Eli Lilly’s patent named a particular chemical salt. Actavis proposed using alternatives which, administered as intended, achieved substantially the same result. The dispute exposed a distinction in patent law. Reading the words of a claim tells the reader what it says, but a competitor may still infringe by making an immaterial change to the invention.
The patent and the competing products
Lilly’s patent concerned pemetrexed, a cancer treatment, used with vitamin B12 to reduce serious side-effects. The claim described the use of pemetrexed disodium to manufacture a medicine for that combination treatment. The identity of the named salt, rather than the therapeutic use of vitamin B12, became central to the dispute.
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Actavis’s proposed products also combined a pemetrexed compound with vitamin B12, but the active ingredient was pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium rather than pemetrexed disodium. Actavis said the claims were limited to the named salt. Lilly said marketing or use would be direct infringement, and that there would in any event be indirect infringement because pemetrexed disodium would be involved when the products were prepared for administration. The dispute also concerned the French, Italian and Spanish designations of the patent.
Arnold J held that none of the products would directly or indirectly infringe in any of the four jurisdictions. The Court of Appeal agreed that there was no direct infringement, but held that there would be indirect infringement in all four.
Scope of protection and equivalents
Direct infringement is governed by section 60(1) of the Patents Act 1977, framed so as to have as nearly as practicable the same effect as the European Patent Convention. Article 69 provides that protection is determined by the claims, with the description and drawings used to interpret them. The Protocol requires a middle course between a strict literal meaning and treating the claims merely as a guideline, combining fair protection for the proprietor with a reasonable degree of certainty for third parties. Its article 2 requires due account to be taken of equivalents.
Lord Neuberger, with whom Lord Mance, Lord Clarke, Lord Sumption and Lord Hodge agreed, held that infringement is best approached as two issues, each considered through the eyes of the skilled addressee. The first is whether the variant infringes on a normal interpretation of the claims. The second is whether it nonetheless infringes because the variation is immaterial. Conflating those issues into one question of interpretation, as earlier domestic cases had done, risked both wrong results and confusion between the meaning of a document and the scope of patent protection.
On ordinary interpretation, none of the Actavis products meant pemetrexed disodium. For the second issue, the Court reformulated the three Improver questions as guidelines. Despite falling outside the literal meaning, does the variant achieve substantially the same result in substantially the same way as the inventive concept? Would it be obvious to the skilled person, reading the patent at the priority date but knowing that the variant achieves substantially the same result, that it does so in substantially the same way? Would that reader nevertheless have concluded that strict compliance with the literal meaning was an essential requirement of the invention? Infringement without literal infringement requires affirmative answers to the first two questions and a negative answer to the third.
Application to the Actavis products
The products worked in the same way as the invention: each ultimately involved a medicament containing the pemetrexed anion and vitamin B12. Actavis accepted that the first question was answered yes.
It was not enough simply to ask the chemist whether, without testing, it could have been predicted that each substitute would work. The second question supplied one piece of knowledge: that the variant did achieve substantially the same result. With that knowledge, would the skilled person at the patent’s priority date see that it did so in substantially the same way? The Court held that the answer was yes for these alternative forms of pemetrexed.
The third question was also answered in Lilly’s favour. The Court of Appeal had given too much weight to the claim language. The contrast between general references to antifolates and the specific claim did not show an intention to exclude every other pemetrexed compound. There was no teaching that the sodium cation mattered. The claims reflected the experiments actually described, but disclosure is not the same as the scope of protection. No plausible reason was identified for a rational patentee to confine protection so narrowly.
The prosecution file did not change the result. Recourse to it should be sceptical and limited: either the point must be truly unclear from the specification and claims and unambiguously resolved by the file, or ignoring the file must be contrary to the public interest. The examiner had required limitation to pemetrexed disodium because the teaching did not expressly extend further. That disclosure objection did not determine how far equivalents fell within the scope of protection.
France, Italy and Spain
Having considered the evidence on each national designation, the Court also found direct infringement in France, Italy and Spain. The three countries recognised protection for equivalents. The Court examined their approaches rather than assuming that a UK finding bound the foreign courts.
Indirect infringement
The cross-appeal concerned what would happen if the products did not directly infringe. The Court of Appeal had found indirect infringement where Actavis knew, or it was obvious, that end users would dilute the products in saline. That preparation mattered because of the substances present in the resulting solution. The Supreme Court upheld the finding on that conditional basis, which also applied to the three foreign designations.
Verdict: The Supreme Court unanimously allowed Lilly’s appeal. The proposed products directly infringed in the United Kingdom, France, Italy and Spain. It dismissed Actavis’s cross-appeal. Had there been no direct infringement, the Court of Appeal’s finding of indirect infringement to the extent it specified would have stood.
Source: Actavis UK Limited and others (Appellants) v Eli Lilly and Company (Respondent) [2017] UKSC 48
