Supplementary protection certificates for medicinal products: When is a “product” protected by a basic patent in force?

The Court of Justice of the European Union (“CJEU”) has issued a judgment assessing the implications of one of the requirements to issue a supplementary protection certificate (“SPC”) for medicinal products established in Regulation 469/2009 of May 6, 2009 on the supplementary protection certificate for medicinal products, specifically, the requirement that “the product [understood as an active ingredient or combination of active ingredients] is protected by a basic patent in force.”

Background

A pharmaceutical company holding a European patent (the “Patent”) on a method that helps regulate blood sugar levels by administering inhibitors of an enzyme—one of which (the “Inhibitor”) is patented ex post by one of its licensees—filed an SPC application on the Inhibitor before the German Patents and Trademarks Office. That application was based on the Patent, as basic patent, and a marketing authorization on the product issued by the European Medicines Agency.

The Office denied the SPC application based on the fact that the Patent did not specifically disclose the Inhibitor, despite the fact that it fulfilled the functional definition of one of the inhibitors listed on the Patent’s claims.

The company filed an appeal before the Bundespatentgericht, and, aside from the claims and observations of the parties (see paragraphs 11 to 20 of the judgment), the court referred three preliminary questions to the CJEU:

First and second question

Is it necessary for a product to be protected by a basic patent in force (…) that it be part of the subject of protection defined by the claims and, therefore, that it be available to the expert as a specific embodiment? Is it not sufficient for the requirements this article (…) if the product in question (…) is not otherwise indicated in individualized form as a specific embodiment of the information protected by the basic patent?

The CJEU resolved the two questions together based on its Teva UK judgment (C-121/17, EU:C:2018:585), reviewed in this blog post. The court established that, when the product—the Inhibitor—is not expressly referred to in the basic patent’s—the Patent—claims, two requirements must be met for it to be considered included in its scope of protection.

(i) The product must be included, for a person skilled in the art, in the invention protected by the patent (i.e., taking into account the claims, description and drawings of the patent in question).

Regarding the question referred, the CJEU explained that, although the Inhibitor was not expressly mentioned in the Patent’s claims, it satisfied the functional definition of one of its claims. Therefore, it held that it was included in the invention.

(ii) An expert must be able to specifically identify that product in view of the elements disclosed by the patent and based on the date of filing or priority.

The CJEU entrusts the task of checking whether the subject of the SPC is within the limits of what an expert could “objectively infer directly and unequivocally from the specification of that patent” to the Bundespatentgericht. That is because the Inhibitor was not explicitly disclosed in the Patent as a specific embodiment of the invention but was included in a general functional definition of one of its claims.

Third question

Is a product not protected by a basic patent in force excluded from protection, even it is covered by the functional definition in the claims but was developed after the filing date of the basic patent as a result of an independent inventive step?

The CJEU reminds of the legal effect of the SPC as an element of industrial property and highlights its aims—to encourage research and cover investments—(see paragraph 46), and it offers a clear answer to this third question: a product that is the subject of an SPC developed after that date and following an independent inventive step “cannot be regarded as coming within the scope of the subject matter of the protection conferred by that patent.”

The CJEU recently ruled on one of the requirements to issue an SPC (we reviewed it in this blog post), which, added to the judgment, undoubtedly helps define SPCs for medicinal products and the “rules” for interpreting each of their issuing requirements.

Author: Raúl Pérez Terol