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…

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,…

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…

In this case the Federal Court of Justice (FCJ) allowed a compulsory licence under a patent for a pharmaceutical active ingredient for the first time ever. The Court held that a public interest in such a licence may still exist where it concerns only a small group of patients. In particular, the interest may be…

The Productivity Commission released its final report into Australia’s IP arrangements in December 2016 (covered in our post earlier this year, ‘IP Rights vs IP Wrongs’).  Now, the Australian Government has weighed in on the Commission’s recommendations, supporting some and ‘noting’ others. With respect to patent law, the Government supports the following recommendations: Add an…

Since Warner-Lambert successfully defended its pregabalin patent and obtained injunctions against generic market entry in Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238 (see our coverage of the case in ‘Carving out the principles: a comparative review of the Australia and UK Lyrica cases’), the Australian Lyrica dispute has continued through…

by Nicholas Round At the start of this month, the UK Supreme Court took a break from its recent post-Brexit work interpreting (and developing) constitutional principles to hear an intellectual property matter. This rare Supreme court foray for a patent produced a ripple of excitement across the UK IP litigation community not least because (uniquely…