Combination of active ingredients – scope of protection – Gilead
Gilead’s application for interim injunction against Mylan was refused by the interim relief Judge of the Paris District Court on 5 September 2017. On the basis of its SPC 032, Gilead tried to prevent Mylan from launching in France a generic version of TRUVADA®, a drug notably treating HIV using a combination of two active ingredients (tenofovir disoproxil fumarate and emtricitabine).
The interim relief judge considered that the SPC 032 was likely to be held invalid, in that it would go beyond the invention initially covered by the patent the SPC 032 was supposed to extend the duration of which.
This decision is of interest as it deals with two main topics:
- the scope of the SPC which is based on a European Marketing Authorization (MA) the validity of which imposes to remain within the scope of the main patent; and
- the criterion used to assess the risk of invalidity of a patent/SPC to have an application for interim injunction rejected: serious challenge of validity or obvious invalidity?
Facts and Proceedings:
Gilead is the owner of:
- the European patent No 0 915 894 (the “EP 894”), filed on 25 June 1997 covering the use of tenofovir disoproxil used alone or in combination with other therapeutic ingredients, notably for treating HIV, until it expired on 25 July 2017;
- the European MA No EU 1/04/305001, granted on 21 February 2005 for TRUVADA®, a combination of tenofovir disoproxil and emtricitabine;
- the SPC 032, granted on 21 December 2016 and set to expire on 24 February 2020, covering said combination.
25 July 1997 - 25 July 2017
tenofovir disoproxil - OR -
tenofovir disoproxil + other therapeutic ingredients
** no specific mention of emtricitabine**
26 July 2017 - 21 February 2020
tenofovir disoproxil + emtricitabine
Anticipating the expiration of EP 894, Mylan filed a European MA application for a generic of TRUVADA®, which was granted on 16 December 2016.
This launched a battle in Europe with Mylan commencing action for revocation of Gilead’s SPC and/or Gilead applying for preliminary injunctions.
In three EU countries (Sweden, the Netherlands and Greece), Gilead’s application for an SPC had been refused. In some of the countries where an SPC had been granted, Gilead filed cases in some European jurisdictions. In Spain and Belgium, Gilead obtained an interim injunction against Mylan. In Italy and Germany, the cases are still pending, being noted that in Germany an action for revocation against the SPC has been filed and the Bundespatentgericht has issued a negative preliminary opinion against the SPC. In Ireland, after Mylan and McDermott Laboratories had undertaken not to launch their generics until a hearing that took place on 3 October 2017, the High Court rejected Gilead’s application for an interlocutory injunction against Mylan and Teva on 7 November 2017. In Switzerland, the Federal Patent Court upheld the validity of the SPC on 3 October 2017, and preliminarily enjoined Teva from distributing its generic of TRUVADA®; an appeal is currently pending before the Federal Supreme Court.
In the UK, several invalidity actions have been filed against the SPC. On 13 January 2017, the High Court referred the following prejudicial question to the Court of Justice concerning the interpretation of Article 3(a) of Regulation 469/2009: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”
On 4 April 2017, the President of the Court of Justice turned down a request for expedited proceedings made by the High Court, which suggest that following its usual timeline, a decision is to be expected by the first half of 2018.
In France, on 20 September 2016, Mylan filed in France an action for revocation of the SPC 032, arguing that the combination of tenofovir disoproxil and emtricitabine was not specifically claimed in EP 894, so that Article 3(a) of the SPC Regulation No 469/2009 of 6 May 20091 would have been breached and should have been an obstacle to the grant of the SPC.
Then, Gilead filed on 13 July 2017 a preliminary injunction application with an emergency motion to be heard on very short notice (référé d’heure à heure), asking for a “provisional injunction and placing under seal” of Mylan’s generic until a decision on the merits would be made, under a noteworthy €1,000,000 daily penalty payment.
Mylan launched a generic of TRUVADA® on the French market on 26 July 2017, a day after the expiry of EP 894.
On 5 September 2017, the interim relief judge recalled the conditions set out by the No 469/2009 Regulation to obtain an SPC, and adopted the interpretation set out by the Court of Justice in four notable decisions handed down on 24 and 25 November 2011 (Medeva (C-322/10), Daiichi-Sankyo (C-6/11), Yeda (C-518/10), and University of Queensland (C- 630/10).
These rulings had indeed required the active ingredients within the SPC request to be “explicitly specified in the wording of the main patent’s claims”, and had rejected the former “infringement test” that had previously been applied by numerous European national courts and which was more favorable to patentees:
(Former) Infringement Test
SPC validly granted as long as its active ingredients infringe the main patent's claims
SPC 032 does infringe EP 894 = SPC 032 is valid
(New) ECJ Interpretations
SPC only validly granted if its active ingredients are explicitly specified in the wording of the main patent's claims
emtricitabine not mentioned in EP 894 = SPC 032 is not valid
It is interesting to note that in Switzerland, which does not fall under the ECJ’s jurisdiction, the Federal Patent Court maintained the infringement test, pointing out that the ECJ’s aforementioned case law led to a “terminological mess”.
The Paris Judge recalled and adopted the reasons set out in a further Court of Justice ruling in the Eli Lilly case (C-493/12), which conceded that an ingredient defined according to a functional definition (as opposed to a structural one) was not, per se, precluded from being eligible for an SPC, as long as the patent’s claims relate, implicitly but necessarily and specifically, to the active ingredient in question.
Finally, the Judge also recalled the Sanofi (C-443/12) ruling in which the Court of Justice stated that SPC protection can only be sought on a main patent’s central inventive concept.
The Judge noted that Gilead’s EP 894 had not “implicitly but necessarily and specifically” referred to emtricitabine either in its claims or description, and therefore could possibly not teach a combination of tenofovir disoproxil and emtricitabine to the skilled person.
She judged that although claim 27 of its EP 894 did not specifically refer to emtricitabine, it was a functional claim that would have necessarily led the skilled person to choose emtricitabine as a further ingredient to combine to tenofovir disoproxil.
In light of the above facts and case law, the Paris Judge held that the validity of Gilead’s SPC 032 was seriously challenged in light of Article 3(a) of the SPC Regulation and that the SPC 032 was “likely to be void”, making any infringement unlikely. It dismissed Gilead in all of its claims, and ordered it to pay €100,000 to Mylan for legal costs.
Interestingly, the Paris Judge applied the same line of reasoning in a recent decision on the merits (Mylan v. Merck Sharp & Dohme, 30 November 2017, RG No 16/14466), in which it ruled that Merck’s SPC No 08 C 0021 was void as it exceeded the scope of the main patent’s claims.
The Paris Judge nonetheless did open the door to validly obtaining more than one SPC in instances where a main patent contains more than one central inventive concept, staying in line with the ECJ’s Georgetown University v. Octrooicentrum Nederland ruling of 12 December 2013 (C-484/12).
Of further interest is the serious challenge criterion applied by the interim relief judge to decide on this SPC preliminary proceedings.
Over the past few years, French case law has indeed diverged on the means available to a defendant to validly oppose a request for an interim injunction, with the majority of case law considering that the existence of serious challenge as to the validity of the title (patent or SPC) makes it possible to object to the injunction.
However, another stream of the case law has adopted a narrower interpretation whereby the defendant could only oppose the interim injunction request by proving the “obvious” nullity of the title.
Here, the Paris Judge chose the first interpretation, keeping with the decision of the French Supreme Court (Cour de cassation) of 21 October 2014, which validated the criterion of serious challenge and rejected the criterion of obvious nullity once adopted by the Paris Court of Appeals and First Instance Court.
Takeaways and Open Questions:
In light of the request for a preliminary ruling referred to the ECJ by the High Court concerning Article 3(a) of Regulation 469/2009, and the uncertainty surrounding the interpretation thereof, could the French interim relief judge indeed still assert that there was a high risk invalidity of the SPC?
Furthermore, should Gilead have spontaneously offered financial guarantees to improve its chances of obtaining an interim injunction, as it did in the Irish litigation where it had undertaken to compensate any financial loss caused by Mylan’s withdrawal of its generic pending the injunction hearing? In other terms, can a serious challenge still be successfully raised by a defendant when the applicant offers to compensate any financial loss caused by an injunction in case it is wrongfully granted?
In addition, we might wonder whether the Judge would have reached the same decision if the action for revocation of the SPC 032 would not have already been pending when the action for preliminary injunction was filed. Indeed, the action for revocation of the SPC 032 had been filed almost one year before Gilead sought the preliminary injunction.
This case confirms that if the strategy consisting in filing a patent/SPC revocation action before any launch is still a way of preventing interim measures in France, this trend had declined to some extent when Courts applied the criterion of obvious nullity of the patent to reject preliminary measures. The strategy of generics will recover some interest as the mere filing of a patent revocation might become a hurdle to preliminary measures.
This has to be prepared well in advance when the dossier is prepared and the application for marketing authorization filed.
Finally, the main takeaway of this decision is that patentees seeking to extend their protection with an SPC should ensure that it remains within the scope of the main patent, regardless of the language included within their marketing authorizations.
1) “A certificate shall be granted if (…): (a) the product is protected by a basic patent in force”.