On 15 June
2006, the Full Federal Court of Australia handed down its judgment in Merck & Co Inc v Arrow Pharmaceuticals Limited [2006]
FCAFC 91.
Under
Australian law, a patent specification which incorporates by reference the
entire disclosure of one or more prior art documents is more likely to be
invalidated for lacking a manner of new manufacture.
The classic
test for the required degree of disclosure in a prior art reference was
reiterated by the Full Court — would a skilled addressee have been able
to at once perceive, understand, and be able practically to apply the
discovery without the necessity of making further experiments?
Comment
The two grounds argued on
appeal were whether the patent claimed a manner of new manufacture (s 18(1)(a)) and novelty (s 18(1)(b)(i)).
Manner of
new manufacture
To
invalidate a patent on this ground, it is necessary to demonstrate that there
is no invention disclosed on the face of the specification.
Arrow
argued that the patent was invalid on this ground since:
on comparing the description of the
prior art in the patent to the claims, it merely claimed a known drug (alendronate) administered in a known way (oral
alendronate) for a known indication (osteoporosis). The only difference being 70 mg once a week
rather than 10 mg once a day.
on comparing the disclosure in the
prior art documents which were incorporated by reference (Strein and
Goodship), the claims of the patent merely added rest periods (Strein) and
use of alendronate for the treatment of osteoporosis (Goodship). (Although Goodship assumed this in any
event.)
In the
words of the Judges of the Full
Court:
“We see no invention in
asserting that a patient is more likely to comply with a continuous weekly
regime than with an intermittent regime involving periods of weekly
administration and rest periods.â€
“The Patent specification
discloses no new substance, no new characteristic of a known substance, no
new use and no new method. There is,
therefore, no manner of new manufacture.â€
Novelty
The two key
issues argued in relation to novelty were whether the prior art ‘Lunar
News’ articles had been adequately published and whether there was an
anticipatory degree of disclosure in them.
The Full Court
swiftly dealt with the first argument by the simple expedient of reminding
Counsel of the wording of the Patents Act.
In relation
to the degree of disclosure, Merck argued that the Lunar News articles merely
disclosed a need for further testing rather than a full disclosure of the
claimed invention. However, the Full
Court reiterated the classic test, namely that all that is required is that a
person of ordinary knowledge of the subject would at once perceive,
understand, and be able practically to apply the discovery without the
necessity of making further experiments.
Background
The patent
in suit was AU 741818 for an invention entitled ‘Method for
inhibiting bone resorption’. It
basically claims a method of treating osteoporosis in a human comprising oral
administration of alendronate (Fosamax) at a dosage interval of once per week.
Arrow had originally commenced revocation proceedings under s 138 of the Patents
Act.Merck did not defend the claims of the Patent as granted
but proposed and secured amendments to the claims so that only ten claims
were finally pursued.Arrow asserted
invalidity of seven of those claims, all of which were held invalid at first
instance: Arrow Pharmaceuticals Limited v Merck & Co Inc [2004] FCA
1282.