Patents Court rules SPC invalid in Truvada case

September 2018

In last month's Synapse we reported the ruling of the CJEU in the Teva UK Ltd & Others v Gilead Sciences Inc (Case C‑121/17 – the 'Truvada Case'). The case has now returned to the English Patents Court, where the Truvada SPC in dispute has been held invalid.

What the decision was about

The case concerns Article 3(a) of Regulation (EC) No 469/2009 (ʽSPC Regulationʼ), which requires that in order for a product to be capable of protection by a supplementary protection certificate (SPC) it must be 'protected by a basic patent in force'. In the Truvada Case, the SPC at issue protects Gilead's HIV treatment, Truvada, consisting of a combination of tenofovir disoproxil fumarate (TD) and emtricitabine in a fixed dose tablet. The relevant claim of the patent, claim 27, does not expressly identify the emtricitabine ingredient, but merely talks of the optional combination with 'other therapeutic ingredients'.

To establish whether this combination is protected by the basic patent in force, the CJEU ruled that the correct test is to ask whether:

…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.

The CJEU stated, however that it would be for the referring court to check whether this test is satisfied in this case. The case was therefore returned to Mr Justice Arnold in the English Patents Court to apply the CJEU ruling to the facts.

The decision of the Patents Court

In his decision, dated 18 September 2018, Arnold J held Gilead's SPC invalid. In doing so, the judge addressed each of these above parts of the test. As regards the first part, the patent said nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it did not even mention emtricitabine. All the patent said is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly, there was no basis for the skilled person to understand that the combination embodies the technical contribution of the patent.

As regards the second part of the test, it was clear that emtricitabine is not specifically identifiable in the patent. It was not mentioned in the Patent and was 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 was 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 was addressed.

Arnold J would not give Gilead permission to adduce further evidence directed to the new test set by the CJEU, considering this to be an abuse of process that would necessitate a second trial.

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Paul England

Paul is a senior associate and professional support lawyer specialising in patents law in our London office.

"There was no basis for the skilled person to understand that the combination embodies the technical contribution of the patent."