Steven H. Sklar

Shareholder

Steven H. Sklar

Steven H. Sklar

Shareholder

Overview

As a seasoned patent litigator and counselor, Steve Sklar understands the importance of focusing on what matters. That means being there for his clients when and where they need him; quickly yet thoughtfully providing the clear answers and practical guidance that can help them make informed business decisions. It also involves keeping his attention squarely on the key substantive issues that will determine the outcome of a case without indulging in costly and counterproductive disputes and distractions.

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Steve’s extensive background in pharmaceuticals and biotechnology helps him advance his clients’ interests in a wide range of contested matters, and he is particularly experienced in patent litigation arising under the Hatch-Waxman Act. Steve’s well-earned reputation as a determined and skilled advocate is reflected in the accolades he consistently receives from his peers and the trust his clients put in him to address their most consequential challenges.  His many successes include a recent victory, both at trial and on appeal to the Federal Circuit, in litigation involving a leading opioid addiction treatment drug product.

Developing effective patent strategies tailored to each client’s unique objectives, Steve advises clients on issues of patentability, infringement, validity and, enforceability, and also engages in patent prosecution, principally in the pharmaceutical and chemical arts.

Steve has published several articles on topics of particular interest to the pharmaceutical and biotechnology industries. He is also a frequent speaker on pharmaceutical patent issues, including recent engagements in India and China. A magna cum laude graduate of Washington University in St. Louis, Steve earned his law degree, cum laude, from Northwestern University School of Law, where he received the Order of the Coif and was Associate Articles Editor of the Northwestern University Law Review.

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

Admissions

  • 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

Honors

  • Listed in The Best Lawyers in America® in the area of Litigation – Intellectual Property, 2022-2026
  • Named in the Illinois Super Lawyers list, Intellectual Property Litigation, 2013-2025
  • Recognized by Managing IP as an IP Star, 2022-2025
  • 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

Professional Affiliations

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

Articles, Publications & Lectures

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 Bloomberg BNA. 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:

  • “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug,” Pharmaceutical Law & Industry Report, Vol. 13, No. 5, Bloomberg BNA, January 30, 2015
  • “Biosimilars Policy, Accelerating Medical Breakthroughs Among Year’s Key Topics,” Pharmaceutical Law & Industry Report, 13 PLIR 79, Bloomberg BNA, January 16, 2015
  • “In Plavix Case, Apotex Pays $442 Million In Infringement Damages to BMS, Sanofi,” Pharmaceutical Law & Industry Report, 12 PLIR 210, Bloomberg BNA, February 10, 2012.
  • “User Fees, Drug Shortages, Off-Label Issues Among PLIR Board’s Top Concerns for 2012,” Pharmaceutical Law & Industry Report, 10 PLIR 48 Bloomberg BNA, 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, Bloomberg BNA., April 8, 2011.
  • “D.C. Circuit Rules Against FDA’s Stance on Generic Exclusivity Forfeiture,” Pharmaceutical Law & Industry Report, Vol. 8, No. 10, Bloomberg BNA, 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, Bloomberg BNA, November 7, 2008.
  • Obviousness of the Unexpected: Understanding How a Compound Patent Defeat in Baraclude May Raise New Questions for Prior Art, American Conference Institute’s Paragraph IV Disputes Master Symposium (September 30, 2015)
  • Exploring the Use of Reissue Applications to Amend Invalidity Findings, American Conference Institute’s Second Annual Paragraph IV Disputes Master Symposium (September 30, 2014).
  • The End of Roche v. Bolar?: Understanding How New 271(e)(1) Controversies May Alter the Course of Brand Name and Generic Strategies in Paragraph IV Litigation Relative to Safe Harbor Research Exceptions, American Conference Institute’s Paragraph IV Disputes Master Symposium (October 4, 2013)
  • Label Carve-Outs and Listing Strategies: Practical Tips for Minimizing Downstream Exposure to Paragraph IV Challenges and Drafting Codes to Limit Carve-Out Opportunities, Momentum’s International Congress on Paragraph IV Litigation (September 24, 2013)
  • Global Pharma Sourcing (Chairman and speaker), informEx conferences (December 7, 2011)
  • 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)

Insights

Steven H. Sklar

Steven H. Sklar

Shareholder

  • Office: Chicago
  • Phone: 312-616-5600
  • Fax: 312-616-5700
  • Email: ssklar@leydig.com

As a seasoned patent litigator and counselor, Steve Sklar understands the importance of focusing on what matters. That means being there for his clients when and where they need him; quickly yet thoughtfully providing the clear answers and practical guidance that can help them make informed business decisions. It also involves keeping his attention squarely on the key substantive issues that will determine the outcome of a case without indulging in costly and counterproductive disputes and distractions.

Steve’s extensive background in pharmaceuticals and biotechnology helps him advance his clients’ interests in a wide range of contested matters, and he is particularly experienced in patent litigation arising under the Hatch-Waxman Act. Steve’s well-earned reputation as a determined and skilled advocate is reflected in the accolades he consistently receives from his peers and the trust his clients put in him to address their most consequential challenges.  His many successes include a recent victory, both at trial and on appeal to the Federal Circuit, in litigation involving a leading opioid addiction treatment drug product.

Developing effective patent strategies tailored to each client’s unique objectives, Steve advises clients on issues of patentability, infringement, validity and, enforceability, and also engages in patent prosecution, principally in the pharmaceutical and chemical arts.

Steve has published several articles on topics of particular interest to the pharmaceutical and biotechnology industries. He is also a frequent speaker on pharmaceutical patent issues, including recent engagements in India and China. A magna cum laude graduate of Washington University in St. Louis, Steve earned his law degree, cum laude, from Northwestern University School of Law, where he received the Order of the Coif and was Associate Articles Editor of the Northwestern University Law Review.

Honors

  • Listed in The Best Lawyers in America® in the area of Litigation – Intellectual Property, 2022-2026
  • Named in the Illinois Super Lawyers list, Intellectual Property Litigation, 2013-2025
  • Recognized by Managing IP as an IP Star, 2022-2025
  • 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

Professional Affiliations

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

Articles, Publications & Lectures

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 Bloomberg BNA. 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:

  • “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug,” Pharmaceutical Law & Industry Report, Vol. 13, No. 5, Bloomberg BNA, January 30, 2015
  • “Biosimilars Policy, Accelerating Medical Breakthroughs Among Year’s Key Topics,” Pharmaceutical Law & Industry Report, 13 PLIR 79, Bloomberg BNA, January 16, 2015
  • “In Plavix Case, Apotex Pays $442 Million In Infringement Damages to BMS, Sanofi,” Pharmaceutical Law & Industry Report, 12 PLIR 210, Bloomberg BNA, February 10, 2012.
  • “User Fees, Drug Shortages, Off-Label Issues Among PLIR Board’s Top Concerns for 2012,” Pharmaceutical Law & Industry Report, 10 PLIR 48 Bloomberg BNA, 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, Bloomberg BNA., April 8, 2011.
  • “D.C. Circuit Rules Against FDA’s Stance on Generic Exclusivity Forfeiture,” Pharmaceutical Law & Industry Report, Vol. 8, No. 10, Bloomberg BNA, 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, Bloomberg BNA, November 7, 2008.
  • Obviousness of the Unexpected: Understanding How a Compound Patent Defeat in Baraclude May Raise New Questions for Prior Art, American Conference Institute’s Paragraph IV Disputes Master Symposium (September 30, 2015)
  • Exploring the Use of Reissue Applications to Amend Invalidity Findings, American Conference Institute’s Second Annual Paragraph IV Disputes Master Symposium (September 30, 2014).
  • The End of Roche v. Bolar?: Understanding How New 271(e)(1) Controversies May Alter the Course of Brand Name and Generic Strategies in Paragraph IV Litigation Relative to Safe Harbor Research Exceptions, American Conference Institute’s Paragraph IV Disputes Master Symposium (October 4, 2013)
  • Label Carve-Outs and Listing Strategies: Practical Tips for Minimizing Downstream Exposure to Paragraph IV Challenges and Drafting Codes to Limit Carve-Out Opportunities, Momentum’s International Congress on Paragraph IV Litigation (September 24, 2013)
  • Global Pharma Sourcing (Chairman and speaker), informEx conferences (December 7, 2011)
  • 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)

Insights