HomeWebcastParagraph IV Challenges: Exploring Emerging Trends and Developments
Online CLE Paragraph IV CLE

Paragraph IV Challenges: Exploring Emerging Trends and Developments

Live Webcast Date: Tuesday, May 14, 2019 at 3:00 pm - 5:00 pm (ET)
Intellectual Property LawPharmaceutical & Life SciencesLive Webcast
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Add Reminder to My Calendar 05/14/2019 2:00 pm 05/14/2019 5:00 pm America/New_York The Knowledge Group Webinar: Paragraph IV Challenges: Exploring Emerging Trends and Developments The event starts in an hour. If you have not registered, please go to the link below to sign up today.https://www.theknowledgegroup.org/checkout/?add-to-cart=106053\r\n Filing a Paragraph IV (PIV) patent challenge remains to be one of generic drug manufacturers’ strategies to gain entry into the market before the patents’ expiration. Although, pursuing a challenge presents significant business opportunities, it poses additional complexities. Another strategy, which generic manufacturers use, is one which involves challenging patents but waiting for the results of another challenger’s litigation. \n \nWith the expected increase in generic drug manufacturers’ use of post-grant proceedings, counsel to both brand and generic companies should, therefore, be prepared with the emergence of new developments that will shape the Paragraph IV litigation landscape. \n \nJoin a panel of key thought leaders and practitioners assembled by The Knowledge Group as they bring the audience to a road beyond the basics of pursuing or defending against a paragraph IV challenge and as they delve into an in-depth analysis of the current trends and recent filings. Speakers will also provide the audience with the best litigation practices and practical strategies to help their clients cope with the evolving legal climate. \n \nKey topics include: \n \n \n Paragraph IV Challenges – Latest Trends \n Recent Legal and Regulatory Developments \n Managing Litigation Risks and Challenges \n 2019 Legal Roadmap for Paragraph IV Litigation \n Best Litigation Practices and Practical Tips \n \n https://www.theknowledgegroup.org/webcasts/paragraph-iv-challenges-2019/

Online CLE Paragraph IV

Filing a Paragraph IV (PIV) patent challenge remains to be one of generic drug manufacturers’ strategies to gain entry into the market before the patents’ expiration. Although, pursuing a challenge presents significant business opportunities, it poses additional complexities. Another strategy, which generic manufacturers use, is one which involves challenging patents but waiting for the results of another challenger’s litigation.

With the expected increase in generic drug manufacturers’ use of post-grant proceedings, counsel to both brand and generic companies should, therefore, be prepared with the emergence of new developments that will shape the Paragraph IV litigation landscape.

Join a panel of key thought leaders and practitioners assembled by The Knowledge Group as they bring the audience to a road beyond the basics of pursuing or defending against a paragraph IV challenge and as they delve into an in-depth analysis of the current trends and recent filings. Speakers will also provide the audience with the best litigation practices and practical strategies to help their clients cope with the evolving legal climate.

Key topics include:

  • Paragraph IV Challenges – Latest Trends
  • Recent Legal and Regulatory Developments
  • Managing Litigation Risks and Challenges
  • 2019 Legal Roadmap for Paragraph IV Litigation
  • Best Litigation Practices and Practical Tips

Who Should Attend

  • Bio/Pharma Companies
  • Healthcare Institutions
  • Medical Providers
  • Drug Manufacturing Executives
  • In-house Counsel
  • Patent Attorneys
  • Patent Agents
  • Litigators
  • Other Related/Interested Professionals and Organizations

Faculty

Online CLE Paragraph IV
Gregory B. Sephton, Ph.D.
Partner
Pierce Bainbridge Beck Price & Hecht LLP
Online CLE Paragraph IV
Pablo D. Hendler
Partner
Jones Day

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Online CLE Paragraph IV

Gregory B. Sephton, Ph.D., Partner
Pierce Bainbridge Beck Price & Hecht LLP

Pablo D. Hendler, Partner
Jones Day

Online CLE Paragraph IV

Online CLE Paragraph IV

Gregory B. Sephton, Ph.D.PartnerPierce Bainbridge Beck Price & Hecht LLP

Gregory B. Sephton, Ph.D., has over 25 years of experience in all aspects of patent litigation and has played leading roles in litigating and trying patent cases for a number of technology leaders, including Emory University, AstraZeneca, Novartis, Sanofi and Warner Chilcott. Most recently, Gregory led Forward Pharma to a $1.25 billion settlement in its worldwide patent dispute with Biogen over rights to its Tecfidera® multiple sclerosis treatment.

His litigation experience spans diverse technologies involving medical devices, chemicals, pharmaceuticals and biologicals. Greg also advises clients on patent strategy, as well as ex parte and inter partes patent reexaminations. He has particular experience litigating billion dollar pharmaceutical patent cases under the Hatch-Waxman Act, including involving anti-viral drugs, insomnia drugs, drugs for Alzheimer’s disease, anti-fungal drugs, anti-bacterial drugs and treatments, and anti-ulcer drugs, as well as a wide array of drug formulation technologies. He also has significant experience in intellectual property counseling, due diligence and transactions.

Prior to joining Pierce Bainbridge, Gregory was a partner at Kramer Levin Naftalis & Frankel LLP. Before that, he spent over 20 years at the Chambers Band 1-ranked New York IP boutique, Fitzpatrick, Cella, Harper & Scinto, where he was also a partner. Gregory holds degrees from the University of Toronto (B.Sc. Hons), Brandeis University (Ph.D., biochemistry, under a Merck grant) and Suffolk University (J.D.).

Online CLE Paragraph IV

Pablo D. HendlerPartnerJones Day

Pablo Hendler has counseled clients for nearly 25 years in intellectual property matters. Focusing his practice on life science patent litigation, he is well-equipped to counsel clients in pharmaceutical, biotechnology, and medical device litigation.  Specifically, Pablo has served as lead counsel, in both the Federal Courts and the Patent Trial and Appeal Board.  His extensive litigation experience, and his background as a researcher and inventor, has served him well in counseling clients on how to successfully cross the intersection of FDA and patent law.

Pablo's clients have consistently praised him as an "excellent lawyer" and for his "sterling" work in ANDA litigations. They are comforted by his "seen-and-done-it-all experience" who “blends deep patent law and regulatory knowledge.” 

Pablo has written and spoken on a broad range of patent-related topics, particularly in the area of Hatch Waxman litigation.

Online CLE Paragraph IV

Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   Live Webcast

Prerequisite:
   General knowledge of patent litigation

Course Code:
   147929

NY Category of CLE Credit:
   Area of Professional Practice

Total Credits:
   2.0 CLE

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About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Pierce Bainbridge is a top-tier litigation firm that is changing the way companies and individuals approach major disputes.  We are relentless, creative, and aggressive, and we’re always on the hunt for strategic and tactical advantages that can benefit our clients and secure victory.  Our team is composed of the finest trial lawyers from the best law schools who were trained at the biggest law firms in the world.

We know how to win – and that’s what we do best. Attorneys at our firm have won jury verdicts and settlements totaling well over $3 billion dollars.  We provide our clients with a high-stakes litigation force to vindicate and protect their rights.

We approach every case with unparalleled dedication, precision, and creativity.  We learn our clients’ business, understand their disputes, analyze our opponents, and do everything it takes to obtain the best outcome possible.

We know that litigation can be expensive, so we strive to handle cases in an extraordinarily efficient manner without compromising the outstanding quality of our work. Unlike our competitors, we’re always willing and able to devise creative and unorthodox fee arrangements that take account of the business needs of each of our clients.

Website: https://www.piercebainbridge.com/

Jones Day is a global law firm with more than 2,500 lawyers in 43 offices across five continents. The Firm is distinguished by: a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.

Website: https://www.jonesday.com/

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