Scientific Advisor Profile
Howard E. Rosenberg, Ph.D.
Frommer Lawrence & Haug LLP
Author, FDA Lawyers Blog, www.fdalawyersblog.com
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.
Omeprazole, ranitidine, escitalopram, paroxetine
Omeprazole, ranitidine, paroxetine, alendronate, clarithromycin, seretide, citalopram, escitalopram, galantamine, levofloxacin
Omeprazole, ranitidine, paroxetine, citalopram, escitalopram
Ranitidine, omeprazole, clarithromycin, paroxetine, galantamine, pioglitazone, escitalopram, levalbuterol.
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
M.A. Chemistry (Hons), The Queen's College, Oxford, 1968-1972
Ph.D. Medicinal Chemistry, University of Manchester, 1972-1975
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 2011, 7th EGA Legal Affairs Forum, SPCs Cases.
January 2009, Biotech and Pharmaceutical Patenting, Munich, Germany, Speaker on Panel "EU Sectorial Enquiry".