Scientific Advisor Profile

Email this Page

Howard E. Rosenberg, Ph.D.

Scientific Advisor
Frommer Lawrence & Haug LLP

Suite 13, Imperial Place
4 Maxwell Road
Borehamwood, Hertfordshire WD6 1JN
United Kingdom
Telephone: +44 (0) 20 8213 3068
hrosenberg@flhlaw.com
vCard

Author, FDA Lawyers Blog, www.fdalawyersblog.com

Scientific Areas

Chemistry
Pharmacy

Summary

Howard Rosenberg has spent over 30 years in the pharmaceutical industry and for much of that time has been involved in intellectual property matters.

Dr. Rosenberg qualified as a medicinal chemist, having read Chemistry at The Queen's College, Oxford, and then completed a Ph.D. in the Pharmacy Department of the University of Manchester. He then entered the pharmaceutical industry and spent several years in medicinal chemistry research, firstly synthesizing radio-labeled compounds at May and Baker and then nine years at Beecham Pharmaceuticals researching into several different disease areas before changing direction and moving to Generics [UK] Ltd. in 1986. The company then became Merck Generics where he was the Group Intellectual Property (IP") and Active Pharmaceutical Ingredient ("API") Strategy Director and was responsible for the start up of several distinct and diverse teams covering areas ranging from IP to API synthesis. He then ensured that these different groups were combined into one team and under his leadership they afforded strong scientific input into supporting the company worldwide. He was involved not only with IP matters on an international scale but in Regulatory Affairs including assisting/visiting API facilities and assessing the corresponding Drug Master Files. He helped to instigate and develop the lobby organization, now known as the European Generic Medicines Association ("EGA"), for the European generics industry. He has given numerous presentations at various symposia both in UK and abroad covering IP, aspects of APIs, and other matters of concern to the generic industry.

Dr. Rosenberg has worked with law firms and attorneys on many pharmaceutical patent cases throughout the world. Examples of the more significant cases are as follows.

Australia:
Omeprazole, ranitidine, escitalopram, paroxetine

European Union:
Omeprazole, ranitidine, paroxetine, alendronate, clarithromycin, seretide, citalopram, escitalopram, galantamine, levofloxacin

Canada:
Omeprazole, ranitidine, paroxetine, citalopram, escitalopram

USA:
Ranitidine, omeprazole, clarithromycin, paroxetine, galantamine, pioglitazone, escitalopram, levalbuterol.

Experience

Frommer Lawrence & Haug LLP [Scientific Advisor]January 2009 - Present


The UK office enables Frommer Lawrence & Haug LLP ("FLH") to extend and enhance its assistance to its clients, both U.S. and non-U.S., by providing an international input and outlook. Developing products, whether as an innovator or generic, requires knowledge and understanding of the wider intellectual property scenario, the regulatory requirements and the consequences that differing jurisdictions have on the market place. Having a European office, and with contacts in other major jurisdictions, enables FLH's clients to better assess outcomes particularly for the U.S. and European markets. Investigating patent and regulatory information internationally better enables tactical and strategic product development and helps reduces surprises.


Generics [UK] Ltd. (Merck Generics) [Group IP and API Director] 1986-2008


Dr. Rosenberg was responsible for the start up of several distinct and diverse teams covering areas ranging from intellectual property to API synthesis. He then ensured that these different groups were combined into one team and under his leadership they afforded strong scientific input into supporting the company worldwide. He was involved not only with Intellectual Property matters on an international scale but in Regulatory Affairs including assisting/visiting API facilities and assessing the corresponding Drug Master Files. He helped to instigate and develop the lobby organization, now known as the European Generic Medicines Association ("EGA"), for the European generics industry.


May and Baker [Radiochemist] 1975-1977


Synthesis and purification of radio-labeled drugs


Beecham Pharmaceuticals [Research Scientist] 1977-1986


Medicinal Chemistry Research for novel drugs in the following areas:

  • Anti-inflammatory 1977-1982
  • Anti-Psychotic 1982-1984
  • Chronic Organic Brain Disease 1984-1986

Education

M.A. Chemistry (Hons), The Queen's College, Oxford, 1968-1972
Ph.D. Medicinal Chemistry, University of Manchester, 1972-1975

Membership

Royal Society of Chemistry (Currently Law Group, Treasurer March 2012)

Recent Representative Publications

April 2004, Journal of Generic Medicines, Is marketed -- The story and the ECJ Decision. The case of Generics [UK], vol. 1, no. 3, pp. 238-241(4).

Recent Representative Speeches

March 2012, 8th EGA Legal Affairs Forum, SPCs Case Overviews: Escitalopram.

June 2011, 13th International Workshop on Physical Characterization of Pharmaceutical Solids (IWPCPS-13), IP Adventures in CJEU, EPO and National Courts.

March 2011, 7th EGA Legal Affairs Forum, SPCs Cases.

February 2011, World Generic Medicines Congress Europe 2011, International IP Developments.

January 2009, Biotech and Pharmaceutical Patenting, Munich, Germany, Speaker on Panel "EU Sectorial Enquiry".