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Editorial

SPCs for medicinal products – the opinion of the Advocate General in the Neurim case

On 3rd May 2012, Advocate General Verica Trstenjak issued her opinion in case C-130/11, also known as the Neurim case. Should the Court of Justice choose to accept the findings of the opinion, it will improve the possibility for the pharmaceutical industry in Europe to obtain SPCs for medicinal products.

Neurim Pharmaceuticals Ltd (Neurim) discovered in its research that certain formulations of melatonin can be used as a medicine for insomnia, and submitted an application for a European patent concerning certain formulations of melatonin in 1992.

Neurim applied for a marketing authorisation to place the melatonin formulation in question on the market as a medicinal product for human use. The authorization was however, not granted until June 2007. This medicinal product for human use is currently sold under the name Circadin.

After the grant of the authorisation, Neurim Pharmaceuticals accordingly applied for a SPC. The application was based on the June 2007 marketing authorisation and designated that marketing authorisation as the first authorisation to place the product on the market within the meaning of Article 3(d) of Regulation No 1768/92 (now Regulation 469/2009).

The UK Intellectual Property Office (IPO) refused the application. It said that Neurim’s marketing authorisation was not the relevant first authorisation to place the product on the market, since there was an earlier authorisation for melatonin for use in sheep, granted between January and March 2001. The veterinary medicinal product was sold under the trade mark ‘Regulin’.

Neurim brought an action against the refusal of its application before the national court, which confirmed the IPO’s decision. Neurim then appealed against that judgment to the UK Court of Appeal. The Court of Appeal was in doubt with regards to the interpretation of Article 3(d) of the Regulation, and thus referred to the European Court of Justice for a preliminary ruling. Though Court of Appeal referred 5 questions, the essence of the referral which the Court of Justice will have to decide upon can be found in the first question:

“In interpreting Article 3 of Regulation (EEC) No 1768/92 [now Regulation (EC) No 469/2009] (“the SPC Regulation”), 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?”

The Advocate General delivered her opinion in the case 3rd May 2012. Essentially, the Advocate General finds that the Regulation 1768/92 after a literal interpretation of article 3(d) provides that a supplementary protection certificate for an active ingredient or for a combination of active ingredients may be applied for only on the basis of the first marketing authorisation to place that active ingredient or that combination of active ingredients on the market as a medicinal product for human use or as a veterinary medicinal product. As such, any further authorisation to place that active ingredient or that combination of active ingredients on the market as a medicinal product is to be regarded as a later authorisation, of which according to the wording of Article 3(d) an application for a SPC cannot be made.

However, finding that such an interpretation in a case like in the main proceedings would be contrary to the aims of Regulation 1768/92, the Advocate General finds that the literal interpretation article 3(d) must be supplemented by a schematic-teleological interpretation.

In the view of the Advocate General, Article 3(d) must be interpreted “to the effect that a supplementary protection certificate may be granted for a product protected by a basic patent in force only on the basis of the first valid marketing authorisation, in the Member State for which the application is made, for a veterinary medicinal product or a medicinal product for human use which contains that product and is within the scope of protection of that basic patent.”

Such an interpretation of Article 3(d) would, according to the Advocate General, ensure “that in principle a supplementary protection certificate may be applied for, in respect of each basic patent, on the basis of the first authorisation to place the product on the market as a medicinal product which is within the scope of protection conferred by that basic patent.”

The Advocate General holds that new formulations or indications of an active ingredient should not get a SPC if the use covered by the former marketing authorization is within the scope of protection of the basic patent for the SPC-application. However, if use according to the former marketing authorization is not within the scope of the basic patent, the former marketing authorization will not prevent that an SPC is granted based on a new marketing authorization.

It is interesting that the Advocate General uses the expression “within the scope of protection conferred by the basic patent”, since in the Medeva decision uses the expression “specified in the wording of the claims” with respect to article 3(a).

In the view of the Advocate General, this would also prevent manufacturers of medicinal products from being able to optimise the protection granted by a basic patent ”through the phased authorisation of several uses of a product protected by a basic patent as a medicinal product in order to undermine the system of limitation of the duration of supplementary protection certificates envisaged by the legislature through several ‘first’ marketing authorisations as a medicinal product for different uses of a product which are all within the scope of protection of the same basic patent.”

With regards to the determination of the term of the SPC, ref. Article 13(1) of the Regulation, the Advocate General follows the same reasoning. The first authorisation to place a product on the market in the European Union as a medicinal product should be interpreted as the first authorisation to place a product on the market in the European Union as a medicinal product which is within the scope of protection conferred by the basic patent designated by the applicant.

Should the Court of Justice accept the findings of the advocate general, it may to some degree improve the pharmaceutical industry’s ability to obtain patent term extension for more medicinal products in the European Union. Pharmaceutical research has increasingly involved new formulations and new therapeutic utilizations of old active substances, but previous judgements from the ECJ, notably C-431/04 Massachusetts Institute of Technology and C-202/05 Yissum has so far been viewed as “closing the door” for granting SPCs in such cases. It has also been the assumption that case C-31/03 Pharmacia, which said that the Regulation does not differentiate between marketing authorizations for humans and veterinary medicinal products, blocked for obtaining a SPC in cases such as the one in Neurim.

The opinion of the Advocate General is therefore more in accordance with the purpose of the Regulation than the strict practice the European Court of Justice have demonstrated in previous cases.

However, one consequence of the Advocate General’s opinion is even more complexity regarding the understanding of the rules with regards to the conditions in which cases a SPC can be obtained. A lack of clarity also leads to the risk of a heterogeneous development in practice among the national patent offices of the member states of the European Union. Such disparities are contrary to the purpose of the Regulation, which underlines the importance of harmonization to avoid creating obstacles to the free movement of medicinal products within the European Union.

The opinion of the Advocate General is not binding to the Court of Justice, and the Court have in a previous case regarding SPCs derogated from an opinion, ref. C-431/04 Massachusetts Institute of Technology.

The opinion of the Advocate General can be found here.


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