On 29 January 2019 the Patent and Market Court of Appeal handed down a preliminary injunction ruling in Sandoz v GD Searle LLC relating to the supplementary protection certificate (SPC) for darunavir.
The ruling clarifies that SPCs enjoy a validity presumption for the purpose of a preliminary injunction ruling in the same way as patents. However, in the instant proceedings, the court found that Sandoz, against which the lower court had issued a preliminary injunction, had managed to rebut the presumption.
The court also ruled on the conditions on which an active ingredient which is covered but not specifically identified by a patent claiming a Markush formula can be considered protected by the basic patent. The court then applied the principles set out by the European Court of Justice (ECJ) in its recent Teva decision (C-121/17).
Searle held a patent claiming certain compounds defined by a Markush formula, and a SPC was granted in Sweden for darunavir based on said basic patent. It was not contentious that the active ingredient darunavir fell within the scope of protection afforded by the basic patent and the validity of the patent was not questioned. However, Sandoz objected on the grounds that the SPC should not have been granted as darunavir was not specifically mentioned by the patent and it would take an inventive effort to identify and characterise darunavir on the patent's priority date.
The Patent and Market Court of Appeal reasoned that SPCs, just like patents, are granted only after a thorough examination of the conditions for such grant in administrative proceedings. An SPC should thus enjoy a presumption of validity in preliminary injunction proceedings, such as that afforded to patents.
The Patent and Market Court of Appeal cited the ECJ's preliminary rulings in Medeva (C-322/10), Eli Lilly (C-493/12) and Teva (C-121/17) and referred to the criteria for determining whether a product is covered by a basic patent identified in Teva. The Patent and Market Court of Appeal recognised that a reference for preliminary ruling on the interpretation of Article 3(a) of the SPC Regulation(1) in relation to patent claims framed as Markush formulae was pending before the ECJ.
However, the Patent and Market Court of Appeal found that the Teva criteria are general in nature and as such can also be applied in relation to a claim using a Markush formula to define the claimed substances.
Turning to the case facts, the Patent and Market Court of Appeal explained that the basic patent described approximately 100 preferred chemical compounds. Darunavir was not expressly mentioned in the basic patent, neither by name nor by formula. One of the substituents in the claimed Markush formula could be heterocyklyloxycarbonyl. According to the Patent and Market Court of Appeal, the number of compounds which, in addition to darunavir, comprise the general heterocyklyloxycarbonyl group is huge.
The relevant SPC had been granted before the preliminary ruling in Teva and the criteria set out therein had thus not been considered in the examination before the SPC had been granted. The Patent and Market Court of Appeal held that the post-grant case law should be considered in determining whether the validity presumption for the SPC could be rebutted. Based on evidence offered by Sandoz to the effect that darunavir was developed only some years after the basic patent's priority date and that this required an inventive effort, the Patent and Market Court of Appeal held that a person skilled in the art would be unlikely to specifically identify darunavir based on all of the information in the patent and the prior art on the patent's priority date. Therefore, the court ruled that the conditions for awarding a preliminary injunction had not been met.
Notably, the courts decision was not unanimous. The minority did not consider the principles set out in Teva to have decided the issue of what should be considered protected by basic patents using claims based on Markush formulae for the purpose of granting SPCs and also questioned whether Sandoz had proven that the development of darunavir required an inventive effort.
The Patent and Market Court of Appeal's analysis means that every embodiment of the invention according to a basic patent claiming chemical compounds identified by a Markush formula cannot be considered "protected by a basic patent" in the sense of Article 3(a) of the SPC Regulation. It remains to be seen how the ECJ will rule on the matter. In the meantime, SPCs arising from patents claiming chemical compounds identified by a Markush formula will likely be harder to enforce in Sweden.
For further information on this topic please contact Björn Rundblom Andersson at Westerberg & Partners Advokatbyrå Ab by telephone (+46 8 5784 03 00) or email ([email protected]). The Westerberg & Partners Advokatbyrå Ab website can be accessed at www.westerberg.com.
Endnotes
(1) EU Regulation 469/2009 (6 May 2009) on medicinal product SPCs.
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