Actavis UK Limited v Merck & Co. Inc, 21 May 2008 [2008] EWCA Civ 444

Merck owned a patent for the use of a new dosage regime for Finasteride, a drug for male pattern baldness. The High Court revoked the patent for lack of novelty on the basis of an earlier Merck patent which disclosed the use of Finasteride for treating prostate enlargement and had also mentioned its use for male pattern baldness. It was held that claims to a new dosage regime for the same indication did not amount to a patentable second medical use, the Court considering itself bound by an earlier Court of Appeal decision, Bristol Myers Squibb v Baker Norton.

However, the Court of Appeal allowed Merck’s appeal. The Court held that second medical use claims did not require a novel therapeutic application in the sense of a distinct and different indication, but that novelty could reside in a new dosage regime (or other form of administration). The Court agreed with what it considered was settled EPO law set out in Genentech to the effect that this followed from Article 54(5) EPC and the logic of the EPO’s decision in Eisai allowing second medical use claims. Moreover, the Court considered that Bristol Myers Squibb did not in fact hold that dosage regime patents were invalid for lack of novelty. However, importantly, the Court went on to hold that even if it did, it was not bound to follow that earlier decision.  

In doing so, it departed from the previously established rules of English precedent whereby the Court of Appeal is bound by its own decisions. It set out a new exception to the rules of precedent as follows:  

“..this court is free but not bound to depart from the ratio decidendi of its own earlier decision if it is satisfied that the EPO Boards of Appeal have formed a settled view of European Patent law which is inconsistent with that earlier decision. Generally this Court will follow such a settled view.”  

This is of major significance and demonstrates the extent to which the English Courts are now seeking to follow the EPO where possible (see also the comments in Conor v Angiotech and Symbian below).  

Interestingly, just before the judgment was handed down, it became clear that there is a reference to the Enlarged Board of Appeal in Kos Life Sciences on this very issue. Not all agree that the EPO position is settled but the Court of Appeal stood by its decision, extending time for leave to appeal to the House of Lords. In the meantime we await the Enlarged Board’s decision.  

In practice, it should be borne in mind that, whilst a new dosage regime may be novel, it will not often be inventive. The Court of Appeal stated that in most cases such regimes would be obvious as it was standard practice to investigate dosage regimes.