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.
25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the “nivolumab” case law on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 (hereafter the SPC Regulation). In this case, Dana-Farber…
SPCs are often valuable and therefore important to their proprietors. Indeed, such is the potential value of an additional period of exclusivity, that in the last decade or so, we have seen SPCs challenged where only a few weeks or even a few days of the SPC term remain. It is therefore hardly surprising, especially…
On 18 October 2021, the Russian IP Court rendered the decision in Geropharm vs. Novo Nordisk. While dismissing the claims, the IP Court has given the green light to a new legal mechanism of challenging a Patent Term Extension (‘PTE’) and Supplementary Protection Certificate (‘SPC’). It used to be problematic for generic companies to meet…
As any aficionado of American legal history will be well aware, Judge Holmes, the third most cited American legal scholar of the 20th century, was nicknamed “the Great Dissenter.” This was a tribute to the 55 dissenting opinions that he wrote during his 29 years serving at the U.S. Supreme Court. Interestingly, over the years…
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…
