Best Strategies and Practical Tips in Winning Paragraph IV Disputes
The Paragraph IV litigation landscape is continuously evolving and transforming, with recent Supreme Court patent decisions on construction, personal jurisdiction and 101 patent eligibility and other uncommon circumstances affecting critical Paragraph IV components. Recent legal and regulatory changes, updates on PTO grant procedures, and the ever complex settlement landscape under Actavis are significant factors that also contribute to the drastic changes in the pharmaceutical patent practice.
In this LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will discuss the significant and latest issues impacting every aspect of Paragraph IV litigation. Speakers will also offer best strategies and practical tips on how to meet these challenges head-on and win a Paragraph IV dispute.
Key topics include:
- Patent Eligibility (Section 101)
- Obviousness (Section 103)
- ANDA Litigation and PTO Post Grant Procedures
- Paragraph IV Court Decisions
- FDA Use Code Challenges
- Section VIII Carve-Outs
Kathleen B. Carr, Member
- The effect that PTAB determinations (decisions on institution and final PTAB decisions) have on federal district court litigation.
- Working with two different standards of proof in parallel district court and PTAB proceedings: does it make a difference?
- Planning for the effect that PTAB proceedings may have regarding the 30-month stay in federal district court litigation
Rachel K. Hunnicutt, Partner
- The new rules for challenging FDA Use Codes; any meaningful impact at FDA and in district court.
- Review of federal circuit cases on section viii carve-outs; whether a carve-out precludes induced infringement as a matter of law.
- How district courts have been applying federal circuit case law; tips for being successful in the district courts on Rule 12 motions when arguing that a carve-out precludes induced infringement.
Nigamnarayan Acharya, Shareholder
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
- Patent eligibility under Section 101
- Obviousness under Section 103
Who Should Attend:
- Patent Legal Counsel
- Pharma Industry Lawyers
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Litigators
- Patent Consultants
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Drug Manufacturing Companies
- Drug Manufacturing Executives
- Other Related/Interested Professionals
Nigam’s practice is focused on establishing and defending intellectual property rights, through litigation and client counseling, in the fields of patents and trademarks. He has particular experience in patent disputes and prosecution, Hatch-Waxman matters and large-scale trademark registration and enforcement projects, including Trademark Trial and Appeal Board matters. He regularly counsels companies on using intellectual property portfolios to enhance equity investments and on Hatch-Waxman matters, which includes work in relation to Abbreviated New Drug Applications (ANDAs). He analyzes the patent landscape relating to new product proposals and works closely with scientists at an early stage to counsel on design-around strategies for ANDA filings.
Nigam’s practice is focused on establishing and defending intellectual property rights, through litigation and client counseling, in the fields of …
Kathleen has led trial teams in multibillion- and multimillion-dollar Hatch Waxman pharmaceutical patent litigation, and has successfully served as lead counsel for over 20 years on many cases in both federal and state court. She has argued successfully before the US Court of Appeals for the First Circuit, and prevailed in appeals before the Federal Circuit. She is registered to practice before the US Patent and Trademark Office.
Kathleen is recommended by the Legal 500 United States for Health Care: Life Sciences. She is listed in Best Lawyers in America for IP litigation, and has been listed as an LMG “Life Sciences Star” for IP litigation since its inaugural publication in 2012. Kathleen recently was elected to the Fellows of the American Bar Foundation, which is limited to one percent of lawyers licensed to practice in each jurisdiction.
Kathleen has led trial teams in multibillion- and multimillion-dollar Hatch Waxman pharmaceutical patent litigation, and has successfully served as lead …
Rachel advises clients on a wide range of U.S. Food and Drug Administration (FDA) regulatory matters, including life cycle management issues such as market exclusivity periods, Orange Book patent listings, Paragraph IV litigation, and patent term extensions. In addition, Rachel has extensive experience in all phases of Hatch-Waxman patent litigation.
Rachel advises clients on a wide range of U.S. Food and Drug Administration (FDA) regulatory matters, including life cycle management …
Print and review course materials
Method of Presentation:
Experience in pharmaceutical law
NASBA Field of Study:
Business Law - Technical
NY Category of CLE Credit:
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About Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
Baker Donelson gives clients access to a team of more than 650 attorneys and public policy advisors representing more than 30 practice areas to serve a wide range of legal needs. Clients receive knowledgeable guidance from experienced, multi-disciplined industry and client service teams. Ranked as the 64th largest law firm in the U.S., Baker Donelson is recognized by FORTUNE magazine as one of the "100 Best Companies to Work For."
About Mintz Levin
Mintz Levin’s IP Litigation team deals with all aspects of patents, trademarks, copyrights, and trade secrets, including validity, infringement, enforceability, and litigation of such rights. The life science IP team has particular experience handling Hatch-Waxman Litigation, helping innovators protect their hard-earned inventions, which are so crucial to success in marketing new pharmaceuticals. The Hatch-Waxman litigation team works with clients to anticipate challenges to their patents, prepare for potential ANDA filings or other infringement issues, and vigorously and efficiently protect these highly important patent rights. The team includes attorneys who are highly experienced in the space, have exceptional technical knowledge and training, and have achieved outstanding successes in cases such as Takeda v. Mylan, Takeda v. Alphapharm, and Mitsubishi Chemical v. Barr. The practice leaders have been recognized as Leading Practitioners in Managing Intellectual Property, Best Lawyers, and Super Lawyers, among others.
About Wiley Rein
Wiley Rein is a dominant presence in Washington, DC, with more than 240 attorneys and public policy advisors. Our firm has earned international prominence by representing clients in complex, high-stakes regulatory, litigation, and transactional matters. The firm operates at the intersection of politics, law, government, business, and technological innovation, representing a wide range of clients—from Fortune 500 corporations to trade associations to individuals—in virtually all industries, including energy, manufacturing, defense, aerospace, intelligence, information technology, professional services, telecommunications, health care, A&E, and construction. Many of the firm’s lawyers and public policy advisors have held high-level positions in the White House, on Capitol Hill, and in federal agencies, including the U.S. Department of Defense, the U.S. Patent and Trademark Office, and the U.S. Department of Justice. In addition, several of our attorneys also have active high-level security clearances.