Rosuvastatin - Netherlands

On Nov 24, 2017, Dutch Supreme Court issued its ruling in Rosuvastatin case & affirmed most of appeal court’s arguments of finding infringement, validity & dismissed the appeals of Resolution Chemicals Limited.

           

Shionogi is the holder of the supplementary protection certificate 300125 for the product ‘Rosuvastatinum, if required in the form of a non-toxic pharmaceutically acceptable salt, in particular calcium salt’. The SPC, which is based on European patent, EP0521471 has been exclusively licensed to Astrazeneca & it markets rosuvastatin calcium under the brand name Crestor®. The SPC expires on 29 June 2017, unless the application for paediatric extension of the SPC is granted. In that case, the duration of the SPC will be extended to 29 December 2017. EP’471 claims compound rosuvastatin acid or a “non-toxic pharmaceutical salt thereof”. Resolution obtained a marketing authorization for the marketing of rosuvastatin zinc and intends to put that product on the market in the Netherlands.

On 17 April 2014, Resolution initiated proceedings against AstraZeneca in which Resolution inter alia moved that the District Court nullifies claims 1 and 2 of the Dutch part of EP’471 and the dependent claims, and further nullifies SPC 300125 to the extent that the subject matter of this SPC pertains to a compound other than rosuvastatin calcium and/or rosuvastatin sodium based on ground of added subject matter.

By virtue of a judgment dated 15 July 2015, the District Court of The Hague nullified the SPC to the extent that the protection it confers extends to products other than the non-toxic pharmaceutically acceptable salts of rosuvastatin in which the cation comprises an alkali metal ion, an alkaline earth metal ion or an ammonium anion. The District Court held that the average skilled person would read the feature “a non-toxic pharmaceutically acceptable salt thereof” mentioned in EP’471 in conjunction with the definition that the invention previously discloses in paragraph [0007] of the description (which was also in the original application), i.e. the term “a non-toxic pharmaceutically acceptable salt” refers to a salt in which the cation is an alkali metal ion, an alkaline earth metal ion, or an ammonium ion” and would take this to be a limiting definition and understand that the proprietor only wanted to confer protection for those salts for use with rosuvastatin. The District Court further held that rosuvastatin salts - other than the calcium or sodium salt - do not constitute added subject matter, while the rosuvastatin acid does. The declaratory judgment of non-infringement claimed by Resolution was awarded.

AstraZeneca initiated an appeal against the District Court’s judgment. By virtue of a ruling dated 16 February 2016, the Court of Appeal of The Hague set aside the District Court’s judgment and dismissed Resolution’s claims. The question to be answered was how the claim feature ‘or a non-toxic pharmaceutically acceptable salt thereof’ in claim 1 of EP’471 must be interpreted. AstraZeneca’s point of view was that the paragraph [0007] would only be regarded as a non-exhaustive list & should not be construed as limiting definition. While Resolution took the position that in light of paragraph [0007] of the description, this feature must be interpreted such that ‘salt’ only comprises one of the salts mentioned in paragraph [0007]. The Court of Appeal did not find Resolution’s approach as correct. Appeal court further said that although this further description must be taken into account as part of the description in interpreting the patent claim, this is without prejudice to the fact that the question regarding whether such description must be taken to be restrictive depends on the question of how the average skilled person would understand this further description, taking into account the description and his general professional knowledge on the priority date. Based on the findings, in contrast to the District Court, the Court of Appeal found that on the priority date, the average skilled person did not have valid reasons to assume that the patent proprietor only wanted protection for the salts of rosuvastatin mentioned in paragraph 7 and waived the broader protection that claim 1 offered according to its literal wording.

Court of appeal further held that in interpreting a claim in light of the description, the inventive idea underlying the words of the claim must be taken into account as a point of view. As found before, this inventive idea can be formulated as finding a new group of statins, specifically including rosuvastatin, with an HMG-CoA reductase inhibitory effect. After all, as the average skilled person knows on the priority date, the salt form in which statins are administered is irrelevant for their biological activity, because the anion of the statin is the active ingredient and the salt only serves to administer the rosuvastatin anion in tablet form. To the extent that Resolution intended to contend that according to the Protocol, the claims must be interpreted in light of the description, so that there is no room for taking the inventive idea underlying the words of the claim into account, or at least that the wording of the description must prevail, this point of view is dismissed. After all, an interpretation of the patent claims in light of the description must always start from the perspective of the average skilled person on the priority date, taking into account his general professional knowledge. This perspective is in part determined by the inventive idea.

With respect to added subject matter Resolution took the position that claim 1 of EP’471 is invalid due to breach of Section 75 (1) c ROW (added subject matter) to the extent that the claim pertains to anything other than rosuvastatin sodium or calcium salt, because the original application allegedly does not directly and unambiguously disclose rosuvastatin acid or other salt forms to the average skilled person. Appeal court held that the rosuvastatin is disclosed in the application, the average skilled person would also read – or, in other words, be reminded of – the possible choices for R4 other than sodium or calcium, i.e. the acid form and other salt forms, as well. Because this choice is not relevant for the biological activity of rosuvastatin, this does not provide any (technical) information that cannot be directly and unambiguously inferred from the original application. Position R4 determines the acid or salt form. Hydrogen (meaning the hydrogen ion that the acid form produces) and cations that can form non-toxic pharmaceutically acceptable salts with a statin are already explicitly mentioned in the original application as belonging to the group from which the parameter for the R4 position can be selected. The explicitly disclosed sodium and calcium salts from this group are examples of this – which the skilled person takes to be non-exhaustive. For this reason, the average skilled person understands that he can vary the R4 position with one of the other ions mentioned, without this having any impact on the biological activity of the explicitly disclosed rosuvastatin. Based on the above, the Court of Appeal believed that no added subject matter was involved, because claim 1 of EP 471 also extends to rosuvastatin acid as well as non-toxic pharmaceutically acceptable salts other than the sodium and calcium salt.”

Thus Supreme Court dismissing the various appeals of Resolution held that:

 ü  Complaints in cassation directed against Court of Appeal’s interpretation that definition given in paragraph 7 of the description is not a limiting definition, is incomprehensible and in breach of Article 69 EPC, do not hold.

 ü  Court also feels that the complaints directed against the Court of Appeal’s interpretation of the grounds for appeal and the finding that no added subject matter is involved are unsuccessful.

Thus, Court concludes that the appeals in cassation are dismissed.

This opinion was delivered by AG G.R.B. Van Peursem, where he said that the Supreme Court could use this case to clarify whether the waiver doctrine from Van Bentum/Kool is still valid law. This is a difficult disputed point in the patent practice (and in the case at issue, as well), which would benefit from clarity regarding this point.

“I believe that the waiver doctrine stems from the era of the abandoned protective scope doctrine of the essence and does not fit (or no longer fits) within the correct application of Article 69 EPC according to the Protocol on the interpretation of this article, as this has also been almost fully worked out in the Netherlands. Because according to prevailing Dutch patent law, the inventive idea is no longer the starting point in determining the protective scope, but is a point of view that may play a role in this, I believe that in practical terms, it is possible to arrive at a system that comes close to the waiver doctrine: in my opinion, in the scope of the point of view of the inventive idea, in conformance with Article 69 EPC, it is possible to include this when considering whether according to the average skilled person, the intention was to limit the extent of the protection. On balance, this is the method that the Court of Appeal used in the ruling that is challenged in the case at issue. This differs slightly (not radically) from the waiver doctrine as we know it, but in practice, this will rather frequently produce similar results in terms of outcome”.