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

A live 90-minute CLE webinar with interactive Q&A


Thursday, October 26, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, September 29, 2017


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.

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

Eyal H. Barash
Barash Law, Lafayette, Ind.

Mr. Barash specializes in legal services for emerging knowledge-based companies with a special emphasis in life science companies. He has a particular focus in counseling companies in solid form patent applications including cocrystals, polymorphs, amorphous dispersions, and salts including prosecution, licensing, and litigation strategies.

Dr. Steef Boerrigter, Senior Research Investigator, Materials Science
SSCI, West Lafayette, Ind.

Dr. Boerrigter holds a PhD in Materials Science from Nijmegen University in the Netherlands on the subject of crystal morphology prediction. At SSCI, he is a group leader in Materials Science and performs experimental screening for polymorphs, salts, and cocrystals. His group specializes in crystal growth for single-crystal structure elucidation. He developed computational methods for virtual coformer screening. Previously, he worked on a Marie-Curie postdoctoral fellowship at the imaging company Agfa-Gevaert on modeling of morphology alteration by tailor-made additives as well prediction of the color changes of dyes when they crystallize into pigments. In 2003 he joined the Industrial and Physical Pharmacy department at Purdue University, where he has co-instructed the Pharmaceutical Solids course. His research mainly focused on polymorph prediction, structure solution from powder X-ray data, and he maintained the departmental powder diffraction instrument.


Live Webinar

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This webinar is eligible for at least 1.5 general CLE credits.

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Customer Reviews

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Kohler

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Patent Law Advisory Board

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Locke Lord

David S. Bloch

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Winston & Strawn

Irah H. Donner

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Manatt

Ian N. Feinberg

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Feinberg Day Alberti & Thompson

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Partner

Orrick

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