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.
Discussions are under way at the World Intellectual Property Organization (WIPO) and the World Health Organization (WHO) on enabling wider access to some patented drugs and medical supplies during the coronavirus pandemic. According to press agency Reuters, director-general of the (WIPO) Francis Gurry made this clear during a conference last week. “This is a hot…
by Dr. Simon Klopschinski In the wake of the evolving Corona pandemic the German government intends enacting amendments to the German Act on the Prevention and Control of Infectious Diseases in Humans (Gesetz zur Verhütung und Bekämpfung von Infektionskrankheiten beim Menschen – Infektionsschutzgesetz – IfSG), which could also have an impact on patents. The bill…
On Friday 13 March 2020, Birss J handed down a pair of judgments in the litigation between Evalve (a member of the Abbott group of companies) and Edwards Lifesciences, a veteran of UK patent litigation over the past decade. In the first judgment Evalve’s two UK patents, EP (UK) 1 408 850 and EP (UK)…
Today, Advocate General (AG) Mr. Giovanni Pitruzzella handed down his opinion in the referral C-673/18 (Santen). The case concerns an SPC based on a second medical use/formulation patent and stems from a referral to the CJEU made by the Paris Court of Appeal with decision of 9 October 2018 in Santen v. INPI (see here…
In the present preliminary case the consequence of the termination of the agreement between Medical Workshop and Sharpsight was that Medical Workshop was no longer able to use the name Invitria for the sale and marketing of the ophthalmalogic product protected by a patent owned by the single shareholder of Sharpsight. Case date: 16 October 2019…
The Dutch authorities have handed over to the European Medicines Agency (EMA) its new premises, located in the Zuidas business area of Amsterdam. On 15 November EMA’s Executive Director Guido Rasi ‘signed the lease agreement and thanked the Dutch authorities for reaching this important milestone on time’, according to a report on the EMA website. EU…
One of the features that render the European Union’s Supplementary Protection Certificate (SPC) unique in comparison to similar legal instruments in other jurisdictions, including the United States and Japan, is that there is no legal provision expressly calling for any specific relationship or agreement between the patent proprietor (and SPC applicant) on the one hand,…
In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple – condition that an SPC can only be granted for an active ingredient (or a combination of active ingredients) that is “protected” by the…
Among the flurry of pre-summer vacation judgments coming from the Patents Court is one from Mr Justice Birss (17 July 2019), concerning the validity of Hoffman-La Roche’s patent EP (UK) 2 007 809. EP’809 is a formulation patent for the monoclonal antibody vedolizumab, marketed as Entyvio® and used to treat ulcerative colitis and Crohn’s disease….
Pemetrexed, yet again: last Wednesday the District Court of The Hague, swimming against the current and after a deep dive in the prosecution file, decided that Fresenius did not infringe Eli Lilly’s ‘pemetrexed disodium’ patent with a generic product that does not contain pemetrexed disodium, not even by equivalence. The basic facts of the widespread…
