Supreme Court
Published August 3, 2017
Actavis UK Ltd and Others v Eli Lilly and Co
Before Lord Neuberger of Abbotsbury, Lord Mance, Lord Clarke of Stone-cum-Ebony, Lord Sumption and Lord Hodge
[2017] UKSC 48
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Judgment July 12, 2017
When considering whether a product, which was a variant of a patented product, infringed the patent because the variation was immaterial, there were three particular questions that it was helpful to ask, although the application of the questions did not amount to a strict rule.
The Supreme Court so stated when allowing the appeal of the defendant, Eli Lilly and Co, and dismissing the cross-appeal of the claimants, Actavis UK Ltd and other companies in the Actavis group, against the decision of the Court of Appeal (Lord Justice Longmore, Lord Justice Kitchin and Lord Justice Floyd) ([2015] Bus LR 1068) which reversed the decision of Mr Justice Arnold ([2015] Bus LR 154) who had granted Actavis declarations of non infringement of Eli Lilly’s patent for pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 (and, optionally, folic acid) for the treatment of cancer. The Court of Appeal held that Actavis had indirectly infringed Eli Lilly’s patent. The Supreme Court held that the infringement was direct.
Mr Daniel Alexander, QC, Mr Thomas Raphael, QC, and Ms Isabel Jamal for Actavis; Mr Thomas Mitcheson, QC, Mr Andrew Waugh, QC, and Mr Stuart Baran for Eli Lilly.
Lord Neuberger, with whom the other members of the court agreed, said that it was common ground that it was appropriate to consider the present case by reference to the European Patent Convention 2000. The Protocol on the Interpretation of article 69 of the Convention was crucial to Eli Lilly’s case.
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The drafting of the Protocol bore all the hallmarks of the product of a compromise agreement. That was unsurprising. There was an inevitable conflict between the desirability of giving an inventor an appropriate degree of protection in a particular case and the need for clarity of principle as to the extent of such protection generally; and, of course, there was an unavoidable tension between the appropriateness of giving an inventor a monopoly and the public interest in maximising competition.
In addition, the Convention and the Protocol applied in many different states that had different traditions and approaches in relation to the law of patents. Any patent system had to strike a balance between the two competing factors referred to at the end of article 1 of the Protocol, namely: “a fair protection for the patent proprietor [and] a reasonable degree of legal certainty for third parties”. The balance could not be struck on an ad hoc case-by-case basis without any guiding principles, as that would mean that there was no legal certainty. On the other hand, striking the balance by adopting a normal approach to interpretation would risk depriving patentees of a proper measure of protection.
In his Lordship’s view a problem of infringement was best approached by addressing two issues, each of which was to be considered through the eyes of the notional addressee of the patent in suit, that was, the person skilled in the relevant art.
Those issues were: (i) did the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) did the variant nonetheless infringe because it varied from the invention in a way or ways which was or were immaterial? If the answer to either issue was “yes”, there was an infringement; otherwise, there was not.
Issue (i) self-evidently raised a question of interpretation, whereas issue (ii) raised a question that would normally have to be answered by reference to the facts and expert evidence.
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His Lordship had wondered whether the question whether issue (ii) truly involved a question of interpretation raised what was merely an arid issue of categorisation. However, that nettle needed to be grasped, because, so long as the issue was treated as one of interpretation, it would lead to a risk of wrong results in patent infringement cases and it would also lead to a risk of confusing the law relating to the interpretation of documents.
Issue (ii) involved not merely identifying what the words of a patent claim would mean in their context to the notional addressee, but also considering the extent if any to which the scope of protection afforded by the claim should extend beyond that meaning.
Issue (i) involved solving a problem of interpretation that was familiar to all lawyers concerned with construing documents. While the answer in a particular case was by no means always easy to work out, the applicable principles were tolerably clear.
However, issue (ii) posed more difficulties of principle: what was it that made a variation “immaterial”? In that connection, Mr Justice Hoffmann’s three questions in Improver Corporation v Remington Consumer Products Ltd ([1990] FSR 181, at page 189) provided helpful assistance. Each of the three questions required some exegesis, and, particularly the second question, some reformulation.
It was right for the court to express in its own words its reformulated version of those questions. In doing so, it was right to emphasise that the questions were guidelines, not strict rules. While the language of some or all of the questions might sometimes have to be adapted to apply more aptly to the specific facts of a particular case, the three reformulated questions were as follows:
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(i) Notwithstanding that it was not within the literal meaning of the relevant claim(s) of the patent, did the variant achieve substantially the same result in substantially the same way as the invention, that was, the inventive concept revealed by the patent?
(ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieved substantially the same result as the invention, that it did so in substantially the same way as the invention?
(iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
In order to establish infringement in a case where there was no literal infringement, a patentee would have to establish that the answer to the first two questions was “yes” and that the answer to the third question was “no”.
It was appropriate for the United Kingdom courts to adopt a sceptical, but not absolutist, attitude to the suggestion that the contents of the prosecution file of a patent should be referred to when considering a question of interpretation or infringement.
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While it would be arrogant to exclude the existence of any other circumstances, his Lordship’s current view was that reference to the file would only be appropriate where (i) the point at issue was truly unclear if one confined oneself to the specification and claims of the patent, and the contents of the file unambiguously resolved the point, or (ii) it would be contrary to the public interest for the contents of the file to be ignored.
The first type of circumstance was self-explanatory; the second would be exemplified by a case where the patentee had made it clear to the European Patent Office that he was not seeking to contend that his patent, if granted, would extend its scope to the sort of variant that he now claimed infringed.
Solicitors: Bird & Bird LLP; Hogan Lovells International LLP.