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
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.
- Solid forms
- FDA co-crystal guidance
- 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?
Eyal H. Barash
Mr. Barash specializes in legal services for emerging knowledge-based companies with a special emphasis in life science... | Read More
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.Close
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
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.Close