Patenting Repurposed Drugs: Overcoming Subject Matter Eligibility, Prior Art, and Obviousness Hurdles

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Thursday, April 11, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Faculty

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.

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.

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.
Description
The development of new drugs is typically a long, expensive, and arduous process with a high failure rate. Consequently, companies seek to repurpose previously approved drugs to treat conditions that were not originally intended or approved, or to market a new dosage form. Alternatively, drug candidates that failed to meet a clinical endpoint but have shown some positive attributes can be investigated for a new use. The repurposing of drugs may cost significantly less with a shorter development timeline.
Obtaining patent protection can be challenging because the drugs involved are already known and uses and various dosage forms may already be disclosed in the prior art. Without patent protection or FDA exclusivity, commercialization of the drug is not likely.
As with all patents, repurposed drugs often face the hurdles of subject matter eligibility, novelty, and obviousness. Usually, repurposed drugs are subject matter eligible, but the claims should be carefully written to minimize the likelihood of Section 101 issues. The Section 102 requirement that the repurposed drug be novel can be challenging as there may be a lot of prior art. Obviousness under Section 103 may pose the most significant challenge as Section 103 rejections can be difficult to overcome without at least some evidence of secondary indicia.
Listen as our authoritative panel of patent attorneys examines key considerations when seeking to patent a repurposed drug. The panel will address subject matter eligibility, novelty, and obviousness hurdles, as well as offer guidance on overcoming these challenges.
Outline
- Interplay between FDA exclusivity and patent exclusivity
- Novelty
- Obviousness
- Subject matter eligibility
- Best practices for overcoming hurdles and patenting repurposed drugs
Benefits
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?
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