On 30 April 2020 the CJEU gave its ruling in C-650/17 (Royalty Pharma). The judgment, which is reviewed in detail below, confirms that SPC applications are allowable when the product is not explicitly recited in the claims. However, it is implied that the product will need to be disclosed to a high degree of specificity elsewhere in the patent.
The case was previously joined with C-114/18 (Sandoz and Hexal) because both referrals concern the interpretation of Article 3(a) of the SPC Regulation. Article 3(a) requires that:
"A[n SPC] shall be granted if... the product is protected by a basic patent in force"
However, in December 2019 the referring UK court withdrew its request for a ruling in Sandoz and Hexal. Advocate General Hogan had by that point already issued his opinion on both referrals (see our discussion here), but the judgment of the full court is confined to the questions referred in Royalty Pharma.
Background
The referral in Royalty Pharma was made by the German
Bundespatentgericht (Federal Patent Court) in a case concerning the
refusal by the DPMA (German Patent Office) of an application for an
SPC for the diabetes product Januvia due to failure to comply
with Article 3(a).
The product comprises the active ingredient sitagliptin, a DP IV
inhibitor. The basic patent
EP1084705 effectively claims DP IV inhibitors defined as a
functional class, for the treatment of diabetes. However,
sitagliptin is not disclosed in individualised form in EP1084705.
It was developed after the filing date of the basic patent by a
licensee. The licensee obtained a separate patent for sitagliptin,
on the basis of which it was granted its own SPC.
The Bundespatentgericht considered that there were conflicting
views regarding how to assess the requirements of Article 3(a),
including the relevance of a so-called 'core inventive
advance' test applied by the judge for a corresponding case in
the UK.
Accordingly, it referred the following questions to the CJEU:
"1. Is a product protected by a basic patent in force pursuant
to Article 3(a) of Regulation (EC) No 469/2009 only if it forms
part of the subject matter of protection defined by the claims and
is thus provided to the expert as a specific embodiment?
2. Is it not therefore sufficient for the requirements of Article
3(a) of Regulation (EC) No 469/2009 if the product in question
satisfies the general functional definition of a class of active
ingredients in the claims, but is not otherwise indicated in
individualised form as a specific embodiment of the method
protected by the basic patent?
3. Is a product not protected by a basic patent in force under
Article 3(a) of Regulation (EC) No 469/2009 if it is covered by the
functional definition in the claims, but was developed only after
the filing date of the basic patent as a result of an independent
inventive step?"
Following the July 2018 delivery of the judgment in
C-121/17 (Teva) (see our briefing
here), which also concerned Article 3(a), the CJEU invited the
Bundespatentgericht to confirm whether it wished to maintain its
referral and, if so, on what grounds.
The Bundespatentgericht maintained its referral on the grounds that
the CJEU did not explicitly criticise the 'core inventive
advance' test in their ruling in Teva, and thus it remained
unclear the extent to which such a test may be relevant to Article
3(a).
The oral hearing took place in June 2019, with Advocate General
Hogan's opinion issuing in September 2019. Royalty Pharma
subsequently requested re-opening of the oral procedure on the
grounds that the Advocate General's opinion contained errors.
Specifically, they asserted that the patent relied upon for Royalty
Pharma's SPC application was misidentified in the opinion (the
wrong number was quoted), and also that the Advocate General had
misinterpreted CJEU case law.
The CJEU denied the request. It is settled case-law that the Court
may order the reopening of the oral procedure, but only if it
considers that it is insufficiently informed, or that the case
turns on the basis of an argument which has not been discussed
between the parties, or that one of the parties has submitted a new
development which could have a decisive influence. It does not
provide for the parties to file observations in response to
conclusions presented by the Advocate General. Royalty Pharma's
criticism of the Advocate General's interpretation of the case
law was considered to fall into this latter category, and so did
not occasion re-opening the oral procedure. The factual error in
identification of the patent number was held not to be
material.
The Ruling
In its introductory remarks (paragraphs [30] – [32]), the
CJEU state explicitly that the 'core inventive advance'
test is not relevant for the interpretation of
Article 3(a). Although it is acknowledged that this test was not
explicitly excluded, the CJEU states that its ruling in Teva
provides a test that relies solely on the interpretation of the
claims of a basic patent in line with the Protocol on
Interpretation of Article 69 EPC.
Having established this background, the CJEU turns to the first and
second referred questions, which are considered together in a
condensed form. This is paraphrased as:
"Must Article 3(a) of Regulation No 469/2009 be interpreted as
meaning that a product is protected by a basic patent in force...,
if the product meets a general functional definition in one of the
claims and necessarily falls under the invention covered by the
patent, but cannot be derived individually from the teaching of the
patent as a specific embodiment?"
The CJEU goes on to explain that (in effect) it believes this
question has already been answered in Teva. As such the court has
broadly followed the reasoning of Advocate General Hogan. It is
confirmed in paragraph [37] that, where a product is not explicitly
recited in the claims, the two cumulative conditions set out in
Teva must be met in order for Article 3(a) to be satisfied:
(1) The product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by the basic patent.
(2) The person skilled in the art must be able to identify the product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned.
This conclusion is essentially repeated in paragraph [43] as the
answer to referred questions 1 and 2. However, in paragraphs [38]
– [42] the CJEU provides some additional guidance as to how
the test should be applied, with a particular view to the facts
before it for sitagliptin.
The CJEU considers it to be clear from the referral itself that
sitagliptin is not explicitly recited in the claims, and that the
referring court evidently find it to fall under the invention of
the basic patent. Thus, although the CJEU notes that it is for the
referring court to decide these matters, the CJEU considers both
that the two part test must be applied and also that the first part
of that test is satisfied.
However, the CJEU notes that the referring court appears to have
doubts that sitagliptin satisfies the second part of the test and
has (effectively) asked the CJEU to clarify the degree of
specificity required.
In paragraph [40], the CJEU states that the referring court must
satisfy itself that the subject matter of the SPC is within the
limits of what the person skilled in the art, on the filing or
priority date of the basic patent, is objectively able to deduce
directly and unambiguously from the specification
of the patent as filed, taking into account general knowledge and
the state of the art considered at the filing or priority
date.
In paragraph [41], the CJEU repeats that there is no requirement
for the product to be explicitly disclosed as an individual
embodiment. However, they go on to state in paragraph [42] that,
when the product is not explicitly disclosed in the claims of the
basic patent, but falls within a general functional definition
(such as in the present case), the skilled person must be able to
deduce directly and unambiguously from the
specification of the patent as filed that the product falls under
the invention covered by the basic patent.
The CJEU does not explicitly conclude that sitagliptin fails this
test. However, they give a very strong hint in their answer to the
third question. The third question is interpreted by the CJEU as
asking: whether Article 3(a) is not satisfied if a product that
falls within a functional definition of the claims was developed
after the filing date of the application for the basic patent,
following an autonomous inventive step? The CJEU effectively
concludes in paragraph [50] that it is impossible to grant an SPC
under such circumstances.
A number of broad generalisations are made in reaching this
conclusion. Specifically, in paragraphs [45] and [46], the CJEU
takes the position that the protection conferred by the basic
patent must be assessed at the filing date or priority date of the
patent, since otherwise the patentee could "unduly
benefit" from the results of research that were not known at
these dates. The CJEU appears to consider grant of an SPC in such
circumstances to be contrary to the aim of the SPC regulation,
which is to offer an additional period of exclusivity in order to
incentivise research.
The CJEU appears to have interpreted "research" in this
context to mean late-stage, clinical research into a specific
product. This is consistent with a trend in recent CJEU case law,
which does not appear to recognise value in also incentivising
broader, early-stage research. This is particularly unfortunate,
since the SPC regulation explicitly does not favour any specific
type of research.
The Implications
The ruling can be interpreted as simply confirming that the two
part test of Teva applies to products comprising single active
ingredients as well as to combinations. However, the more
significant implication is that it continues the general trend of
CJEU case law from
C-322/10 (Medeva), through
C-493/12 (Eli Lilly), to
C-121/17 (Teva) itself, which is towards a stricter
interpretation of Article 3(a). This inevitably favours SPCs based
on patents which protect late-stage inventions arising during
clinical development of specific products, over early-stage
research which may open up a new field without necessarily
identifying (or needing to identify) a specific active
ingredient.
Of particular concern to innovators holding broader, earlier
patents to a general therapeutic concept will be the CJEU's use
of the wording directly and unambiguously (highlighted above in
paragraphs [40] and [42]). This echoes the so-called 'gold
standard' applied by the EPO when assessing whether or not a
feature is present in an application for the purposes of Article
123(2) EPC (prohibition against extending beyond the content of the
application as filed). The same standard is applied by the EPO when
assessing whether or not a feature is present in a prior art
document for the purposes of Article 54(2) EPC (requirement for
novelty). Readers familiar with the EPO will be aware that this
standard is applied strictly.
Assuming that the CJEU's choice of words was deliberate, it
implies that if the product is not explicitly recited in the
claims, it will nonetheless need to be disclosed to a high degree
of specificity elsewhere in the patent. Indeed, applying the
strictest possible interpretation, it may suggest that the
disclosure in the underlying patent application as filed should be
such that (if the application were hypothetically still pending at
the EPO) it would be possible to amend the claims to recite the
product without facing an objection under Article 123(2) EPC. Put
another way, the implication is that whilst the claims of the
patent may not expressly recite the product now, in order for an
SPC to be granted it is necessary that they could have done so.
Even if this judgment is not interpreted as strictly as the
directly and unambiguously language may imply, it
nonetheless suggests there will be challenges to securing SPC
protection based on a patent that does not individually disclose
the active ingredient(s) of an authorised product.
This is more likely to be problematic in the field of complex
biological molecules (e.g. antibodies), for which it may be more
difficult to satisfy the two-part test in the absence of a literal
disclosure of the individual molecule. By contrast, the small
molecule field may be more forgiving. It could be argued, for
example, that given a disclosure of C1-C6 alkyl and specific
examples of "methyl" and "propyl", the skilled
person can directly derive "ethyl" even though it is not
individually disclosed.
Prospective applicants should in any case continue to base their
SPC applications on patents which claim the product as specifically
as possible.
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.
