"And with one bound, the Court of Appeal was free ..."

Fresh off the Air Berlin flight from INTA, the IPKat discovered this decision of the Court of Appeal for England and Wales (Lords Justices Ward, Jacob and Rimer) awaiting him: it's Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444 against the decision of Mr Justice Warren that Merck's patent for a medicament for treating baldness was invalid.

This case turns on the UK's Patents Act 1977, s.2(6), which is derived from Article 54(5) of the European Patent Convention, Art.54(5). Under s.2(6):

"In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art".

Merck held a patent for anti-baldness drug finasteride, which Actavis wanted to revoke. At the patent's priority date, back in 1993, Merck sold finasteride tablets as PROSCAR for the treatment of benign prostatic hyperplasia (prostate enlargement), the conventional dose being 5mg a day, this patent apparently dating back to 1978. The disputed patent claimed the use of a low dose of finasteride for the treatment of androgenic alopecia (a condition which included both male and female pattern baldness). Merck sold finasteride tablets for male baldness as PROPECIA, the dosage being just 1mg a day. Merck also filed a patent application ('382) in 1988 for methods of treating baldness with certain compounds that included finasteride.

When Actavis applied to revoke Merck's patent it argued that, for a second medical use claim to be valid, its novelty had to be in the new therapeutic application: novelty could not, it maintained, reside in nothing more novel than a dosage scheme for treatment of the same disorder as previously treated. According to Actavis, '382 disclosed the therapeutic application - the treatment of androgenic alopecia.

Warren J agreed with Actavis and revoked the patent. In his view it was well established that second medical use claims had to have a specified therapeutic application or purpose that was not only non-obvious but which was also new. That novelty had to reside in the second or subsequent therapeutic use. He added that, having regard to the description of the underlying chemistry of '382 and its specification, there was no novelty in the use of finasteride as a possible treatment for male pattern baldness. Even if a small dosage which it was now apparent could result in successful treatment, rather than the much larger doses mentioned in '382, that was just a different dosing regime.

Merck appealed, citing Eisai/Second Medical Indication [1985] OJEPO, 64, a decision in which an Enlarged Board of the European Patent Office had said, at para.23:

"It is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case where the process of manufacture as such does not differ from known processes using the same active ingredient".

This, said Merck, had become settled EPO practice -- though it was contrary to an earlier decision of the Court of Appeal in Bristol-Meyers Squibb v Baker Norton [2001] RPC 1. Merck maintained that Bristol-Meyers was not a good case to follow. Either it had no ratio decidendi at all or its reasoning was sufficiently unclear to preclude the court from following it. Failing that, even if there were a ratio, the court should recognise that this was an appropriate opportunity not to apply it.

The Court of Appeal allowed Merck's appeal.

* First, it held that a new dosage regime was enough to confer novelty in a Swiss form claim. In the EPO, Germany and New Zealand, Swiss claims in which the novelty depended on a new treatment by a different dosage regime or method of administration had been treated as novel and not as merely being claims to a method of administration.

* Bristol-Meyers did not rule clearly that a Swiss claim lacked novelty if the only difference between it and the prior art was a new dosage regime for a known medical condition.

* the function of rules of precedent was to produce certainty. Where a particular 'precedent' ws itself obscure, any attempt to follow it was likely to perpetuate uncertainty rather than achieve certainty.

* the Court of Appeal was free -- but not bound -- to depart from the ratio decidendi of its own earlier decision when it was satisfied that the EPO Boards of Appeal had formed a settled view of European patent law which was inconsistent with that earlier decision. In principle, therefore, the Court of Appeal would follow the settled view of the EPO in such a situation -- and this was such a decision.

The IPKat is content with this. On the assumption that Bristol-Meyers was a binding precedent to contrary effect, he thought Warren J had got it right -- but he's happy to see the Court of Appeal taking a view that has the effect of affirming the stability and predictability of the patent system rather than undermining it. Merpel bets the EPO is really happy to see Lord Justice Jacob waving an olive branch in its direction, after the post Aerotel/Macrossan debacle (see IPKat here and here).

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