When a patented invention is an active ingredient in a drug or plant protection product, its commercial use is subject to the granting of an authorization issued by a competent authority. The problem with this procedure is that it can sometimes take up to ten years. Despite this, the period of validity of the patent continues to run during this time and the patent holder cannot exploit his patent commercially. To overcome this problem, he can request the issuance of a supplementary protection certificate (SPC). It is a title allowing to extend the term of protection of a product included in the composition of a drug covered by a patent. It compensates for the time required to obtain marketing authorization for new drugs, which can significantly delay monopoly exploitation of the patent. It is a way to benefit from additional protection at the expiration of the patent for a maximum duration of 5 and a half years. This title is issued by the various offices of the European Union on the basis of Community regulation n ° 469/2009 . Substantive and formal conditions must be met to obtain the issuance of this right. These are provided for in article 3 of the said regulation which states that “ The certificate is issued, if, in the Member State where the request referred to in article 7 is presented and on the date of this request : […] B) the product, as a medicinal product, has obtained a valid marketing authorization […] d) the authorization mentioned in point b) is the first marketing authorization of the product, as medicine . “. This means that the marketing authorization (MA) must be the first that has been granted.
The qualification of an MA as the first marketing authorization
However, there are various problems with this notion of “first marketing authorization”. First of all, can we consider that an MA is the first if an MA was subsequently issued for a different drug but containing the same active ingredient? A negative answer to this question would imply that the drug will not be able to obtain a CCP. A second question which arises as a result of this is whether the scope of the protection of the basic patent must be taken into account in the qualification of an MA as a “first marketing authorization. on the market.
By a decision of 19 July 2012 , the Court of Justice called into question the jurisprudential interpretation of a rule which had until then been constant. Indeed, by the Neurim judgment, the CJEU considered that “ the mere existence of a previous marketing authorization obtained for the medicinal product for veterinary use does not preclude the issuance of a certificate additional protection for a different application of the same product for which a marketing authorization has been granted, provided that this application falls within the scope of the protection conferred by the basic patent invoked in support of the certificate application additional protection . ”
This decision means that a CPP can be obtained for a later and different application from an already known product. Yet questions to which the judges did not answer persist: should the scope of this judgment be limited to the facts of the case or can it be applied more broadly?
General application would imply that national patent offices would have the possibility of interpreting the concept of “different application”. This option would run counter to the objective of the CCP regulation, which aims to harmonize regulation within the internal market. Indeed, each national patent office will ask itself the question: what does the concept of “different application” refer to? Does it refer to the dosage? Can a new formulation be considered to be a different application of the same product? Will a therapeutic application for a different disease qualify?
This is a set of questions to which national patent offices have had to answer, each adopting its own interpretation which leads to heterogeneity in the application of Community law on the territory of the European Union.
Faced with these difficulties, on July 19, 2020, the CJEU carried out a real reversal of case law. this. In its Santen judgment, it stated that a marketing authorization cannot be considered to be the first marketing authorization when it relates to a new therapeutic application of an active principle, or ‘a combination of active ingredients, which has already been the subject of a Marketing Authorization for another therapeutic application.
The Supplementary Protection Certificate
In this case, the company Santen is a pharmaceutical laboratory holder of a European patent which protects in particular an ophthalmic emulsion in which the active principle is ciclosporin and a marketing authorization for the Community medicine Ikervis whose active principle is cyclosporin. On the basis of the patent and the market authorization, Santen applied for a Supplementary Protection Certificate (SPC) for a product called “ciclosporin for use in the treatment of keratitis”.
This request was rejected by the director of the INPI. He based himself on article 3 of regulation 469/2009 and considered that a marketing authorization had already been granted in 1983 for a medicinal product, marketed under the name of “Sandimmun” whose main active ingredient was “cyclosporine”. The question therefore arose as to whether the drugs Sandimmum and Ikervis have the same therapeutic application. In this situation, the Paris Court of Appeal questioned the CJEU in order to submit several preliminary questions to it.
The first issue is as follows: “ Should the notion of ‘different application’, within the meaning of the [Neurim judgment], be understood strictly […] or extensively ”? A strict interpretation by European judges would consist either in considering that the different application consists in applying a product to humans following an application for veterinary use, or in indicating a new therapeutic field in a new medical specialty, or finally be assessed according to more demanding criteria than those used to assess the patentability of the old invention. On the contrary, a broad interpretation would amount to considering that the different application includes different therapeutic indications and diseases, but also different formulations, dosages and / or modes of administration.
CCPs concerning medicinal products are governed by regulation n ° 469/2009. Article 3 of the said regulation imposes several cumulative conditions to be observed in order to obtain the issuance of a SPC, it is in particular provided in point d) that the authorization to place the product on the market, valid must be ” the first authorization to place the product on the market, as a medicinal product ”.
The European judges have come to put an end to the debate concerning the scope of the Neurim judgment: should it be limited to the specific facts or could it have a broader scope which would therefore imply a possibility of interpretation by national patent offices?
The Court takes the decision to reverse its case law and closes the debates on Article 3 (d) of the CCP Rules. First, she wondered about the meaning of the term “product” defined by Article 1 b) as “ the active ingredient or the composition of active ingredients of a drug “. Then the question arises as to what an “active ingredient” is. Regulation No. 469/2009 does not provide a definition of this concept, it is therefore necessary to define it in accordance with the meaning given to it in everyday language. In this regard the Court ruled that the concept of “active principles” does not include “ substances entering into the composition of a medicinal product which do not exert a specific action on the human or animal organism </ em> ”. Consequently, this concept refers to substances which have a specific therapeutic effect. Thus the concept of product refers to substances which have a specific therapeutic effect, in this sense, the European judges consider “ that the fact that an active principle, or a combination of active principles, is used for the purposes of a new therapeutic application does not confer on it the quality of a separate product when the same active principle, or the same combination of active principles, has been used for the purposes of another therapeutic application already known . “
The second preliminary question that the Paris Court of Appeal has asked to the CJEU is as follows: can an MA granted for a new therapeutic application of an active ingredient and which is the first to fall within the scope of protection of the basic patent, can it be considered to be the first MA granted within the meaning of Article 3, point d) of Regulation No. 469/2009 aimed at requesting a SPC?
The European judges noted that “ the said provision does not refer to the scope of protection of the basic patent “. They consider that taking into account the scope of protection of the basic patent to determine the first marketing authorization within the meaning of Article 3 (d) would call into question the definition of the concept of “product” mentioned above. With this assertion, the Court of Justice reverses its case law from the Neurim judgment in which it took into account the scope of protection of the basic patent to define what is a product.
The question therefore arises: how should we define the concept of “first marketing authorization” taking into account that the scope of protection of the basic patent is no longer taken into account in this definition?
Thus, the judges emphasize that if an MA has been issued for a therapeutic application of a product, but another has already been issued previously for another application of the same product, then it will be the latter that will be considered the first. Marketing authorization within the meaning of article 3 d) of directive n ° 469/2009.
Finally, the CJEU answers the preliminary questions as follows: “ a marketing authorization cannot be considered to be the first marketing authorization, within the meaning of [article 3, under d ), of Regulation No 469/2009], when this relates to a new therapeutic application of an active ingredient, or of a combination of active ingredients, which has already been the subject of a marketing authorization. market for another therapeutic application . ”
This decision marks a real break with Neurim jurisprudence. Although it can be challenged, the CJEU dismisses all the uncertainties that went with previous case law and sets out a clear and unambiguous rule.
Eternoscorp remains at your disposal for any questions regarding the supervision of your innovations and the possibility of extending the term of their protection.