UK - Truvada SPC does not comply with Article 3(a)

Last week, Mr Justice Arnold handed down his judgement in Teva UK Limited & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (here), following the CJEU's  preliminary ruling in C-121/17 (here).

In brief, Teva UK Limited, Accord Healthcare Limited, Lupin Limited and Generics UK Limited challenged the validity of Gilead's SPC (SPC/GB05/041) for a "composition containing both Tenofovir disproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine".  They contended that the SPC does not comply with Article 3(a) of the SPC Regulation.  Gilead contended that the product described in the SPC was protected by the basic patent, EP (UK) 0 915 894.   In his first judgement (here), Mr Justice Arnold referred the following question to the CJEU: "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?".  The CJEU provided its judgement in C-121/17 in July 2018.  Mr Justice Arnold applied the two tests described in C-121/17 and found that the SPC does not comply with Article 3(a).  His reasoning is set out below:

1. The first test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under the invention covered by that patent. As explained above, this is not a simple extent of protection test. Rather, the combination must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent.

1. As the Court of Justice rightly says at [56], the Patent says nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it does not even mention emtricitabine. All it says at [0047] is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly, as the Court rightly indicates, there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent. TD embodies the technical contribution of the Patent, but that is a different matter.

1. The second test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, each of the active ingredients must be specifically identifiable, in the light of all the information disclosed by the patent. There is no dispute that TD is specifically identifiable. In my view it is clear that emtricitabine is not specifically identifiable. Once again, it is not mentioned in the Patent. It is not even a member of a specific class of compounds mentioned in the Patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention. Furthermore, although emtricitabine was known at the priority date, there is no evidence that it was known that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed.

1. As counsel for the Claimants submitted, this result is perfectly consistent with the objectives of the SPC Regulation. As noted in my first judgment at [24], Gilead obtained a marketing authorisation in respect of Viread, which contains TDF, on 5 February 2002, less than five years after the application for the Patent was filed. Thus Gilead did not suffer sufficient regulatory delay in exploiting the Patent to warrant the grant of an SPC in respect of Viread. Moreover, although Gilead applied for and was granted a patent for the combination in Truvada, that patent was revoked by the Opposition Division of the European Patent Office and Gilead's appeal against that decision was dismissed. Thus Gilead made no invention in devising the combination which warranted the grant of a patent, let alone an SPC.

C-121/17 - Teva ruling out now

The CJEU gave its ruling today in C-121/17 (here), Teva UK Ltd and others v Gilead Sciences Inc.

In brief, the question referred by Justice Arnold, was:

What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/2009?

The Court has ruled as follows:

"Article 3(a) of Regulation 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 with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: 

–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."

C-121/17 - The Advocate General advises the CJEU

The Opinion of Advocate General Wathelet in the UK reference for a preliminary ruling from the Court of Justice of the European Union in Case C-121/17 (Teva UK Ltd and others v Gilead Sciences Inc.) was posted on the Curia website (here) this morning.  At the time of this blogpost, the Opinion was only available in French.

As a recap, the referring court asked the following question:

What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/20091 ?

The Advocate General has advised the Court to rule as follows (thanks to Google translate):

"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, precludes the issue of a certificate supplementary protection relating to active ingredients which do not appear in the wording of the claims of the basic patent. The fact that a substance or composition falls within the scope of the protection of the basic patent is a necessary, but not sufficient, condition for constituting a product protected by a patent within the meaning of Article 3 (a) of Regulation No 469/2009. 

A product is protected by a patent within the meaning of Article 3 (a) of that Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and specifically identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically and precisely as well as individually identifiable in the wording of the claims of the basic patent."