Inducement to Infringe in Hatch-Waxman Litigation: Strategies for Patent Drafting, Prosecution, and Litigation
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE course will provide patent counsel with suggestions on claim and label language; to proactively coordinate patent, regulatory, and clinical personnel; and to maintain consistency between claims and likely or actual label language throughout patent prosecution and label negotiation with the FDA.
Outline
- Traditional infringement analysis focus is on claim language, but inducement to infringe analysis in the Hatch-Waxman context additionally focuses on the label language
- Recent court treatment
- Strategies and tactics
- Maintain the coordination referenced above throughout the U.S. patent prosecution and label negotiation with FDA
- Maintain consistency between claims and likely or actual label language
- Coordinate patent, regulatory, and clinical personnel early
Benefits
The panel will review these and other notable questions:
- What are the lessons from recent decisions?
- What are the best approaches to maintain consistency between claims and likely or actual label language?
- What are the steps to maintain the coordination of patent, regulatory, and clinical personnel throughout the patent prosecution and label negotiation with the FDA?
Faculty
Mark J. Feldstein, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and... | Read More
Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.
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Justin J. Hasford
Partner
Finnegan Henderson Farabow Garrett & Dunner
Mr. Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation... | Read More
Mr. Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation at the trial and appellate levels on behalf of pioneer pharmaceutical companies. He has particular experience with cases arising from Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act. Justin also has litigated antitrust cases and business method patent cases. He counsels clients on issues of infringement, validity, enforceability, unfair competition, licensing, due diligence, and IP portfolio management. He has extensive experience advising clients regarding the interplay between patent and regulatory laws, including Orange Book listing of patents for drugs approved by the FDA.
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Thomas L. Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
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Jill K. MacAlpine, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling,... | Read More
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.
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Barbara R. Rudolph, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and... | Read More
Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and biotechnology cases over the past twenty years. She serves as lead counsel in pharmaceutical and biotechnology disputes and has extensive litigation experience in federal courts. She has argued before the U.S. Court of Appeals for the Federal Circuit and authored an amicus brief submitted to the U.S. Supreme Court in a landmark biotechnology patent case. She devises strategies to protect clients' valuable intellectual property involving sophisticated technologies in the pharmaceutical and biotechnology industries.
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