Gilead Sciences inc. & anor v Teva B.V. and Norton 9 Waterford) (t/a Teva Pharmaceuticals Ireland)

Factual and Procedural Background

The plaintiffs, Company A and Company B, initiated separate proceedings against two sets of defendants, Company C and Company D, respectively, alleging that the defendants' marketing of generic pharmaceutical products containing a combination of two active agents infringed a Supplementary Protection Certificate (SPC) based on Irish Patent No. EP 0915894 (the 894 Patent). The SPC was granted on 11 August 2009 and was due to expire on 20 February 2020. The priority date of the 894 Patent is 26 July 1996, and the patent had expired on 25 July 2017.

The defendants counterclaimed asserting that the SPC was invalid on the basis that the combination of the two active agents was not protected by the 894 Patent, specifically contending that one of the agents was neither identified nor specified in the patent claims and that the combination was not part of the invention.

The proceedings were initially scheduled for hearing in 2018 but were adjourned pending a preliminary ruling from the Court of Justice of the European Union (CJEU) following a reference made by the High Court of England & Wales in related UK proceedings. The CJEU judgment was delivered in July 2018, after which the present proceedings resumed and were heard together with evidence admissible across both cases. The hearing concluded on 23 May 2019 and judgment was delivered on 11 October 2019.

Legal Issues Presented

1. Whether the SPC is valid, specifically whether the combination of the two active agents is “protected by a basic patent in force” within the meaning of Article 3(a) of the SPC Regulation.
2. How the CJEU’s two-limb test from Teva UK Ltd v. Company A applies to the interpretation of the 894 Patent and the SPC validity.
3. The proper construction of Claim 27 of the 894 Patent, particularly the scope and meaning of “other therapeutic ingredients” and whether it implicitly and necessarily covers the combination of the two active agents.
4. The identity and knowledge scope of the “person skilled in the art” for interpreting the patent in this context.
5. Whether the second active agent was specifically identifiable and part of the common general knowledge or prior art as of the priority date.
6. Whether the combination of the two active agents falls within the limits of the invention covered by the patent.

Arguments of the Parties

Plaintiff's Arguments

• The SPC is valid because the combination of the two active agents falls within the scope of the invention covered by the 894 Patent.
• Claim 27, which refers to a pharmaceutical composition comprising one of the claimed compounds together with “other therapeutic ingredients,” would be understood by the skilled person as referring to combination therapy for HIV, involving at least two antiretroviral drugs.
• The two active agents, including the second agent, were specifically identifiable by the skilled person as of the priority date based on prior art and common general knowledge, including clinical development data and scientific literature.
• The CJEU’s test in Teva v. Company A requires that the product be identifiable implicitly but necessarily and specifically by the skilled person in light of the patent and prior art, which is met here.
• The fact that combination therapy was the standard of care for HIV at the priority date supports the interpretation that Claim 27 is focused on HIV treatment.

Defendants' Arguments

• The SPC is invalid because the combination of the two active agents is not protected by the 894 Patent as required by Article 3(a) of the SPC Regulation.
• Claim 27 does not reflect any inventive advance beyond Claims 1 to 25 and the phrase “other therapeutic ingredients” is too broad and optional, making it incapable of specifically and necessarily identifying the second active agent.
• The 894 Patent is broadly directed to improving oral bioavailability of certain nucleotide analogs and covers a wide range of viral infections, not specifically or primarily HIV.
• The second active agent was not known to be therapeutic or safe for human use as of the priority date and was not part of the common general knowledge of the skilled person.
• The skilled person for interpreting the patent comprises a team of a medicinal chemist and a clinician with a broad focus on viral infections, not narrowly focused on HIV.
• The CJEU test requires both limbs to be satisfied: the combination must fall necessarily under the invention and each active ingredient must be specifically identifiable, which is not the case here.
• Commercial considerations are irrelevant to patent construction, and the broad terms of the patent do not lead to an irrational or commercially unviable result.

Table of Precedents Cited

Court's Reasoning and Analysis

The court analyzed the validity of the SPC by applying the two-limb test established by the CJEU in Teva UK Ltd v. Company A, which requires:

1. That the combination of the two active ingredients must necessarily fall under the invention covered by the patent, assessed from the perspective of a person skilled in the art with the common general knowledge as of the priority date, and in light of the patent's description and drawings.
2. That each active ingredient in the combination must be specifically identifiable by the skilled person in the light of all information disclosed by the patent and the prior art as of the filing or priority date.

The court rejected the plaintiff’s submission that the first limb is confined to an “extent of protection” test focused solely on the claims. Instead, the court emphasized an “invention-focused” approach, construing the claims in light of the description and drawings to ensure the SPC protection does not extend beyond the invention disclosed.

The skilled person was identified as a team comprising a medicinal chemist and a clinician with broad expertise in viral infections, not narrowly focused on HIV. This reflected the wide range of viruses covered by the patent, including Hepatitis B and herpes viruses, not exclusively HIV.

Regarding the first limb, the court found that the invention described in the 894 Patent relates to intermediates (prodrugs) improving oral bioavailability of phosphonomethoxy nucleotide analogs for treating a broad spectrum of viral infections. The patent contains no substantive disclosure of a combination involving the two active agents, and the reference to “other therapeutic ingredients” in Claim 27 and paragraph 0047 is generic and optional, with no specificity or technical detail supporting a combination with the second agent.

The court accepted the evidence of the experts, including the plaintiff’s own expert, that the invention does not extend to the combination of the two agents and that Claim 27’s wording does not focus on HIV treatment or mandatory combination therapy.

On the second limb, the court considered whether the second active agent was specifically identifiable as a therapeutic ingredient as of the priority date. Although some evidence indicated that the compound was known and in early clinical development (phase 1 trials), it had not been established as therapeutic or safe for human use at the priority date. The limited clinical data available was insufficient to qualify it as a “therapeutic ingredient.”

The court further held that the relevant skilled team would not have had the knowledge that the compound had successfully passed phase 1 trials, as the key scientific publication (the “Wang abstract”) was not widely known or accepted and was not part of common general knowledge. The promotional press release relied on by the plaintiff was also insufficient to establish common general knowledge.

The court rejected the plaintiff’s argument that Claim 27’s optional reference to “other therapeutic ingredients” implied combination therapy consistent with the standard of care for HIV, noting that the optional nature of the claim is incompatible with the mandatory combination therapy required for effective HIV treatment as of the priority date.

Overall, the court concluded that neither limb of the Teva v. Company A test was satisfied: the combination product did not fall within the invention covered by the patent, nor was the second active agent specifically identifiable as a therapeutic ingredient as of the priority date.

Holding and Implications

The defendants' counterclaims are allowed, and the SPC is revoked.

This decision results in the invalidation of the SPC protecting the combination product containing the two active agents. Consequently, the plaintiffs' claims against the defendants for infringement of the SPC are dismissed. The court did not establish any new precedent beyond the application of the CJEU’s established test to the facts of this case.