http://ipkitten.blogspot.com/2020/10/hague-court-of-appeal-sets-dutch.html
Hot off the press is a decision by the Hague Court of Appeal (CoA) of 27 October 2020 handing Eli Lilly another win in its pan-European battle over infringement of its pemetrexed patents [here, in Dutch].
Eli Lilly’s patent enforcement campaign has resulted in numerous decisions, including landmark rulings on the doctrine of equivalents in the UK and Germany. The ruling by the Hague CoA contributes to this bounty of legal fodder on the doctrine of equivalence in two important ways.
First, it reverses the District Court’s 2019 decision which, in rejecting Eli Lilly’s claims, constituted an outlier among European decisions in this dispute [here]. Second, the CoA laid down the Dutch approach to the doctrine of equivalents, synthesizing prior decisions and bringing it in line with approaches taken elsewhere in Europe. To this Kat’s knowledge, this is the first time that the CoA has so explicitly set out a principled application of the doctrine of equivalents.
The CoA’s formulation of the equivalence test
The crux of the pemetrexed cases is that Eli Lilly’s patent claims a combination of vitamin B12 (claim 1) and B12 with a folic binding protein binding agent (claim 2) together with a specifically specified salt: pemetrexed disodium. The question is whether generic companies can avoid infringement of these claims by using a different salt (in the case of Fresenius, the Dutch defendant: tromethamine).
The CoA began its analysis by citing Article 69 of the European Patent Convention and its Protocol. Section 1 of the Protocol stipulates that in the interpretation of a patent, a position must be taken that “combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties”. Section 2 adds that “due account shall be taken of any element which is equivalent to an element specified in the claims.”
In applying these principles, the CoA performed a two-step test: in the first step, the question is whether the accused product conforms to all features of the claim. If not, the second step inquires whether differing features are nevertheless equivalent to the claim features. According to the CoA [at 4.4], this is currently the “leading” approach in most European jurisdictions. Dutch courts, however, had previously also taken a one-step approach whereby account is taken of equivalents in the initial interpretation of the claim. While not explicitly disapproving the one-step approach, the CoA’s application of the two-step approach and its emphasis on its conformity with the law of other EPO states suggest that going forward, the two-step approach will become the standard also in the Netherlands.
The CoA laid down four principles for application of the second step:
- The differing feature must be technically equivalent to the claimed feature. This is the case if “the product or process with the differing feature also solves the problem that the patent solves, and the differing feature performs the same function as the claimed feature in this context” [at 4.7].
- From the point of view of fair protection for the patent proprietor, it must be appropriate to take into account equivalents when determining the patent’s scope of protection. This means that the invention must be disclosed such that “it is apparent to the skilled person that the invention can also be performed with elements that differ from the feature of the patent claim” [at 4.8]. The CoA noted that “the degree of novelty” brought by the patented invention is relevant here, “because a high degree of novelty can inhibit the applicant’s possibilities to adequately foresee and describe all embodiments” [at 4.9].
- Next, protection by way of equivalence must not be at odds with the reasonable degree of legal certainty due to third parties. This requirement will be satisfied where “the skilled person understands that the patent claims leave room for equivalents, because the teaching of the patent is clearly broader than the wording of those claims and the skilled person sees no good grounds to limit the scope of protection to the feature listed in the claims” [at 4.10].
- Lastly, in appropriate cases it must be examined whether the allegedly infringing product is novel and inventive in relation to the prior art. In light of the Gillette principle, it would not be justified to grant the patent holder protection against products that are not novel or inventive over the prior art (an issue that was also touched upon by Arnold LJ in FibroGen v. Akebia, Katpost here).
The CoA first found that Fresenius did not “literally” infringe Eli Lilly’s patent, i.e. under the first step in the CoA’s approach. “Literal” is perhaps somewhat misleading as the scope of protection under the first step is not limited to the literal text of the claims, but to the claims as interpreted under Article 69 EPC and the first – though not second – section of the Protocol. Because Eli Lilly had itself argued that the skilled person would understand that pemetrexed disodium differs from the salt used by Fresenius, it was clear that the patent claims could not be “literally” infringed.
However, the CoA considered Fresenius’ product equivalent to the claimed composition and applied the four principles set out above as follows.
As to the first principle, the CoA held that the salt used by Fresenius was technically equivalent to pemetrexed disodium. Although each salt has different specific properties that may be more or less advantageous in the treatment of specific cancers, the function of the salt in the composition was the same in both cases: neutralisation of pemetrexed-anions to make the product suitable for storage and sale. Because the salt in Fresenius’ product performs this particular function in the same manner, it was considered technically equivalent to pemetrexed disodium.
As to the second principle, the CoA held that the skilled person reading the patent would understand that the claimed invention could also be performed using a different salt. In fact, the patent would encourage the skilled person to search for alternative salt forms. The CoA dismissed Fresenius’ objection that the skilled person would not have found the formulation with tromethamine because Fresenius was granted a patent on its formulation: the CoA held that a follow-up product may well contain a further feature that is inventive, but still apply the teaching of the patent. That was the case here, and in these circumstances it would be unfair to deny the patentee protection for this application of their invention.
As to the third principle, the CoA held that the skilled person would not see grounds to assume that the protection sought by the patentee was specifically limited to pemetrexed disodium. Having already established that the patent itself, in combination with the common general knowledge, would provide no grounds for assuming this limitation, the CoA focused on the prosecution history of the patent. The limitation to pemetrexed disodium was introduced during prosecution and because the District Court could find no compelling reasons for introducing it, the District Court had considered it a conscious limitation of the claims to, specifically, pemetrexed disodium.
The CoA disagreed: the limitation was introduced to overcome an objection on the basis of Art. 123(2) EPC (added matter), which cannot limit the patent’s scope of protection (otherwise it would add matter). According to the CoA, the fact that including equivalents in the patent document during prosecution is prohibited on the basis of Art. 123(2) EPC does not preclude claiming protection for those same equivalents under Art. 69 EPC [at 4.45]. This is because (i) including equivalents in the patent itself would arguably extend the scope of protection to “equivalents of equivalents”; and (ii) including equivalents in the patent may help confer novelty or inventive step on the patent, which the original application may have lacked.
The CoA also dismissed Fresenius’ reference to “circumstantial” evidence of a conscious limitation, which the District Court had found persuasive. Thus, the fact that Eli Lilly did not oppose the examiner’s request to introduce the limitation or that it is a “pharmaceutical giant” with thorough expertise of patent prosecution did not mean that third parties could reasonably assume the limitation to pemetrexed disodium signaled a waiver of protection for other salts that could be equivalent.
Lastly, as to the fourth principle, Fresenius had not contested that its product was novel and inventive over the prior art (they had a patent after all), so that this principle provided no basis for rejection of Eli Lilly’s claims.
The CoA thus concluded that Fresenius infringed the patent. It subsequently upheld the patent in an elaborate inventive step analysis, noting that its conclusion on validity diverged from the findings of the German Federal Patent Court, but that on the basis of the submissions before it, the CoA could not subscribe to the view of its German colleagues.
And so, yet another win for Eli Lilly was secured. In addition to setting the standard for equivalence in Dutch law, the decision provides a prime example of judicial dialogue. The CoA refers to other European decisions and explains its diverging views where possible: the outcome is a further step towards a harmonized European approach to equivalence – with our without a Unified Patent Court…
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