Declaratory Judgment in Hatch-Waxman Cases: What ANDA Litigants Should Know in 2016
In 2015, in Apotex Inc. v. Daiichi Sankyo Inc., Apotex sued for a declaratory judgment of non-infringement of a Daiichi-owned, but disclaimed patent. The Federal Circuit Court decided that the statutorily disclaimed patent nevertheless may support declaratory judgment jurisdiction and meet Article III case and controversy requirement under certain conditions. It concluded that, even though Daiichi has already disclaimed the drug patent, declaratory judgment of non-infringement could be maintained by Apotex and therefore could trigger forfeiture of Mylan’s exclusivity period.
In reversing the district court's decision, the Federal Circuit Court explained that the case presented a substantial controversy, between parties with adverse legal interests of enough importance to warrant a declaratory judgment. Under the Hatch-Waxman Act, the court also disagreed with Mylan’s argument that, without at least tentative approval of Apotex’s ANDA, the injury is too speculative to create a case for declaratory judgment.
However, this decision doesn’t guarantee the same clarity in other cases and litigation. The haze over the nuances of the Declaratory Judgment Act and the forfeiture provisions of the Hatch-Waxman Act may still loom over the heads of many parties and litigants.
The Knowledge Group has assembled a panel of key thought leaders and practitioners to provide an opportunity to discuss the issues raised by the Apotex Inc. v. Daiichi Sankyo Inc. decision in a two-hour LIVE Webcast. The panel of speakers will summarize past cases, review the recent Federal Circuit Court decision, and discuss the implications and pending confusion wrought by the Declaratory Judgment in Hatch-Waxman Cases. Speakers will also offer best practices in avoiding and mitigating future litigation risks.
Some of the major topics that will be covered in this course are:
- Declaratory Judgment Act - An Overview
- MMA Forfeiture Provisions
- Case-or-Controversy Requirements
- Recent Cases
- Apotex Inc. v. Daiichi Sankyo Inc.
- MedImmune, Inc. v. Genentech, Inc.
- Janssen Pharmaceutica NV v. Apotex Inc.
- ANDA Applications
- Critical Issues and Implications
- Potential Litigation Risks and Remedies
- Possible Statutory Actions
- Best Practices
Mark Remus, Partner
Brinks Gilson & Lione
- Introductory segment
Hassen A. Sayeed, M.D., J.D., Partner
Ropes & Gray LLP
- Apotex v. Daiichi Sankyo case (Does a case or controversy exist where a DJ of non-infringement is filed concerning a disclaimed OB patent?), and if time permits, Purdue Pharm. Products v. TWI Pharms. (D.N.J.) (Does a covenant not to sue preclude a DJ action by an ANDA filer)?
Candice C. Decaire, Partner
Kilpatrick Townsend & Stockton LLP
- Dey Pharma case in which the Fed. Cir. clarified the parameters of DJ to ANDA para IV disputes and dj case statistics since this decision.
Christine Willgoos, Special Counsel
Kramer Levin Naftalis & Frankel LLP
- Overview of the state of personal jurisdiction issue (set for early January oral arguments)
Gurpreet Singh Walia, M.D., J.D., Special Counsel, Attorney at Law
Cohen & Gresser LLP
- Declaratory Judgments in Hatch-Waxman litigation after MedImmune, Inc v Genetech, Inc. 127 SCt 764, 771 (2007))
Who Should Attend:
- Healthcare Law Attorneys
- FDA Attorneys
- Biotech/Pharma Industry Lawyers
- Patent Licensing Attorneys
- Drug Manufacturing Executives
- Health Industry Advisors
- Patent Litigators
- Other Related/Interested Professionals
Hassen A. Sayeed, M.D. is an experienced patent litigator based in the firm’s New York City office. Recognized as a “Rising Star” by Super Lawyers in 2014 and 2015, Dr. Sayeed is one of the few patent litigators in the United States who holds a medical degree. He counsels life sciences clients in all aspects of complex patent litigation at the district court and appellate levels to help businesses achieve their strategic goals. Dr. Sayeed has litigated cases involving small-molecule pharmaceuticals, biotechnology and medical devices. He also has more than a decade of experience with cases arising under the Hatch-Waxman Act on behalf of pioneer pharmaceutical companies.
Hassen A. Sayeed, M.D. is an experienced patent litigator based in the firm’s New York City office. Recognized as a …
Christine Willgoos works primarily on patent litigation in the pharmaceutical and biotechnology and has extensive experience in leading trial and appellate teams in Hatch-Waxman and biologic drug litigations concerning blockbuster drugs. She also has significant courtroom experience, including trial, preliminary injunction, oral argument, Markman, and direct and cross examination of witnesses.
Ms. Willgoos counsels clients in business and legal matters relating to patent portfolios including antitrust, patent prosecution, life-cycle management and regulatory issues. She has handled a variety of cases, including those concerning humanized antibody technology, recombinant DNA vectors, antidepressant drugs and dermatologic drugs, as well as medical devices, semiconductors, telecommunications and electronics.
Ms. Willgoos graduated cum laude from Boston University School of Law. She received a Master of Forensic Science in Forensic Molecular Biology from George Washington University and a Bachelor of Science in Biochemistry from the State University of New York College at Geneseo.
Christine Willgoos works primarily on patent litigation in the pharmaceutical and biotechnology and has extensive experience in leading trial and …
Mark Remus is a seasoned patent litigator, and has extensive experience with pharmaceutical litigation under the Hatch-Waxman Act. Having advised clients on a wide range of drug products and technologies, he is also experienced in FDA practice and strategy related to generic pharmaceutical products, including controlled correspondence, citizen petitions, suitability petitions and labeling carve-outs.
He has served as lead counsel on numerous patent infringement litigation matters, and he has successfully represented clients in jury trials, bench trials, and appeals to the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court. Intellectual Asset Management (IAM) magazine writes that Mark is “[a]lways one of the best lawyers in the courtroom, he has an even temperament for litigation and is precise in everything he does,” calling him “quite a force to be reckoned with.”
Mark is listed in The Best Lawyers in America© 2016 and in the IAM Patent 1000 2015—The World’s Leading Patent Professionals, and was ranked in the top 100 attorneys in the 2015 Illinois Super Lawyers list.
Mark Remus is a seasoned patent litigator, and has extensive experience with pharmaceutical litigation under the Hatch-Waxman Act. Having advised …
Dr. Walia practices commercial and intellectual property litigation in a variety of disciplines, including pharmaceutical patent litigation, Hatch-Waxman litigation (including ANDA litigation), and products liability. He also practices healthcare, regulatory, and compliance law. Prior to law school, he completed his premedical education from Delhi University and earned a medical doctorate degree from Armed Forces Medical College, the second highest ranked medical school in India. He practiced as an attending anesthesiologist physician in several American hospitals. He was named byManaging IP as a 2015 “IP Star” in the areas of reexamination, Hatch Waxman, Orange Book, and PTAB.
He earned his J.D. from St. John’s University School of Law where he served as Editor-in-Chief of the New York Real Property Law Journal, the Articles & Notes Editor of the American Bankruptcy Institute Law Review, president of the Patent Law Society, and as a member of the Moot Court Honor Society. Prior to joining the firm, Dr. Walia practiced at Kaye Scholer, LLP. Dr. Walia is a member of the firm’s Diversity Committee.
Dr. Walia practices commercial and intellectual property litigation in a variety of disciplines, including pharmaceutical patent litigation, Hatch-Waxman litigation (including ANDA …
Candice Decaire is a partner at Kilpatrick Townsend & Stockton LLP. She practices intellectual property law, with a special focus on patent litigation. Her practice includes:
- counseling and representation in patent litigation, arbitration, ITC investigations, and inter partes review proceedings concerning diverse technologies such as computer hardware and software, biologics, pharmaceuticals, carpet, thermal imaging/night vision equipment, “bullet proof” armor, industrial bearings, aircraft equipment, and medical devices;
- assisting clients proactively to manage and to protect their intellectual property and data, including by advising clients about Internet, privacy, and cybersecurity law, including privacy policies, website terms and conditions, and relevant practices and procedures; strategies for obtaining timely and appropriate intellectual property and contractual protection and reducing risks of liability.
University of Georgia School of Law, summa cum laude, Order of the Coif Smith College, A.B., Ada Comstock Scholar
Candice Decaire is a partner at Kilpatrick Townsend & Stockton LLP. She practices intellectual property law, with a special focus …
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About Ropes & Gray LLP
Ropes & Gray is one of the world’s premier law firms, with more than 1,100 lawyers and legal professionals serving clients in major centers of business, finance, technology and government. The firm has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Tokyo and Seoul, and has consistently been recognized for its leading practices in many areas, including private equity, M&A, life sciences, health care, finance, investment management, hedge funds, tax, intellectual property, litigation, securities litigation, government enforcement, and privacy & data security.
About Kramer Levin Naftalis & Frankel LLP
Kramer Levin Naftalis & Frankel LLP is a premier, full-service law firm with offices in New York, Silicon Valley and Paris. With more than 375 attorneys in 20-plus practice areas, Kramer Levin has the deep knowledge and expertise to provide a full range of innovative legal solutions. Yet, our size enables us to remain focused on serving the individual needs of our clients. As we grow, we continue to draw on the qualities that have fueled the firm’s earliest successes: a single-minded commitment to excellence, an entrepreneurial spirit and a dynamic yet practical approach to achieving superior results for our clients. Firm lawyers are leading practitioners in their respective fields, who understand their clients’ businesses, demonstrate a strong focus on client service and offer innovative and practical solutions. The firm represents Global 1000 and emerging growth companies, institutions and individuals, across a broad range of industries.
About Brinks Gilson & Lione
The attorneys, scientific advisors and patent agents at Brinks Gilson & Lione focus their practice in the field of intellectual property, making Brinks one of the largest intellectual property law firms in the U.S. Clients around the world rely on Brinks to help them protect and enforce their intellectual property rights. Brinks attorneys provide counseling in all aspects of patent, trademark, unfair competition, trade secret and copyright law. More information is available at www.brinksgilson.com.
About Cohen & Gresser LLP
Cohen & Gresser is a midsize law firm with offices in New York, Paris, and Seoul. We represent clients in complex litigation and corporate transactions throughout the world. Founded in 2002, Cohen & Gresser LLP has been recognized in Chambers USA, Legal 500, and Benchmark Litigation, and has grown to nearly sixty lawyers in six practice areas: Litigation and Arbitration, Intellectual Property and Technology, White Collar Defense, Corporate, Tax, and Employment Law.
About Kilpatrick Townsend & Stockton LLP
Kilpatrick Townsend is a full-service, international law firm with more than 620 lawyers in 18 offices worldwide. We have deep experience in the areas of intellectual property, litigation and corporate transactions. A close collaboration between the firm's practice areas ensures that we are well-positioned to serve all of our clients' needs. Offering the full range of services, Kilpatrick Townsend is one of the few general practice firms with a core commitment to intellectual property law. With more than 300 attorneys devoted to IP law, Kilpatrick Townsend offers clients specialization that exceeds even the most well-known boutique firms. For more information, please visit: www.kilpatricktownsend.com.