Pharma / Life science : Supplementary protection certificates : consequences of the latest ECJ decisions14 January 2021
Since their creation in 1992, the supplementary protection certificates (SPC) have been fueling the judicial news and, in particular, that of the European Court of Justice, which regularly rules on the interpretation of the Regulation (EC) n°469/2009 defining their validity and effects.
The year 2020 has not failed in that tradition as the ECJ has issued two new and much awaited decisions, aimed at clarifying two of the conditions for obtaining a SPC:
– The first one, in interpretation of Article 3 (a) of the above Regulation, which requires that the “product” (i.e. the active ingredient or combination of active ingredients) subject matter of the SPC application, be “protected by the basic patent” invoked in support of that application.
– The second, ruling on the meaning of the concept of “ first authorisation to place the product on the market as a medicinal product “, in relation with a new therapeutic application. It should indeed be remembered that, according to Article 3 (d),the issuance of the SPC is also conditional on the fact that the “product” has obtained, as a drug, a valid marketing authorization (MA), and that the said MA is the first, for this product.
These new decisions, which help to dispel some ambiguities regarding the application of these two criteria, herald a change in the SPC issuing practices in France.
THE ROYALTY PHARMA RULING : FUNCTIONAL CLAIM AND PRODUCT “PROTECTED BY A BASIC PATENT”
Insufficiency of a general functional description in the absence of a disclosure- in Royalty Pharma (judgement C650/17 dated 30 April 2020), the Court was asked to interpret the concept of “product protected by a basic patent” within the meaning of Article 3 (a), in a case where the said product is not claimed by name or structure in the basic patent, but is covered by a functional formula.
A “functional” claim defines the subject matter of the invention by its function (primary technical effect, not to be confused with its result). This type of functional definition encompasses an indeterminate field of possible solutions, which is acceptable in terms of patentability according to caselaw. But what if a SPC is applied on the basis of such a patent, for a product meeting the said function?
This was the issue for Sitagliptin, a product for which Royalty Pharma had filed a SPC application before the German Patent Office, on the basis of a patent where it was only functionally claimed under the formulation “Dipeptidyl peptidase-4 inhibitor” (or DPIV, an enzyme whose inhibition helps to regulate the sugar level of people suffering from diabetes mellitus) and was not mentioned in the description, not being disclosed at the date of filing of the patent.
This is not a new issue: in 2013, the ECJ had already accepted, in its Case
C-493/12 Eli Lilly, that a product covered by a “functional” claim could give rise to the grant of an SPC, provided that said claim, interpreted in the light of the description of the invention, allow to conclude that “they relate, implicitly but necessarily and specifically, to the product in question“.
However, these criteria – “necessarily” and “specifically” – imposing a two-stage test, have proved to be tricky to apply. Given this ambiguity, the ECJ has therefore been requested to clarify the modalities of this test. First of all in its ruling
C-121/17 Teva, handed down in 2018; then again with this Royalty Pharma ruling, which is in line with the previous one.
Without going into detail of the facts at the origin of these two preliminary questions, the lessons of this case law concerning the interpretation of Article 3(a) can be summarized as follows:
A product cannot be regarded as “specifically” covered if, although it meets the functional definition, it was not disclosed at the date of filing or priority of the patent.
On the other hand, the product does not need to be disclosed in an example of an embodiment of the invention within the description, to be considered as necessarily and specifically covered. It is sufficient that a person skilled in the art is able to identify it as a necessary characteristic for the solution of the technical problem, in the light of all the elements disclosed in the description, his general knowledge and the state of the art at the filing or priority date of the basic patent.
Furthermore, where the product consists of a combination of active ingredients, as was the case in Teva, the combination itself must appear as a necessary characteristic for the resolution of the technical problem, and each active ingredient must in addition meet the “specific” identification requirement.
Practical consequences – This case law has a direct effect on the nature of the INPI’s examination of SPC.
The INPI considered until now that it should not carry out a prior art analysis of the patent in the presence of functional claims (on the assumption that, under the preparatory work of the Regulation, industrial property offices should not have to re-examine the basic patent in the context of the SPC examination) and, indeed, in most cases used to require that the product be referred to as an example of an embodiment in the description to consider it covered by a functional claim.
The INPI will therefore have to extract itself from the strict boundaries of the patent, to delimit the content of the prior art, and to define the skilled person and his general knowledge.
One can assume that it will place on the applicant the burden of proof of the “necessary and specific” character and more specifically :
– of the fact that the active ingredient(s) constituting the product was (or were) in the state of the art at the filing or priority date of the basic patent,
– of the fact that the person skilled in the art, on the basis of the content of the patent and his general knowledge at the filing or priority date of the patent, would have thought of the product as a necessary characteristic to solve the technical problem.
On the other hand, as third party observations are not allowed in the SPC examination procedure, it will not be possible for a competitor to contradict the elements produced by the applicant in the course of the examination procedure. In order to do so, the competitor will have to appeal against the decision of the INPI to issue the SPC, or bring an action for invalidity against the SPC.
As for the French courts, they have already had to apply this case law, at least the Paris Court of Appeal, which concluded on 19 June 2020 (RG n° 18/15906, Gilead / Mylan) to the nullity of the French SPC equivalent to the English SPC which had given rise to the referral to the CJEU in the Teva case. The latter concerned a pharmaceutical composition of two active ingredients, tenofovir disoproxil (“TD”) and emtricitabine, indicated in the treatment of HIV and had been issued on the basis of a claim expressly covering the TD “and, where appropriate, other therapeutic ingredients”. The Court ruled that the person skilled in the art, based on the prior art at the date of filing of the patent and his general knowledge, and having regard to all of the elements contained in the patent (no reference was made to emtricitabine in the description), would not have thought of emtricitabine as an “other therapeutic ingredient” to be combined with TD in the treatment of HIV.
While this ECJ caselaw suggests a more flexible application, at least by the INPI, of Article 3(a), the same cannot be said for Article 3(d) following the Santen judgment.
THE SANTEN RULING: NO MORE SPC FOR NEW THERAPEUTICAL APPLICATIONS.
This other decision, handed down by the Grand Chamber on 9 July 2020 in case C‑673/18, followed the preliminary question referred by the Paris Court of Appeal in the case Santen SAS v. Director General of the INPI, and was related to the notions of “first [marketing authorization], as a medicinal product” within the meaning of Article 3(d), and of “different [therapeutic] application”, contained in its judgment of 19 July 2012, Neurim Pharmaceuticals (C‑130/11). The Court’s decision provides two important insights:
Confirmation of the strict understanding of the concept of “product”: the ECJ recalls, as it has done in the past (see C‑31/03 of 19 October 2004, Pharmacia Italia, and C-202/05 of 17 April 2007, Yissum), that the term “product” is strictly defined in Article 1(b) of Regulation 469/2009 as the active ingredient (or combination of active ingredients) of a medicinal product and that minor changes to the medicinal product, such as a new dosage, the use of a different salt or ester, or a different pharmaceutical form, do not make it a different “product”. The Court adds that the way an active ingredient is used does not have any impact on its definition, i.e. the fact, for the product, to be used in a new therapeutic application does not make it a different “product” from the same active ingredient in another therapeutic application.
Reversal of the Neurim case law on new therapeutic applications: under Article 3(d), a SPC may be granted for a product only where its MA is “the first authorization to place the product on the market as a medicinal product”.
In Neurim, the Court had held that the existence of an earlier marketing authorization (in this case a veterinary MA) did not preclude the granting of a SPC for the product used in a different application and for which a new marketing authorization (a “human” one in this case) was issued, provided that this new application fell within the scope of protection of the basic patent.
On this point, Santen is an explicit reversal, as the Court states that the ‘first marketing authorization’ means the first MA for a medicine incorporating the active ingredient in question, regardless of the therapeutic application of the active ingredient for which that authorization was issued. The scope of protection of the basic patent is not relevant in this regard.
The Neurim decision had led to many questions and differences of application of the concept of “different application” within the EU patent offices. For example, some recognized the existence of a new application only in the case of a human MA succeeding a veterinary MA. Others questioned the need to include in this concept the new formulations, before the CJEU responded in the negative in its Abraxis judgment of 21 March 2019 (C-443/17) which already foreshadowed the abandonment of the Neurim case law.
In France, the INPI had circumscribed the notion of “new therapeutic application” to the case of a new therapeutic indication. This had thus led it to consider as “different applications”, for example, on the one hand, the treatment of multiple sclerosis and, on the other hand, the prevention of organ rejection following a transplant or the treatment of leukemia, on the one hand, the treatment of breast cancer, and on the other hand the one of kidney cancer. In addition, and even in the presence of different therapeutic indications, it concluded to the same therapeutic application if the active principle exerted the same pharmacological, immunological or metabolic action (function) (e.g. the use of the Pasireotide to block the release of adrenocorticotrophin hormone, even if in one case it was used to treat Cushing’s disease and in the other, acromegaly).
Practical consequences – These criteria, which had the merit of proposing a nuanced application of the Neurim case-law and had, moreover, been taken up by the Advocate General in his conclusions in the Santen case, nevertheless raised their own questions (is such an examination within the competence of an industrial property office?) and limits (e.g. is the use of the same active ingredient, on the one hand, as a general anaesthetic during surgery and, on the other hand, for the treatment of paroxysmal acute or post-operative pain, to be considered as the “same indication”? same question applies to the treatment of shingles and chickenpox, which are two different diseases caused by the same herpes virus). Like its European counterparts, the INPI will now return to a strict application of Article 3(d) and require that the marketing authorization invoked in support of the SPC application be the first, for the product, whatever the therapeutic application. Thus, the practice of issuing SPCs will be more restrictive.
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