Why are so many cases of a Supplementary Protection Certificate (“SPC”) of a medicinal product ending before the ECJ?

bnt Life Science & Pharma can provide you legal services and advice in the patent/SPC application process.

What is an SPC?

A Supplementary Protection Certificate (SPC) is an intellectual property right, which may extend patent protection (max. 20 years) of medicinal products for max. 5 additional years. For example, if a patent is filed on 1 January 2000 and a Marketing Authorization (“MA”) is granted on 1 January 2010, the 5 years’ SPC protection will commence on 1 January 2020. As a result, EU based manufacturers, who hold a basic patent to a medicinal product, can enjoy longer exclusive protection of their IP rights after their product was granted MA in the EU.

What is covered by the basic patent?

A basic patent protects the active ingredients and/or combinations of active ingredients of a medicinal product for the purpose an EU manufacturer designates for it in the patent application. If an EU manufacturer invents a new medicinal product, the company will usually seek a patent protection under the EU patent law (the “inventor”). For example, the inventor includes in its basic patent application that it seeks protection for an active ingredient “A” designed for the treatment of disease “B” and this patent is granted. Within 6 months prior to the expiry of the patent for the medicinal product, the inventor applies for the SPC for this active “A” ingredient for the treatment of disease “B”. In this situation, no problem will arise.

So far so good?

What if the EU manufacturer (the patent holder) markets a medicinal product, which contains a combination of active ingredient A (covered by a basic patent) + an active ingredient, which is not explicitly covered in the basic patent? Historically, there have been numerous referrals to the ECJ on points of law relating to SPCs as regards the question above, and this trend is culminating.

On 25 July 2018, the ECJ rendered its long-awaited decision in a case concerning the medicinal product Truvada, clarifying that a combination product is eligible for an SPC, if the claims in the underlying patent relate necessarily and specifically to that combination of active ingredients (even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent).

In this case, Gilead produced the medicinal product Truvada which consisted of two active ingredients. The claims in Gilead’s basic patent mentioned expressly only the first of those two active ingredients, and the second was only covered by the phrase “other therapeutic ingredients”.

The ECJ formulated in its judgement a new 2-parts test to determine whether a product is protected by a basic patent or not, i.e.:

1. if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent and

2. whether each of those active ingredients was specifically identifiable by the person skilled in the art.

Gilead did not pass this test.

As a result, the England and Wales High Court of Justice (Patents Court) invalidated Gilead’s SPC on the ground that the patent failed to identify all the drug’s active ingredients. As you can see, obtaining SPC for medicinal products may become problematic, when it comes to a combination medicinal product. It is usually too late if the basic patent is already filed and does not cover all active ingredients of a product, and does not meet criteria of ECJ’s 2-parts test described above. Therefore, priority should be given to the formulation of patent applications.

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