Insights

Brussels and Doha – April 1, 2024: The Legal 500 Europe, Middle East & Africa (EMEA) 2024 edition has recognized 16 practice areas and 11 lawyers in Crowell & Moring’s Brussels and Doha offices. The 11 individual lawyers received 18 total rankings across the 16 different practice areas.

Brussels – March 20, 2023: Chambers and Partners has ranked four Crowell & Moring practice groups and six individual lawyers in the Chambers Europe 2023 guide. The rankings are driven by independent interviews of clients and members of the legal community.

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing.  In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance.  In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’.  As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.

Examiner interviews are an optional but important and effective part of patent examination process that are beneficially conducted early and, in some cases, more than once during patent prosecution.  Interviews are in-person, telephone or online conferences between the Examiner and the patent attorney or patent agent representing the patent applicant. When conducted early in the patent examination process, interviews may reduce the time required to obtain a patent and increase the odds of obtaining an allowance.  As discussed below, interviews can help foster a cooperative interaction with the examiner to supercharge the prosecution process.

As reported in earlier Client Alerts, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In response, some manufacturers withdrew their patents, and others agreed to cap certain out-of-pocket costs for their drugs, resulting in a “victory lap” of media activity from the FTC in April.

More companies than ever before are launching smart medical devices and industry growth seems endless as new products and technologies are announced daily. However, before companies push products to market, it’s crucial to understand key aspects of device approval, and company and patient protection. In this webinar, our speakers will outline intellectual property strategies, U.S. Food and Drug Administration considerations, and data cybersecurity concerns that are inherent to all smart medical devices. They will explore the legal issues that can significantly decrease the risk profile and potential liabilities throughout a product's lifecycle and create safer, more reliable products for consumers.