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

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


Conducted on Thursday, October 26, 2017

Recorded event now available

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Program Materials

This CLE webinar will provide guidance to patent counsel on solid form patents, how to patent them, and challenges that are in the process. 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.

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 such forms to provide drug substance protection beyond 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 solid form claims are drafted, and review lessons from recent cases.

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Outline

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

Benefits

The panel will review these and other key issues:

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

Faculty

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
Senior Research Investigator, Materials Science
SSCI

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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