Search Results for: howard rosenberg

On December 11, 2013, FLH Scientific Advisor Howard E. Rosenberg, Ph.D. will speak on: “Patent Settlements/Pay-for-Delay – are they so incompatible?” as part of the International Broadcasting Convention (“IBC”) International Patent Litigation Conference held in London, England, at The Bloomsbury Hotel, 16-22 Great Russell Street, London WC1B 3NN. Dr. Rosenberg’s presentation is a “Case Study” […]

FLH’s Scientific Advisor Howard E. Rosenberg, Ph.D will be speaking on Patentability of Pharmaceutical Solids at the Pharmaceutical Solids at the Thirteenth International Workshop in Indianapolis, Indiana on June 21, 2011. The series of workshops will be held June 20 – June 23, 2011. Event details may be found here.

FLH’s Scientific Advisor Howard E. Rosenberg, Ph.D will present on “Recent developments on SPCs” covering “The medicinal product – Review of relevant case law” at the 7th European Generic Medicines Association (“EGA”) Legal Affairs Forum in Brussels, Belgium. Subtopics include “The medicinal product defined”, “Where/when is the first MA (Marketing Authorisation) – problems with EU […]

FLH’s Scientific Advisor Howard E. Rosenberg, Ph.D. will present on “International IP Developments” covering subtopics “Topical IP (intellectual property) cases”, “EU (European Union), patents and SPCs” and “Review of other jurisdictions around the world” at the World Generics Medicines Congress Europe 2011 in London, United Kingdom. The Congress will be held at The Hilton London […]

FLH’s Scientific Advisor Howard E. Rosenberg, Ph.D will present on Supplementary Protection Certificate (SPC) cases: Generics (UK) Ltd. v. Synaptech and Synthon v. Merz Pharma at the Royal Society of Chemistry Law Group, Seminar on Recent Chemistry Case Law – Patents. The Seminar will be held at the Royal Society of Chemistry, Burlington House, Picadilly, […]

by Howard Rosenberg The EU ban on stem cell patents, issued in an October 2011 Court of Justice of the European Union (“CJEU”) opinion, continues to generate controversy and input from a wide variety of viewpoints. This week Aurora Plomer, professor of law and bioethics at Sheffield University argued that the ban not only imperiled […]

by Howard Rosenberg The MHRA announced yesterday in a press release that the first ever children’s medicine to hold a Paediatric Use Marketing Authorization (PUMA) had been granted by the European Commission. For many years it has been recognized that medicines are generally developed and designed for adults with their use in children coming as […]

By Howard Rosenberg Last week saw five reported cases of other manufactures’ drugs being found in Nurofen Plus packets. The anti-psychotic Seroquel XL had been found in four packets of Nurofen Plus in England and Neurontin, a prescription medicine for epilepsy, had been found in one packet of Nurofen Plus bought from an independent pharmacist […]

by: Howard Rosenberg. Ph.D. The FDA recently released a report on the ‘Pathway to Global Product Safety and Quality’, it highlights yet again its problems in safeguarding America’s food and medical products particularly in reference to imported goods. The concern for pharmaceuticals imported from facilities which, in the main, have not been inspected by FDA […]

Marketing Authorizations: Innovator Drugs and Biologics (October 2010) by Brian J. Malkin, Ami E. Simunovich, Pharm.D., R.Ph., Howard E. Rosenberg, Ph.D., and Stephanie Roberts Generic, Hybrid, and Biosimilar Medicinal Products (October 2010) by Brian J. Malkin, Ami E. Simunovich, Pharm.D., R.Ph., Howard E. Rosenberg, Ph.D., and Stephanie Roberts Regulatory Exclusivities, Patent Term Extension, and Litigation […]