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.
The eagerly awaited CJEU decision on the two joined referrals Teva v. MSD (C-119/22) and MSD v. Clonmel (C-149/22) relating to SPCs for combination products was handed down today on December 19, 2024. The two referrals arose from national litigation involving SPCs for a combination of active ingredients, i.e., the combination of sitagliptin and metformin…
As we are approaching the holiday season, Sweden has a special gift for SPC applicants and proprietors. This comes in the wake of the recent decision PMÄ 7804-24 of November 11, 2024, in which the Swedish Patent and Market Court endorsed a change of practice regarding the manner in which the SPC term is calculated….
After Novartis had obtained a preliminary injunction against Pharmathen, it observed that there were still infringing acts being performed. In the first instance, the provisions judge sided with Novartis and ordered that Pharmathen had to pay EUR 7,500,000 as a penalty. On appeal Pharmathen tried to reverse this verdict, but its efforts were in vain….
The first Over-the-Counter Continuous Glucose Monitor (CGM) ever cleared in the United Stated by the FDA was launched by Dexcom. The Stelo Glucose Biosensor System (commercial name) has been cleared for anyone 18 years or older who does not use insulin (such as individuals with diabetes treating their condition with oral medications, or those without…
Reading the title of this paper, perhaps you will smile, thinking about all the discussions that this issue has already ignited, even before the UPC came into force. Since the beginning, most patentees in the pharmaceutical field were suspicious concerning the new jurisdiction, especially regarding the same old question: pro-patentee or not? Hostile/not hostile to…
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…
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…
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…
