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.
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…
The so-called proportionality defense according to Sec. 139(1) clause 3 (hereinafter simply “proportionality defense”) is one of the newest provisions of the German Patent Act. It has only been introduced in August 2021 through the Patentrechtsmodernisierungsgesetz, a typical German word monster, of which an informative summary was posted here. The main driver of this proportionality…
The Brazilian pharmaceutical market is growing fast and is expected to become the fifth largest in the world by the next decade. While the country struggles to recover from economic downturn, the health care sector plays a key role in political speeches and the overall approach by the government. The Brazilian Constitution establishes access to…
As per the EPC definition, a substance or composition that is already known to have been used in a “first medical use” may still be patentable for any second or further use, provided that said use is novel and inventive. Even though the first medical use was the subject of patent protection within the EPC…
25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the “nivolumab” case law on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 (hereafter the SPC Regulation). In this case, Dana-Farber…
The “patent linkage system” is in general a system wherein market approval of generic drugs is linked with the status of the originator drug’s patents, for the purpose of early resolution of patent disputes and ensuring the stable and consistent supply of generic drugs. Japan has not statutorily adopted the patent linkage system, but the…
