Pharma

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.

Inventive step, Patents, Pharma, Pharmaceutical patent, Priority right, Spain, Sufficiency of disclosure, Validity

(Clifford Chance)/ /2 Comments

This morning, the Barcelona Appeal Court has announced a judgment of 18 July 2024, reversing the judgment of 15 January 2024 from Commercial Court number 4 of Barcelona, which had found patent EP 1,427,415 (“EP ‘415”), protecting apixaban, to be invalid. The main highlights of the decision may be summarized as follows: The first interesting…

Case Law, Pharma, Russia

(ARS-Patent)/

This post is continuation to the previous one published on October 27, 2023 and available  here. Although the approach may still be reconsidered by the Presidium of the Russian Supreme Court, the current update should already be taken into account while developing the patenting strategy in the jurisdiction. Background There are two pending court cases…

(Compulsory) license, Japan, Pharma

(Abe, Ikubo & Katayama)/

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93 of the Patent Act, which was filed by Vision Care and VC Cell Therapy (the “Claimants”) on July 13, 2021, was withdrawn upon settlement.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…

Case Law, Infringement, Injunction, Inventive step, Litigation, Patents, Pharma, Pharmaceutical patent

(Bristows)/

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…

Biologics, Brazil, Generics, Guidelines, Infringement, Pharma

(RNA Law)/

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…

Equivalents, Infringement, Inventive step, Litigation, Novelty, Patents, Pharma, United Kingdom, Validity

(Bristows)/ /2 Comments

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)…

Brazil, Patents, Pharma

(RNA Law) and (Licks Attorneys)/

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…

European Union, Legislation, Pharma, SPC, Unitary Patent

, (Vossius & Partner)/ /5 Comments

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…

Case Law, CJEU, Infringement, Injunction, Pharma, Pharmaceutical patent, SPC, Switzerland, Validity

(MLL Legal Ltd.)/

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…

Brexit, Case Law, Litigation, Pharma, SPC, United Kingdom, Validity

(Bristows)/

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…