On Jun. 12, 2020, Supreme Court of Netherlands followed
Advocate General’s Opinion and upheld preliminary injunction (PI) decision of
lower court by dismissing the appeal.
The heart of the issue was the scope of the EP (NL) 1313508
patent which is held by Lilly. The patent entitled, “Combination containing an
antifolate and methylmalonic acid lowering agent”. This second medical
indication patent claims treatment of cancer with pemetrexed disodium in
combination with vitamin B12 & folic acid. The patent is valid in the
Netherlands until Jun. 14, 2021. Lilly markets the medicine Alimta® (Pemetrexed
disodium). The active ingredient in Alimta® (after solution) consists of
pemetrexed anions. In Alimta®, the anions are bound to sodium ions to form the
pemetrexed disodium salt. The active substance in Fresenius Kabi's Pemetrexed
for injection is Pemetrexed diacid with tromethamine instead of Pemetrexed disodium
as in Alimta 100 mg / 500 mg powder for concentrate for solution for infusion.
When reconstituted and diluted for administration, the active moiety remains
the same irrespective of the salt form. The marketing authorization for
Pemetrexed Fresenius was granted on July 22, 2016.
On Aug. 03, 2017 Lilly has claimed an infringement
prohibition & argued that Pemetrexed Fresenius falls under the scope of
protection of EP 508. Preliminary Relief Judge of the District Court of The
Hague on Oct 24, 2017 issued an injunction against Fresenius Kabi’s pemetrexed product.
Court of Appeal of The Hague on May 08,
2018 affirmed the decision. Fresenius then appealed the decision. Advocate
General Van Peursem provided opinion on Apr. 01, 2020 on the said matter. The
actual assessment was done to see whether Pemetrexed Fresenius falls within the
equivalent scope of protection of EP 508. Specifically, the question was whether
the limitation of the claims introduced by Lilly during prosecution could
preclude infringement under equivalence. During prosecution Lilly amended
claims from antifolate to pemetrexed disodium. AG opined that in the eyes of
the average skilled person, there is no conscious choice based on a
technical reason, which would lead them to understand that the intention here
is to claim only the disodium salt. According to the court, this technical
choice cannot be deduced from the description by the person skilled in the art nor
does the person skilled in the art read any indications that a salt study was
carried out on which the choice for disodium salt. The average skilled person
would see that disodium was just a suitable salt form. The disodium salt was
only mentioned because it already existed (Alimta). The professional does not
see such a deliberate limitation as intended by Fresenius on the basis of his
general professional knowledge.
Moreover, the inventive idea of EP 508 lies in the use of
vitamin B12 and optional folic acid in combination with the antifolate
pemetrexed (not limited to pemetrexed disodium), thereby reducing the serious
toxic side effects of the pemetrexed anions while the efficacy of the
pemetrexed anions in the inhibition of tumor growth is maintained. The person
skilled in the art knows that only the anion is responsible for the efficacy
(and toxicity) of pemetrexed, he also finds confirmation for the insight that
the invention relates rather to the active form of pemetrexed after
administration and not to the specific disodium salt form disclosed
therein , in the description of the mouse model.
Court of Appeal correctly considered that amendment to
claims made during the granting procedure at the direction of the Examiner does
not prevent a patent holder from relying on the application of Article 2 of the
Protocol (equivalence) when determining the scope of protection. Claims were
amended to avoid Art. 123(2) rejection (added matter) raised by Examiner. Added
matter and scope of protection are clearly distinguishable issues. A limitation
of the claims under Article 123 paragraph 2 EPC would result in the patent
holder never being able to claim protection of equivalents. This could lead to
too limited scope of protection.
Therefore, the appeal in cassation was dismissed & PI
upheld.
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