Broadcast Date: Friday, September 16, 2022
from 12:00 pm to 1:30 pm (ET)


Several court cases continue to shape the biotech and pharmaceutical patent litigation in the United States and Canada.

In the United States, Amgen Inc. v. Sanofi-Aventis (2021) has revived the discussion on the enablement of genus claims in biotechnology inventions. Moreover, the multiple filings for abbreviated new drug applications (ANDA) also raise concerns, particularly in cases that may provoke multidistrict litigation. These and other developments further expand the patent litigation landscape, introducing new regulations that practitioners must be aware of to avoid legal pitfalls.

In Canada, summary trials are increasingly affecting the way litigation is proceeding. Issues concerning cases that impact the scope of the Notice of Allegation, certificates of supplementary protection, and the Patent Medicines Price Review Board, as well as those relating to claim construction, obviousness, and patentable subject matter, must be considered.

Join a panel of key thought leaders and distinguished professionals organized by The Knowledge Group as they provide a comprehensive discussion of the recent litigation trends in the biotech and pharmaceutical industry. Speakers, among other things, will also offer practical tips and strategies in this ever-changing regulatory landscape.

Some of the major topics that will be covered in this course are:

  • Recent Litigation Trends and Developments in the Biotech and Pharmaceutical Industry
  • Enablement of Genus Claims for Biotechnology Inventions
  • Multiple Filing of Abbreviated New Drug Applications (ANDA): Implications
  • Recent and Notable Court Cases
  • What Lies Ahead


Course Level:



Advance Preparation:

Print and review course materials


Method of Presentation:

On-demand Webcast (CLE)



General knowledge of Biotech and Pharmaceutical Patent Law


Course Code:



NY Category of CLE Credit:

Area of Professional Practice


Total Credits:

1.5 CLE

Speaker Panel:

Melanie Szweras, Partner
Bereskin & Parr LLP

Melanie Szweras is a partner with Bereskin & Parr LLP. Melanie’s practice focuses on biotechnology and pharmaceutical patents including drafting and prosecution of such applications; providing validity and freedom to operate opinions as well as patent litigation matters. Melanie also advises on regulatory matters, such as labeling and advertising, for consumer goods and regulated products such as food and drugs.

Melanie is a lecturer for the second-year Intellectual Property Law Course at the Lincoln Alexander School of Law at Ryerson University. She also lectures on aspects of Biotechnology and The Application Process at the University of Toronto’s Patent & Trade Secrets Law course and Osgoode Hall’s LLM Patent Law course.

Ronald E. Cahill, Partner, IP and Litigation Depts. Chair, Life Sciences Practice Group
Barnes & Thornburg LLP

Ron Cahill is well-respected for his work with clients of virtually all sizes to solve their most challenging intellectual property problems.  A first chair IP trial attorney and Chair of the Barnes & Thornburg national Life Sciences Practice Group, he specializes in breaking down complex life sciences intellectual property issues for juries, judges, and the PTAB.  Clients also ask him to present strategic intellectual property options to their management and boards, including whether to launch litigation and how to gain leverage in business, investment, and licensing negotiations.

Ron’s work covers a wide range of life sciences products, technologies, and legal issues, with recent engagements including CAR-T cancer treatments, small molecule enzyme inhibitors, personalized medicine, and genetic engineering of metabolic systems to produce desired outputs.  Recent legal issues have included the scope of written description and enablement in the drug discovery context, the obviousness of engineered biologics, infringement based on biochemical function and property limitations, induced infringement of method of treatment claims, and the strategic use of IPRs to avoid litigation.

Jason A. Lief, Partner
Windels Marx Lane & Mittendorf, LLP

Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion-dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence.

Jason’s cases include major Hatch-Waxman pharmaceutical litigations (Zantac®, Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, Ceftin®, Intuniv®, Vyvanse®, Oxtellar XR®, Angiomax®, and Lialda®), as well as biotech, chemical, and consumer product patent cases. Jason has also litigated trade secret, trademark, copyright, and IP contract disputes. He has argued before the U.S. Court of Appeals for the Federal Circuit and appeared in foreign courts pursuant to the Hague Convention.  Jason has also successfully litigated in the inter partes review (IPR) arena.



Melanie SzwerasPartner

Bereskin & Parr LLP

  • Pleadings: Scope of the Notice of Allegation
  • Summary trials – becoming increasingly popular
  • Claim construction, obviousness, overbreadth, patentable subject matter
  • Certificates of Supplementary Protection



Ronald E. Cahill, Partner

Barnes & Thornburg LLP

  • The latest on inducing infringement through labels and other public statements;
  • Emerging IPR strategies: When to expect IPRs as a supplement or replacement for Federal Court litigation; and
  • New PTO guidance and recent inequitable conduct cases involving submissions to other government entities, including the FDA.



Jason A. Lief, Partner

Windels Marx Lane & Mittendorf, LLP

  • “The Rise of the Section 112 Defense” in U.S. Pharmaceutical Patent Cases – Survey of case-law from pre-Ariad to Ariad to Juno Therapeutics
  • “Sudden Death in U.S. Patent Cases” – Early Dispositive Motions on
    1. Section 101
    2. Summary Judgment of Invalidity
    3. Dedication-Disclosure Doctrine

Date & Time:

Friday, September 16, 2022

12:00 pm to 1:30 pm (ET)

Who Should Attend:

  • Patent Attorneys and Consultants
  • Biotech/Pharma Industry Lawyers
  • Patent Managers
  • Intellectual Property Attorneys and Consultants
  • General Counsel


Melanie SzwerasPartner
Bereskin & Parr LLP
Ronald E. CahillPartner, IP and Litigation Depts. Chair, Life Sciences Practice Group
Barnes & Thornburg LLP
Jason A. LiefPartner
Windels Marx Lane & Mittendorf, LLP



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