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.
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…
The combination of two well-known high blood pressure medicines did not result in unexpected patient benefits. The U.S. Court of Appeals for the Federal Circuit has upheld a decision by the Patent Trial and Appeal Board denying as obvious over prior art an application to patent a method of co-administering two well-known antihypertensive agents to…
On January 26, 2023, Regeneron Pharmaceuticals, Inc., who sought to invalidate Amgen Inc.’s Japanese patent (JP5705288) covering an isolated monoclonal antibody used as cholesterol medication, won an appeal case in the IP High Court (Case No. 2021 (Gyo-ke) 10093). What was surprising in this case was that the IP High Court’s invalidity conclusion was the…
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…
On 21 March 2023, Meade J gave a bumper judgment in the revocation action brought by Gilead in respect of two of NuCana’s patents from the same family (EP (UK) 2 955 190 and EP (UK) 3 904 365, the “Patents”), which relate to nucleoside analogues. Filling 102 pages, the judgment raises a number of…
The Brazilian healthcare legislation establishes in the legal definitions of generic drugs (article 3, items XX and XXI, Statute #6,360 of 1976[1]) that their labels must have all and the same therapeutic indications of the reference-listed drug. The law only allow differentiation in characteristics like product’s size and shape, shelf life, package, and excipients[2]. The…
Everything flows, and the Dutch cross-border injunction flows like no other. From its source in the The Hague all the way to the cradle of Europe: Greece. So decided the Dutch Courts in the Novartis vs. Pharmathen case. The willingness of the Dutch Courts to assume jurisdiction to grant cross-border relief in international patent cases…
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…
The healthcare sector in Brazil is one of the most important in the world in view of the size of the population (+220 million people) and the availability of a universal public healthcare system. The action of antibodies as therapeutic agents may involve processes of neutralization, opsonization and activation of immune complement system, transforming them…
