STEERING THROUGH FDA AND INTO SUCCESS

Date: 21.01.2018 |

JLM-BioCity announces:
“STEERING THROUGH FDA AND INTO SUCCESS”
Feb 4, 2018 18:30
with
Alan Minsk, Partner, Arnall Golden Gregory, LLP
& Michael D. Hammer, PhD, Partner, JMB Davis Ben-David

Many companies view the FDA as an obstacle. With correct planning of your business, your technology development and your IP, the FDA can be used as a stepping stone to success.

“CHALLENGES AND OPPORTUNITIES WHEN COMMUNICATING WITH THE US FDA”
Alan Minsk, Partner, Arnall Golden Gregory, LLP
Whether your company is large or small, a medical device, pharmaceutical, or food company, or U.S.-based or not, proper communications with the FDA is essential to obtain approval and to stay in compliance. Many companies become frustrated when they believe that FDA isn’t seeing how promising and successful their product can be or feel that FDA is a nuisance, more than a help, in advancing medical and therapeutic advancements. We will review common mistakes companies make when communicating with FDA in the pre- and post-approval phases of product development, and opportunities that exist to improve such communications.

“BROADER IS NOT ALWAYS BETTER: PATENT CLAIMING STRATEGIES AND THE FDA”
Michael D. Hammer, PhD, Partner, JMB Davis Ben-David
The FDA maintains a list of “Approved Drug Products” known as the Orange Book. When a generic drug maker submits an Abbreviated New Drug Application (ANDA) to obtain approval for a generic version of a drug listed in the Orange Book, it must certify whether the listed drug is covered by an existing patent. Among the possibilities for this certification is a statement by the ANDA Applicant that an indicated patent is either invalid or that it will not be infringed by the proposed generic drug. Under US patent law, such a certification can be the basis of an infringement suit against the ANDA Applicant. Patent Attorneys often try to obtain broad claims to an invention, but for winning an ANDA suit, which will require comparison with the highly-specific Orange Book listing, a broad claim may not be a better claim. In this presentation, we will discuss how regulatory and patenting strategies can have far-reaching implications for the strength of a patent in the face of an ANDA challenger.

JLM-BioCity is delighted to announce that this event is sponsored by the Azrieli College of Engineering.

Presentations will be in English.

RVSP to reserve your place. We request 20 NIS upon entrance to the event to help cover costs. JLM-BioCity is a non-profit organization. ENTRANCE WILL ONLY BE FOR PEOPLE WHO HAVE RVSP’ED AND SENT THEIR NAME IN HEBREW AND CAR LICENCE to good.o.joe@gmail.com

About our invited speakers:

* Alan Minsk, Partner, Arnall Golden Gregory, LLP

Alan G. Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia and Washington, D.C. Mr. Minsk advises companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration and the Drug Enforcement Administration. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. * Michael D. Hammer, PhD, Partner, JMB Davis Ben-David

Dr. Mike Hammer is a registered US Patent Attorney with a J.D. from Lewis and Clark Law School, a PhD. in Molecular Genetics and Cell Biology from the University of Chicago, and a BA in Biology from Oberlin College. Dr. Hammer is a member of the Oregon State Bar.

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