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.
In 1976, Tom Scholz—a MIT-trained engineer and sonic perfectionist—spent months layering guitar tracks in the basement of his Boston apartment to produce More Than a Feeling, a song whose depth came not from its melody, but from its structure. The track was not written; it was architected. Nearly five decades later, the biotech and pharmaceutical…
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.,…
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…
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…
Although the equation A + B = C seems self-evident (even for a five years old boy: remember you), the fact remains that it needed clarification by the Court of Justice of the European Union (“CJEU”), in relation to SPCs for product combinations (in application of article 3 c) of the SPC Regulation), which has…
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…
