Supplementary Protection Certificates - Teva UK Ltd and others v Gilead Sciences, Inc.
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| Truvada tablets |
Jane Lambert
Court of Appeal (Lord Justices Lewison, Floyd and Dingemans) Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec2019)
This was an appeal against Mr Justice Arnold's decision in Teva UK Ltd and others v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (18 Sept 2018) to revoke supplementary protection certificate ("SPC") numbered SPC/GB05/041. The reason for the revocation is that art 3 (1) 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 OJ L 152, 16.6.2009, p. 1–10 requires a product that is protected by an SPC to have been protected previously by a basic patent. One of the products that had been included in the SPC was emtricitabine. That had not been protected expressly by European patent (UK) number EP0915894, The appeal came on before Lord Justices Lewison, Floyd and Dingemans on 10 Dec 2019. In Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec 2019), the Court of Appeal dismissed the appeal and upheld the judgment of the court below.
The challenge by Teva UK Ltd. and a number of other pharmaceutical companies to the SPC came before Mr Justice Arnold in Teva UK Ltd and others v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 Jan 2017). His lordship opined at paragraph [91] of his judgment that the test to be applied in order to determine whether a product is "protected" by a basic patent within the meaning of art 3 (a) of Regulation 469/2009 was unclear. The learned judge, therefore, referred the following question to the Court of Justice of the European Union:
"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?"
In Case C‑121/17, Teva UK Ltd. and others v Gilead Sciences Ltd. ECLI:EU:C:2018:585, EU:C:2018:585, [2018] EUECJ C-121/17, the Court replied:
"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."
In the light of the Court's response, Mr Justice Arnold held that the SPC was invalid and refused to allow Gilead Scinces Inc. to adduce additional evidence at a further hearing.
Gilead appealed tp the Court of Appeal on the ground that the judge had erred in failing to find that the two limbs of the above test were satisfied in this case. It submitted that he had gone wrong in law in two ways. First, he had applied the "inventive advance" or "technical contribution" test. Secondly, he had assessed compliance with the second limb by reference to the common general knowledge when the court had expressly ruled that all the prior art formed the relevant pool of knowledge. It also submitted that the judge had been plainly wrong to refuse to admit the fresh evidence to make good Gilead's case under the second limb. The CJEU's test was new, and Gilead could not have anticipated the need for expert evidence as to the prior art and common general knowledge to the extent which the new test required.
Delivering the judgment of the Court, Lord Justice Floyd said at paragraph [81] of his judgment:
"The question raised by the first limb of the CJEU's test is whether the combination of the active ingredients TD and emtricitabine must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by the patent."
"The question raised by the first limb of the CJEU's test is whether the combination of the active ingredients TD and emtricitabine must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by the patent."
That was not the same thing as the "inventive advance" or "technical contribution" class which was clearly bad law. In his lordship's judgment,
the first limb is simply a more elaborate exposition of the "necessarily" part of the test first advanced in Eli Lilly, namely that "the claims relate … necessarily … to the active ingredient in question". His lordship agreed with the contention that this limb means that a claim to "a formulation comprising compound A" does not protect a combination of A and B. That is because the presence of B is not a necessary part of the invention claimed. It follows that, to protect a combination product, a claim must require the presence of two compounds, not just one.
In this case, claim 27 of EP0915894 claimed:
In this case, claim 27 of EP0915894 claimed:
"A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients."
The adverb "optionally" was crucial. Lord Justice Floyd observed at [95]:
"The addition of "other therapeutic ingredients" to TD in claim 27 is expressly made optional. That is no different in principle to a claim which "comprises" TD, which we know is not good enough to protect a combination."
Since emtricitabine was at best optional and had not been mentioned specifically in the basic patent it could not be protected by the SPC. As Gilead had failed to satisfy the first limb of the CJEU's test it was unnecessary to consider the second. That limb presented difficult issues of law that were best left to a case that turned on them.
Anyone wishing to discuss this case may call me on +44 (0)20 7404 5252 during normal business hours from 6 Jan 2020. Alternatively, I will deal with any enquiries that are made through my contact form.
"The addition of "other therapeutic ingredients" to TD in claim 27 is expressly made optional. That is no different in principle to a claim which "comprises" TD, which we know is not good enough to protect a combination."
Since emtricitabine was at best optional and had not been mentioned specifically in the basic patent it could not be protected by the SPC. As Gilead had failed to satisfy the first limb of the CJEU's test it was unnecessary to consider the second. That limb presented difficult issues of law that were best left to a case that turned on them.
Anyone wishing to discuss this case may call me on +44 (0)20 7404 5252 during normal business hours from 6 Jan 2020. Alternatively, I will deal with any enquiries that are made through my contact form.
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