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.
“Jamais deux sans trois”. The French Supreme Court (“Cour de Cassation”) has issued no less than seven decisions relating to SPCs on February 1st, 2023. After having reported the two relating to the interpretation of article 3 a) of the SPC Regulation last week (nivolumab and pembrolizumab cases), I will report today a decision rendered…
In two decisions rendered on February 1st, 2023, the French Supreme Court (“Cour de cassation”) overturned the decisions of the Paris Court of Appeal which had confirmed the rejections by the French PTO (“INPI”) of the supplementary protection certificate (“SPC”) applications for nivolumab and pembrolizumab. On this occasion, the Supreme Court clarified the interpretation of…
An outburst of anger of a president and his re-election, social tensions, industrial actions: for anyone familiar with the world of patents it will be clear that all this refers to the European Patent Office, which drew a lot of attention on the Kluwer Patent Blog last year, even more than the biggest change in…
There are currently two referrals on SPC law pending before the Court of Justice of the European Union (CJEU), both of which concern the interpretation of Article 3(c) of the SPC Regulation (EC) 469/2009. This provision essentially ensures that the same person cannot obtain more than one SPC for the same product (active ingredient), which…
Just over 2 years after the SPC waiver Regulation (EU) 2019/933 (amending the Regulation (EC) No 469/2009) entered into force (1 July 2019), and only a few months after the end of the transitional provisions for application of the SPC waiver under Art. 5(10) of the Regulation (2 July 2022), I have decided to follow…
To date, final decisions from the Spanish Patent and Trademark Office (“SPTO”) dealing with matters such as patents or supplementary protection certificates (“SPC”) may be appealed before the administrative law chamber of what are known as the Tribunales Superiores de Justicia (“High Courts of Justice”). Although these Courts are highly specialised in public law matters,…
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…
