Sheep don't follow authorisation: CJEU decides on Neurim SPC application

Background – SPCs prior to Neurim

It is almost 20 years since SPCs were introduced across the European Union, firstly for medicinal products, and later for plant protection products, that require marketing authorisation by a regulatory body. The aim of SPCs is to compensate the patent holder for the patent term lost due to the need to obtain marketing authorisation. In the EU, SPCs can extend the term of protection for such a patented product by up to five years. As the term of the SPC is often the time when the product achieves its peak sales, obtaining SPCs is of critical importance to the pharmaceutical and agroscience industries.

Thousands of SPCs have been granted for medicines and plant protection products containing a new, patented, approved active ingredient. However, when the active has previously been approved, the award of SPCs based on patents directed to new formulations of that active or new medical uses of the active has been a controversial matter in the EU. Article 3(d) of the Regulation 469/2009 ("the SPC Regulation"), which sets out the criteria for obtaining an SPC for a medicinal product, requires that the marketing authorisation for the product be the first authorisation to place that product on the market.

Previous decisions of the CJEU rejected attempts to obtain SPCs for reformulations or new uses of previously approved products. In the MIT case (C-431/04) the CJEU rejected an SPC for a formulation of the previously approved chemotherapeutic agent carmustine in a slow-release polymer matrix. The CJEU refused to consider the formulation as a combination of actives as carmustine was the only therapeutically active agent in the formulation for the treatment of brain tumours, even though the presence of the polymer avoided the toxic effects of the active and made it possible to use this active for that indication.

In Yissum (C-202/05) the CJEU also rejected an SPC application for a formulation of the previously approved active calcitriol, even though the earlier marketing authorisation was for a different use of that active. The CJEU ruled the use of a product did not form part of the product definition, and consequently considered Yissum's authorisation not to be the first authorisation for that product. The CJEU also followed its MIT decision in rejecting Yissum's arguments that the different excipients in the formulation made it a combination of actives. However, it should be noted that both of these earlier cases were decided under Article 1(b) of the Regulation, which relates to how the Regulation defines the term "product", rather than the question of whether the authorisation of the new formulation counts as "the first authorisation" for the active ingredient under Article 3(d).

In Pharmacia Italia (C-31/03) the CJEU took an even stricter line and rejected an SPC based on a product authorised for the first time for a human use, in view of an earlier marketing authorisation of the same active as a veterinary product. However, in this case the earlier veterinary authorisation pre-dated the earliest possible date (01 January 1985) for which SPCs could be awarded under the Regulation.

In view of these decisions, prior to Neurim it appeared that the CJEU had firmly closed the door to SPCs for medicines wherein the active ingredient had been previously authorised in any form and for any indication.

Neurim - the facts

Neurim Pharmaceuticals had carried out research into the use of the natural hormone melatonin for treating insomnia, leading to a marketing authorisation (MA) for their product Circadia® which contains melatonin as the active ingredient. Neurim then applied for an SPC based on this MA and their European patent for their formulation, the claims of which were limited to its use in treating nocturnal melatonin deficiency or distortions in humans.

Article 3(d) of the SPC regulation (469/2009), which sets out the criteria for obtaining an SPC for a medicinal product, requires that the MA for the product be the first authorisation to place that product on the market. The UK IP Office refused Neurim's SPC application on this ground, in view of an earlier granted MA (to a different company) for the use of melatonin for regulating reproduction in sheep. The UK High Court agreed.

Questions referred and answered

The UK Court of Appeal were more receptive to Neurim's argument that the relevant MA that should be considered when applying Article 3(d) should be an MA covered by the basic patent (and that the earlier MA for use in sheep was therefore irrelevant as it was not covered by the basic patent). Lord Justice Jacob commented that if Neurim were wrong, the SPC Regulation would not be fulfilling its key objective, namely to encourage pharmaceutical research. The Court of Appeal referred the following five questions to the CJEU:

1. In interpreting Article 3 of [the SPC Regulation], when [an MA] (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 [MA] (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 MA 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 SPC Regulation, “the first [MA] 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?

3. Are the answers to the above questions different if the earlier [MA] has been granted for a veterinary medicinal product for a particular indication and the later [MA] has been granted for a medicinal product for human use for a different indication?

4. Are the answers to the above questions different if the later [MA] required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?

5. Are the answers to the above questions different if the product covered by the authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?

Unlike many courts in common law countries, the CJEU frequently applies a ‘teleological’ interpretation to matters of EU law: in other words, an interpretation based on the underlying purpose of the legislation. As with previous decisions on SPCs, such an interpretation can frequently result in an outcome which appears to conflict with the literal wording of the legislation.

The CJEU considered questions 1 and 3 together. The Court noted that the fundamental purpose of the SPC Regulation is to encourage pharmaceutical research, and that an SPC based on a second medical use patent can only cover the use of the authorised product specified in the patent. Based on this, the CJEU considered that it may be possible for an SPC to be granted for an authorised use (Use B) of a known active ingredient based on a patent limited to Use B, even if an MA has already been granted for the active ingredient for an earlier therapeutic use (Use A). The Court considered that, in such a situation, only the MA for Use B would be considered the first MA for that product. The Court therefore answered questions 1 and 3 by ruling that the prior MA for use as a veterinary product did not preclude the grant of a later SPC for a different use, provided that use (as specified in the later MA) fell within the limits of the basic patent on which the SPC application was based.

The CJEU applied similar reasoning when answering question 2, which relates to the duration of the SPC. The Court considered that the date of the later MA (ie that covering Use B) to be the relevant date for calculating the duration of the SPC, and ruled the date of the earlier MA for Use A irrelevant.

Finally, the Court answered questions 4 and 5 by ruling that neither the procedure for obtaining the MA, nor the ownership of the basic patents, made any difference to the answers to the previous questions.

Discussion

The CJEU's ruling is very generous to the applicant, and is excellent news for research into new uses of known medicinal products. It also shows that the Court continues to consider the underlying purpose of the Regulation, even if this conflicts with a literal wording of the Article.

Once again, however, the CJEU's reasoning is incomplete and has left a number of questions unanswered. Firstly, it is unclear from the decision whether the MA for Use A needs to relate to a veterinary use of the product for the exception to apply, or whether an earlier MA for a human Use A of the product would also be disregarded provided that the patent on which the SPC application was based is limited to Use B. The Court referred to an earlier veterinary use when answering the questions, but also referred to an earlier MA for human use in its reasoning. A further reference to the CJEU may ultimately be required to answer this question.

Secondly, the Decision appears to conflict with the CJEU's earlier decision in Pharmacia, which ruled that the date of an earlier MA for a veterinary use, rather than that of a later MA for a human use, should be considered the first MA for calculating the duration of the SPC. It also appears to conflict with its ruling in Yissum, in which it ruled the use of a product did not form part of the product definition and therefore rejected an SPC application in view of an earlier MA for a different use of the same product. This latest decision made no reference to either Pharmacia or Yissum in its reasoning, and is difficult to reconcile with either.

Finally, it remains to be seen whether this decision will ultimately be considered a narrow exception to the general provisions of Article 3(d) by being limited to the specific case where an earlier veterinary MA for the same product exists, or paves the way for a more liberal interpretation of the SPC Regulation generally. In view of the number of exceptions now allowed by the CJEU to many of the eligibility criteria of the Article, it is possible a new Regulation will ultimately be required to provide legal certainty.