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NL – Pharmathen v. Novartis / Appeal

25 Nov 2022

Pharmathen Global B.V. v. Novartis A.G., Court of Appeal The Hague, The Netherlands, 15 November 2022, Case no. ECLI:NL:GHDHA:2022:2327

Novartis is the holder of – inter alia – European patent EP 2 377 519 B1  entitled ‘Pharmaceutical Composition Comprising Octreotide Microparticles’

Novartis markets an injectable Long Acting Release (hereinafter also: ‘LAR’) product containing octreotide under the name Sandostatin LAR. Octreotide is similar to the body’s own hormone somatostatin and it blocks the production of many types of hormones. Octreotide is prescribed in the treatment of various cancerous tumors of organs that produce hormones. Microparticles consisting of a biodegradable poly(lactide-co-glycolide) (hereinafter: PLG) polymer and octreotide acetate are injected into the muscle by means of an injection. The microparticles slowly release the octreotide into the bloodstream.

Within the Pharmathen group, Pharmathen Greece produces injectable octreotide LAR products in Greece. In the manufacture of these products, Pharmathen SA uses PLGA polymers called Purasorb.

Novartis is of the opinionthat Pharmathen infringes Novartis’ patent by producing its octreotide LAR products. Previously, the Dutch provisional relief Judge granted Novartis’ claim to prohibit Pharmathen from infringing Novartis’ patent for all countries where Novartis’ patent is in effect. Pharmathen appealed and largely fails.

It is not in dispute between parties that the method used by Pharmathen Greece and Pharmathen Global does not literally infringe EP 519. It is also common ground between the parties that Pharmathen Greece and Pharmthen Global use a PLG product called Purasorb from Corbion for the production of ocreotide acetate microparticles, which is made with glucose as an initiator. Novartis argues in this regard that Purasorb is equivalent to a linear PLG within the meaning of EP 519. Pharmathen Global disputes that.

The Court of Appeal applies the four requirements for equivalence as formulated in the earlier Eli Lilly v. Fresenius / Pemetrexed judgment and agrees with Novartis:

The method applied by Pharmathen Greece and Pharmathen Global also solves the problems underlying the patent and Purasorb fulfills the same function in that context as the claimed linear PLG. The second requirement of equitable protection of the patent holder has also been met. Pharmathen Greece and Pharmathen Global apply the teachings of the patent in their practices and thus realize the associated benefits. This, according to the Court of Appeal, argues in favor of bringing that method under the scope of EP 519.

The Court of Appeal also finds that there is a sufficient degree of legal certainty. The person skilled in the art will understand that the patent claims leave room for equivalents, because the teaching of the patent for the person skilled in the art is clearly broader than just the use of the claimed linear PLG and also includes the use of Purasorb.

The fact that Purasorb does not literally qualify as ‘a linear PLG’ within the meaning of EP 519 is related to the fact that no method was available at the priority date to accurately determine the degree of branching of PLGs and that PLGs were therefore classified according to the initiator used. However, at the time that Pharmathen Greece and Pharmathen Global started applying their method, the publication of [… 1] had appeared. In it [… 1] introduced a method with which the degree of branching of PLGs could be determined fairly accurately and he published data on Purasorb, among others, which make it clear that Purasorb contains a considerable proportion of linear PLG. In light of this new information and the knowledge that the advantages of the invention could be realized with Purasorb, it was sufficiently clear to the average person skilled in the art that Purasorb is an equivalent of the linear PLG claimed in EP 519 and that the method of Pharmathen Greece and Pharmathen Global therefore falls within the scope of protection of EP 519.

The Court of Appeal therefore finds that Pharmathen infringes EP 519 and confirms the judgment of the provisional relief Judge in that respect. However, the Court of Appeal does not think an additional injunction based on unlawful acts is in place:

“Novartis has not argued that Pharmathen Global is acting unlawfully in any other way than through the aforementioned facts, which amount to infringement by Pharmathen Global. There is therefore no ground for granting the claimed injunction against unlawful conduct, in addition to the claimed infringement injunction, and Novartis has no interest in this either. Given the manner in which Pharmathen Global is infringing, in particular by managing Pharmathen Greece, the requested order to instruct Pharmathen Greece to cease the infringement is an appropriate remedy in addition to the infringement injunction, albeit excluding infringements of the Greek part of EP 519 to avoid a collision with the Greek judgment.”

A copy of the decision (in Dutch) can be read here.