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 April 2023, the European Commission (EC) published the pharmaceutical legislation package, including the proposal for a Pharmaceutical Directive[1] , and further proposals for regulations on SPCs[2]. Article 85 of the proposed Directive aims at providing an amended provision for the so-called Bolar exemption, currently codified in Article 10(6) of Directive 2001/83/EC. The initial EC proposal…
A sweeping reform of the European Union’s legislation on supplementary protection certificates for medicinal products and plant protection products is currently underway, which features the introduction of a new centralized SPC examination procedure at the EUIPO as well as the creation of a new unitary SPC on the basis of the unitary patent, as previously…
After years of preparation, the European Union’s draft legislation for a sweeping reform of the existing legal regime on supplementary protection certificates (SPCs), which includes the establishment of a centralized SPC filing and examination procedure as well as the introduction of a unitary SPC, has finally been published today on April 27, 2023. This draft…
When the European Commission earlier today published the legislative proposals aimed at introducing a unitary SPC to be examined by a central examination procedure, one of the Beatle’s most beautiful songs immediately sprang to mind: The Long and Winding Road. In particular, the European Commission has published several legislative proposals, four of which are relevant…
“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,…
