Broadcast Date: Friday, September 16, 2022
from 12:00 pm to 1:30 pm (ET)
Overview:
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
Credit:
Course Level:
Intermediate
Advance Preparation:
Print and review course materials
Method of Presentation:
On-demand Webcast (CLE)
Prerequisite:
General knowledge of Biotech and Pharmaceutical Patent Law
Course Code:
149871
NY Category of CLE Credit:
Area of Professional Practice
Total Credits:
1.5 CLE
How to Claim CLE Credits Per State:
https://knowledgewebcasts.com/how-to-claim-cle-credits-per-state/
CLE State Requirements:
https://knowledgewebcasts.com/cle-state-requirements/
CPE State Requirements:
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.
Agenda:
SEGMENT 1
Melanie Szweras, Partner
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
- PMPRB
SEGMENT 2
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.
SEGMENT 3
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
- Section 101
- Summary Judgment of Invalidity
- 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
| Image | Name | Summary | Price | Buy |
|---|---|---|---|---|
 | Antitrust 'No-Poach' Agreement Enforcement: Key Focus Areas in 2024 | CLE: 1.5 Credits | Broadcast Date: Check back for updates or Click Here and get notified of the new date | Price Includes CLE & Recording | $69.00 | |
 | Antitrust & IP Landscape: Navigating the Challenges of AI & Algorithm | CLE: 1.0 | Broadcast Date: Monday, December 9, 2024 from 12:00 PM to 1:00 PM (ET) | Price Includes CLE & Recording | $69.00 | |
 | Asbestos Litigation: Demystifying Trends, Developments, and Defense Strategies | CLE: 1.0 Credit | Broadcast Date: Thursday, May 26, 2022, from 12:00 PM to 1:00 PM ET | Price Includes CLE & Recording | $69.00 | |
| Asbestos Litigation: What's Changing in 2024 and Beyond | CLE: 1.5 Credit | Broadcast Date: Tuesday, July 9, 2024, from 12:00 pm to 1:30 pm (ET) | Price Includes CLE & Recording | $69.00 | |
| Breaking Ground: Mastering Patent Eligibility in the Realm of ML, AI, and Software Innovations | CLE: 1.0 Credit | Broadcast Date: Monday, July 29, 2024, from 3:00 pm to 4:00 pm ET | Price Includes CLE & Recording | $69.00 | |
 | Cannabis Unleashed: Unveiling Legal and Business Fundamentals | CLE: 1.0 | Broadcast Date: Tuesday, June 4, 2024, from 12:00 PM to 1:00 PM (ET) | Price Includes CLE & Recording | $69.00 | |
| Cartel Investigations: A Blueprint for Defense | CLE: 1.5 Credits | Broadcast Date: Tuesday, May 21, 2024, from 12:00 PM to 1:30 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Class Action Litigation: A Comprehensive Guide to Recent Developments and Best Practices | CLE: 1.5 Credits | Broadcast Date: Thursday, August 8, 2024, from 12:00 PM to 1:30 PM (ET) | Price Includes CLE & Recording | $69.00 | |
| CLE Processing | Online Payment for CLE Processing | $35.00 – $150.00 | |
 | Cybersecurity Management: Best Practices in a Remote Environment | CLE: 1.5 Credits | CPE: 1.5 Credits (Not eligible for QAS (On-demand) CPE credit) | Broadcast Date: Thursday, April 22, 2021 from 12:00 pm to 1:30 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | Demystifying Economic Sanctions: Strategies for Success in a Global Economy | CLE: 1.0 Credit | Broadcast Date: Tuesday, May 14, 2024, from 12:00 pm to 1:00 pm ET | Price Includes CLE & Recording | $69.00 | |
 | Demystifying Recent Trends in PFAS Litigation: Product Liability and Beyond | CLE: 1.0 Credit | Broadcast Date: Wednesday, September 11, 2024, from 12:00 PM to 1:00 PM (ET) | Price Includes Recording | $69.00 | |
 | Executive Compensation: Hot Topics and Emerging Trends | CLE: 1.0 Credits| Broadcast Date: Monday, November 18, 2024, from 12:00 PM to 1:00 PM (ET) | Price Includes Recording | $69.00 | |
 | Hatch-Waxman Case-Law Developments and New Jersey Practice Insights | CLE: 1.0 Credit | Broadcast Date: Wednesday, October 23, 2024, from 12:00 PM to 1:00 PM (ET) | Price Includes CLE & Recording | $69.00 | |
 | Mastering the Art of Demonstrating and Recouping Lost Profit Damages: A Hands-On Guide | CLE: 1.0 Credit | Broadcast Date: Tuesday, November 12, 2024. from 12:00 PM to 1:00 PM (ET) | Price Includes CLE & Recording | $69.00 | |
 | Maximizing Your Innovation ROI: R&D Tax Credits in 2024 and Beyond | CLE: 1.0 CLE | 1.0 CPE (Not eligible for QAS (On-demand) CPE credit) | Broadcast Date: Thursday, March 28, 2024, from 12:00 PM to 1:00 PM ET | Price Includes CLE & Recording | $69.00 | |
| Navigating Challenges in Patent Damages Analysis: Key Considerations for Litigants and Counsel | CLE: 1.0 Credit | CPE: 1.0 Credit (Not eligible for QAS (On-demand) CPE credit) | Broadcast Date: Wednesday, December 13, 2023, from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | Navigating Double Patenting in the USPTO Era of Rulemaking | CLE: 1.5 Credits | Broadcast Date: Tuesday, February 25, 2025, from 12:00 PM to 1:30 (ET) | Price Includes CLE Credits & Recording | $69.00 | |
 | Navigating Insurance Claims: Tips for Policyholders and Best Practices for Adjusters | CLE: 1.0 Credits | Broadcast Date: Thursday, May 9, 2024, from 12:00 PM to 1:00 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Navigating the Evolving Patent Damages Landscape: Key Insights and Best Practices | CLE: 1.0 Credits | Broadcast Date: Thursday, June 27, 2024, from 12:00 PM to 1:00 PM (ET) | Price Includes CLE & Recording | $69.00 | |
 | Navigating the FTC's Final Rule on Noncompete Agreements: Critical Insights for Employers | CLE: 1.5 Credits| Broadcast Date: Wednesday, September 4, 2024, from 12:00 PM to 1:30 PM (ET) | Price Includes CLE Credits & Recording | $69.00 | |
 | New York Online CLE Bundle 2023 | This bundle allows you to complete 24 New York CLE credits. These courses are all on-demand and can be completed at your convenience.
| $199.00 | |
 | Preventing Ransomware Attacks: A Practical Guide to Enhancing IT Security and Resiliency | CLE: 1.5 Credits | Broadcast Date: Monday, September 13, 2021 from 12:00 pm to 1:30 pm (ET) | Price Includes CLE & Recording | $69.00 | |
| Speaker Preferred Package (Online Payment) | Speaker Preferred Package (for Credit Payment processing) | $599.00 – $799.00 | |
| Sponsorship | Online Payment for Sponsorship | $5,500.00 – $15,000.00 | |
| Supercharging Privilege Review With AI, Analytics, and Automation | CLE: 1.0 Credit| Broadcast Date: Friday, February 25, 2022 from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | The Future of Insurance Claims: Using Generative AI to Combat Bad Faith | CLE: 1.5 Credits| Broadcast Date: Wednesday, December 18, 2024, from 12:00 PM to 1:30 PM (ET) | Price Includes CLE Credits & Recording | $69.00 | |
 | The Hows and Whys of Child Abuse Reporting: A Comprehensive Ethical Guide for Lawyers | CLE: 2.0 Credits | Broadcast Date: Wednesday, June 29, 2022 from 12:00 pm to 2:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
| The SEC’s New Pay Versus Performance Rule: 2024 Guidance for Companies and Investors | CLE: 1.0 | Broadcast Date: Wednesday, November 6, 2024, from 12:00 pm to 1:00 pm ET | Price Includes CLE & Recording | $69.00 | |
 | Trade Secrets, and What You Need to Know to Protect Them | CPE: 2.0 Credits | Broadcast Date: Thursday, December 5, 2024, from 12:00 PM to 2:00 PM (ET) | Price Includes CLE Credits & Recording | $69.00 | |
 | Trade Secrets: The New Frontier of Intellectual Property | CLE: 2.0 |CPE: 2.0 (Not eligible for QAS (On-demand) CPE credit) | Broadcast Date: Thursday, April 11, 2024, from 12:00 PM to 2:00 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Understanding R&D Tax Credits and Amortization: Navigating Changes and Maximizing Benefits | CLE: 1.5 Credits | CPE: 1.5 Credits (Not eligible for QAS (On-demand) CPE credit) | Broadcast Date: Wednesday, August 30, 2023 from 12:00 PM to 1:30 PM (ET) | Price Includes CLE & Recording | $69.00 | |
| Unlocking Innovation: Navigating Patentability for ML, AI, and Software Inventions | CLE: 1.5 Credits | Broadcast Date: Monday, March 25, 2024, from 12:00 PM to 1:30 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Winning Patent Litigation: Essential Strategies and Tactics | CLE: 1.0 Credit | Broadcast Date: Wednesday, April 25, 2024 from 12:00 PM to 1:00 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Practical Trademark Perspectives from U.S. and Canadian Counsel | CLE: 1.5 Credits | Broadcast Date: Tuesday, September 28, 2021 from 3:00 to 4:30 PM ET | Price Includes CLE & Recording | $69.00 | |
 | Effectively Manage KYC Compliance: Keep Up with the Times by Getting Back to Basics | CLE: 1.0 Credit | Broadcast Date: Wednesday, August 11, 2021 from 3:00 PM to 4:00 PM ET | Price Includes CLE & Recording | $69.00 | |
 | OFAC Regulations and the Economic Sanctions Compliance Programs: Best Practices | CLE: 1.0 | Broadcast Date: Thursday, September 29, 2022 from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | 'Zombie' LIBOR for USD Contracts: Navigating the Critical Issues | CLE: 1.0 Credit | CPE: 1.0 Credit (Not eligible for QAS (On-demand) CPE credits) | Broadcast Date: Wednesday, May 12, 2021 from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | Calculating Lost Profits in Construction Claims: A Practical Guide | CLE: 1.0 Credit | CPE : 1.0 Credit (Not eligible for QAS (On-demand) CPE credits) | Broadcast Date: Monday, January 25, 2021 from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 | |
 | False Claims Act and COVID-19 Implications: Key Considerations and Best Practices | CLE: 1.0 Credit | CPE: 1.0 Credit (Not eligible for QAS (On-demand) CPE credits) | Broadcast Date: Wednesday, February 24, 2021 from 12:00 pm to 1:00 pm (ET) | Price Includes CLE & Recording | $69.00 |
SPEAKERS
Join Over 160,000 Professionals Empowering Their Careers
Learn anywhere from over 3000+ live and recorded CLE, CPE & Technology Webcasts.
