Gregory D. Fernengel

Gregory D. Fernengel

Partner
Phone: 216.363.9212
Email: gfernengel@faysharpe.com
Fax: 216.363.9001
Team Member Since: 2019
Practice/Technical Competence:

Greg Fernengel focuses his practice on intellectual property law (patent, trademark, and copyright), regulatory law, and business contracts. Greg is an experienced patent attorney, who has also been a registered pharmacist for over 20 years.  His combined experience differentiates him from other lawyers.  Due to his vast knowledge, he has been asked to speak frequently at conferences and symposiums.

His dual professional degrees have been an asset to numerous pharmaceutical clients, as well as clients in the chemical and mechanical fields.  He has provided counsel to everyone from Fortune 100 corporations to individual inventors, and has served his clients in both in-house and outside counsel roles.  Prior to joining Fay Sharpe, Greg was already well-known in the pharmaceutical community due to his leadership roles at Bedford Laboratories and Roxane Laboratories, generic drug divisions of Boehringer Ingelheim.  Greg was a key contributor to the Hatch Waxman IP and Regulatory strategy along with the overall business strategies of the companies.

Pharmaceutical Experience

Greg has counseled clients on many areas in the pharmaceutical space including: Hatch-Waxman patent and regulatory exclusivity strategy; pharmaceutical patent litigation; freedom to operate and patentability opinion work; patent and trademark preparation and prosecution; pharmaceutical lifecycle management; Paragraph IV Abbreviated New Drug Application (ANDA) and 505b2 New Drug Application (505b2 NDA) filing and launch strategies, FDA Orange Book exclusivity and forfeiture analysis, FDA Citizen Petition counsel, biosimilar and over-the-counter product filing and launch strategy, Hatch-Waxman litigation, State Board of Pharmacy licensing, DEA license consultation, patent and trademark settlement negotiation and licensing, and patent, trademark and copyright portfolio management.

Patent Experience

Greg’s patent experience includes: freedom to operate and patentability opinions, patent litigation, patent drafting, and patent prosecution, both domestically and overseas. Greg’s experience is in the pharmaceutical field, chemical, biochemical, cannabis, and mechanical arts, along with design patents. Greg also has vast experience with in-licensing and out-licensing of patents.

Regulatory Guidance

Greg’s regulatory experience includes: Abbreviated New Drug Application (ANDA) and New Drug Application (505b1 and 505b2 NDAs) filing and launch strategy consultation; FDA Citizen Petition counsel; over-the-counter product and biosimilar regulatory strategy; State Board of Pharmacy licensing requirements and negotiations with Boards of Pharmacy; State Medical Board and telemedicine requirements; DEA license consultation; Medical Marijuana/Cannabis advice and counsel; 510k/ Premarket Approval medical device counseling.

Business Contracts

Greg has experience providing counsel in business contract law with a primary focus on business development deals, including: strategic co-development partnerships, sales and marketing deals, confidentiality agreements, and in-licensing and out-licensing of pharmaceutical products.

Copyrights, Trademarks & Trade Secrets

Greg has provided counsel on the filing of copyrights and trademark applications, as well as enforcement of registered copyrights and trademarks.  Greg has also provided counsel regarding trade secret infringement and misappropriation. Client’s have ranged in size from independent artists through large corporations.

Registrations:

Member Ohio Bar; U.S. District Court (Northern District of Ohio); registered to practice before the U.S. Patent and Trademark Office

Memberships:
  • American Pharmacists Association
  • Cleveland Metropolitan Bar Association
  • Cleveland Intellectual Property Law Association
Education:
  • Case Western Reserve University School of Law (J.D., 2003)
  • The Ohio State University (B.S., Pharmacy, 1998)
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