Recent developments in US patent law will provide both challenges and opportunities for creating effective intellectual property and commercialization strategies for prenatal molecular diagnostic methods and may ultimately influence provider and patient access to certain tests.

In Mayo v. Prometheus [1], the US Supreme Court addressed the legal standards for patent-eligible subject matter under 35 USC §101, with important implications for patents directed to diagnostic methods.

To view the full text, click here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.