Accord vs. NPS; cinacalcet, District Court of The Hague 6 February 2019, Case No. ECLI:NL:RBDHA:2019:934
Introduction
Shire-NPS Pharmaceuticals Inc. (“NPS”) was the patentee of EP 1 203 761 B1 (“EP 761”) titled “Calcium receptor-active compounds” that was granted on 19 January 2005. The subject matter of EP 761 is, inter alia, the pharmaceutical compound cinacalcet, which is used for the treatment of hypercalcemia and related diseases (in essence, cinacalcet, helps the body maintaining normal calcium levels). On the basis of EP 761, a supplementary protection certificate was granted by the Dutch Patent Office to Amgen for the product Mimpara (the “SPC”) which SPC expires on 25 April 2020 (which is the date of expiry of the paediatric extension). As the reader will probably be aware of, Accord Healthcare Ltd. and its Dutch affiliate Accord Healthcare B.V. (together in singular “Accord”) are active in the field of selling and marketing generic drugs.
To clear the way for its generic cinacalcet, Accord seeks the nullification of the Dutch designation of EP 761 and – consequently – the SPC. Accord bases its nullity attack on the lack of inventive step. More in particular, Accord argues that EP 761 was obvious over three related applications filed by the patentee (being WO-A-9418959, WO-A-9304373 and WO-A-9511221).
Selection invention
Since EP 761 claims one specific compound from a broader list of known calmimetic compounds (cinacalcet), EP 761 was considered to be a selection invention. In line with EPO case law, the District Court of The Hague holds that for cinalcalcet to be inventive, it should be established that:
(i) there is a technical contribution to the prior art, which is the case in the event of an unexpected advantages, and, provided that this contribution is present, it should be considered whether
(ii) the skilled person would have made the selection in the hope of solving the underlying technical problem or in expectation of some improvement or advantage.
(i) Unexpected advantages of cinacalcet
According to Accord, the prior art discloses the same class of compounds as cinacalcet (in terms of basic structure and calcimetic activity range), and, cinacalcet does not have any unexpected advantages. NPS, on the other side, contends that the technical contribution of cinacalcet is that cinacalcet is more works better than the compounds disclosed in the prior art in terms of calcimimetic activity, toxicity and bioavailability. In this respect, NPS relies on post-published evidence.
The District Court does not accept this post-published evidence, since the claimed effects are not been described let alone being made plausible in the application. Other potential positive effects do not relate to cinacalcet only, so could not contribute to the inventive step.
(ii) Would the skilled person have made the selection?
With respect to the question of whether the skilled person would have selected cinacalcet in the expectation of finding the higher activity, the debate between the parties focuses on whether the skilled person would adopt a “try and see” attitude. Accord argues that this is the case, because routine testing is sufficient to determine which of the compounds within the general formula has a better therapeutic effect than the compound disclosed in the prior art. Moreover, the prior art explicitly invites the skilled person to test and, moreover, these tests are described in detail in the prior art. The person skilled in the art will have a reasonable expectation that carrying out these tests will lead to finding a compound that provides an improved therapeutic effect and, in performing these tests, the skilled person will inevitably (also) encounter cinacalcet.
NPS alleges that the skilled person does not know beforehand whether these tests will result in finding a calcimimetic compound with a higher efficacy than the calcimimetic compounds already known in the prior art. The District Court does not follow this defence, referencing the prior art while holding that the skilled person will have the reasonable expectation to find a molecule with a higher activity than has been found before. The Court decides that just because the skilled person is encouraged by the prior art to conduct this research to find other suitable (new) calcimimetic molecules, the skilled person will not be discouraged by the nature and scope of the that research.
Conclusion
Consequently, the District Court holds that EP 761 does not involve an inventive step and nullifies the patent. Furthermore, it declares the SPC annulled and grants Accord a cost award of EUR 200,000.
A copy of the judgment (in Dutch) can be read here.
Headnote: Jeroen Boelens, NautaDutilh
