Patenting Repurposed Drugs: Overcoming Subject Matter Eligibility, Prior Art, and Obviousness Hurdles
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE course will guide counsel on patenting repurposed drugs. The panel will examine the interplay between FDA exclusivity and patent exclusivity, key considerations when seeking to patent a repurposed drug, and addressing novelty and obviousness hurdles. The panel will discuss how to address these challenges in a manner that maximizes product exclusivity.
- Interplay between FDA exclusivity and patent exclusivity
- Subject matter eligibility
- Best practices for overcoming hurdles and patenting repurposed drugs
The panel will review these and other key issues:
- What evidentiary support should counsel provide to bolster its assertion of validity/patentability for repurposed drugs?
- What considerations and tactics should patent counsel implement to anticipate and overcome novelty and/or obviousness rejections?
- How should applicants draft their patent application to reduce the likelihood of rejection?
John M. Covert
Sterne Kessler Goldstein & Fox
Mr. Covert focuses on technologies that involve organic chemistry, such as pharmaceuticals, coatings, fuels, lubricants... | Read More
Mr. Covert focuses on technologies that involve organic chemistry, such as pharmaceuticals, coatings, fuels, lubricants and pesticides. He is experienced in a number of interdisciplinary areas, including computer-aided drug design, combinatorial chemistry and medical devices. He provides counseling with regard to patent portfolio strategy and management with issues that range from licensing, collaborations and technology acquisitions, to patent validity, infringement and design around strategies. He has performed intellectual property due diligence investigations and has assisted in all aspects of technology transfer in the pharmaceutical and biotechnology fields. He has also created and managed patent portfolios; performed freedom-to-operate clearances; created patent strategies for protection of developmental candidates as they progress through pre-clinical and clinical development to commercial stage; cleared biological targets for clients to begin new drug discovery; resolved inventorship disputes; and worked with clients to design products that avoid third party patents.Close
Marsha Rose Gillentine, Ph.D.
Sterne Kessler Goldstein & Fox
Dr. Gillentine primarily focuses on the pharmaceutical industry. She is intimately familiar with the Hatch-Waxman Act... | Read More
Dr. Gillentine primarily focuses on the pharmaceutical industry. She is intimately familiar with the Hatch-Waxman Act and Biologics Price Competition and Innovation Act and understands patent litigation strategy in the context of the statutory schemes and Patent Office Litigation. She has provided hundreds of patentability, noninfringement, and invalidity opinions. She has rendered opinions in a variety of technology areas including: small molecules, therapeutic antibodies, polymorphs, salts, synthesis, pharmaceutical formulations, and pharmacokinetics. She also assists clients in implementing lifecycle management strategies, including those for precision medicine patent portfolios. Her practice encompasses both domestic and foreign patent prosecution, including patent drafting and patent prosecution. She has drafted and prosecuted patents related to various pharmaceutical issues.Close
Gaby L. Longsworth, Ph.D.
Sterne Kessler Goldstein Fox
Dr. Longsworth is a director in the firm's Biotechnology & Chemical Practice. She is sought out by innovator... | Read More
Dr. Longsworth is a director in the firm's Biotechnology & Chemical Practice. She is sought out by innovator and generic pharmaceutical companies world-wide for her insights and knowledge of intellectual property and Hatch-Waxman law. Dr. Longsworth counsels biopharmaceutical clients from around the world in all areas of patent procurement, including domestic and foreign patent preparation and lifecycle management strategies. She also counsels clients in IP due diligence evaluations for raising and investing in growth capital, executing strategic partnerships and M&A transactions, and going public. Dr. Longsworth practices primarily in the fields of biotherapeutics, small molecules, biologics, immunotherapy, antibody technologies, microbiome-based technologies, synthetic biology, DNA amplification/PCR, diagnostics, vaccines, viral vectors and drug delivery.Close