The applicant, Teva, sought an order for the revocation of the Irish designation of European Patent No. (IE) 1379220 entitled “Inhalation Capsules” (the “220 Patent”) on the grounds of (i) obviousness, (ii) an “AgrEvo” challenge and (iii) insufficiency.  The Court ruled in Boehringer’s favour by upholding the validity of the 220 Patent and rejecting all…

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 a precedent case before the Russian Intellectual Property Court, the judges pointed out that mere registration of a generic drug long before the patent expiry may constitute a threat of infringement that is prohibited under domestic law. This position in this case may result in an extra defense against unfair registrations. On 24 April 2018,…

Establishing a unitary SPC is one of the recommendations of the study carried out by the Max Planck Institute for Innovation and Competition for the European Commission. Either an (existing or a future) EU authority or the European Patent Office can be charged with granting these unitary SPCs. According to the study, the choice between…

The Court of Appeal dismissed Boehringer Ingelheim’s application for permission to appeal the first instance Patents Court decision that EP (UK) 1,379,220 lacked inventive step.  The Court of Appeal also considered and overturned the existing judicial guidance on granting permission to appeal in patent matters. Case date: 16 December 2016 Case number: A3 2016 0271 Court: Court of…

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…

In an interference proceeding, the Patent Trial and Appeal Board correctly determined that claims 65-67 of applicant General Hospital Corporation’s (GHC’s) U.S. Patent Application No. 13/789,575 for methods of removing hair by using nanoparticles to damage hair follicles lacked sufficient written description under § 112 of the Patent Act, the U.S. Court of Appeals for…

Yesterday, 25 April 2018, AG Wathelet has handed down his opinion in the Teva v Gilead reference (Case C-121/17) suggesting that the question should be answered as follows: “The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for…

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…