Advocate General (AG) Jääskinen has given his opinion on the preliminary ruling from the Court of Appeal (United Kingdom) in Case C-539/13 regarding the Specific Mechanism and the obligations of the involved holder or beneficiary of a patent or supplementary protection certificate ('SPC') and importers. The view of the AG is that it is clear from the wording of the Specific Mechanism, that the right to prevent the importation of products covered by that mechanism is not automatic and is dependent on the right holder exercising an option to restrict the parallel importation or marketing of the pharmaceutical product at issue. Therefore, the Specific Mechanism is inapplicable unless the patent owner demonstrates his intention to exercise the option to object to parallel imports falling within its remit within one month after the notification. If he fails to do so, the protected products may be lawfully imported without his consent from the new Member State to the old Member State. However, the AG makes clear that the patent owner is only precluded from relying upon his rights with regard to any import that occurred prior to the demonstration of his intention to rely upon his rights.
If followed by the Court of Justice of the European Union (CJEU), this opinion would clarify the obligations of the relevant parties under the Specific Mechanism and bring this issue closer in line with the decisions concerning the parallel import of medicinal products within the European Union (EU) and trade mark law obligations. In particular, with regard to the latter, the CJEUassumes that adequate functioning of the notice system presupposes that the relevant parties make sincere efforts to respect each other's legitimate interests. Similarly, in Germany, the Federal High Court of Justice assumes that there is a relationship of statutory law between the trade mark owner and the parallel importer which is subject to the principle of good faith. Therefore, behaviour which violates the principle of good faith by acting with significant delay and failing to offer adequate answers prevents the violating party from asserting claims based on its trade mark rights.
The relevant appendices of the Acts of Accession for some Eastern European States introduced a mandatory notification scheme through the Specific Mechanism. With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, and Bulgaria, Romania, and Croatia, the holder or beneficiary of a patent or SPC for a medicinal product filed in a Member State at a time when such protection could not be obtained in one of the above-mentioned new Member States for that product, may rely on the rights granted by that patent or SPC in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection, even if the product was put on the market in that new Member State for the first time by him or with his consent. Therefore, the Specific Mechanism provides an exemption from the principle of exhaustion which prevents a trade mark proprietor as well as a patent holder from relying on the exclusive rights conferred by the trade mark or patent where goods have been placed on the market within the EU by the patent holder with his consent.
Any person intending to import or market a medicinal product covered by the Specific Mechanism, in a Member State where the product enjoys patent or supplementary protection, must demonstrate to the competent authorities in the application regarding that import, that one month's prior notification has been given to the holder or beneficiary of such protection. According to the European Medicines Agency, parallel importers are required to specify the Member States of Origin and of Destination of the medicinal product they intend to parallel-import and to specify whether the Specific Mechanism applies to the concerned notification when submitting an initial notification, an annual update or notification of a change. Parallel importers are also requested to confirm that the patent holder or beneficiary has been given one month's advance notice in their application when the Specific Mechanism applies, by attaching a copy of the prior letter to the notification. However, the legal responsibility for enforcing intellectual property rights will remain with the patent holder.
The AG's Opinion
The AG answered the preliminary questions referred, as follows:
Questions 1, 2a and 2b
May the holder, or his beneficiary, of a patent or SPC rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so? How must that intention be demonstrated? Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?
The AG affirmed the first question, that the patent protection provided for by the Specific Mechanism is broader than that supplied under EU trade mark law. In trade mark law, the trade mark proprietor may oppose parallel import of goods put on the market in the Union by him or with his consent, only "where there exist legitimate reasons … especially where the condition of the goods is changed or impaired after they have been put on the market", particularly through repackaging. By contrast, the Specific Mechanism does not impose any obligation on a patent owner to justify a refusal to permit the importation of products falling within the scope of that mechanism. However, this does not mean that a patent owner could never have an obligation, supported by the fundamental principle of free movement of goods, to take due account of the legitimate interests of a potential parallel importer. The potential parallel importer under the Specific Mechanism has a legitimate interest protected by EU law to know, in clear terms, his own legal position vis-à-vis the patent owner. Therefore, the entitlement of the latter to invoke and rely upon the rights provided for in the Specific Mechanism must be construed as being conditional on the patent owner having reacted to the notification received and having informed the notice provider that he opposes the proposed importation and marketing of the pharmaceutical product in issue. The patent owner needs to respond promptly and, in turn, respect the legitimate interests and expectations of the potential importer to receive a reply to the notice, with a view to being able to take informed investment decisions. As a consequence, in the absence of a response within the one month time-limit from the patent owner, a potential importer who has complied with the obligation to notify is permitted to commence importing.
Any failure to respond to a notification only prevents the seeking of redress with respect to importation in the form of damages, or other remedies, for the period before the importer was informed of the patent owner's intention to rely on his patent rights. The patent owner may, within the limits of good faith, withdraw his acquiescence to parallel imports, but only with regard to the periods after the importer was duly informed.
Questions 3a and 3b
The referring court inquires as to whether notification of the intention to import pharmaceutical products provided for in the second paragraph of the Specific Mechanism may only be given by the person actually intending to import the products concerned. If the answer to the question is in the negative, the court seeks guidance regarding the category of persons that may provide such notification.
In distinction to the trade mark law rules, the AG states that it is important for the patent owner, that the potential infringer, namely the person intending to import and place the pharmaceutical product on the market, is identified in the prior notification because unlike trade mark owners, in situations falling within the scope of the Specific Mechanism, the patent owners are not required to tolerate any parallel imports to which they object. However, precisely who provides the notification is irrelevant.
By its fourth question, the referring court sought additional guidance as to the addressee of the notification provided for in the second paragraph of the Specific Mechanism. It asks which persons are covered by the term "beneficiary", and particularly whether a "beneficiary" of a patent or SPC encompasses only persons who have a legal right under national law to bring proceedings to enforce that patent or SPC, or whether it includes the marketing authorisation holder of the pharmaceutical product concerned, when that market authorisation holder forms part of the same group of companies as the actual holder (or beneficiary) of the patent or SPC. The referring court further enquired as to whether or not a marketing authorisation holder, although not a beneficiary, can be a valid recipient of the notification for other reasons.
Unlike the notifying entity, the person(s) to whom prior notification shall be given is clearly identified by the second paragraph of the Specific Mechanism as "the holder or beneficiary of such [patent or SPC] protection". According to the AG, with regard to other linguistic versions of the Specific Mechanism, a "beneficiary" is a person who derives enforceable legal rights from the holder. Therefore, the AG states that the prior notification laid down in the Specific Mechanism must be made to the holder of the patent or the SPC, or to a person who, in accordance with national law, may enforce these rights because the very purpose of the notification is to enable the patent owner to rely on his patent rights. The AG does not consider this to be an unreasonably difficult requirement because the identities are easily available on public patent registers.