On May 08, 2018, Court of Appeal The Hague handed down its
decision in ALIMTA case & denied appeal filed by Fresenius & Teva
against lower court’s decision of infringement.
Lilly markets the Alimta® for the treatment of certain lung
cancers (tumor growth). The active ingredient in Alimta® (after solution)
consists of pemetrexed anions. In Alimta® the anions are bound to sodium ions
and thus the pemetrexed disodium salt is formed. Lilly is holder of the
European patent EP (NL) 1 313 508 for a 'Combination containing an antifolate
and methylmalonic acid lowering agent'.
Fresenius and Teva both appealed an interlocutory judgment
of 24 October 2017 (the first instance judgments). In the first instance, Lilly
has demanded that the relief judge prohibit Fresenius & Teva from
infringing the Dutch part of EP 508. Lilly has argued for that “pemetrexed
tromethamine” product of both appellants’ falls within the scope of protection
of EP 508. The preliminary relief judge awarded the infringement prohibition. Both
Fresenius & Teva appealed.
The question that kept the parties divided is whether pemetrexed
tromethamine falls within the scope of protection of EP 508. Court said that the
person skilled in the art knows that only the anion is responsible for the
efficacy (and toxicity) of pemetrexed. He furthermore finds confirmation for
the insight that the invention relates more to the active form of pemetrexed
after its administration and not to the specific disodium salt form disclosed
therein in EP’508. In the opinion of the court, the average person skilled in
the art would recognize that the disodium salt form was not mentioned in the
description for the technical advantage associated with that salt form or a
salt test (for which the description does not contain any indication), but
rather because the disodium salt form was available. Precisely because, on the
basis of his general professional knowledge, the average person skilled in the
art knew that the acid form and other salt forms of pemetrexed were also
possible. He understood that the explicit mention of disodium was motivated by
the fact that this form already existed and had been used in research into the
invention and therefore should rather be seen as illustration. It was clear to
him that also for other forms of pemetrexed they were within the inventive
concept of EP 508, while the description did not give rise to the assumption
that there was a technical reason for the patent holder to limit himself to the
disodium salt form.
In the Court's opinion, the description does not give the
average person skilled in the art any reason to suppose that there is a
technical reason why Lilly intended to limit the scope of protection of EP 508 to the disodium salt form of
pemetrexed. The experts of appellants have also failed to clarify this. The
court agreed with Lilly that the pemetrexed diacid with tromethamine in the
appellant’s product should be regarded as a technical equivalent to pemetrexed
disodium. The cations differ, but do not play a role in the function, mechanism
of action and outcome of both drugs. In both cases there is dissociation in
aqueous solution, whereby the same active pemetrexed anion becomes available,
which performs the same function, namely to work as an antifolate in the body,
with the same result: the prevention of tumor growth and toxicity.
Thus, the appeal was dismissed & infringement affirmed.
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