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Hatch-Waxman Disputes in District Court and at the PTAB: Strategic Considerations and Recent Developments

Produced on June 30, 2020

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Course Information

Time 102 minutes
Difficulty Intermediate

Course Description

This program will focus on Hatch-Waxman litigation, which is a special species of patent litigation involving generic pharmaceutical challenges to innovator patents. Hatch-Waxman litigation has been around for almost four decades and has generated a well-developed body of case law in federal courts. More recently, generic challengers have begun to use the IPR process at the PTAB as an additional means to challenge innovator patents. Managing these parallel proceedings at the PTAB and in district court presents a specific set of challenges, opportunities, and strategic options for both patent owners and challengers. This is especially true given the statutory timelines mandated for Hatch-Waxman litigation (a 30-month stay of generic drug approval) and IPRs (18-months from filing). This course, presented by Travis Bliss, Erin Dunston, Phil Hirschhorn, and Aaron Pereira of Panitch Schwarze Belisario & Nadel LLP, will examine the practice and strategy of such parallel proceedings, and also discuss recent developments, trends, settlement issues, and other considerations for companies and counsel.


Learning Objectives:

  1. Explore recent trends in Hatch-Waxman litigation 

  2. Identify noteworthy updates on IPR practice at the PTAB

  3. Examine the interplay between PTAB and district court in Hatch-Waxman cases

  4. Discuss the Strategic use of parallel proceedings

  5. Gain updates on settlements and so-called pay-for-delay agreements


Credit Information

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Faculty

Erin M. Dunston

Panitch Schwarze Belisario & Nadel LLP

Over the course of her nearly twenty-year career, Erin M. Dunston’s practice has been a purposeful mix of patent prosecution and litigation.  Having handled many patent litigations, Erin recognizes how every word in prosecution may ultimately be analyzed by the fact-finder and thus strives for efficient, law- and science-driven prosecution.  Her extensive prosecution experience, in turn, is invaluable when analyzing prosecution documents and issues as part of litigation.  With a background in biochemistry, she concentrates her practice primarily in the fields of biotechnology, pharmaceuticals, medical devices, and associated computer technology.

In terms of patent prosecution, counseling, and strategy, Erin learns her clients’ businesses and how a given project will advance the client’s business objectives, from both offensive and defensive standpoints.  Erin also works closely with clients to satisfy budget constraints and assist in leveraging and monetizing patent assets.

To date, Erin has handled more than 20 district court litigations and more than 25 inter partes reviews (IPRs) and more than 40 interferences before the Patent Trial and Appeal Board (P.T.A.B).  Assisting both patent owners and putative infringers/petitioners, this experience ranges from pre-filing analyses all the way through appeals to the U.S. Court of Appeals for the Federal Circuit.   

Her deep experience in patent law has been recognized by several leading IP organizations and awards programs.  Erin has been selected for inclusion among The Best Lawyers in America each year since 2018.  She also has been recognized in IAM’s Patent 1000 list – a best-in-class listing of patent prosecution, licensing, and litigation practitioners.  For several years, she has been named an IP Star by Managing Intellectual Property and a Leading Intellectual Property Lawyer by Chambers USA.  Erin also received Lawyer Monthly’s Women in Law 2016 Award for her contributions to the practice of biotechnology law.

Practice Areas

Education

  • University of the Pacific, McGeorge School of Law, J.D., 1999
  • Boston College, B.S., 1996, Biochemistry

Bar Admissions

  • District of Columbia
  • Virginia
  • U.S. Patent and Trademark Office (USPTO
  • Supreme Court of the United States (SCOTUS)
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. District Court for the Eastern District of Virginia




Philip L. Hirschhorn

Panitch Schwarze Belisario & Nadel LLP

Philip L. Hirschhorn focuses his practice on patent litigation and counseling. He prides himself on working with clients to understand their business thoroughly, including the ways in which intellectual property litigation affects their business objectives. Clients can rest assured that Phil will go the extra mile, both on his own and as part of a team, to help clients solve their legal challenges.

Phil’s extensive experience, spanning more than 30 years, includes bench trials, jury trials, and arbitrations. He has represented clients in traditional infringement/validity litigations as well as Hatch-Waxman (Paragraph IV) litigations.  Phil also has experience handling copyright, trademark/trade dress, and trade secret litigation. Phil advises clients on commercial patent licensing agreements.  The subject matter of these engagements is diverse, including chemical, pharmaceutical, consumer products, medical devices, graphics, visualization technologies, apparel, and radiotherapy software and devices.

Phil counsels clients on the interplay between the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) and district court actions. He has extensive experience PTAB litigation experience, having assisted both patent owners and petitioners.

Phil’s prowess in intellectual property law has earned him many accolades over the years. Managing Intellectual Property has named him an IP Star nearly every year since 2013, and he has been named among IAM’s Patent 1000 list several times. He also has been named a New York Super Lawyer in the practice area of patent litigation.

Phil earned a bachelor’s degree from Columbia College and his law degree from Fordham University School of Law, where he also served as Associate Editor of the Fordham Law Review and Editor of the Fordham Environmental Law Report.

Phil is a frequent speaker on IP litigation topics such as recent developments in Paragraph IV litigation, patent damages, and trade secret litigation.  He is a current Vice Chair of the PTAB/TTAB committee of the Federal Circuit Bar Association and the immediate past chair of the Patents Committee of the New York City Bar Association.

Practice Areas

Education

  • Fordham University, J.D., 1988, Associate Editor of the Fordham Law Review, Editor of the Fordham Environmental Law Report
  • Columbia College, B.A., 1984

Bar Admissions

  • New Jersey
  • New York
  • Supreme Court of the United States (SCOTUS)
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. Court of Appeals for the Second Circuit
  • U.S. Court of Appeals for the Ninth Circuit
  • U.S. District Court for the District of New Jersey
  • U.S. District Court for the Eastern District of New York
  • U.S. District Court for the Southern District of New York
  • U.S. District Court for the Western District of New York
  • U.S. District Court for the Western District of Wisconsin




Travis W. Bliss

Panitch Schwarze Belisario & Nadel LLP

Dr. Travis 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 intellectual property law when counseling a client on an IP issue, thereby providing his clients with a comprehensive view of the IP landscape. Travis 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. Travis’s flexibility and adaptability to consider and work in the newest legal proceedings and technologies give value to clients who are looking for optimal solutions specific to their business needs.

Travis served as chair of the IP Biotechnology & Life Sciences Practice Group at Buchanan Ingersoll & Rooney P.C. before joining Panitch Schwarze. From a technology standpoint, Travis's practice falls largely within the life sciences field, including pharmaceuticals and biologics, diagnostic testing methods/apparatus, and treatment methods.  Travis’s practice also includes a large focus on novel plant varieties in the agriculture, horticulture, and cannabis/hemp industries, including procuring patent and trademark protection for novel varieties and monetizing those IP rights through licensing. His efforts in IP counseling in procurement in the cannabis and hemp space have allowed Travis to be ranked as a “Band 1” attorney in the area of Cannabis Law by Chambers USA.

Whether counseling clients on the most advantageous intellectual property avenues to pursue for a particular technology or counseling clients on the most practical ways to avoid or overcome the intellectual property of competitors, Travis strives to assist his clients from the planning stages all the way through execution to make sure his clients are getting the most out of their intellectual property assets.

Prior to entering the legal profession, Travis earned both a bachelor of science degree and a Ph.D. in animal science from the University of Delaware, with course work and research that focused on animal and plant genetics, molecular immunology, biotechnology, and bioinformatics. His Ph.D. dissertation addressed gene expression in avian macrophage cells using EST libraries and DNA microarrays, and he also participated in research projects that involved diagnostic testing, pathogen identification, vaccine analysis, and cell culture. These undergraduate and graduate programs gave Travis technical experience in numerous areas of the chemical and biological arts.

In addition to his regular legal work, Travis volunteers as a pro bono child attorney for the Delaware Office of the Child Advocate.  He also serves on his neighborhood civic association and volunteers as a coach for softball, wrestling, and basketball for a local youth club. In his spare time, he is an avid gardener and he also enjoys making hard cider from locally sourced sweet apple cider.

Practice Areas

Education

  • Widener University, J.D., 2007, summa cum laude
  • The University of Delaware, Ph.D., 2004, Animal Science focusing on Molecular Genetics, Immunology, and Biotechnology
  • University of Delaware, B.S., 1999, Animal Science with a concentration in Agricultural Biotechnology; Biology Minor

Bar Admissions

  • Delaware Supreme Court
  • District of Delaware
  • USPTO




Aaron L. J. Pereira

Panitch Schwarze Belisario & Nadel LLP

Aaron L. J. Pereira is a litigator and patent attorney, with a background in chemical & biomolecular engineering, and a decade of experience with all aspects of patent litigation, procurement, and counseling.

As a litigator, Aaron is known for his ability to distill dense technical records into simple and winning legal arguments and has done so in federal courts around the country, at the ITC, and before the Patent Office. He has counseled some of the world’s largest and most sophisticated companies on matters of global patent strategy, market-entry, and product competition. Aaron also has experience managing 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. 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 also brought and defended copyright, trademark, Lanham Act, and general business tort claims in complex commercial litigation.    

Aaron is also a registered patent attorney with several years of experience prosecuting patents in the chemical, pharmaceutical, and medical device space. This includes having managed the worldwide prosecution of several families of pharmaceutical dosage formulations and drafting patent applications on pharmaceuticals and the methods and products of organic syntheses. Aaron also has experience rendering patent opinions.

In addition to litigating and prosecuting patents, Aaron has significant expertise in IP diligence. He has run several large IP reviews in support of multibillion-dollar acquisitions and private equity financing, in a variety of industries, with a focus on life sciences. Through this work, Aaron has developed a keen understanding of both the buy and sell-side of such transactions and a familiarity with the types of advice and reports needed to see them through to completion. He leverages this knowledge to counsel both startup companies and those that would support or acquire them.

Aaron is active in bar associations and voluntary organizations, including the New York City Bar Association, where he serves as the current Chair of the Patents Committee. Aaron holds a joint J.D. and L.L.M. from the Benjamin N. Cardozo School of Law with a specialization in Intellectual Property and has a B.S. in Chemical & Biomolecular Engineering from the University of Notre Dame.

Practice Areas

Education

  • Benjamin N. Cardozo School of Law, Master of Laws (LL.M.)
  • Benjamin N. Cardozo School of Law, Juris Doctor, (J.D.)
  • University of Notre Dame, Bachelor of Science, (B.S.)

Bar Admissions

  • New York