THE BOTTOM LINE
- Shorter Monopoly for Foundational Patents: Owners of broad, foundational patents face a significant hurdle in extending their patent terms via a Supplementary Protection Certificate (SPC) for specific drugs that are not explicitly named in the original patent, even if they fall under its general claims. This can accelerate the entry of generic or biosimilar competitors.
- Increased Value of Follow-On Patents: This ruling highlights the commercial importance of obtaining separate, specific patents for newly developed drugs. For companies licensing-in technology, the follow-on patent becomes the more critical asset for long-term market exclusivity, as reliance on the licensor’s foundational patent for an SPC is risky.
- Divergence in European IP Strategy: The decision reinforces a strict interpretation of EU law that may differ from other jurisdictions. The fact that similar SPCs were granted in other European countries underscores the need for a nuanced, country-by-country IP strategy rather than a one-size-fits-all approach.
THE DETAILS
The District Court of The Hague has rejected an application for a patent term extension for the cancer drug durvalumab, dealing a blow to holders of broad, pioneering patents. The case involved Dana-Farber Cancer Institute, which owns a foundational European patent covering a class of cancer therapies that work by targeting the PD-L1 protein. While AstraZeneca’s blockbuster drug, durvalumab, falls within this class, it was not specifically identified or described in Dana-Farber’s original patent. Dana-Farber sought a Supplementary Protection Certificate (SPC)—a mechanism to extend a patent’s life to compensate for lengthy drug approval processes—arguing its patent was the “basic patent” protecting the drug. The Dutch Patent Office, and now the court, disagreed.
The court’s decision hinged on the well-established “two-step test” from EU case law for determining if a product is “protected by a basic patent.” The first step asks whether the product falls under the invention covered by the patent’s claims, which in this case it did. However, the application failed at the crucial second step: could a person skilled in the field, at the time the patent was filed, have specifically identified the product based on the patent’s disclosures and the existing state of technology? The court found that the original patent only provided a general, functional description (“an antibody that binds to B7-4/PD-L1”) and routine methods for creating such antibodies. It did not provide any specific “pointers” that would lead a researcher directly and unambiguously to the exact molecular structure of durvalumab.
The court noted that developing durvalumab required years of subsequent research and a series of independent choices—a process it did not consider “routine experimentation.” This was further evidenced by the fact that other licensees, using the same foundational patent, developed entirely different drugs (avelumab and atezolizumab) with distinct properties. Furthermore, the existence of a separate, later patent granted specifically for durvalumab was seen as strong evidence of a new, independent “inventive step.” The ruling makes it clear that for SPC purposes, simply providing a roadmap to a class of potential products is not enough; the specific commercial product must be clearly identifiable from the outset.
SOURCE
Source: Rechtbank Den Haag (District Court of The Hague)
