Paul A. Braier, Ph.D.

Paul A. Braier, Ph.D.

Partner

pbraier@gbpatent.com

Firm Practice Areas/Practice Groups

Client Counseling, Licensing and Technology Transfer
Litigation and Trial
Pharmaceutical
Biosimilars
Biotechnology
Chemical

Experience

Technical Expert – Greenblum and Bernstein, P.L.C. – 1995-1999
Patent Attorney – Greenblum and Bernstein, P.L.C. – 1999-Present

Offices/Professional Activities

Seminar producer and presenter, International Generic Pharmaceutical Alliance, annual conferences, 2000-Present
Seminar producer and presenter, European Generic Medicines Association, annual conferences, 2007-Present

Notable

Pharmaceutical practice is concentrated in Hatch-Waxman pharmaceutical counseling and litigation.

Professional Associations and Memberships

American Chemical Society

Representative Publications

Braier, P., “A Statistical Glimpse into the First Three Years of Post-Issuance Proceedings under the AIA.”  12 Journal of Generic Medicines 34-37 (2015).

Braier, P., “Losing Sleep over REMS?:  The Impact of Enhanced Safety Measures on Generic Access.”  11 Journal of Generic Medicines 146-149 (2015).

Braier, P., “The role of the product label in patent infringement.”  9 Journal of Generic Medicines 144-148 (2012).

Braier, P., “A Brief Summary of The America Invents Act.”  9 Journal of Generic Medicines 29-32 (2012).

Braier P., “Recent Developments in Hatch-Waxman patent term extensions.” 8 Journal of Generic Medicines 57-62 (2011).

Braier P., “When the Generic Has No Remedy: FDA, Use Codes, and the Case of Novo Nordisk v. Caraco.” 7 Journal of Generic Medicines 363-370 (2010).

Majiduddin, F.K., Braier, P., “Recent Cases Highlight Shortcomings and Inconsistencies in the Law: In re Ciprofloxacin; Celgene v. KV and SB Pharmco v. Mutual.” 6 Journal of Generic Medicines 167-75 (2009).

Angres, M., Braier, P., “Standing up for Generic Manufacturers: The Increasing Ability to Challenge NDA Patents.” 6 Journal of Generic Medicines 73-78 (2008).

Braier, P., “Acarbose: A Case Study in the Forfeiture of the 180-Day Exclusivity.” 5 Journal of Generic Medicines 235-240 (2008).

Goldberg, N., Braier, P., “Federal Circuit Abandons ‘Affirmative Duty of Due Care’ Willful Infringement Standard and Clarifies the Scope of Waiver Resulting m the ‘Advice of Counsel’ Defense.” 5 Journal of Generic Medicines 153-58 (2008).

Greenblum, N., Fink, M., Roylance, S., Pejic, P.B., Myers-Payne, S.C., Braier, P., (2008). “Generic Drugs in a Changing Intellectual Property Landscape” The Pharmaceutical Regulatory Process, Second Edition, pps. 143-180, Ira R. Berry and Robert P. Martin, eds., Informa Health Care

Braier, P., Jayaprakash, Azza M., “Indirect Patent Infringement in the U.S.: Points to Consider for Generic and API Manufacturers.” 4 Journal of Generic Medicines 287-92 (2007).

Braier, P., “The ABC’s of ANDAs: A primer on the generic drug approval process in the United States” PharmaChem, 8-11 (June, 2005).

Braier, P., Roylance. S., Greenblum. B., “U.S. Case Law Developments in 2005.” 3 Journal of Generic Medicines 237-43 (2005).

Braier, P., “New Medicare law brings changes to Hatch-Waxman Act.” 1 Journal of Generic Medicines, 267-272 (2004).

Languages

Spanish (proficient)

Education

College of William and Mary, B.Sc. (Chemistry) (With High Honors, 1986)
The University of Chicago, Ph.D., Chemistry (1993)
Hebrew University, Lady Davis Postdoctoral Fellowship
Georgetown University Law Center, J.D. (1999)
Member, Journal of Legal Ethics

Courts

Supreme Court of Virginia
U.S. Court of Appeals for the Federal Circuit

Bar Admissions

1997, USPTO
1999, Virginia