A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
In mathematics, the law of numbers makes it possible to interpret the probability as a frequency of occurrence, thus justifying the principle of surveys, and presents the expectation as an average. This theory alone could very well summarize the decision of the Paris Court of Appeal regarding the Osimertinib SPC’s rendered on February 9, 2021….
The long and winding road, as The Beatles would put it, that led to the judgments of the CJEU in Teva et altri v. Gilead Sciences (Case C-121/17) and Royalty Pharma v. Deutsches Patent und Markenamt (Case C-650/17), which renewed the Court’s case law on the meaning of “product“, started in the Medeva judgment (Case…
Regulation (EU) 2019/933, amending the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (hereinafter referred to as the Regulation) was published in the Official Journal of the European Union on 11th June 2019 and thus came into effect on 1st July 2019. The amended Regulation establishes the so-called “SPC waiver”, that excludes…
Each time I hear “TRUVADA”, the catchy chorus of the Beatles’ Ob-La-Di Ob-La-Da sounds different to me… However, TV addicts or literature lovers also keen on pharmaceutical litigation should not have failed to notice a more disturbing coincidence: “Gilead” is moreover the sweet name given to the dictatorship where The Handmaid’s Tale is set –…
In his (or her) younger years at school, a once to be Dutch patent litigator was learned that the Netherlands share a borders with Germany and Belgium. On the geography maps, they seemed to be set in stone. History class already provided a different perspective: now friendly neighbours would once surprise each other with unannounced…
The Court of appeal of Paris, in a decision on the merits, has ruled that the SPC covering the combination of ezetimibe and simvastatine is invalid. The decision was rendered on September 25, 2020, in a case opposing Merck and Teva (free translation available here).This is the first decision in Europe on the merits to…
The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…
With the rendering of the judgment in Royalty Pharma (C-650/17) by the Court of Justice of the European Union today on 30 April 2020, a series of referrals relating to the interpretation of Article 3(a) of the SPC Regulation, which requires that the product of an SPC must be “protected” by the basic patent, finally…
The IP Tribunal of the Supreme People’s Court (SPC) recently issued a decision in Dunjun v. Tengda ((2019) SPC IP Civil No. 147), holding that the manufacturer’s making and selling of routers directly infringed a telecommunication method-of-use patent even though the manufacturer itself did not perform one single step of the patented method. This article…
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…
