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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

  • work Practice Area

    Patent

Date & Time
  • event Date

    Thursday, April 30, 2020

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$347.00
CLE
ALL

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.

Faculty

Eyal H. Barash
Member
Barash Law, LLC

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.

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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 morphology prediction. At AMRI West Lafayette, 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.

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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.

Outline

  1. Solid forms
  2. FDA co-crystal 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 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?