India, Legislation, Pharma

(Intellectual Property Attorney, India)/

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…

China, EPO, European Union, FRAND, PCT, SEP, TRIPS

(City, University of London) and (West Bengal National University of Juridical Sciences)/

A judicial and academic debate on standard essential patents (SEPs) in China has recently arisen. The issuance of anti-suit injunctions (ASIs) by Chinese courts in a relatively short period of time (between 2019 and 2020) and the ensuing TRIPS/WTO dispute between the EU and China over the TRIPS compatibility of such ASIs, exemplify such debate….

European Union, Legislation, Pharma, SPC

(European Patent Attorney | Director IP at Adalvo) and (European Patent Attorney | VP IP at Adalvo)/ /1 Comment

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…

Equivalents, Infringement, Patents, United Kingdom

(Bristows)/

On 25 October 2023, HHJ Hacon (sitting as a High Court Judge), rendered his judgment in Philip Morris v Nicoventures[1].  The Claimants (“PMI”) sought revocation of EP (UK) No. 3 367 830 B1 (“EP 830”) and the defendants (“BAT”) counterclaimed for infringement.  EP 830 was held to be invalid for lack of inventive step and…

EPO

/ /8 Comments

The political environment at the EPO remains bumpy. Though some progress is made in relatively minor adjustments of the working conditions, the SUEPO trade union and staff committees remain largely ignored in major reforms. SUEPO writes this in its Annual Report 2022, which was published this week: ‘Numerous meetings take place between staff representatives and…

Brazil, Patents, Pharma, SEP

, (RNA Law)/

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…

European Union, Legislation, Pharma, SPC, Unitary Patent

, (Vossius & Partner)/ /14 Comments

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…

Generics, Infringement, Inventive step, Sufficiency of disclosure, United Kingdom

(Bristows)/

A hefty judgment was recently handed down by Mellor J concerning a patent for a modified release formulation of mirabegron. The patent was held to be valid and not infringed by Sandoz, while infringement with respect to Teva (which had admitted infringement with an earlier version of its product but sought a declaration of non-infringement…