Leydig, Voit & Mayer, LTD. Intellectual Property Law
Steven H. Sklar Law Professional

312-616-5600 (phone)
312-616-5700 (fax)
Chicago Office

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Education

Northwestern University School of Law, J.D., cum laude, 1996

  • Order of the Coif
  • Northwestern University Law Review, Associate Articles Editor

Washington University, B.S. in Chemical Engineering, magna cum laude, 1991

Steven H. Sklar

Member

Mr. Sklar focuses his practice on intellectual property matters with emphasis on patent litigation and counseling in the pharmaceutical and biotechnology fields. Mr. Sklar has particular experience on issues arising under the Hatch-Waxman Act. He has expertise in developing patent strategies and advises clients on issues of patentability, infringement, validity and enforceability. He also engages in patent prosecution, principally in the pharmaceutical and chemical arts.

Mr. Sklar presently serves on the firm’s Finance Committee.

Professional Affiliations

  • Intellectual Property Law Association of Chicago (IPLAC)
  • Intellectual Property Owners Association (IPO)

Articles and Publications

Mr. Sklar has published several articles on topics of particular interest to the pharmaceutical and biotechnology industries including:

  • "Congress Debates The Future of Generic Biologics," Corporate Counsel (September, 2007)
  • "Congress Gets Down to Business in 2007: Legislation on Authorized Generics, Brand-Generic Settlements, and Generic Biologics Debated," BNA Pharmaceutical Law and Industry Report (February, 2007)
  • "Extended-Release Drug Patents: Can They Save Big Pharma's Blockbuster Medicines From the Generic Scrap Heap?" BNA Pharmaceutical Law and Industry Report (February, 2006)
  • "Paxil and Polymorph Patents: Have Things Gone From Bad to Worse for Big Pharma?" BNA Pharmaceutical Law and Industry Report (March, 2003)

He currently serves on the Editorial Advisory Board for the Pharmaceutical Law and Industry Report published by the Bureau of National Affairs. In addition, Mr. Sklar has been frequently quoted as an authority on patent issues impacting the pharmaceutical industry in many publications including IPLaw360. Recently, he was quoted in the following articles:

  • “User Fees, Drug Shortages, Off-Label Issues Among PLIR Board’s Top Concerns for 2012,” Pharmaceutical Law & Industry Report, Vol. 10, p. 5, The Bureau of National Affairs, Inc., January 13, 2012.
  • “Court Says Generic Rx Firms Lack Standing To Sue Over Validity of Colitis Drug Patent,” Pharmaceutical Law & Industry Report, Vol. 9, No. 14, The Bureau of National Affairs, Inc., April 8, 2011.
  • “D.C. Circuit Rules Against FDA’s Stance on Generic Exclusivity Forfeiture,” Pharmaceutical Law & Industry Report, Vol. 8, No. 10, The Bureau of National Affairs, Inc., March 5, 2010.
  • "FDA Says Hi-Tech Forfeited Exclusivity; Way Paved for Approval of All Cosopt ANDAs," Pharmaceutical Law & Industry Report, Vol. 6, p. 1260, The Bureau of National Affairs, Inc., November 7, 2008.

Honors

  • Named to the 2009 Illinois Rising Stars list, as published in Illinois Super Lawyers
  • Selected by peers as a Leading Lawyer in Intellectual Property Law – Leading Lawyers Network
  • Listed among the Top Lawyers in Illinois in Intellectual Property Law – Chicago Lawyer
  • Selected by clients and peers to appear in The International Who's Who of Life Science Lawyers 2008

Representative Matters

Mr. Sklar is currently involved in numerous litigations over pharmaceutical drug products such as, for example, adapalene (Differin®), doxepin (Silenor) and sildenafil (Viagra).

He has been involved in patent litigation over various blockbuster medicines including oxaliplatin (Eloxatin®), pemetrexed (Alimta®), minocycline (Solodyn®), venlafaxine (Effexor® XR), desloratadine (Clarinex®), clopidogrel (Plavix®), clarithromycin (Biaxin® XL), amlodipine/benazepril (Lotrel®), ipratropium/albuterol (DuoNeb®), paroxetine (Paxil®), pioglitazone (Actos®), quinapril (Accupril®), cisplatin (Platinol®), pamidronate (Aredia®), terazosin (Hytrin®) and ranitidine (Zantac®).

Recently, he was lead patent counsel on behalf of Andrx in Andrx Pharmaceuticals, LLC v. GlaxoSmithKline over Wellbutrin® XL that resulted in a multi-million dollar settlement to Andrx.

Speaking Engagements and Presentations

  • Lifecycle Management Strategies for Blockbuster Medicines: Brand and Generic Perspectives, LexisNexis 3rd Annual Pharma and Biotech Conference, Shanghai, China (September 22, 2011)
  • Pharmaceutical IP-Regulatory Life Cycle Management Strategies, BNA's Pharmaceutical Patent Laws – A Prescription for Success (November 12, 2008)
  • The Follow-On Biologics Struggle Continues: The 2008 Update Impacting the Debate, Institute for International Research’s 9th Annual Generic Drugs Summit (June 19, 2008)
  • Throwing Down the Gauntlet: Paragraph IV Notice Letter – Delivery and Receipt, American Conference Institute's 2nd Annual Paragraph IV Disputes (April 30, 2008)
  • Bioequivalence: What Patent Lawyers Need to Know, American Conference Institute’s FDA Boot Camp (September 26, 2007 and September 19, 2006)
  • Follow-On Biologics: What Patent Lawyers Need to Know, American Conference Institute’s Pharma-Biotech Patent Boot Camp (June 21, 2007)
  • Understanding the Use of Patents on Polymorphs and Crystal Forms in Product Life Cycle Management by Brand and Generic Pharmaceutical Manufacturers, IQPC’s Polymorphism and Crystallization 2006 Conference (May 23, 2006)
  • Latest Decisions Involving Declaratory Judgment Actions, 2005 Generic Pharmaceutical Association Legal Symposium (May 18, 2005) 
  • The Use of Declaratory Judgment Actions by ANDA-Filers, Institute for International Research’s 5th Annual Generic Drugs Summit (September 29, 2004)

Bar Admissions and Registrations

  • Illinois
  • Registered to practice before the U.S. Patent and Trademark Office

Courts

  • U.S. Court of Appeals for the Federal Circuit
  • U.S. District Court for the Northern District of Illinois