Suppose you are a (patent) attorney in a pharmaceutical company and want to advise your company how to best protect the results of a clinical trial designed to find out the best possible treatment regimen of a certain known and approved drug X. The researchers of your company have devised and been allowed to conduct…

On October 8, 2017, the Chinese Communist Party and the State Council jointly issued a special opinion on the reform of drug and medical device approval system (“Innovation Opinion”). The Innovation Opinion together with an earlier China Food and Drug Administration (“CFDA”) document (“Circular No. 55”) issued in May 2017 (collectively “Reform Opinion”), propose that…

The afternoon of the first day of C5’s Pharma & Biotech conference in Amsterdam (27 February 2018) concluded with a lively panel session on biosimilars. Chaired by Bristows partner Dom Adair, the panel comprised Dr Corinna Sundermann (Senior Vice President, IP, Fresenius Kabi), Dr Lorenz Kallenbach (Corporate Patent Counsel, Merck) and Brian Coggio (Of Counsel, Fish…

Over the last few decades, the United States has been incrementally harmonizing its patent law with the rest of the world.  Those efforts continued with the signing of the America Invents Act (“AIA”) in 2011.  For example, the AIA created a first inventor-to-file patent system, while all but eliminating the best mode requirement. One area…

Three pending cases have the potential to reshape – or even eliminate – inter partes review, a procedure for challenging patent validity introduced by the 2011 America Invents Act (“AIA”).  On November 27, the Supreme Court will hear oral argument in two of those cases.  In Oil States Energy Services, LLC v. Greene’s Energy Group,…

When a company is not prepared to charge a socially acceptable price in the Netherlands for a medicine, the government should use other instruments such as compulsory licences, encouraging pharmacy preparation and allowing patients to order medicinal products abroad in order to ensure that the medicine is available for patients. The Dutch Council for Public…

On 23 October 2017, IP Australia released the draft Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2017 for public comment.  The purpose of the Bill is to implement the Government’s response to the Productivity Commission’s recommendations on Australia’s IP Arrangements (our coverage of the Government’s response can be found…

Last year, Actavis, Teva and Mylan (“Actavis”) sought revocation in the English Patents Court of two patents relating to tadalafil, which is sold by Eli Lilly (“Lilly”) as the active ingredient in CIALIS® to treat erectile dysfunction and pulmonary arterial hypertension. As is the usual course, ICOS (the patentee) and Lilly (the exclusive licensee) subsequently…

Allergan’s assignment of the patents on one of its blockbuster drugs to an American Indian tribe in an attempt to dismiss a USPTO inter partes review (IPR) proceeding on “tribal sovereign immunity” grounds has shaken up the patent bar – with some dismissing this as, at most, a temporary loophole and others saying “why didn’t…

Patent lawyers in the UK have spent the last three months pondering, debating and at times indulging in an element of despair (to put it mildly) about what might be the impact of the judgment of the Supreme Court in Actavis v Eli Lilly [2017] UKSC 48 on issues of validity (see here). Today they…