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

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.