the U.S. and Beyond," Pune, India 2011


"Developments in US Law: Patent Eligibility and the US Biosimilar Pathway", World Intellectual Property Congress, sponsored by AIPPI, 2010, Paris, France.

"Navigating the US Biosimilar Pathway", Hyderabad India, 2010

"IP Strategies for Launching Biosimilar Ventures in the US", Bangalore India, 2010

"The Impact of Bilski on Pharmaceutical and Biotechnology", Akron School of Law, 2009

"Patenting Biotechnology Inventions in the U.S. - Focus on Recent Developments in Utility Patent Law" Greater Noida, India, 2008

"Written Descriptions of Biotechnology and Pharmaceutical Inventions" Greater Noida, India, 2008

"Determining Inventorship in Complex Multifaceted Pharmaceutical and Biotechnology Patent Applications" Greater Noida, India, 2008