The Russian Patent Office (Rospatent) has introduced new provisions relating to the assessment of patentability of “use” inventions. Background On September 27, 2024, the Russian Ministry of Economic Development issued Order No. 610, which came into effect on November 10, 2024 (hereinafter – the Order). The Order supplemented provisions on analyzing the patentability of inventions…
On February 20, 2024, a Brazilian Congressman introduced a bill to amend the national IP Statute (Law #9,279/96) and regulate the ownership of inventions generated by artificial intelligence systems. Bill #303/2024 proposes the addition of a paragraph to Article 6 of the IP Statute, which regulates ownership of inventions, with the following wording: “in the…
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…
Divisional filings are one of the most controversial topics in patent prosecution in Brazil. The Patent Office (BRPTO) severely limits the ability of patent applicants to file divisionals. For instance, the BRPTO rejects divisionals filed after receiving a notice of allowance, after receiving a denial or during the appeal stage. Article 26 of the Brazilian…
On December 21, 2023, the China National Intellectual Property Administration (CNIPA) issued the final version of the revised Implementing Rules for the Patent Law and the Guidelines for Patent Examination, which will become effective on January 20, 2024. These Regulations complete legislative efforts on changes to the Chinese patent system introduced by the 4th amendment…
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. The change will come into effect 60 days after the amended text…
I) Introduction The science of biochemicals and the realm of Section 3(d) of Indian Patents Act! Can there be a reconciliation between the two? This question is a hot topic of discussion amongst the Indian biochemical patent community following the recent decision (Novozymes vs The Assistant Controller of Patents and Designs) pronounced by the Madras…
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…
Brazil’s president published, on September 27, Decree No. 11,715/2023 which institutes the “National Strategy for the Development of the Economic-Industrial Health Complex”. This decree aims at directing public and private investments towards the health and innovation sectors to reduce the Public Health System’s (SUS) vulnerability and increase access to medicines. It aims to do this…
