The Supreme Court concluded that it was appropriate for it to reformulate the so-called Improver (or ‘Protocol’) questions, which provide guidance as to whether a variant is immaterial where there is no literal infringement. The significant change is the introduction of hindsight into the determination of the second question: “Would it be obvious to the…

As a follow-up to our previous post “The Federal Circuit Has Its Final Say On the “On-Sale” Bar Under the AIA,” the Supreme Court has granted certiorari in the Helsinn v. Teva case, which concerns whether the America Invents Act (“AIA”) changed the longstanding “on-sale bar” rule.  This means that at least four of the nine…

In July 2017, the Patents Court of Barcelona handed down a decision finding that “Swiss-type” claims were affected by the Reservation made by Spain when it ratified the European Patent Convention (“EPC”), whereby European patents, insofar as they confer protection on chemical or pharmaceutical products “as such“, shall be ineffective in Spain. In particular, the…

As most readers will know, yesterday the European Commission published a proposal to amend Regulation 469/2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”) aimed at introducing a so-called “manufacturing exemption for export purposes” (in short, a “manufacturing waiver”). The rationale behind it is that the introduction of this new exemption to…

The European Commission has proposed to introduce an ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs) to ‘help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU’. According to a press release of 28 May 2018, ‘Supplementary Protection Certificates extend patent protection for medicinal products which must…

On 28 March 2018, the Australian Government introduced the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 to the House of Representatives. This follows IP Australia’s public consultation in October 2017 of an exposure draft of amendments for Australia’s IP laws that included, among other matters, a mechanism to phase out the…

On 28 March 2018, the Australian Government introduced the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 in the House of Representatives. This follows IP Australia’s public consultation in October 2017 of an exposure draft of amendments for Australia’s IP laws that included, among other matters, a mechanism to phase out the…

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…