Trends in Paragraph IV Challenges: What Lies Ahead in 2017 and Beyond
The Hatch-Waxman Act encourages generic drug manufacturers to challenge active drug patents and gain market entry before those patents expire. The generic company, who is the first to file its Abbreviated New Drug Application (ANDA) with a Paragraph IV certification and prevails subsequent lawsuit, is granted 180 days of market exclusivity. This is a valuable opportunity that attracted many generic drug manufacturers - like Teva, Actavis, Mylan, and Sandoz - to be aggressively involved in Paragraph IV filings.
Over the years, the percentage of brand name drugs facing Paragraph IV patent challenge has increased. Additionally, patent challenges occur much earlier in time after the branded product is approved and launched.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will provide the audience with an analysis of the recent trends in Paragraph IV patent challenges. They will also discuss significant court decisions and settlement outcomes on patent challenges.
Key topics include:
- Important rule changes
- What’s pending in the courts at various levels
- Supreme Court treatment in these matters
- Guidelines for providing notice
- Practice tips IPR’s and ANDA litigations
- Recent Trends on Patent Challenges
- Factors Influencing These Trends
- Paragraph IV Court Decisions and Settlements
Dean L. Fanelli, Partner
Seyfarth Shaw LLP
Jamaica Szeliga, Partner
Seyfarth Shaw LLP
Parithosh K. Tungaturthi, Patent Agent
Seyfarth Shaw LLP
- ANDA Patent Statistics and Trends
- Updates on Legal Theories and Practices
- Notice Letters
- On-Sale Bar
- Obviousness-Type Double Patenting
- Injunctive Relief
- Antitrust Concerns
- ANDA IPRs and Top Cases
- Pending Legislation and Other Developments
Who Should Attend:
- Patent Legal Counsel
- Pharma Industry Lawyers
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Litigators
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Drug Manufacturing Companies
- Drug Manufacturing Executives
- Other Related/Interested Professionals
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. Fanelli’s expertise lies in patent portfolio creation and management, counseling, technology transactions, due diligence, opinion work, including drafting novelty, freedom-to-operate, and invalidity opinions, and inter partes review and post grant review proceedings. Dr. Fanelli also has significant experience with the interplay between patent and FDA laws under the Hatch-Waxman Act, and he regularly handles IP issues attendant to mergers, acquisitions, and financing for life sciences companies as well as ANDA analyses associated with Hatch-Waxman paragraph IV litigation.
Dr. Fanelli received his J.D. from The George Washington University Law School and received his Ph.D. in organic chemistry from Temple University, where he studied the syntheses of biologically active amino acids and amino acid derivatives under the supervision of Dr. Franklin A. Davis.
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. …
Jamaica Szeliga is a partner in the Litigation Department of Seyfarth Shaw LLP’s Washington, D.C. office.
Ms. Szeliga’s practice focuses primarily on intellectual property litigation relating to pharmaceutical, biotechnology, and chemical matters. She also litigates patent disputes involving other technologies, including medical devices, mechanical inventions, communications, and high tech products, and further has significant experience in design patent litigation.
With respect to litigation, Ms. Szeliga has participated in several bench and jury trials and managed litigations at all stages. As part of her experiences, Ms. Szeliga has drafted and argued dispositive motions, coordinated complex fact discovery, managed expert discovery, taken and defended fact and expert depositions, examined witnesses at trial, engaged in mediation and dispute resolution processes, and briefed multiple appeals. She also has been a member of several joint defense groups, and has litigated against such groups, particularly in the context of Hatch-Waxman ANDA matters.
Jamaica Szeliga is a partner in the Litigation Department of Seyfarth Shaw LLP’s Washington, D.C. office. Ms. Szeliga’s practice …
Parithosh K. Tungaturthi is a patent agent in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. With over 12 years of experience, Dr. Tungaturthi focuses his practice in the areas of patent prosecution, due diligence and opinion work, including drafting novelty, freedom-to-operate, and invalidity opinions. Dr. Tungaturthi’s practice also includes Hatch-Waxman litigation and FDA Regulatory and Compliance matters.
Dr. Tungaturthi has significant expertise in a broad range of disciplines including antibody engineering and therapeutics, cancer immunology, molecular diagnostics, genetic engineering, stem cell technology, pharmaceuticals, active pharmaceutical ingredients, formulations, drug delivery, vaccines, medical devices, and plant breeding and biotechnology. He also has experience in nanotechnology, polymer chemistry, organic and inorganic chemistry, biomaterials, and biofuels.
Prior to joining the firm, Dr. Tungaturthi worked at prominent law firms in the Washington, D.C. area and at the U.S. Patent and Trademark Office.
Dr. Tungaturthi earned his J.D. from The University of Baltimore School of Law. He received his Ph.D. in Molecular Biology and Immunology from Thomas Jefferson University and is a graduate of Louisiana State University, where he received his B.S. in Microbiology and conducted research in Organic Chemistry. Dr. Tungaturthi’s undergraduate and graduate research studies have been published in peer-reviewed scientific journals.
Parithosh K. Tungaturthi is a patent agent in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. With …
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Method of Presentation:
Experience in pharmaceutical law
NASBA Field of Study:
Business Law - Technical
NY Category of CLE Credit:
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About Seyfarth Shaw LLP
Seyfarth Shaw LLP has more than 850 attorneys and provides a broad range of legal services in the areas of intellectual property, labor and employment, employee benefits, litigation, corporate and real estate. With offices in Atlanta, Boston, Chicago, Houston, London, Los Angeles, Melbourne, New York, Sacramento, San Francisco, Shanghai, Sydney and Washington, D.C., Seyfarth’s clients include over 300 of the Fortune 500 companies and reflect virtually every industry and segment of the economy. A recognized leader in delivering value and innovation for legal services, Seyfarth’s acclaimed SeyfarthLean client service model has earned numerous accolades from a variety of highly respected third parties, including industry associations, consulting firms and media. For more information, please visit www.seyfarth.com.