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.
As of February 2021, it is still too early to have a clear and complete view of how the COVID-19 health, economic, and social crisis has affected patent filing trends and how innovation specifically dedicated to cope with the present “new normal” situation is the object of patent protection. This pandemic has prompted patent offices…
Biologic drugs, many of which are antibodies, represent an increasing share of the pharmaceutical market. In recent years, numerous broad functional patent claims directed at therapeutic antibodies have come under attack for failing to satisfy the written description and enablement requirements. The proper scope of these requirements has divided the biopharmaceutical industry. In its latest…
Readers of the Blog should remember the French landmark French judgment rendered in September 2020 in the European Pemetrexed saga, which condemned Fresenius to pay € 28 million in damages (see here). This time the action brought by Eli Lilly on French territory concerns the same drug but is directed against another generic commercialized by Zentiva….
As reported in last week’s post, on 20 January 2021 Birss J handed down what may be his last first instance decision before his elevation to the Court of Appeal. The first post on the judgment considered the issues of identifying the skilled person, insufficiency and infringement. This second part considers the decision relating to…
On 20 January 2021 Birss J handed down what may be his last first instance decision before he takes his place in the Court of Appeal. If that turns out to the case then Illumina Cambridge Limited v Latvia MGI Tech SIA and others is a substantial judgment to mark this departure. In this case…
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…
