Advocate General Trstenjak has today handed down her Opinion in Neurim Pharmaceuticals v The Comptroller-General of Patents, a reference concerning the possibility of obtaining SPC protection relying on a marketing authorisation ("MA") where an earlier MA has already been granted for the same active ingredient.
If the CJEU adopts the AG's schematic approach, SPCs may be granted despite the existence of an earlier MA for the same active ingredient, so long as the previously authorised use does not fall within the scope of protection of the basic patent on which the SPC application is based.
As the pharmaceutical sector increasingly explores second medical uses and different formulations for known active ingredients, this Opinion, if followed by the CJEU, may have a significant impact on the period of protection afforded to such products through the SPC regime.
It will take time to fully appreciate the ramifications of this Opinion if followed by the CJEU. Suffice to say they are likely to be significant.
In the latest in a string of references1 on the interpretation of Article 3 of Council Regulation EEC No 1768/92 ("the SPC Regulation")2 , the Court of Justice of the European Union ("the CJEU") has been asked to clarify the meaning of Article 3(d). Article 3(b) stipulates that a SPC may only be granted where an authorisation to place the product onto the market has already been granted. Article 3(d) states that that MA must be "the first authorisation to place the product on the market as a medicinal product".
In April 1992, Neurim Pharmaceuticals ("Neurim") filed a patent application for the use of a formulation of the hormone melatonin in the treatment of insomnia. In June 2007, Neurim obtained a MA for the patented formulation, under the brand name Circadin.
Neurim subsequently filed a SPC application, based on the June 2007 MA as the first authorisation to place the product on the market within the meaning of Article 3(d).
The UKIPO objected to the SPC application on the basis that an earlier MA had been granted in 2001 for the use of melatonin in sheep to start an early breeding season. The earlier MA was granted under Council Directive 81/851/EEC, which relates to veterinary medicinal products and the use in sheep did not fall within the scope of Neurim's patent.
The UKIPO's decision was upheld by the High Court on appeal and subsequently came before the UK Court of Appeal, which referred five questions to the CJEU. In summary these questions were:
- When an earlier MA has been granted for a medicinal product, does Article 3(d) preclude the grant of a SPC based on a later MA which is for a different medicinal product comprising the same active ingredient where the protection of the basic patent does notextend to the product that was the subject of the earlier MA?
- If the grant of the SPC is not precluded, does the “first authorisation to place the product on the market in the Community”referred to in Article 13(1) of the SPC Regulation need to be an authorisation for a medicinal product that falls within the limits of the protection conferred by the basic patent?
- Does it matter if the earlier MA was granted for a veterinary medicinal product for a particular indication and the later MA was granted for a medicinal product for human use for a different indication?
- Does it matter if the later MA required a full application for marketing approval?
- Does it matter if the product covered by the earlier MA is within the scope of protection of a different patent which belongs to a different registered proprietor than the SPC applicant?
The AG started by considering the literal wording of Article 3(d). She concluded that, on a purely literal interpretation, the active ingredient constituted the "product" and so a SPC could only be applied for on the basis of the first authorisation to place an active ingredient, or combination of active ingredients, on the market. On this interpretation no SPC could be based on the MA for Circadin, given the existence of an earlier (veterinary) MA for melatonin for a different use.
The AG went on to interpret Article 3(d) on the basis of the "scheme and objective" of the SPC Regulation. She observed that, under national law, it is possible and permissible for an active ingredient to be the subject matter of different patents. This is consistent with the definition of "basic patent" in Article 1(c) of the SPC Regulation. Considering each paragraph of Article 3 in turn, the AG concluded that in principle paragraphs (a), (b) and (c) permit the grant of more than one SPC for a product.
The AG concluded that the schematic analysis supported an interpretation of Article 3(d) as permitting the grant of more than one SPC for a product. She suggested that this was also consistent with the objective of the SPC Regulation, to extend the term of patent protection for active ingredients used in medicinal products. It was also consistent with the recognition in Article 54(5) of the EPC of second medical uses.
The AG stressed the importance of bearing in mind the balance of interest sought by the EU legislation. Accordingly, Article 3(d) should be interpreted by reference to the basic patent and the scope of protection of that basic patent.
The AG suggested that Article 3(d) does not preclude the grant of SPCs where there has been an earlier MA granted relating to the same active ingredient. A SPC may be granted on the basis of a second or further authorisation to place an active ingredient on the market, where that later authorisation is the first authorisation permitting the product to be placed on the market within the scope of the basic patent.
In relations to questions 2-5, it followed from the answer to question 1 that the period of protection is calculated from the date of the first MA for the medicinal product falling within the scope of protection of the basic patent. It is irrelevant whether the MA is granted for a human or a veterinary product, whether the later MA application was made by the full or the abridged procedure and whether the MA applicant holds the patent protecting the original MA.
The AG commented on the differing approaches that have been taken by the CJEU to the interpretation of the SPC Regulations. Whilst the interpretation that she proposes will be popular with patentees, it remains to be seen whether her schematic-teleological approach will ultimately be followed by the CJEU.