Drug Substance Patents: FDA Guidance, Protecting Composition-of-Matter Patents, Drafting Solid Form Claims

Description

Composition-of-matter patents, listed as "drug substance" patents, are considered the most valuable of Orange-Book listable patents. More frequently, however, approved drugs having no or limited composition-of-matter patent protection are being launched.

For smaller companies looking to partner, especially those developing re-tasked assets, composition-of-matter protection is critical to substantiate value in deal-making. While reliance on other categories of patents may help, science-based approaches can often create new intellectual property to "reset" the drug substance patent clock and create a new composition-of-matter estate.

These tactics take advantage of "solid forms" and involve salts, cocrystals, polymorphs, or amorphous active pharmaceutical ingredients. These forms may be independently patentable over traditional composition-of-matter patents based on covalently bound molecules and may also be listable in the Orange Book.

Listen as our authoritative panel examines solid forms, provides specific examples of products in the Orange Book using patents to provide drug substance protection beyond the composition of matter, and discusses both patentability and infringement issues related to such patents. The panel will also discuss the recent FDA guidance on cocrystals and implications for patent strategy, outline how to draft substantial form claims, and review lessons from past cases.