Broadcast Date: Wednesday, September 27, 2023
from 12:00 pm to 1:00 pm (ET)


Patent litigation remains prolific in the life sciences industry as ensuring protection becomes more challenging and complex due to the involvement of technologies. Some issues plaguing patent owners and intellectual property (IP) lawyers concern the Section 101 jurisprudence related to innovations in the life sciences industry. Moreover, landmark cases like Amgen Inc. v. Sanofi continue to shape the patent landscape, posing profound impacts on invention enablement. These and other developments continue to pose risks that practitioners should be wary of. Canadian jurisprudence deals with similar issues and in some cases, patent practice diverges between the US and Canada.

Listen as experienced patent attorneys Melanie Szweras (Bereskin & Parr LLP) and Kevin E. Noonan, Ph.D. (McDonnell Boehnen Hulbert & Berghoff LLP) provide a comprehensive discussion of the latest trends and challenges in protecting patents in the life science sector. Speakers, among other things, will offer practical tips and strategies for navigating this dynamic regulatory environment.

Key topics include:

  • Life Science Patents: Latest Regulatory Developments in the US and Canada
  • Current Challenges and Regulatory Issues Faced by Patent Owners and IP Lawyers
  • Notable Cases in the US and Canada
  • What Lies Ahead


Course Level: 



Advance Preparation: 

Print and review course materials


Method of Presentation:

On-Demand Webcast



General knowledge of patent laws


Course Code:



NY Category of CLE Credit:

Areas of Professional Practice


Total Credit:

1.0 CLE

Speaker Panel:

Melanie Szweras, Partner
Bereskin & Parr LLP

Melanie Szweras is a partner with Bereskin & Parr LLP and a member of the Life Science’s practice group. She is also co-leader of the Privacy/Regulatory, Advertising, Marketing & Regulatory practice group.

Melanie’s practice focuses on drafting and prosecution of applications relating to biologics, diagnostics, biotechnology, food and pharmaceuticals. Melanie offers strategic advice and expertise to her clients, provides validity and freedom to operate opinions and is involved in related patent litigation and licensing.

Melanie’s privacy work includes advising organizations on compliance with Canadian privacy laws, including PIPEDA, assisting with preparation of privacy policies, terms and conditions, outsourcing agreements and general management of personal information. Her regulatory work includes advising on Health Canada regulated labelling and advertising and on health-related regulations, such as those relating to notices of compliance, certificates of supplementary protection and the Patented Medicines Price Review Board.

Melanie 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. Melanie is the Vice-Chair of the Continuing Professional Development Committee for the Intellectual Property Institute of Canada (IPIC) . Melanie also is the Issues Leader of the American Intellectual Property Law Association (AIPLA) Biotechnology Committee.

Melanie received numerous awards throughout her education, including the Medical Research Council Studentship and a University of Toronto Open Scholarship. She was also the Bronze Medalist for her class of 2003 at Osgoode Hall Law School.

Kevin E. Noonan, Ph.D., Partner
McDonnell Boehnen Hulbert & Berghoff LLP

Kevin E. Noonan is co-Chair of MBHB’s Biotechnology and Pharmaceuticals Practice Group. Dr. Noonan is an experienced patent lawyer, molecular biologist and renowned thought leader in biotechnology and pharmaceutical patent law. Over the past 30 years, he has counseled some of the largest biotechnology and pharmaceutical companies in the world on intellectual property issues.

He helps these companies protect their innovations and advance business goals by developing effective patent portfolio strategies. His work includes helping companies develop global patent filing and prosecution strategies, evaluate litigation risks, and manage patent term extensions. Dr. Noonan also has successfully represented clients in numerous interference proceedings. He has filed amicus briefs in landmark cases involving pharmaceutical and biotechnology patent issues to district courts, the Federal Circuit and the U.S. Supreme Court.

Dr. Noonan is the co-founder of and regular contributor to Patent Docs, a website featuring news and commentary on patent law. He is a co-editor and contributing author of the book, “Claim Construction and the Federal Circuit,” and a contributing author of “Antitrust Issues in Intellectual Property Law.” He also regularly speaks about intellectual property issues at events around the world.

Prior to becoming an attorney, Dr. Noonan was a molecular biologist, earning a doctorate from Princeton University, and a National Cancer Institute postdoctoral fellow.


Melanie SzwerasPartner

Bereskin & Parr LLP

Canadian perspective on the patenting of Life Sciences Inventions. In particular, in relation to the following topics:

  1. Patentable subject matter (genes, higher life organisms, methods of medical treatment, diagnostic methods)
  2. Protection of antibodies (sufficiency of disclosure, enablement, utility/sound prediction, selection patents)
  3. Unity of Invention (double patenting, how it differs from US practice)
  4. Patent Term (Certificates of Supplementary Protection, Patent term extension (new in Canada))
  5. Patented Medicines Price Review Board Update
  6. Miscellaneous prosecution tips (excess claims fees, disclosure grace period calculation, limited number of OAs and RCEs)

Kevin E. Noonan, Ph.D., Partner

McDonnell Boehnen Hulbert & Berghoff LLP

U.S. perspective on the patenting of Life Sciences Inventions. In particular, in relation to the following topics:

  • Patentable subject matter (natural products generally, diagnostic methods, proposed legislation and prospects)
  • Protection of antibodies (enablement and written description issues)
  • Double patenting issues with regard to terminal disclaimers and PTA/PTE; In re Cellect decision
  • Status of CRISPR patenting in US
  • Biologics, biosimilars, and Federal policies on drug pricing
  • Post-grant review issues (Fintiv, Director review, trends, standard or review/judgment, more proposed legislation)

Date & Time:

Wednesday, September 27, 2023

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

Who Should Attend:

  • Patent Attorneys and Consultants
  • Intellectual Property Lawyers and Consultants
  • Biotechnology/Pharmaceutical Lawyers
  • Patent Managers
  • Intellectual Property Managers
  • Patent Agents
  • General/In-House Counsel
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Melanie SzwerasPartner
Bereskin & Parr LLP
Kevin E. Noonan, Ph.D.Partner
McDonnell Boehnen Hulbert & Berghoff LLP



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