article
House of Lords clarifies the UK's approach to insufficiency
1 May 2009
A patent, to be valid, must be sufficient. To be sufficient, the
specification as a whole must enable the skilled man to perform the
invention using his or her skill or knowledge, allowing for
ordinary trial and error.
This can be difficult in practice. Often, an invention lies not
in the discovery of a product, but rather in the first method of
creating a known product. What if in showing one such method, a
claim of the patent claims the product? Does the claim lack
validity for insufficiency?
Biogen v Medeva concerned the invention of a method of making
artificially constructed DNA molecules which, when introduced into
a host cell, would cause that cell to make antigens of the
hepatitis B virus. Whilst the inventive step was the method
applied, the patent claimed – in part - the product created.
Lord Hoffmann held the claim in question to be invalid for
insufficiency. He stated that such a claim will be invalid where it
claims “every way of achieving a result when it enables only one
way and it is possible to envisage other ways... care is needed not
to stifle further research and healthy competition by allowing the
first person who has found a way of achieving an obviously
desirable goal to monopolise every other way of doing so.”
‘Biogen insufficiency’ therefore became the accepted principle
that, where the inventive concept is not a thing but a way of
making a thing that the art knew it wanted to make, a claim not
limited to that method will be insufficient.
In the recent case of Generics v Lundbeck, the patent claimed
products and processes relating to the antidepressant drug
escitalopram, for which the closest prior art was citalopram.
Whereas citalopram is a racemate comprising (+) and (-)
enantiomers, escitalopram comprises the pure (+) enantiomer. The
inventive step therefore lay in finding a way to separate the
enantiomers. Importantly, the resultant product did not itself lack
novelty nor was obvious. However, the Claimants also contended that
the product claim was ‘Biogen insufficient’. At first instance
Justice Kitchin agreed, applying Biogen.
The Court of Appeal took a different view. Lord Hoffman
(unusually coming down from the Lords to deliver the leading
Judgment) distinguished his decision in Biogen, asserting:
“In an ordinary product claim, the product is the invention. It
is sufficiently enabled if the specification and common general
knowledge enables the skilled person to make it. One method is
enough.”
Lord Hoffmann noted that Biogen concerned a “product-by-process”
claim, so formulated because a simple product claim would have
lacked novelty. It had been therefore treated as a class, which
naturally could result from a wide variety of possible processes.
In disclosing only one such process, it failed for
insufficiency.
The case then went to the House of Lords, presenting the
intriguing possibility of a ruling that the interpretation given by
Lord Hoffman (who could not sit, having sat in the Court of Appeal)
of his own decision in Biogen had been incorrect. Fortunately or
unfortunately, the House of Lords declined to do this. The leading
Judgment of Lord Neuberger agreed that, where a product is claimed,
the disclosure of one method of making that product will render the
claim sufficient. In doing so he addressed the objection that the
patentee is thereby obtaining a monopoly exceeding his technical
contribution to the art:
“…to put it at its lowest,…the respondent's technical
contribution in this case was to make available, for the first
time, a product which had previously been unavailable, namely the
isolated (+)-enantiomer of citalopram. On that basis, it would
appear to follow that the respondent was entitled to claim the
enantiomer.”
The decision is interesting, in that Lord Hoffmann has
effectively confined the ratio in Biogen to its somewhat esoteric
facts. However, the decision also follows the line consistently
adopted by the Lords in recent decisions (including Conor
Medsystems Inc v Angiotech Pharmaceuticals Inc), in stating that
the inventive concept is the product or process as claimed, not
some abstract concept construed from the claim. Such a “vague
paraphrase” is capable of being much wider than the actual wording,
thereby subjecting it to charges of lack of novelty, obviousness,
or insufficiency that the wording itself does not warrant.
This article was first published in
WIPR
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