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Will Supplementary Protection Certificates soon become much more widely available?

11 May 2012

Background

Neurim Pharmaceuticals obtained the first ever authorisation for a human use of the active ingredient melatonin. Based upon this authorisation, they marketed the product Circadin® (as a treatment for insomnia, a therapeutic indication for melatonin patented by Neurim).

Having both a marketing authorisation and a patent for melatonin, Neurim applied for SPC protection. However, Neurim's UK SPC application was rejected because the authorisation for Circadin® was not deemed to be the first UK authorisation for a medicinal product containing melatonin, as required by Article 3(d) of the SPC legislation; there had been an earlier one for an unrelated veterinary use. An appeal to the UK High Court was dismissed for the same reason.

However, Neurim's arguments received a more sympathetic hearing during their further appeal to the UK Court of Appeal. The Court agreed that the purpose of the SPC legislation was to provide an additional period of exclusivity to applicants such as Neurim, who face a substantial regulatory burden and delay in order to reach the market (and therefore experience a much reduced period of effective patent term).

To clarify whether Article 3(d) of the SPC legislation can be interpreted in a manner favourable to Neurim, the Court of Appeal referred a number of questions to the CJEU. The first and broadest of these essentially asks whether the grant of a SPC is precluded when:

(i) the SPC application is for active ingredient X;
(ii) the SPC application is based upon authorisation MA2 and patent A;
(iii) there is an earlier authorisation, MA1, to a medicinal product containing X; and
(iv) selling, for the use specified in MA1, the old medicinal product containing X would not infringe patent A.

The Advocate-General's Opinion

Surprisingly, the opinion of the Advocate-General is essentially that the answer to the question above is "no".

If confirmed by the CJEU, this could well lead to much wider availability of SPC protection for newly authorised medicinal products that are patent-protected but that contain previously authorised active ingredients.

Our Comments

Taking into account the CJEU's decisions in the recent Medeva and Georgetown University et al. cases (see our IP Update no. 165), the Advocate-General's opinion could be interpreted to mean that SPC protection should be available if, in a particular territory:

• there is a basic patent that "protects" (by specifying in the claims) the active ingredient(s) specified in the SPC application;
• there is a valid authorisation for a medicinal product that comprises the specified active ingredient(s); and
• there has been no prior (human or veterinary) authorisation that is for a medicinal product comprising the same active ingredient(s) and that is within the scope of protection of the basic patent relied upon in the SPC application.

However, the opinion of the Advocate-General is controversial in that it raises at least as many questions as it attempts to answer. In particular, it casts doubt upon how other provisions of the legislation (such as Article 3(c), which limits the extent to which multiple SPCs can be issued for the same product) are to be interpreted in the light of the proposed, new interpretation of Article 3(d).

More significantly, the Advocate-General's opinion appears to be inconsistent with a significant body of SPC case law of the CJEU that interprets the legislation in a much more restrictive manner. This fact is acknowledged by the Advocate-General, as she comments that there are "several lines of case-law which are, in some cases, difficult to reconcile".

Outlook and Implications

It is not certain that the CJEU will answer the questions referred to it in the same manner as the Advocate-General. This is not least because of uncertainties generated by the A-G's opinion and the difficulty of reconciling that opinion with the established case law of the CJEU.

Nevertheless, there is now at least a realistic possibility that the CJEU will reach a decision that significantly liberalises the SPC system in Europe. If this happens, SPCs could become available based upon new authorisations for old active ingredients, wherein the new authorisations are in respect of medicinal products that are the first to embody a patented innovation relating to the active ingredient(s) of those medicinal products. The patented innovation could perhaps relate to any aspect of the active ingredient(s) such as, for example, a new formulation, a new indication or a new salt, enantiomer or physical form.

Possible Action

Do you have an interest in a patent (or patent application) in Europe that protects an innovative aspect of a medicinal product for which marketing approval will be, or has been, sought in Europe (by you or a third party)?

If you do, then we recommend that you seek the advice of our SPC experts on whether supplementary protection may be available.

In view of the possible liberalisation of the SPC system, it will be particularly important to contact us if your medicinal product contains an old active agent and had previously seemed unlikely to qualify for SPC protection. Even before the CJEU reaches its final decision in Neurim, an SPC application may now be appropriate, especially if the final deadline for submitting the application is fast approaching.

If you require any further information, please contact John Miles, Mike Snodin or Michael Pears of our SPC & Regulatory Group. If you would like to be placed on a circulation list for more detailed discussions and articles relating to SPCs and regulatory affairs, please contact Kerry Meadwell (kerry.meadwell@potterclarkson.com).

 

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