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

Recording of a 90-minute premium CLE webinar with Q&A

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Conducted on Thursday, April 30, 2020

Recorded event now available

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This CLE course will guide patent counsel on solid form patents, how to patent them, and process challenges. The panel will also discuss implications of the current cocrystal guidance by the FDA and provide a survey of, and lessons from, cases relating to solid form patents.


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.



  1. Solid forms
  2. FDA co-crystal guidance
  3. Survey of cases relating to solid form patents


The panel will review these and other key issues:

  • A brief scientific introduction to solid forms
  • What are the critical patentability issues when preparing solid form patents?
  • How are pharmaceutical companies using solid form patents?
  • What is different about claiming solid form patents concerning "organic chemistry" claims in other composition-of-matter patents?
  • What impact does the FDA guidance on cocrystals have on patenting the composition of matter?


Barash, Eyal
Eyal H. Barash

Barash Law

Mr. Barash specializes in legal services for emerging knowledge-based companies with a special emphasis in life science...  |  Read More

Boerrigter, Steef
Dr. Steef Boerrigter

Sr. Research Scientist
AMRI West Lafayette

Dr. Boerrigter holds a PhD in Materials Science from Nijmegen University in the Netherlands on the subject of crystal...  |  Read More

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