For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

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Thursday, 22 May 2008

"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).

Are bald men sexier? Click here and here
Should judges wear wigs? Click here and here
Why cats wear hats here

8 comments:

Anonymous said...

"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 of earlier decision."

Presumably now the Court of Appeal are free to follow the EPO approach to excluded subject matter in the forthcoming appeal in Symbian given that in Duns Licensing (T 0154/04) Steinbrener was adament that the EPO approach was settled?

Anonymous said...

"Free - but not bound"

I thought of Duns Licensing too but of course so did he. My bet is the following will be quoted when that argument is raised - "In the unlikely event that we are convinced that the commodore [the EPO] is steering the convoy towards the rocks we can steer our ship away".

Anonymous said...

This case reminds me a lot of the recent escitalopram case. In both trials the patent was (at least in part) revoked in the first instance for some problematic (in)-admissibility reason, while no in-depth discussion of novelty or obviousness took place. The Appeal Court took nicely care of the admissibility, but in both appeals questions of patentability were hardly addressed.
Hence, winning in the first instance for some bad reason, may result in losing the whole case in face of an obvious lack of novelty or inventiveness.

Anonymous said...

Its not correct to suggest that novelty and obviousness played no part in either escitalopram or finasteride at trial. It was the major issue in both, as can be seen from the the first instance judgments!

Anonymous said...

One way the C of A could handle Duns is to say that, in the civil law EPO, with no Binding Precedent on the stream of hundreds of TBA Decisions coming down from the 24 Senates, "technical" as a test is workable, by Darwinian evolution. Conversely, in an English common law environment, it ain't. BTW, at the EPO last Friday, on "What is Technical" conference, the American professor Adelman concluded that "technical" means "nineteenth Century stuff". The gradual evolution of the EPO concept of "technical" puts him straight out of court on that one and will adequately serve Europe in the 21st century too. But then, he's coming from a common law jurisdiction with Binding Precedent, so his CAFC has to come up with a authoritative single definition for 101 patent eligibility. CAFC Judge Rader was speaking in Munich too, and listening.

Anonymous said...

I'm not convinced that the CoA is able to depart from its own earlier decisions to follow EPO ones [settled EPO practice or not].

Jacob and precedent don't seem to run too smoothly together. There's the question of whether the A/M test follows Merrill Lynch etc [perhaps yes if interpreted as by the PC in Symbian].

Then there's Jacob's criticism of the BoAs in A/M for being inconsistent, which ignores the fact that BoA practice has been settled for several years. In other words, he seems to struggle to understand a civil law [non precedential] system.

Interesting for the Symbian appeal. Will he follow the PC, to try to render the A/M test in conformity with earlier CoA cases? Or stick with 'strict A/M', thus ignoring CoA precedent and the BoAs?

Or follow BoA in Duns and ignore his own precedent in A/M?

I'd bet on option 2. Unfortunately, Option 3 seems very unlikely!

David said...

Was the IPKat responsible for the postscript? See this post, dated 9 May 2008. Interestingly, this has caused the time allowed for an appeal to the House of Lords to be extended to after the EBA arrive at their decision.

Kerry Tomlinson said...

Except that the question of patentability of dosage regimes has been referred to the Enlarged Board in T1319/04.

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