On July 19, 2012, the Court of Justice of the European Union ("CJEU") issued its long-awaited decision in case C-130/11 Neurim Pharmaceuticals (1991) Ltd v. Comptroller-General of Patents.
In its ruling, the CJEU significantly liberalized the current practice for granting Supplementary Protection Certificates ("SPCs"), reducing the limitations imposed on the grant or duration of SPCs by earlier marketing authorizations ("MAs") for the same active pharmaceutical ingredient ("API").
The requirements for the grant of an SPC and for the computation of its duration are laid down in Articles 3 and 13 (1) of European Regulation 469/2009 (the "SPC Regulation"), respectively.
Article 3 (a) to (c) of the SPC Regulation specifies the conditions a product, defined as the API of a pharmaceutical preparation, has to fulfill in order to be entitled to the grant of an SPC. In particular, the API has to be protected by a basic patent in force; a valid MA has been granted, allowing the placing of the API (as a pharmaceutical product) on the market; and the product may not already be the subject of another SPC.
In addition, Article 3 (d) stipulates that the MA relied upon has to be "the first authorization to place the product on the market as a medicinal product."
Article 13 of the SPC Regulation concerns the calculation of the SPC term, specifying that this calculation shall include "the date of the first MA in the Community." Thereby, an earlier date for the MA will result in a shorter SPC duration.
Based on a consistent line of jurisprudence by the CJEU throughout the past years (Pharmacia, C-31/03 in connection with Hässle, C-127/00; MIT, C-431/04; Yissum, C-202/05), it was generally assumed that the earliest MA that issued for a respective API, even if concerning a different indication and/or a different species as covered by the basic patent for which an SPC was sought, was considered to be the "first" MA in view of Articles 3 and 13 of the SPC Regulation.
This had the consequence that such earlier MAs, when issued in the same country for which SPC protection was sought, were deemed to be prejudicial to the grant of an SPC relying on another, later MA (following from Article 3 (d) of the SPC Regulation).
Moreover, earlier MAs issued in any (other) member state of the European Union could at least potentially cut short the duration of SPCs based on a later MA for the same API (following from Article 13 (1) of the SPC Regulation), again irrespective of the therapeutic indication in question.
The reference for a preliminary ruling by the CJEU was made in the course of a dispute between Neurim Pharmaceuticals (1991) Ltd and the UK Intellectual Property Office ("UKIPO"), which had refused to grant an SPC based on an MA granted on June 28, 2007 for the medicinal product "Circadin," a formulation of melatonin for use as a medicinal product for human use for insomnia, and a corresponding European Patent.
The UKIPO's refusal was based on the fact that it had identified an earlier veterinary MA, dating from 2001, for melatonin (i.e., the same active ingredient as Circadin) for use in sheep as a medicine for regulating seasonal breeding activity. UKIPO held that, contrary to Article 3 (d) of the SPC Regulation, Neurim's MA for Circadin was not the first MA to place the product (i.e., the active ingredient melatonin) on the market. Under the SPC Regulation, both human and veterinary MAs are treated equally.
Neurim challenged this decision before the UK High Court of Justice and, since its action was dismissed, before the Court of Appeal (England & Wales) (Civil Division). The Court of Appeal referred to the CJEU for a preliminary ruling essentially on the question of which MA is to be regarded as being a "first" MA in the sense of Articles 3 and 13 of the SPC Regulation.
Ruling of the CJEU
With regard to Article 3 of the SPC Regulation, the Court has now clarified that the existence of an earlier MA as such does not preclude the grant of an SPC, as long as the later MA (and the SPC) concerns a different application of the same product for which a marketing authorization has been granted (C-130/11, item 1 of the Court's ruling).
The Court in this context specified that "if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product." (emphasis added; C-130/11, paragraph 25)
It is of note at this stage that the Court already speaks of a (new) "therapeutic application" and former "therapeutic indications." It is left unclear whether the Court intentionally made this distinction in order to include other cases of new "therapeutic applications" rather than to limit those cases where grant of an SPC is allowed to new (different) medical indications only.
It is of further note that the Court, by referring to the SPC's scope ("in any event, could cover, not the active ingredient, but only the new use of that product"), appears to limit application of its ruling to basic patents not covering the API as such or its use in a pharmaceutical product as covered by the earlier MA.
With regard to Article 13 of the SPC Regulation—which addresses calculation of the SPC term depending on the time period that lapsed between the basic patent's filing date and the first MA granted in the EU—the Court ruled that the criteria according to the SPC Regulation for the assessment of a "first" MA should be the same for Articles 3 and Article 13(1) of the SPC Regulation (C-130/11, paragraph 30 and item 2 of the Court's ruling) and that, accordingly, an MA is considered to be the first MA as long as it concerns a product coming within the limits of protection conferred by the basic patent relied upon for the SPC application.
With regard to the future application of Article 3 of the SPC Regulation, earlier MAs for the same API might no longer be prejudicial to the grant of an SPC relying on a later MA, as long as the later MA concerns another medical indication or a new "therapeutic application," respectively. Given that in the case in question, the new "therapeutic application" was not only a new route of application in the narrow, pharmaceutical sense, but a new application in a different species and different indication, it is fair to conclude that new "therapeutic applications" at least encompasses new indications. It is open, however, whether other line extensions (new formulations, new routes of administration, dosage regimes, unit dosage forms, etc.) would be equally deemed new "therapeutic applications," i.e., in cases where the API has already been used in the same indication.
In addition, the impact of the MIT case (C-431/04) remains unclear, as it was not discussed in either the opinion of the Advocate General leading up to the Neurim decision or in the decision of the Court itself. In MIT, an SPC for a new formulation was denied. However, that case turned on the definition in Article 1 of the SPC Regulation of "combination of active ingredients" and the question of whether the combination of an API and excipient as a (pharmaceutically relevant) carrier was a combination of "active ingredients" under the SPC Regulation. The relationship of the basic patent (or its scope) to the earlier product was not discussed. Also, in that case, the basic patent would not have covered the use of the API in the earlier approved product, given that the basic patent was restricted to the new formulation.
Another open question is whether the nexus made by the Court between the patent and use of the patent in the authorized pharmaceutical ("the new therapeutic application of the same active ingredient, as protected by the new patent") is merely descriptive of the case at hand or a requirement. The wording of Article 3 requires only a patent covering the API and an authorized product using the API, but not an authorized product incorporating the specific use of the API as claimed in the basic patent. For example, a patent may claim use of X in the indication Y, and an SPC could be claimed based on the authorization of X in the indication Z (for what it is worth). If the nexus between patent and label of the authorized pharmaceutical is a requirement, this may result in validity issues for existing SPCs that refer only to the use of the API.
As far as Article 13 of the SPC Regulation is concerned, the wording of the Neurim ruling suggests that MAs concerning the same active ingredient, which have been issued in another member state of the European Union, should not be taken into consideration for the calculation of the term of an SPC relying on a later MA, as long as the later MA relates to a different therapeutic application. Also in this case, the interpretation of the new "therapeutic application" and the corresponding limitations with regard to the basic patent, as discussed in the preceding paragraphs, will have to be employed.
The rather broad and general wording of the decision is not atypical for judgments of the Court. However, while a range of questions on the precise scope of the decision remains, it is clear that the less literal interpretation of Article 3 of the SPC Regulation offers new opportunities to patent proprietors for obtaining SPC protection in cases where an API has already been authorized (and thus commercialized).
Following its recent judgments in the Medeva (C-322/10) and Georgetown (C-422/10) cases, the European Court of Justice has handed down another decision relating to the interpretation of the SPC Regulations that will have considerable impact on the filing and prosecution of patent term extensions. This will open new strategies not only for the pharmaceutical and biotechnology innovator industry seeking to extend the lifetime of their products but also for generic companies trying to enter the market with generic formulations or biosimilars.