Paragraph IV Litigation, IPRs, and New Settlement Risks
Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs
Recording of a 90-minute premium CLE webinar with Q&A
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.
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?
Faculty
Travis W. Bliss, Ph.D.
Partner
Panitch Schwarze Belisario & Nadel
Dr. Bliss counsels a variety of clients ranging from individual inventors to small businesses to Fortune 500 companies... | Read More
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.
Erin M. Dunston
Partner
Panitch Schwarze Belisario & Nadel
Ms. Dunston focuses on inter partes reviews, interferences, district court litigation, opinions, and prosecution... | Read More
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.
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Philip L. Hirschhorn
Partner
Panitch Schwarze Belisario & Nadel
Mr. Hirschhorn has represented clients in Hatch-Waxman (Paragraph IV) litigations, has worked in diverse industries... | Read More
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.
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Aaron L.J. Pereira
Attorney
Panitch Schwarze Belisario & Nadel
Mr. Pereira’s practice encompasses intellectual property litigation and counseling, with specific expertise in... | Read More
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.
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