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

Directors John M. Covert, Marsha Rose Gillentine, Ph.D., and Gaby L. Longsworth, Ph.D. presented the webinar “Patenting Repurposed Drugs: Overcoming Subject Matter Eligibility, Prior Art, and Obviousness Hurdles” hosted by Strafford on Thursday, April 11, 2024.

The CLE course guided counsel on patenting repurposed drugs. The panel examined 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 also discussed how to address these challenges in a manner that maximizes product exclusivity.

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.

Watch the recording as our authoritative panel of patent attorneys reviewed key considerations when seeking to patent a repurposed drug. The panel also addressed subject matter eligibility, novelty, and obviousness hurdles, as well as offered guidance on overcoming these challenges.

Outline

1. Interplay between FDA exclusivity and patent exclusivity
2. Novelty
3. Obviousness
4. Subject matter eligibility
5. Best practices for overcoming hurdles and patenting repurposed drugs

Benefits

The panel reviewed 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?