Paris Court of Appeal - BIOGARAN v/ GILEAD
n° RG 18/15928
Paris Court of Appeal
BIOGARAN v/ GILEAD
BIOGARAN was represented by Marianne Gabriel, Attorney at Law and Arnaud CASALONGA Attorney at Law.
This case involves "Truvada", a drug comprising tenofovir disoproxil combined with emtricitabine for the treatment of patients infected with the HIV virus causing acquired immunodeficiency syndrome or "AIDS".
Gilead is the owner of European Patent No. 0.915.894 (EP 894) entitled "nucleotide analogues" filed on July 25, 1997 under priority of US Patent 6868389 dated July 26, 1996, and granted on May 14, 2003. This patent EP 894 expired on July 24, 2017.
Patent EP 894 explains that the compounds of the invention are useful in the therapeutic or prophylactic treatment of one or more viral infections in humans or animals, including infections caused by DNA viruses, RNA viruses, herpesviruses, retroviruses, hepadnaviruses, butterfly viruses, hantaviruses, adenoviruses and HIV.
Gilead markets a number of drugs containing tenofovir disoproxil, including the drug "Viread" containing tenofovir disoproxil as the sole active ingredient, under marketing authorization (MA) obtained on February 5, 2002.
No complementary protection certificate (CCP) was requested for this product, for which no delay was encountered in obtaining the marketing authorization.
In addition, Gilead obtained on February 21, 2005 a marketing authorization for the drug "Truvada" combining tenofovir disoproxil with emtricitabine and applied on July 19, 2005, on the basis of patent EP 894, for a SPC for this product in France, which was granted on December 21, 2006 under patent no. 05C0032 with an expiration date of February 21, 2020.
It is the question of the validity of SPC No. 05C0032 on the product tenofovir disoproxil associated with emtricitabine that is addressed here.
Equivalents of this PCC have also been requested in many other European countries, giving rise to multiple proceedings involving many generic laboratories.
In the United Kingdom, the English court seised of the same question of the validity of the British equivalent of SPC n°05C0032 had decided, by decision of January 13, 2017, to refer the following question to the ECJ for a preliminary ruling: "What are the criteria for determining whether the product is protected by a valid basic patent within the meaning of Article 3(a) of Regulation n° 469/2009? ”
In France, considering that the CCP n°05C0032 was not valid, Biogaran sued Gilead for the cancellation of the said CCP by act of June 22, 2017.
On July 31, 2017, Gilead filed a summary proceedings against Biogaran, claiming that Biogaran was responsible for launching counterfeit generics on the French market.
Gilead has also initiated other summary proceedings against other generic companies.
In one of these proceedings, the interim relief judge ruled in September 2017 that the validity of CCP No. 05C0032 was seriously challenged under Article 3 a) of Regulation 469/2009, and Gilead opted to withdraw its summary proceedings against Biogaran, which was confirmed by an order issued on November 9, 2017.
By judgment rendered on the merits of the case on May 25, 2018, Biogaran obtained the annulment of CCP n°05C0032 with respect to Article 3 a) of Regulation n°469/2009 and ordered Gilead to pay it the sum of €160,000 on the basis of Article 700 of the French Code of Civil Procedure.
Gilead has appealed this judgment, arguing in particular that the subsequent decision of the CJEU on July 25, 2018 should justify the validity of CCP n°05C0032, and requesting that Biogaran be ordered to pay them the sum of €26,000,000 as a provision for infringement.
As a reminder, in this case, the CJEU had ruled that : "Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a product composed of several active ingredients having a combined effect is "protected by a valid basic patent" within the meaning of that provision, since the combination of the active ingredients of which it is composed, even if it is not explicitly mentioned in the claims of the basic patent, is necessarily and specifically referred to in those claims. To this end, from the point of view of a person skilled in the art and on the basis of the state of the art at the filing or priority date of the basic patent: - the combination of these active principles must necessarily, in the light of the description and drawings of the basic patent, relate to the invention covered by it, and - each of the said active principles must be specifically identifiable, in the light of all the elements disclosed by the said patent".
At the same time, numerous decisions have been handed down in Europe, particularly in England, Germany, Belgium, Italy, Spain, Portugal, Finland, Ireland and the Netherlands, ruling in favor of the annulment of the equivalents to CCP No. 05C0032.
The question was therefore whether CCP n°05C0032 fulfilled the conditions of Article 3 of Regulation n°469/2009 according to which: "The certificate shall be issued if in the Member State where the application referred to in Article 7 is presented and at the date of that application : a) the product is protected by a valid basic patent; b) the product, as a medicinal product, has been granted a valid marketing authorization in accordance with Directive 2001/83/EC or Directive 2001/82/EC as the case may be; c) the product has not already been the subject of a certificate; d) the authorization referred to in point b) is the first authorization to place the product on the market as a medicinal product. ”
In this case, while tenofovir disoproxil was expressly covered by the claims of the basic patent, emtricitabine was not mentioned either in the description or in the claims of the patent, and SPC No. 05C0032 was obtained on the basis of Claim 27 covering "a pharmaceutical composition comprising a compound complying with any of Claims 1 to 25, together with a pharmaceutically acceptable vehicle, and optionally other therapeutic ingredients".
Gilead argued that the words "and where appropriate other therapeutic ingredients" necessarily and specifically referred to emtricitabine in accordance with the jurisprudence of the Court of Justice.
In concluding that SPC No. 05C0032 was invalid, the Paris Court of Appeal explained in clear and concise reasoning that, in accordance with the jurisprudence of the Court of Justice, "the requirement of Article 3(a) of the Regulation that the product be protected by a basic patent in force presupposes that the product be mentioned in the wording of one of the claims or at least, if it is not mentioned by name, that it is necessarily and specifically identifiable as such by the person skilled in the art and that, when it is a combination of active ingredients, each active ingredient is also mentioned in the claims or, failing that, is necessarily and specifically identifiable individually. The judgment thus stated that if it is possible to admit that in order to be considered as protected by the basic patent an active ingredient is not mentioned in the claims of the basic patent by means of a structural definition but simply by means of a functional definition, then it is also important to establish that these claims, interpreted in particular in the light of the description of the invention, implicitly but necessarily refer to the active ingredient in question and this in a specific manner".
The Paris Court of Appeal then indicated that this reasoning is supported by the answer given by the CJEU to the English preliminary question and recalled that "the notion of product protected by the basic patent within the meaning of Article 3 a) refers not to the rules of infringement but to the scope of protection and that under Article 69 of the European Patent Convention (EPC) and its interpretative protocol, the scope of protection is determined by the claims, which must provide both equitable protection for the patent owner and a reasonable degree of legal certainty for third parties".
The Court explained that if "the product can be considered to be protected by the basic patent, even if it is not explicitly mentioned in the claims of the said patent, as long as it meets a functional definition fìguring in one of the claims allowing the person skilled in the art to conclude that it is necessarily and specifically covered by the said functional claim", in this case, "the active ingredient emtricitabine is not mentioned by name in the claims of the basic patent", "Claim 27 above recalled is likely to cover an indeterminate plurality of substances not specifically identified", "Nothing is said either in the description or in the claims about the possibility that TD and emtricitabine can be combined to treat, among other things, HIV. Emtricitabine or its formulation is never mentioned", and "while it is not disputed that the skilled person knew that a combination therapy for HIV was more effective than monotherapy in treating HIV, there is no justification that he would have in 1996, in the general state of his knowledge, necessarily and specifically thought of emtricitabine to combine it with CT when reading Claim 27, which is worded in very general terms".
The Paris Court of Appeal thus "held that no functional formula necessarily and specifically targeted emtricitabine and that therefore the combination of the two products TD and emtricitabine could not be the subject of a SPC on the basis of patent EP 894 and consequently annulled SPC n°05C0032".