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.
A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…
Why would anyone want to have their own supplementary protection certificate (SPC) revoked? – The answer is, quite simply, Article 3(c). Under Article 3(c) of Regulation (EC) 469/2009 on SPCs for medicinal products (and, likewise, under Article 3(1)(c) of Regulation (EC) 1610/96 on SPCs for plant protection products), an SPC shall be granted only if…
(Corrected) The American Food Drug Administration (FDA) will follow the European Medicines Agency from London to Amsterdam because of the Brexit. That is clear from a report on the website of the FDA, describing its international activities. “Since the first foreign office opened in Beijing in November of 2008, FDA’s international presence has grown to…
The District Court of the Hague granted a provisional injunction against Sandoz’ generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which a provisional injunction was warranted, and the SPC appeared to be valid having been held so in the parallell procedure before the UK court….
A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…
In its judgment of 25 July 2018 (Case C-121/17 Teva v. Gilead), the CJEU had its latest say on the interpretation of article 3 (a) of Regulation (EC) 469/2009 concerning the Supplemental Protection Certificates for medicinal products (the “SPC Regulation”). In particular, it concluded that article 3 (a): “[…] must be interpreted as meaning that…
Over the past few years the pan-European and parallel national patent litigation based on Eli Lilly’s pemetrexed patent has attracted considerable attention, as it has resulted in a number of diverse land mark decisions in relation to the doctrine of equivalence, as evidenced by the various posts on the Kluwer Patent Blog. By way of…
In order to provide adequate incentives for the research and development of high-quality medicinal products adapted for paediatric needs, special rewards, such as a 6-month paediatric extension of the term of a Supplementary Protection Certificate (SPC) have been made available in the EU since 2007. Switzerland, which participates in the EU’s single market and traditionally…
The Ukrainian Supreme Court in Merck Sharp & Dohme Corp v Aurobindo Pharma Limited has recently introduce a bold approach to applying interim injunctions in disputes between originators and generics over the registration of patented pharmaceuticals. MSD learned that Aurobindo had filed an application for registration of an allegedly infringing pharmaceutical with the State Expert…
The Swiss Patent Office issued a brief notice regarding a change of practice in the granting of supplementary protection certificates (SPCs) as well as corresponding detailed information on 22 October 2018. Following the Swiss Federal Supreme Court’s judgment 4A_576/2017 of 11 June 2018 relating to the SPC for Truvada, the requirement under Article 140b(1)(a) Swiss…
