Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.
Yes and no, it seems. Well, yes and then no, if recent French decisions are anything to go by. In short, Hesitations Blues reign. This attitude is all the more interesting given that the question, which arose more especially in the FINGOLIMOD case, has been raised before several European courts, all of which are opposed…
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…
On October 24, 2023, the Brazilian government released an Action Plan aiming at fostering the National Intellectual Property (IP) Strategy. The plan was prepared by the Interministry IP Group ( a group created in 2019 to coordinate the federal government activities in the field of intellectual property. Thirteen Ministries form part of GIPI, and the…
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…
A recently published ruling of the Presidium of the Court for Intellectual Rights may turn the issue of cascading divisional applications upside down and endanger many patents granted on such applications. Background A divisional patent application is a separate one that is derived from an initial (parent) application. The necessity of filing such a divisional…
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…
On 25 July 2023, the Court of Appeal handed down its decision in Teva & Sandoz v Astellas[1] concerning the validity of Astellas’ patent to mirabegron for use in the treatment of overactive bladder (“OAB”). At first instance, Meade J had held the patent valid and infringement by the generics’ proposed acts was not separately…
My British colleague has already commented brilliantly on the UK ruling in this case from the point of view of plausibility (see here). For my part, I’d like to comment the French ruling in the same case, which takes the opposite view to the UK decision. We shall see that the French position is particularly…
