Opportunity knocks: widening access to SPCs

On July 19, 2012, the Court of Justice of the European Union (CJEU) issued its ruling in the Neurim case (C-130/11). This decision creates new opportunities for extending the period of effective protection of a product by supplementary protection certificates (SPCs).

In particular, it clarifies that an SPC can be granted for a new, patented medical use of a product for which a marketing authorisation has been obtained, even if an earlier marketing authorisation for a different use of the same product exists.

In the underlying case, Neurim had found that the compound melatonin, a natural hormone that was not patented as such, can be used for treating insomnia in human patients aged 55 or older. A European patent was granted to Neurim for its formulation Circadin. At the time Neurim obtained the authorisation to place Circadin on the market, less than five years of the patent term were left, and Neurim filed an SPC application.

The UK Intellectual Property Office (IPO) refused the SPC application and argued that the marketing authorisation for Circadin was not the first marketing authorisation as required by Article 3(d) of the SPC Regulation (EC) No 469/2009.

The refusal of the IPO was based mainly on the fact that an earlier marketing authorisation had been granted for a melatonin-containing formulation called Regulin, a product that was patented by Hoechst in 1987 for the regulation of the seasonal breeding activity of sheep. This marketing authorisation for Regulin was considered by the IPO as the first marketing authorisation under Article 3(d) of the regulation.

The IPO’s decision was challenged by Neurim before the High Court of Justice. After its action had been dismissed by the High Court, Neurim appealed to the Court of Appeal of England and Wales. Neurim argued that an earlier marketing authorisation should impede the grant of an SPC only if the subject-matter of that earlier authorisation is within the scope of the basic patent that was relied upon in the SPC application.

The Court of Appeal decided to stay the proceedings and, inter alia, referred the following questions to the CJEU:

1. In interpreting Article 3, when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier marketing authorisation on the market within the meaning of Article 4?

2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the regulation, “the first marketing authorisation in the Community” needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?

With respect to the first question, the CJEU ruled that if a patent protects a new therapeutic use of a known active ingredient which has previously been marketed as a medicinal product for treating other indications in humans or animals, the placement on the market of a new medicinal product which exploits the new therapeutic use of said active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC.

According to the CJEU, Article 4 of the SPC Regulation ensures in such a situation that the scope of protection conferred by the SPC does not cover the active ingredient as such, but only its new application.

So in essence, the CJEU confirmed that a later marketing authorisation can be regarded as the first marketing authorisation under Article 3(d) of the regulation, even though an earlier marketing authorisation for the same active ingredient exists, provided that the subject matter of the earlier authorisation is not covered by the basic patent relied upon for the purposes of the SPC application.

If the basic patent does not extend to the earlier marketing authorisation, such earlier authorisation is no longer an obstacle for grant of an SPC for an active ingredient authorised for a new therapeutic use which is protected by the basic patent.

With respect to the second question, the CJEU held that the criteria that have to be applied when interpreting Article 13(1) are the same as those discussed in connection with Article 3(d) of the SPC Regulation. Th is means that Article 13(1) of the regulation must also be understood as referring to the first marketing authorisation for an active ingredient that is within the scope of the basic patent.

The Neurim ruling will further encourage pharmaceutical companies to explore new therapeutic uses of previously authorised active ingredients. As the decision will lead to a change in the practice of the competent authorities in the member states, patent holders should review their portfolios for products that may become eligible for SPC protection under the new jurisprudence.