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").
Issue
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.
Procedural History
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.
Practical Considerations
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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.