Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.
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…
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…
