Teva UK Ltd & Ors v Gilead Sciences, Inc

For Article 3(a) of the SPC Regulation, a combination product is protected by a basic patent only where the claims relate to the combination necessarily and specifically. The first limb requires the combination, viewed through the patent’s description and drawings, to fall necessarily under the invention covered by the patent. A claim which requires compound A but makes the presence of other therapeutic ingredients optional does not protect a combination of A and B for these purposes. Domestic infringement or extent-of-protection rules do not by themselves produce a different result. The court also rejected an additional test based on the inventive advance or technical contribution of the patent.

Several pharmaceutical companies challenged the validity of Gilead’s supplementary protection certificate for a combination of tenofovir disoproxil fumarate and emtricitabine. The relevant patent claimed a pharmaceutical composition containing tenofovir disoproxil and, optionally, other therapeutic ingredients.

Arnold J referred the interpretation of Article 3(a) to the CJEU in the First Judgment, reported at [2017] EWHC 13 (Pat). Following the CJEU’s ruling in the reference, Arnold J held in the Second Judgment that the SPC was invalid and refused further expert evidence. Gilead appealed, arguing that the combination was protected by claim 27 and that both limbs of the CJEU’s test were satisfied. The central issue was whether the optional reference to other therapeutic ingredients necessarily protected the combination.

Appeal dismissed. The Court of Appeal unanimously upheld the conclusion that the SPC was invalid.

1. Article 3(a) requires a combination of active ingredients to be related to the claims necessarily and specifically. Under the first limb of the CJEU’s test, the combination must necessarily fall under the invention covered by the patent, viewed from the perspective of the skilled person and in light of the description and drawings.
2. This is not merely the domestic extent-of-protection inquiry. That inquiry asks whether what is claimed is present in the product. The Article 3(a) question asks whether each component of the combination is required by the claim.
3. Claim 27 did not satisfy that requirement. Its reference to “other therapeutic ingredients” was expressly optional. It therefore required only the presence of tenofovir disoproxil, not a second therapeutic ingredient. The skilled person’s knowledge that combination therapy might be useful in treating HIV could not convert an optional ingredient into a necessary one. The breadth of the claim, which was not confined to HIV treatment or anti-viral agents, reinforced that conclusion.
4. The court rejected the inventive-advance or technical-contribution test. The CJEU had set its face against such a test, and express mention of an ingredient in a claim would not itself establish that the ingredient formed part of the patent’s inventive advance. The correct first-limb inquiry was whether the claim required the combination.
5. The court did not decide the second limb, including whether the reference to prior art imposed only a temporal limit or also a qualitative restriction based on common general knowledge, or how broadly worded functional definitions should be assessed. It also declined to endorse, as a general requirement, proof that an otherwise sufficiently identified ingredient was known at the priority date to be effective in humans or approved for the relevant use. Since the first limb failed, the challenge to the exclusion of further expert evidence did not arise.

• Court of Appeal (Civil Division): dismissed Gilead’s appeal and upheld the invalidity of the SPC.
• High Court, Patents Court: Arnold J referred the Article 3(a) question to the CJEU in the First Judgment, reported at [2017] EWHC 13 (Pat). In the Second Judgment he held the SPC invalid and refused further expert evidence.
• Court of Justice of the European Union: issued the preliminary ruling in the reference, Case C-121/17, reported at [EU:C:2018:585].