Paragraph IV Litigation, IPRs, and New Settlement Risks
Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Tuesday, March 31, 2020
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide counsel on pharmaceutical-related patent challenges from strategy to settlement. The panel will discuss the interplay between Paragraph IV litigation and post-grant proceedings, and where multiple generic challengers fit in the exclusivity scheme. The presenters will also examine critical issues in Inter partes review (IPR) challenges involving pharmaceutical patents. Finally, the presenters will discuss new risks to settlement in light of the changing landscape surrounding antitrust review of pharmaceutical patent settlements.
Faculty

Dr. Bliss counsels a variety of clients ranging from individual inventors to small businesses to Fortune 500 companies in nearly all aspects of intellectual property law. He considers multiple facets of IP law when counseling a client on an IP issue, thereby providing his clients with a comprehensive view of the IP landscape. He prepares and prosecutes patent applications; litigates patent, trademark, and other IP disputes in federal and state courts; represents clients before the U.S. Patent and Trademark Office Patent Trial and Appeal Board; counsels clients in a variety of IP issues, including due diligence, FTO, infringement, and patentability; and prepares and negotiates IP licenses.
Â

Ms. Dunston focuses on inter partes reviews, interferences, district court litigation, opinions, and prosecution — primarily in the fields of biotechnology, pharmaceuticals, and medical devices. Her litigation practice includes classic infringement and declaratory judgment cases, as well as Paragraph IV cases. She has assisted in more than 40 interferences before the Patent Trial and Appeal Board and is knowledgeable on all phases of interference work, ranging from pre-request analyses to preparation for and participation at final hearings and subsequent appeals to the Federal Circuit.

Mr. Hirschhorn has represented clients in Hatch-Waxman (Paragraph IV) litigations, has worked in diverse industries such as graphics, visualization technologies, medical devices, and chemical and consumer products, and also has experience handling copyright and trademark/trade dress litigation. In patent litigations, he has counseled clients on the interplay between Patent Office (PTAB) and district court actions. He has represented clients involved in proceedings in or with the Patent Office, including § 145 actions to obtain patents, ex parte and inter partes reexaminations and adversarial post-grant proceedings, including inter partes reviews.

Mr. Pereira’s practice encompasses intellectual property litigation and counseling, with specific expertise in the chemical, pharmaceutical and biotechnology industries. He has experience with every stage of litigation, from initial investigation and pleadings, through discovery, Markman, motion practice, trial, and appeal, including matters involving parallel proceedings before district courts and the patent office. He has taken and defended depositions of both fact and expert witnesses and served as an integral member of trial teams. He has also managed the worldwide prosecution of several families of pharmaceutical dosage formulations, and was involved in opinion work and the preparation and prosecution of patent applications relating to pharmaceuticals and the methods and products of organic syntheses.
Description
IPR proceedings are a powerful tool for companies to challenge pharmaceutical patents. The number of pharmaceutical-related challenges using the IPR process should continue to climb, given the advantages that IPRs offer compared to district court litigation, as well as the increasing number of abbreviated new drug applications filed with the FDA.
All of this is based on the lower standard of proof and a panel of judges with technical expertise as compared to the federal district courts. As a result, the IPR process is an attractive option for challenging pharmaceutical patents over litigating them in federal court. IPR challenges alone or in conjunction with district court litigation are becoming increasingly common concerning pharmaceuticals.
And should companies instead wish to litigate with the prospect of settlement in mind, ever changing legal rules at both the federal and state levels impact strategy and decision making.
Listen as our authoritative panel of patent attorneys and litigators examines the interplay between Paragraph IV litigation and post-grant proceedings. The panel will also discuss critical issues in post-grant challenges involving pharmaceutical patents as well as how pharmaceutical patents fare in post-grant challenges. The panel will then guide counsel on new risks to patent litigation settlements given evolving law.
Outline
- Interplay between Paragraph IV litigation and IPRs
- Multiple generic challengers and exclusivity
- Pharmaceutical patents in post-grant challenges
- Key issues in post-grant challenges involving pharmaceutical patents
- New risks to pharmaceutical patent settlements
Benefits
The panel will review these and other key issues:
- Where do multiple generic challengers fit into the exclusivity scheme?
- How do pharmaceutical patents fare in post-grant challenges in comparison to all patents?
- What are the crucial issues in post-grant challenges involving pharmaceutical patents?
- What are potential strategies for pharmaceutical companies looking to settle and mitigate risk?
Unlimited access to premium CLE courses:
- Annual access
- Available live and on-demand
- Best for attorneys and legal professionals
Unlimited access to premium CPE courses.:
- Annual access
- Available live and on-demand
- Best for CPAs and tax professionals
Unlimited access to premium CLE, CPE, Professional Skills and Practice-Ready courses.:
- Annual access
- Available live and on-demand
- Best for legal, accounting, and tax professionals
Related Courses

Patent Design Arounds for Both Utility and Design Patents: Minimizing Risk of Infringement, Reducing Likelihood of Competitor Design Arounds, and Maximizing the Chances of Covering Competitors’ Attempted Design Arounds When Preparing a Patent Application
Wednesday, May 28, 2025
1:00 p.m. ET./10:00 a.m. PT

Patent Infringement: Structuring Opinions of Counsel
Friday, May 23, 2025
1:00 p.m. ET./10:00 a.m. PT

Means-Plus-Function Patent Claims Following Xencor: Preamble, Written Description, and More
Thursday, May 15, 2025
1:00 p.m. ET./10:00 a.m. PT