Teva v Gilead: SPC combination products

We have previously published summaries of the reference, Advocate General’s opinion and CJEU’s decision.

Under Article 3(a) of the medicinal products SPC regulation, one of the criteria for SPC eligibility in the EU is that the product is “protected by a basic patent in force”.

Gilead’s SPC was based on its European patent 0 915 894 (the basic patent). This disclosed and claimed tenofovir disoproxil and combinations with “other therapeutic ingredients”. However, it did not define this term nor did it provide any specific examples of what the other therapeutic ingredients may be. In particular, there was no mention of emtricitabine. At trial, the question arose, therefore, as to whether the drug Truvada® was “protected by” Gilead’s basic patent. The trial judge, Mr Justice Arnold, asked the CJEU to clarify the meaning of the phrase “protected by a basic patent in force” in light of the existing case law (in particular, Medeva, C-322/10 and Actavis v Sanofi, C-443/12).

Broadly, the CJEU held that to determine whether Article 3(a) had been complied with, the Court should assess at the filing or priority date of the basic patent:

• Whether a skilled addressee, applying his/her/their common general knowledge, and reading the description and drawings in the patent, could understand without a doubt that the product to which the claims of the basic patent related was a specification required for the solution of the technical problem disclosed by that basic patent; and
• Whether the skilled addressee (in light of his/her/their common general knowledge, the specification and the prior art) was able to specifically identify the product as at the priority date of the patent.

Specifically, in relation to SPCs for products containing a combination of active ingredients, the CJEU ruled that, at the filing 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.

On returning to the English Patents Court, Gilead applied for permission to adduce further expert evidence and for directions to a second trial. Gilead reasoned that the decision of the CJEU developed the law, which could not have been anticipated and for which evidence could not be adduced at the first trial.

The trial judge, Mr Justice Arnold, refused the application drawing an analogy with an application by a patentee (after judgment that the claims were invalid but before an order to that effect) to amend the claims of a patent (with a view to maintaining validity). If such an application necessitated a second trial, it would be an abuse of process and therefore not be permitted. It was incumbent on the parties to bring their cases in full at trial. The same applied to the case at hand. The CJEU’s decision did not change the law, only developed it. In any event, Gilead's proposed new evidence was only directed to the CJEU’s second test, not the first, which it failed to satisfy in any event.

Mr Justice Arnold went on to conclude that the SPC was invalid. Applying the two tests laid down by the CJEU, he reasoned as follows:

• The first test: Mr Justice Arnold held that the patent in suit did not disclose the combination of tenofovir disproxil and emtricitabine to treat HIV (emtricitabine was not mentioned, although the patent disclosed that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients). Mr Justice Arnold concluded that “[a]ccordingly ... there [was] no basis for the skilled person to understand that the combination embodie[d] the technical contribution of the patent.”
• The second test: Again, there was no dispute that tenofovir disoproxil was specifically identifiable, but it was clear that emtricitabine was not specifically identifiable. Furthermore, while emtricitabine was known at the priority date, there was no evidence that it was common general knowledge that it was an effective agent for the treatment of HIV in humans.

It is worth considering this judgment in the commercial context. Five years after the basic patent was filed, Gilead obtained a marketing authorisation for its drug Viread®, which contained tenofovir disproxil fumarate. Therefore, Gilead did not suffer significant regulatory delay to warrant the grant of an SPC in respect of Viread®. Gilead’s subsequent patent for the combination in Truvada® was revoked by the Opposition Division of the European Patent Office, and this decision was upheld on appeal. It follows that Gilead made no invention in devising the combination and so it should not be entitled to an SPC.

See: https://www.bailii.org/ew/case...