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.

Damages, Infringement, Japan, Patents, Pharma

, (Abe, Ikubo & Katayama)/

On May 27, 2025, the Intellectual Property High Court of Japan ruled in favor of Toray Industries, Inc. in a landmark patent infringement lawsuit (Case No. 2021 (Ne) 10037) concerning the extended patent rights for the antipruritic agent “Remitch®” (nalfurafine). The court ordered two generic companies, Sawai Pharmaceutical Co., Ltd. and Fuso Pharmaceutical Industries, Ltd.,…

Case Law, Injunction, Netherlands, Pharma, Unitary Patent

(Hoffmann Eitle)/

Biogen has had mixed success in Europe in enforcing its patent on a second medical use of dimethylfumarate for the treatment of multiple sclerosis. In the present Dutch case, an attempt to obtain an injunction against three different generic companies resulted in a counterclaim for revocation of the (Dutch part of the) European patent. Biogen…

Pharma, SPC, Sweden, Validity

(Vinge)/

The Swedish Patent and Market Court (“PMC”) recently issued a judgment on an important aspect of SPC law, namely the correct interpretation of the term ‘product’ under Article 1(b) of the SPC Regulation (see PMC 16666-23, 21 January 2025, English translation). This action was commenced by STADA, who challenged the validity of an SPC for…

CJEU, European Union, Pharma, SPC

(Vossius & Partner)/

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…

Case Law, Infringement, Netherlands, Pharma

(Hoffmann Eitle)/

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….

Brazil, Enforcement, Pharma

, , (RNA Law)/

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…

Biologics, Pharma, Pharmaceutical patent, UPC

(Dhenne Avocats)/

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…

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…