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…
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…
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…
The focus in The Netherlands on the option of compounding medicines as a means to circumvent the use of (expensive) authorised medicinal products of pharmaceutical companies and to pressurize them into lowering their prices, is confusing and possibly misleading and not necessarily good for patients. Attorney-at-law Hanneke Later-Nijland, also a trained pharmacist and a former…
The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933 of 20 May 2019 (PDF) in the Official Journal of the EU. The manufacturing waiver provisions will enter into force on the 20th day after…
Russian law provides that information on state registration of drugs shall be publicly available. For a long period, MoH used to turn a blind eye to this obligation, keeping information on all filed applications confidential. Absence of this information used to pose additional risks for patent holders lacking information on the upcoming launches of generic…
After the European Parliament adopted a controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling in its last plenary session on 17 April 2019, as previously reported on this blog, the corresponding legislative act has now also been adopted by the Council of the European Union in its meeting today on 14…
The European Parliament has finally adopted the legislation introducing an SPC manufacturing waiver in its last plenary session before the upcoming European elections. The corresponding legislation was endorsed today on 17 April 2019, with 572 votes in favor, 36 votes against, and 22 abstentions. The vote was preceded by a discussion in plenum yesterday late…
