The SPC reform which is currently undergoing the legislative procedure in the European Union has taken a further decisive step forward, as the European Parliament’s Committee on Legal Affairs (JURI Committee) has approved an amended version of the draft text of the four new EU regulations on SPCs for medicinal and plant protection products as…

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…

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…

On 1 March 2021, the Eurasian Patent Office launched the Pharmaceutical Register , covering 8 jurisdictions, including Russia, Belarus, Kazakhstan A demo-version is available on the official website of EAPO.   The new Register contains information on Eurasian patents protecting active substances of drugs. The EAPO specifically indicates that the Pharmaceutical Register shall relate to…

At the beginning of the year, the Russian Government granted the first compulsory license on a series of Big Pharma’s patents.  For the first time ever, “public security” clause has been evoked. According to the Decree 3718-r, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use Gilead’s patents protecting…

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…

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…