ANVISA (the Brazilian regulatory authority) is considering updating rules addressing medical devices in a clear indication that this market is growing and requires more attention. Medical devices play a vital role in healthcare, having evolved from simple tools like thermometers and bandages to sophisticated technologies such as robotic surgical systems, implantable neurostimulators, and AI-powered diagnostics….
The Court of Appeal’s judgment in Optis Cellular Technology LLC v Apple Retail UK Ltd [2025] EWCA Civ 552, handed down on 1 May 2025, is arguably the most significant UK FRAND decision since Unwired Planet v Huawei. It not only overturns the High Court’s FRAND determination but re-establishes the centrality of a comparables-based approach…
*Also co-authored by Tatiana Costa Vaccination plays a crucial role in the prevention of diseases caused by etiological agents. The origins of vaccines trace back to the late 18th century, when Edward Jenner demonstrated the effectiveness of using cowpox as an immunizing agent against smallpox. Vaccines have made an undeniable contribution to public health by…
As patent aficionados are well aware, after the European Patent Office (“EPO”) published Decision G 0002/21, there was widespread expectation across Europe regarding whether or not the few national courts that require some sort of “plausibility” as a precondition for inventive step and/or sufficiency, would adapt their case law to the test introduced by G…
Article 9(4) of Directive 2004/48/EC obliges Member States to ensure that courts may issue provisional measures, including injunctions, without giving prior notice to the defendant in certain circumstances. This applies, in particular, when a delay is likely to result in irreparable harm to the rights holder, or when there may be a real risk that…
Much like Black Sabbath’s iconic track “Paranoid”—an anthem whose unsettling riffs once left skeptics bewildered—I find myself contemplating the equally discordant landscape of Standard Essential Patents (SEPs). As someone known for my passion for both music and the intricacies of patent law, I see uncanny parallels between the dissonant chords of early heavy metal and…
In the UK, as well as in many other countries, being the first to market with a generic or biosimilar to a leading branded medicine is a critical strategy that can offer a major advantage to a company in a highly competitive landscape. Being the first company to launch a generic product has several advantages. …
As is well known in the life sciences community in Europe, both the Commission and the Parliament have proposed reforms to the Medicines Directive which, if implemented, would serve to broaden the ambit of the Bolar exemption in the European Union. It is understood that the European Council is now considering these reforms and it…
Standard Essential Patents (SEPs) are at the heart of global technology markets, particularly in 4G/5G communications. While SEPs ensure interoperability, they also raise significant licensing challenges. As is known, to curb potential abuses, SEP holders must commit to licensing their patents on FRAND terms. However, determining what qualifies as “fair” and “reasonable” remains contentious. This…
A famous joke that must now be over 30 years old quips about the strength of the (German) patent attorney profession: „If all German patent attorneys and their families decide to settle in a single place, they would not even win the communal elections in Miesbach.“ Miesbach is a small town in pretty Upper Bavaria,…
