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 May 30, 2024, the JPO announced that the request for a decision of granting a compulsory non-exclusive license based on public interest under Article 93 of the Patent Act, which was filed by Vision Care and VC Cell Therapy (the “Claimants”) on July 13, 2021, was withdrawn upon settlement. It took more than two…
The recent rivaroxaban PI cases may have caused you to ask yourself whether the American Cynamid principles for determining whether or not to grant preliminary injunctive relief in the UK are dead or at least dying. In this article we consider the facts of the rivaroxaban PI applications and aim to tease out some principles…
Prepared by Rob Rodrigues, Brenno Telles and Dara Offrede On Friday June 21, 2024, the government formally introduced regulations addressing the new framework for Partnerships for Productive Development (PDP). The Ministry of Health published new guidelines (Ordinance #4,472/20241) as part of the government policy to foster the “National Strategy for the Development of the Economic-Industrial…
Advanced Cell Diagnostics v Molecular Instruments [2024] EWHC 898 (Pat) On 23 April 2024, Mr Justice Meade handed down his judgment in the dispute between Advanced Cell Diagnostics (ACD) and Molecular Instruments (MI). ACD is the proprietor of two European patents which relate to in situ detection of nucleic acids in single cells. EP (UK)…
With 1.5 billion chickens and 234.3 million cows, Brazil is an important market for the animal health industry. According to the National Syndicate of the Industry of Animal Health Products (SINDAN, in Portuguese), in 2022, 700 million doses of vaccine were manufactured in Brazil for herbivorous animals, and 21 billion for aviary. The Brazilian animal…
The SPC reform which is currently undergoing the legislative procedure in the European Union has taken a further decisive step forward, as the European Parliament’s Committee on Legal Affairs (JURI Committee) has approved an amended version of the draft text of the four new EU regulations on SPCs for medicinal and plant protection products as…
From the potpourri of decisions that the Swiss Federal Supreme Court handed down last year, I have selected one in subjective hindsight that I consider to be particularly relevant regarding further cases. The outcome of most decisions of the Swiss Federal Patent Court in 2023 heavily depended on the specific circumstances and the effects of…
Question: I applied for my SPC in reliance on the law as set out in Neurim[1], following Santen[2] can I still obtain my SPC? Answer: No, according to the English High Court[3]. In 2018, i.e. before the Santen decision from the CJEU, Merck applied to the UK IPO for an SPC for its medicinal product…
On December 21, 2023, the China National Intellectual Property Administration (CNIPA) issued the final version of the revised Implementing Rules for the Patent Law and the Guidelines for Patent Examination, which will become effective on January 20, 2024. These Regulations complete legislative efforts on changes to the Chinese patent system introduced by the 4th amendment…
On November 28, 2023, the Tokyo District Court issued a preliminary injunction order against Sawai Pharmaceutical Co., Ltd. (“Sawai”) to suspend the manufacture and sale of Sawai’s pharmaceutical product (“Sawai’s Product”) developed and sold as a generic drug of Bristol-Myers Squibb (“BMS”)’s cancer drug “Sprycel®” (Case No. 2023 (Yo) 30214; AIK represented BMS in this…
