On-Demand Content | Virtual Event

AGENDA – ALL TIMES ARE IN EASTERN TIME

2020 was a year unlike any other in recent memory, and with it we saw a large decline in the filing of Paragraph IV cases. However, with the Covid-19 pandemic slowly coming to an end, we expect to see this trend change course. We open the conference with the at look at the newest cases and latest filings in the world of pharmaceutical IP litigation.

Arlene Chow, Partner, LATHAM & WATKINS LLP
More often than not when pharmaceutical patents face “inter partes review”, concurring district court complaints have been filed leaving parties to face litigation on two stages. With this in mind, it is critical for both in-house and outside counsel to be aware the steps necessary to prepare for unforeseen challenges and have a preset course of action in place.

This session offers:
  • Examining the different methods of preparation while facing coinciding challenges to patent rights
  • Selecting the proper witnesses for both “inter partes review” and ANDA litigation
  • Strategizing for how the decision in one challenge may affect the outcome of the other
Irena Royzman, Partner & Head of Life Sciences, KRAMER LEVIN NAFTALIS & FRANKEL LLP
Jeanna Wacker, Partner, KIRKLAND & ELLIS P.C.
Assignor estoppel has always been a two-sided argument in relation to pharmaceutical IP litigation. Those in favor of the doctrine have argued that it creates unfairness by preventing an inventor from profiting by assigning patent rights, then questioning the validity of the patent.  Opponents of the doctrine have argued that it restricts the career mobility of inventors, as doing so would prevent a company from utilizing patent invalidity as a defense should the hiring company be sued by the previous company of the inventor. The Supreme Court ruling in “Minvera Surgical v” Hologic Inc” has provided us with a final answer to the limitations surrounding assignor estoppel.

This session offers:
  • Analyzing the Doctrine of Assignor Estoppel and the limitations surrounding it
  • Examining the ruling of the Supreme Court and Justices concurring and dissenting opinions
  • Redefining the boundaries of assignor estoppel based on the ruling of the court
Betsy Flanagan, Principal, FISH & RICHARDSON P.C.
With a consistent filing IPR’s, the U.S. Patent Trial and Appeal Board (PTAB) has become a place where brand and generic drug manufacturers challenge patents in “inter partes review”. This session allows for audience members to obtain a first-hand perspective of judges hearing these cases.

Honorable Michelle N. Ankenbrand, Lead Administrative Patent Judge, USPTO
Honorable Jacqueline Wright Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial and Appeal Board, USPTO
Honorable Kristi Rupert Sawert, Administrative Patent Judge, USPTO
The decision in “Valeant v Mylan” has set boundaries for what would be considered an improper venue related to Paragraph IV litigation. With the court decision of “infringement occurs for venue purposes only in districts where actions related to the submission of an ANDA occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated”, the boundaries have been determined.

This session offers:
  • Analyzing the limited choices of venue after the exclusion of districts in which only distribution will take place
  • Examining selection of venue when filing suit against a foreign entity
  • Building the supporting argument needed when filing a motion to transfer venue
John Kirkland, Senior Director of IP and Litigation, ALKERMES
Ha Kung Wong, Partner, VENABLE LLP
Government regulators are constantly encourage pharmaceutical companies in the research for treatments of what the FDA defines as a “rare disease”. In an effort to further incentivize the development of these products, the FDA has put a different set of exclusivities in place to protect the IP rights of a product manufacturer as compensation for their work.

This session offers:
  • Filing for an orphan drug designation and the 7-year exclusivity window associated with the product’s approval
  • Examining the FDA’s acceptance of generic product applications and the indications which must be shown within it
  • Analyzing the summary judgement from ‘Catalyst Pharmaceuticals v Jacobus Pharmaceutical’ defining “market exclusivity”
Ryan Coletti, Vice President, Intellectual Property and Litigation, SHIONOGI INC.
Sanya Sukduang, Partner, COOLEY LLP
Kurt Karst, Director, HYMAN, PHELPS & MCNAMARA, P.C.
A multitude of patents regularly come attached with the filing of an NDA. These may include but are not limited to: product patents, process patents, formulation patents, and patents for the method of use. In recent years, we have come to see pharmaceutical companies file ANDA’s with a specific method of use excluded, known as a “skinny label”, in an effort to obtain FDA approval and avoid Paragraph IV litigation. While the issue has previously been argued before the court, the ongoing litigation in ‘GSK v Teva’ may provide us with a final decision on the use of these labels.

This session offers:
  • Exploring the jury ruling of infringement taking place and the multiple appeals that would follow
  • Teva’s petition for a Rehearing En Banc and the Federal Circuit's decision to vacate its prior ruling and offer of a rehearing
  • Examining the current standing of “skinny labeling” and the regulations for method of use labeling when filing an ANDA
John Haberman, Senior Director, IP AT SAREPTA THERAPEUTICS
Bruce Wexler, Partner, PAUL HASTINGS LLP
Donna Meuth, Associate General Counsel Intellectual Property, EISAI
The ongoing COVID-19 pandemic has taken a tremendous toll both nationally and internationally as pharmaceutical companies raced to find a vaccine to slow the spread of the virus. Companies successfully put products to market which has seen positive results. Recently the focus has shifted to those who do not have access to these products and potential IP waivers needed for them to gain access.

This session offers:
  • The stance of the pharmaceutical industry on the waiver of product IP to increase production and use of the vaccine
  • The thoughts of the European Union and their push back to the waiver of the intellectual property rights of the manufacturers
  • President Biden’s stance on the waiver of IP in order to fight the virus and what it may mean for pharmaceutical companies moving forward
Paul Molino, Partner, RAKOCZY MOLINO MAZZOCHI SIWIK LLP
Kevin E. Noonan, Partner, MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
With pharmaceutical companies having become multinational organizations, it remains important to look at intellectual property litigation on an international scale. More and more nations have seen IP cases reach their courtrooms and the rulings have been setting precedents in protecting the intellectual property of U.S. based manufacturers outside of its boarders.

This session will include:
  • China’s implementation of regulations similar to “Hatch-Waxman”, including an orange book, and their potential effect of IP litigation within the nation
  • The recent ruling in favor of Merck in Taiwan’s first patent linkage lawsuit and what it means going forward
  • Working with organizations such as BIO and PhRMA to assist in patent protection and litigation within the EU
Jake M. Holdreith, Partner, Member of the Executive Board, ROBINS KAPLAN LLP
For years the FTC has attempted to take action against the pharmaceutical industry as companies agreed to “pay-to-delay” settlements. The FTC sees these agreements as collusion and a violation of antitrust law, as they believe it allows for a monopoly within the pharmaceutical industry. With a number of recent court decisions in their favor, the pharmaceutical industry must be prepared for future challenges from the government agency.

This session will discuss:
  • The successful challenge by the FTC to the agreement between AbbVie and Teva surrounding Androgel
  • The ruling of the Supreme Court in ‘FTC v Activas’
  • The FTC determination of Impax Laboratories participation in a “pay-for-delay” settlement with Endo Pharmaceuticals
Jeff Bank, Partner, WILSON SONSINI GOODRICH & ROSATI P.C.
With generic pharmaceuticals falling under Paragraph IV of the “Hatch-Waxman Act”, biosimilars fall under the “BPCIA” (Biologics Price Competition and Innovation Act). While the same manufacturer may develop and hold patents in both categories, it is critical to understand the differences in filing for their IP rights as well as the litigation differences.

This session will include:
  • Examining the difference between “Hatch-Waxman” and the “BPCIA”
  • Analyzing the participating in the “patent dance” and the disclosure of information found in the aBLA
  • Exploring how participation in the dance affects the rights of a company to “seek a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product”
Brian Malkin, Partner, MCDERMOTT WILL & EMERY