After three decades of "fall-out" from the decision of the European Patent Office's Enlarged Board of Appeal in Eisai (Second medical indication) [1985] OJ EPO 64, the English Court of Appeal has issued considered, well-reasoned guidance on the construction of patent claims in "Swiss" form. The decision is likely to have impact well beyond British shores.
Warner-Lambert still refused interim relief on the balance of justice
The Court of Appeal's decision of 28 May 2015 concerns Warner-Lambert's appeal from Arnold J's refusal, in January 2015, to award interim relief against Actavis, and his strike-out, in February 2015, of Warner-Lambert's claim for indirect infringement under section 60(2) of the Patents Act. (Our earlier alerts on decisions on this case are: Warner-Lambert refused interim relief based on Swiss form claim: no serious issue to be tried regarding carved-out indication and Arnold J refuses to strike out Warner-Lambert's claim: construction of Swiss form claims is an issue suitable for Supreme Court.)
The Court of Appeal upheld the judge's finding on the 'balance of justice' and confirmed his decision not to award interim relief.
Questions therefore remain about the availability of injunctive relief in the UK to restrain the infringement of patents where the invention resides in a second (or subsequent) use of a known medicine. In particular, where a medicine may legitimately be sold for a non-infringing purpose, injunctive relief to restrain infringement may not be available at either interim or final stages of litigation, irrespective of a finding of infringement.
Patents Court over-ruled on the construction of patent claims in Swiss form
However, the Court of Appeal's rulings on the construction of the Swiss form claim in issue will be welcomed by the patentee in this case, by the pharmaceutical industry more generally and by lawyers in other European Patent Convention (EPC) jurisdictions grappling for guidance on the construction and enforceability of such claims.
Giving the only reasoned judgment, Lord Justice Floyd's key findings were that Swiss form claims - i.e. "Use of X in the manufacture of a medicament for the treatment of Y" - are process claims in which the word "for" does not mean "suitable and intended for". Rather, such claims require knowledge (and for this purpose constructive knowledge is enough), or reasonable foreseeability, of ultimate intentional use for the claimed medical indication. There is no requirement that the manufacturer has that specific intention or desire himself, and so there is no evidential burden upon the patentee with regards to the manufacturer's subjective intent.
With this construction, the Court of Appeal ruled that Warner-Lambert does have an arguable case on the infringement of its patent, both under section 60(1)(c) of the Patents Act - dealings in the direct product of the patented process, and under section 60(2) of the Patents Act - indirect infringement by supply of means relating to an essential element of the invention. Both claims of infringement will now proceed to trial, which is listed to be heard in the Patents Court in late June 2015.
Wider consequences
The decision would seem to pave the way for healthcare bodies, including the National Health Service (NHS), to be found liable for the infringement of patent claims in Swiss form where requisite knowledge is present. This may encourage such bodies to improve their mechanisms and guidance on the prescribing and dispensing of medicines, so as to enable the rights conferred by second medical use patents to be respected and complied with.
Luke Kempton and Ailsa Carter have written an article in Bio-Science Law Review titled "English Court of Appeal rules on the construction of Swiss form patent claims in Warner-Lambert v Actavis".