SPC protection for combinations

Many drugs, including vaccines, oncology therapies, anti-asthmatics and hypertensives are administered as combinations of active ingredients. This is due to a number of different reasons ranging from policy to synergistic interaction. Combination drugs may also require substantial investment, even when one or both components have themselves been available as separate treatments for many years. In many circumstances, this has led those that manufacture and sell such drugs to seek supplementary protection certificates (“SPCs”) to preserve protection and thus protect the investment in the drug from generic competition.

The difficulty for these applicants is that it has proved very difficult to interpret the legislation governing SPCs – Regulation 469/2009/EC ("SPC Regulation") – as regards combination drugs. This is widely thought to be because the SPC Regulation was only drafted to deal with those drugs comprising single, small molecule active ingredients.

This problem primarily lies with Article 3, which deals with the qualifying criteria for SPC protection (see toolkit article Conditions for obtaining an SPC):

Article 3 SPC Regulation states:

Article 3
Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
a) the product is protected by a basic patent in force;
b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
c) the product has not already been the subject of a certificate;
d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

Protection of combinations

KeyThe key questions that have arisen for combination products under this Article are whether a marketing authorisation (“MA”) for a hypothetical product A+B+C is capable of constituting a ‘valid authorisation’ of product A alone, for the purposes of Article 3(b)? Or, can it only serve as an authorisation for A+B+C?

Alternatively, an applicant might seek an SPC to protect product A+B+C, so that its SPC application reflects the MA instead of the patent. In this situation, does a hypothetical patent covering A alone protect the combination product A+B+C for the purpose of Article 3(a)?

To answer these questions, a large number of references were made by national courts to the CJEU.

Principal among these references was the case of Medeva BV’s SPC Applications1, which concerned five SPC applications for a variety of combination vaccines, all of which has been refused.

Under Article 3(a)  the CJEU ruled that an SPC cannot be granted for a combination product that is not “specified” in the wording of the claims of the basic patent. Hence, an application for an SPC on product A+B+C must be supported by a patent claim that specifies A+B+C.

Under Article 3(b) in Medeva,  the CJEU ruled that the SPC need only be sought for one or more of the products for which the MA has been granted. In other words, an SPC can be sought for product A only, based on a marketing authorization for A+B+C.

The results of the Medeva ruling

Patent MA SPC Issue CJEU Ruling
A A+B+C A Is the MA for A+B+C a valid authorisation for an SPC on product A, further to Article 3(b)? Yes
A A+B+C A+B+C Is product A+B+C protected by a patent for A alone, further to Article 3(a)? No

Subsequent rulings of the CJEU have confirmed the approach taken in Medeva.

Infringement by a combination

If an SPC can only be obtained for product A alone, because it is only A that is specified in the basic patent, how does this affect the SPC proprietor’s ability to enforce its SPC for A against third-party use of a combination product such as A+B+C? This question has also been resolved by the CJEU recently, in Novartis v Actavis2:

As a result of the CJEU ruling in Novartis v Actavis, the owner of an SPC for A, would be able to enforce that SPC against a product comprising A in combination with other active ingredients.

This is important for proprietors of combination drugs, given the Medeva ruling. It confirms a wide scope of enforcement of an SPC for A (against A+B+C etc), compensating for the fact that the SPC may need to be limited to one active ingredient if that is all that is covered by the basic patent.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

1Medeva BV’s SPC Applications (Case C-322/10).

2Case C-442/11.

Safe with documents

Paul England

Paul is a senior associate and professional support lawyer in the Patents group based in our London office.