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NL – Sandoz / Teva v. Bristol-Myers Squibb – Opinion AG

05 Feb 2025

Sandoz B.V. v. Bristol-Myers Squibb Holdings Ireland Unlimited Company and Teva B.V., Teva Nederland B.V. & Pharmachemie B.V. v. Bristol-Myers Squibb Holdings Ireland Unlimited Company, Opinion of Advocate-General Van Peursem, Supreme Court of The Netherlands, Case no. ECLI:NL:PHR:2024:1407

Inventive step – Interpretation G 2/21 – Validity Transfer Priority Rights

These two summary proceedings concern patent EP 415 of the pharmaceutical group BMS regarding the active ingredient apixaban. Apixaban is the active substance in a medicine marketed by BMS under the name Eliquis® and is used as a blood thinner for the treatment of thromboembolic disorders. BMS is seeking an injunction against the generic companies Sandoz and Teva. The generics defend themselves, among other arguments, by invoking the invalidity of EP 415.

This case mainly revolves around inventive step and, in that context, how decision G 2/21 of the Enlarged Board of Appeal should be interpreted. The case also concerns whether or not priority rights were transferred correctly, in which G 1/22 and G 2/22 play a leading role.

The interim relief judge rejected BMS’s claim. The Court of Appeal provisionally ruled that EP 415 meets the inventive step requirement taking into account what was decided in G 2/21 and the generics’ attack was provisionally rejected. In addition, it provisionally ruled that BMS can rely on the priority right of US 165.

The generics lodged an appeal in cassation with the Supreme Court. A-G Van Peursem concludes that the appeal in cassation should be dismissed and follows the Court of Appeal’s interpretation.

Inventive step, interpretation of G 1/22

5.26

“A preliminary comment on these complaints is that insofar as they essentially argue that there is a lack of inventive step because no evidence (such as concrete test results) is included in the application, this demonstrates the use of an incorrect standard. As the court of appeal considers in para. 6.8 – unchallenged in cassation – the test of G 2/21 does not mean that it is always required that evidence is already included in the application that the alleged technical effect actually occurs. It depends on the specific circumstances of the case, as the court of appeal rightly infers from G 2/21 in paragraph 6.14, what is required for the skilled person to be able to infer from the application that the alleged effect is ecompassed by the ‘technical teaching’ of that application. In some cases, this may require that test results or a scientific doctrine be disclosed in the application. From paragraph 6.15-6.19, as discussed above, it follows that the court of appeal ruled here that, given the common general knowledge of the skilled person and taking into account what G 2/21 has clarified, this is not required in the specific circumstances of this case. In the preliminary opinion of the court of appeal in these summary proceedings, it is sufficient if the skilled person, armed with his common general knowledge, can deduce from the application that apixaban is a promising candidate to achieve the alleged inhibition effect – and according to the court of appeal, the skilled person will deduce from this that apixaban is even the most promising Xa inhibitor (despite the fact that the application consists of 438 pages with a large series of compounds, as the complaint of the generics in section 3 states).” [Emphasis: A-G]

Transfer of priority right

5.63

“This complaint cannot succeed. BMS has primarily defended itself with the argument that the beneficial ownership of the priority right is sufficient to be allowed to exercise the priority right. If that were not the case, that beneficial ownership would have been transferred on demand (and that can be done without formal requirements under the law of the state of Delaware) into a transfer of also the legal ownership, and that happened implicitly (without formal requirements) here by invoking the priority right by BMS Company. The court of appeal addressed the question at what point the priority right of BMS Pharma was transferred to BMS Company by considering in paragraph 6.44 that the implicit ‘appropriation’ of (also) the legal ownership of the priority rights is provisionally considered to be in accordance with the agreements made between BMS Pharma and BMS Company, namely that Company would file the new patent applications. The court of appeal considers it sufficiently likely for the time being that both the economic and legal ownership of the priority right of BMS Pharma to BMS Company was transferred prior to the application WO 652. The position of Teva et al. has thus been rejected and the defence of BMS on this point has been honored. [Emphasis: A-G]

5.64

“This preliminary judgment on the validity of the transfer seems to me to be in line with the G1/22 and G2/22 ruling that a low bar applies to the assessment of the validity of the transfer of priority rights and that informal or tacit transfers must be accepted under almost all circumstances (see 5.56 above). The judgment is in line with that of the Swedish and French judges in proceedings on the merit on this matter, as the Court of Appeal shows by citing the English translation of those substantive judgments in paragraphs 6.46 and 6.47, about which the court of appeal considers in paragraph 6.45 that the parties in those foreign cases have largely put forward the same arguments on both sides based on the same expert statements as in the present proceedings. Moreover, this concerns an intra-group transfer and agreements made in the context of the takeover of DuPont, whereby it must be borne in mind that the rationale of priority rights is to facilitate the filing of patent applications in international situations. The tenor of the G1/22 and G2/22 judgments seems to imply that such a transfer of priority rights should be viewed (very) favourably and that an opponent can only succeed in overturning the presumption of validity of the priority right in rare, exceptional circumstances. Although specific facts have been put forward by Teva et al. (only later transferred in writing to Company), given the context of takeover agreements and intra-group relationships outlined, in my opinion they do not raise serious doubts about the validity of BMS’ claim to formal priority, given the defence of BMS – if the beneficial ownership of Company would not suffice. In my view, the court of appeal’s reasoning is certainly not inadequate here (these are summary proceedings), also given the substantiated reference to the corresponding judgments of two foreign substantive courts on this matter. The complaint fails on that ground.” [Emphasis: A-G]

A copy of the opinion can be read here.