Sandoz Limited and Hexal AG v G.D. Searle LLC and Janssen Sciences Ireland UC, Court of Appeal (Civil Division), Lord Justice Floyd, London UK, 25 January 2018, [2018] EWCA Civ 49

On 25 January 2018, the UK Court of Appeal handed down its decision in Sandoz v G.D. Searle. Floyd LJ, giving the leading judgment, concluded that previous CJEU case law on the meaning of the requirement under Article 3(a) of the SPC Regulation that “the product is protected by a basic patent in force” is not sufficiently clear to enable him to determine the validity of an SPC owned by Searle. He therefore stayed the appeal and proposed a question to be referred to the CJEU.

At first instance, Arnold J had held that Searle’s SPC does satisfy the requirements of Article 3(a), and had declined to refer a question to the CJEU. See here.

This case relates to the validity of Searle’s SPC for darunavir. The SPC is exclusively licensed to Janssen. The basic patent under which darunavir is said, by the Respondents (Searle and Janssen), to be protected is EP (UK) 0 810 209 (the Patent).

The Patent claims a Markush formula for a class of compounds said to be useful for the treatment of HIV. There was no dispute that darunavir forms part of this class of compounds as it has the shared structural backbone of the claimed Markush formula. Of particular importance to this case, is the fact that darunavir contains a particular substituent group that, whilst known at the priority date, was not said to be part of the common general knowledge of the skilled person at that date, and was not exemplified in the specification of the Patent. The Appellants therefore argued that darunavir was not implicitly but necessarily and specifically disclosed by the Patent, as required by the CJEU’s test in Eli Lilly v Human Genome Sciences (C-493/12).

Addressing the various CJEU tests developed over the last few years, Floyd LJ held that neither the guidance in Medeva v Comptroller-General of Patents (C-322/10) nor Eli Lilly was clear enough to assist in this case. The question of how specifically the basic patent must identify the commercialised active ingredient had been left unanswered.

He stated that whilst a Markush formula might sufficiently identify the active ingredient in some circumstances – such as where the specification identifies individual substituents, or where a class of substituents is set out and the skilled person is able to determine the extent of those classes – he could envisage other circumstances where the class of compounds claimed is too wide or a particular substituent too obscure to say that a compound in such a class or with such a substituent is identified by the patent with sufficient specificity.

The appellant’s common general knowledge test

Floyd LJ therefore agreed with the appellants that it was at least arguable that an active ingredient defined by a Markush formula whose substituents were not in the common general knowledge of the skilled person at the priority date was not sufficiently clearly identified by that patent for the purposes of obtaining an SPC.

In support, he referred to the CJEU’s reasoning at [43] in Eli Lilly, which suggested that it might be permissible to refuse an SPC application by a third party patentee (i.e. using another party’s marketing authorisation) on the basis that the objective of the SPC regulation to reward investment in pharmaceutical research was not furthered. Floyd LJ suggested that, if, as the CJEU’s thinking in that paragraph suggests, the objective of the SPC regulation is to ensure that the patent proprietor has come close to an actual realisation of the product, then it is relevant whether or not the skilled person can, using his common general knowledge, understand whether the patent identifies the product at the priority date.

Secondly, Floyd LJ referred to the German Sitagliptin reference to the CJEU (Decision 14 W (pat) 12/17), in which the German Federal Patents Court, BPatG, expressed the view (contrary to that of Floyd LJ) that the Sitagliptin case and the present case are factually indistinguishable for the purposes of Article 3(a) of the SPC Regulation (even though the claim in that case was a purely functional claim, rather than a Markush claim as in the present case). This difference of approach by national courts, despite applying the same law, illustrated to Floyd LJ the potential for conflicting decisions and as consequence, that the law must be unclear.

The core inventive advance test

At [109], Floyd LJ agreed with Arnold J that the “identification” test derived from CJEU jurisprudence and the emphasis it places on patent claims is flawed. He held that not only does it disregard the purpose of patent claims to set out the limits of a patentee’s monopoly, rather than specifically identify the active ingredients claimed, but it also disregards the fact that patent claims can also be manipulated by skilful drafting to protect combinations, which may or may not actually provide an inventive advance.

As a result, Floyd LJ stated that his preferred test would be the same as the one set out by Arnold J in Actavis v Sanofi (C-443/12) and Teva v Gilead [2017] EWHC 13(Pat) and again at first instance i.e. to ask whether the product to be protected by the SPC embodies the core inventive advance of the basic patent. Floyd LJ stated that he had no doubt that, if this test is adopted, the SPC for darunavir would satisfy article 3(a). He also opined that it would still be open to the CJEU to adopt this core inventive advance test in light of the pending references from the Sitagliptin and Teva v Gilead cases.

The question referred

Floyd LJ referred the following question to the CJEU:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

A copy of the decision can be read here.

Headnote by Constance Crawford, Bristows LLP