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 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…
Historically, China promulgated its first patent law in the 1980s, the result of its reopening and affiliation to the WIPO, which led to the country’s joining important multilateral agreements, such as the Paris Union Convention for the Protection of Industrial Property (1984) and the TRIPS Agreement (2001). This patent law entered into force in 1985…
Innovation in healthcare of all types is on the rise in Brazil. As this article will show, large investments have been made and are continuing to be made across all parts of the sector. With continuing investment, it is more important than ever that all those involved give active consideration to intellectual property rights and…
In an appeal of a PI decision, the Danish Eastern High Court has ruled to uphold the dismissal of Novartis’ application for a preliminary injunction against Glenmark, Zentiva, and Viatris, based on the European patent application 2 959 894. In its decision, the Court firmly stated that a preliminary injunction can only be issued based…
