The Hatch-Waxman and IPR Strategy in Light of Recent Case Decisions: Addressing Emerging Issues
Inter partes review (IPR) proceedings have been an attractive ground for drug companies seeking to challenge the patentability of pharmaceutical products. The IPR allows challengers to maximize the streamlined process of the Patent Trial and Appeal Board (PTAB) while also taking advantage of the benefits provided by the Hatch-Waxman Act. Given this backdrop, the number of challenges utilizing the IPR process is predicted to continuously climb this year and beyond.
Practitioners must, therefore, ensure that they are prepared in this rapidly evolving climate. The need to stay on top of the recent legal developments to devise effective litigation strategies is more crucial than ever. Some of the 2019 rulings which lawyers should consider in developing strategies this 2020 include Return Mail v. U.S. Postal Service, Regents of the Univ. of Minn. v. LSI Corp., and AVX Corp. v. Presidio Components Inc.
Join patent litigators Tony V. Pezzano (DLA Piper) and Aaron L.J. Pereira (Panitch Schwarze Belisario & Nadel LLP) as they delve into an in-depth analysis of the significant issues resulting from the interaction between IPR proceedings and the Hatch-Waxman Act. Speakers will also provide practical strategies in bringing out the best in these lawsuits in light of the current trends and recent court rulings.
Key topics include:
- The Unique Interplay Between Hatch-Waxman and IPR
- Recent Case Decisions
- Current and Emerging Issues
- Effective Litigation Strategies
Aaron L.J. Pereira, Counsel
Panitch Schwarze Belisario & Nadel LLP
- Trends and outcomes for Orange Book and biologic patents in AIA proceedings at the PTAB
- Recent decisions designated precedential or informative by the PTAB, and their impact on parallel Hatch-Waxman litigation
- Strategies and considerations for producing district court discovery in AIA proceedings
- Managing parallel proceedings in Hatch-Waxman cases, and strategies for leveraging PTAB decisions in district court, and vice versa, for branded innovators and generic challengers
Tony V. Pezzano, Partner
- Considerations for Not Proceeding With an IPR Proceeding Prior to or in Parallel With a Hatch-Waxman Action
- Reasons to reconsider filing an IPR Proceeding
- There are persuasive reasons a Federal District Court Judge will not stay a Hatch-Waxman action
- Beware of petitioner estoppel under 35 U.S.C. §315(e)
- The broadest reasonable claim construction is no longer the standard in PTAB
- Live witness testimony is rare in an IPR proceeding
- Avoiding brand forum shopping is no longer in play post TC Heartland
Who Should Attend:
- Patent Lawyers and Agents
- Biotech/Pharma Industry Lawyers
- In–House Counsels
- Intellectual Property Specialists and Managers
- Chief Compliance Officers
Tony Pezzano is a partner in the New York offices of DLA Piper LLP (US). Tony has successfully tried numerous cases in federal district courts and the ITC involving technology innovation across a diverse range of industries. Tony has been lead counsel for brand pharmaceutical companies in over two dozen filed Hatch-Waxman cases during the past ten years involving antibiotic, antiviral, antifungal, anticoagulant, and anti-organ transplant rejection drug products. Tony has also represented both Complainants and Respondents in ITC Section 337 investigations involving biologics, SeaDoos/WaveRunners, wireless communication devices, including mobile phones and tablets, computer routers and Segways/hoverboards. Few attorneys, if any, can match Tony’s record of obtaining both injunctions in Hatch-Waxman cases as well as exclusion and cease and desist orders in ITC Section 337 investigations. Tony is Past President (2009) of the ITC Trial Lawyers Association.
Tony Pezzano is a partner in the New York offices of DLA Piper LLP (US). Tony has successfully tried numerous …
Aaron Pereira is a litigator and patent attorney, with a background in chemical & biomolecular engineering.
Aaron has several years of experience litigating and counseling in the life sciences space, with a special focus on Hatch-Waxman and BPCIA matters. He has managed large parallel litigation in federal district court and at the Patent Office, and has developed a deep understanding of the procedural and substantive interplay between such proceedings. He has been counsel to some of the world’s largest and most sophisticated companies, and regularly advises clients on matters of global patent strategy, market entry, and product competition. As a registered patent attorney, Aaron has prosecuted patents and rendered opinions in the life sciences space. He also has experience running large patent diligence reviews in support of acquisitions and financing.
Aaron is active in professional and affinity groups, and currently chairs the Patents Committee at the NYC Bar Association.
Aaron Pereira is a litigator and patent attorney, with a background in chemical & biomolecular engineering. Aaron has several years …
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Method of Presentation:
General knowledge of patent infringement litigation
NY Category of CLE Credit:
Areas of Professional Practice
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About DLA Piper
With over 90 offices, DLA Piper’s highly-regarded IP practice is recognized as a leading firm across the world. Our patent litigation practice ranks among the most active practices in complex multi-jurisdictional patent disputes before US district courts, the ITC and in key foreign jurisdictions. DLA Piper's patent lawyers also counsel innovative companies on strategic patent prosecution in the US and worldwide. Our trademarks practice manages more than 70,000 marks in over 150 countries, representing many of the top 100 global brands. Many of our IP and Technology lawyers have been recognized as leaders by numerous publications such as Chambers, The Legal 500, The National Law Journal, Law360, The Daily Journal, Managing IP, Intellectual Asset Management, and World Trademark Review.
About Panitch Schwarze Belisario & Nadel LLP
Panitch Schwarze Belisario & Nadel LLP is a boutique IP firm with a nationally ranked team of attorneys, focusing on all areas of patent, trademark, copyright, and trade secret law, across a broad range of technologies. Panitch attorneys regularly represent clients in both ex parte and adversarial proceedings in federal courts and before the U.S. Patent and Trademark Office. The firm’s boutique structure allows Panitch to offer a tailored experience to a broad range of clients, ranging from transnational companies to individual inventors. Panitch’s roots run deep in the domestic and international IP communities.