Paragraph IV Challenges: Exploring Emerging Trends and Developments
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. In the context of medical diagnostics and methods of treatment claims, these challenges include divided infringement and Section 101 problems.
Counsel to both brand and generic companies should be prepared with the emergence of new developments that will shape the Paragraph IV litigation landscape, particularly claims directed to diagnostics and methods of treatment.
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:
- Section 101 Patentability Challenges - Recent Developments for Method of Treatment Patent Claims
- Courts' Application of the Mayo Two-Part Test
- Divided Infringement in Medical Diagnostics and Methods of Treatment Claims
- The Akamai test
- Best Litigation Practices and Practical Tips
Gregory B. Sephton, Ph.D., Partner
Pierce Bainbridge Beck Price & Hecht LLP
Since the Supreme Court’s Mayo decision in 2011, Section 101 patentability challenges have substantially increased, including in life sciences claims directed to, for example, diagnostics and methods of treatment.
This section of the webinar will address recent developments in Section 101 patentability challenges to method of treatment patent claims in Hatch-Waxman Act litigation.
More specifically, how have courts applied the Mayo two part test to determine whether or not methods of treatment claims satisfy Section 101 patentable subject matter.
Pablo D. Hendler, Partner
In the context of medical diagnostics and methods of treatment claims, divided infringement presents a potentially significant problem. Although careful claim drafting may help to avoid this problem, other problems may arise, including Section 101 challenges.
This section of the webinar will address the Akamai test, and how subsequent cases suggest that divided infringement may not be as significant a problem as once thought.
Who Should Attend:
- Bio/Pharma Companies
- Healthcare Institutions
- Medical Providers
- Drug Manufacturing Executives
- In-house Counsel
- Patent Attorneys
- Patent Agents
- Other Related/Interested Professionals and Organizations
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.).
Gregory B. Sephton, Ph.D., has over 25 years of experience in all aspects of patent litigation and has played leading …
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.
Pablo Hendler has counseled clients for nearly 25 years in intellectual property matters. Focusing his practice on life science patent …
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Method of Presentation:
General knowledge of patent litigation
NY Category of CLE Credit:
Area of Professional Practice
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