Title: Santen ‍(C-673/18): CJEU Takes a Restrictive View on⁢ “First Authorisation” for New ⁢Therapeutic Applications


In‌ a recent ruling, the Court of Justice of the European Union (CJEU) delivered a significant judgment in⁣ the case of Santen (C-673/18), impacting the interpretation of EU pharmaceutical law. The decision revolves around the definition of “first ‌authorisation” for new therapeutic applications and marks a⁢ pivotal moment for​ pharmaceutical companies seeking market exclusivity for their innovative products. Let’s delve into the details of this case and understand the ‍implications of​ the CJEU’s‌ restrictive stance on this crucial issue.

The Santen Case: Understanding the Context:

In the Santen case,⁢ the CJEU ‍was tasked with clarifying⁤ the⁣ interpretation of the term “first authorisation” under EU law, particularly in the context⁤ of obtaining supplementary protection certificates (SPCs) for pharmaceutical products.

Key Points from the CJEU Ruling:

  1. The CJEU⁣ ruled that a marketing authorization⁢ for a new therapeutic application of a known ⁣active ingredient does not constitute a “first authorisation” for the purpose of obtaining​ an SPC. This means that a company may ⁣not receive extended market exclusivity for such variations.

  2. The court emphasized that the objective of SPCs is to incentivize research and ​development of new medicinal products, rather than minor variations or improvements⁢ on existing treatments.

  3. The judgment highlights the​ importance of aligning EU pharmaceutical law with the fundamental goal⁤ of fostering innovation and⁤ protecting intellectual ⁣property rights.

    Implications for Pharmaceutical Companies:

    The CJEU’s decision in the Santen case has significant implications for ‌pharmaceutical ⁢companies operating in the ⁢EU. Some key takeaways include:

  4. Limited Market Exclusivity: Companies seeking SPCs for new therapeutic applications of known ‍active ingredients ​may face challenges in obtaining extended market exclusivity under the current interpretation of “first authorisation”.

  5. Focus on Innovation: The ruling underscores the importance of ​focusing on ⁤genuine innovation in drug development to qualify for SPCs ‌and other forms of intellectual ‌property protection.

    Benefits and Practical Tips:

    • Emphasize Innovation: To maximize the chances of obtaining SPCs, pharmaceutical companies should prioritize developing truly innovative products that provide ⁢significant benefits to patients.

    • Seek Legal Advice: ‍Given the complexity of⁢ EU pharmaceutical law, companies ‌are advised to consult with legal ‍experts who specialize in intellectual property and ‌regulatory matters to navigate the regulatory​ landscape effectively.


      The ⁣CJEU’s judgment in the Santen case represents a significant ‍development in EU pharmaceutical ⁢law, particularly concerning the interpretation of “first authorisation” for​ new therapeutic applications. Pharmaceutical companies must ⁢adapt their strategies‍ to align with the court’s restrictive view on ‍market exclusivity to ensure compliance and maintain a competitive edge in the industry.

      Overall,​ the​ ruling highlights ⁣the importance ⁢of innovation and genuine scientific advances in drug development‍ to qualify for extended protection under ‌EU law. By understanding the implications ⁣of the Santen case and implementing strategic measures, pharmaceutical companies‌ can navigate the regulatory landscape effectively and secure their position in⁣ the market.

      [Word Count: 502]

      [Meta Title: Santen (C-673/18): CJEU Takes a Restrictive View on “First Authorisation” for New Therapeutic Applications]

      [Meta Description: Explore the CJEU’s ruling in the Santen (C-673/18) case and learn about the implications for pharmaceutical companies seeking extended market exclusivity for new therapeutic applications under EU law.]

Leave a Reply

Your email address will not be published. Required fields are marked *