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 8 October 2021, His Honour Judge Hacon (sitting as a Judge of the High Court) handed down his decision in an action brought by Royalty Pharma Collection Trust (“Royalty Pharma”) for approximately €23 million in royalty payments from Boehringer Ingelheim GmbH (“Boehringer”) (Royalty Pharma Collection Trust v Boehringer Ingelheim GmbH [2021] EWHC 2692 (Pat))….
In the pharma industry, constant battles have been taking place for many decades between innovators and generics. More recently, battles among innovators have also started to occur. This post concerns a case which may have an impact on the development strategies of innovators, as well as licensing strategies of universities and public research institutions which…
In a surprising decision, the Federal Court has modified the law of patent term extensions in Australia, by clarifying that it’s only the patentee’s goods that are relevant to the proposed extension – not those of a competitor, even if the competitor’s goods came first and also contain a “pharmaceutical substance per se” that is…
We are happy to announce the new International Law Talk Podcast episode on EU competition law developments in the pharmaceutical sector. And this one is twice as good! Not only are we discussing both competition and IP issues, but I also interviewed two leading experts in the field: Michael Clancy and David Hull from Van…
When it comes to the judicial enforcement of pharmaceutical patents in Portugal, over the past few decades the general public has been driven to the misconception that the system protects pharmaceutical industry originators’ tactics to delay the market entry of generics. The European Generic Medicines Association (EGA)’s “Patent-related Barriers to Market Entry for Generic Medicines…
Introduction A key mechanism in patent litigation and specifically for generics is the concept of “launch at risk”. In short the concept means that a product is launched prior to the expiry of a patent despite the risk that the patent proprietor in such case could initiate infringement proceedings which often includes requests for a…
While pressure is building up on TRIPS Council for the suspension of certain obligations under the TRIPS Agreement during the COVID-19 pandemic, the Brazilian Senate approved on 29 April 2021 a bill facilitating the compulsory licensing of COVID-19 vaccines’ patents. The bill will be voted by the Brazilian House of Representatives and, if approved, it…
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….
