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.
Each time I hear “TRUVADA”, the catchy chorus of the Beatles’ Ob-La-Di Ob-La-Da sounds different to me… However, TV addicts or literature lovers also keen on pharmaceutical litigation should not have failed to notice a more disturbing coincidence: “Gilead” is moreover the sweet name given to the dictatorship where The Handmaid’s Tale is set –…
On 4 December 2020, the English Patents Court handed down its decision in Neurim Pharmaceuticals (1991) Limited & Flynn Pharma Limited v Generics UK Limited (t/a Mylan) & Mylan UK Healthcare Limited, the main action proceedings regarding Neurim’s patent for Circadin™, EP 1 441 702 (“EP 702”). The judgment is available here. Many readers will…
On 15 October 2020 Meade J. handed down his first ever written judgment in his new role as a Judge of the High Court in MSD v Wyeth. The neutral citation for the case is [2020] EWHC 2636 (Pat) and a link to the judgment is found here. The Judge had heard the case back…
Declarations from generic drug makers alleged only possible future injury from implementation of the 2019 law that created a presumption that so-called “pay for delay” settlement agreements are anticompetitive. A trade association for the generic pharmaceutical industry failed to demonstrate standing to challenge a California law that created a presumption that “reverse payment” settlement agreements…
The reasoning to develop a strong patent regime is an old and straightforward one. Research and development (R&D) requires incentive and strong intellectual property regime provides that incentive. It is estimated that the total cost of developing a new drug, including the costs of capital and failed R&D efforts, amounts to billions of dollars. Without…
The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…
The tendency of English people to be understated in their use of language (other than on Twitter…) is often joked about with continental friends and colleagues. For example, when an English person expresses a slight disagreement, their continental counterpart might have felt more able to be blunt and say that something is just plain wrong. …
The English Patents Court has often been regarded as a relatively favourable jurisdiction for patentees seeking interim relief in the life sciences arena. This is for various reasons, including the fact that the English Court follows the approach adopted by the House of Lords in the American Cyanamid case, in which an assessment of the…
Emerging Vaccine Nationalism ‘Vaccine nationalism’ could slow the search for a cure for Covid19. [1] The nationalism that prevails in the fight for a Covid19 vaccine is not only overshadowed by the geopolitical tensions between the United States and China, but also by individual nations seeking to find a cure on their own. In the…
With the rendering of the judgment in Royalty Pharma (C-650/17) by the Court of Justice of the European Union today on 30 April 2020, a series of referrals relating to the interpretation of Article 3(a) of the SPC Regulation, which requires that the product of an SPC must be “protected” by the basic patent, finally…
