As most readers will be well aware, one of the hottest topics in the patent world is the broadening of the Bolar provision envisaged in the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, proposed by the European Commission (the “Proposal”).
According to the Proposal, the new Bolar provision would read as follows:
“Exemption to the protection of intellectual property rights
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 […] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
(a) studies, trials and other activities conducted to generate data for an application, for:
(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
(ii) health technology assessment as defined in Regulation (EU) 2021/2282;
(iii) pricing and reimbursement.
(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
This exception shall not cover the placing on the market of the medicinal products resulting from such activities.“
As readers will have noticed, the proposed text would result in a significant broadening of the scope of the Bolar provision. As the last sentence of the draft illustrates, among the wide array of rights conferred by a patent (the right to prevent manufacture, use, offering for sale, sale, import…), the only one that appears to remain in relatively safe territory is the right to prevent acts of selling.
In the Explanatory Memorandum, the European Commission offers the following justification for the broadening of the Bolar provision:
“The ‘Bolar exemption’ (under which studies can be carried out for subsequent regulatory approval of generics and biosimilars during the patent or supplementary protection certificate protection of the reference medicinal product), will be broadened in scope and its harmonised application in all Member States ensured. In addition, procedures for the authorisation of generics and biosimilars will be simplified: as a general rule, risk management plans will no longer be required for generic and biosimilar medicinal products, considering that the reference medicinal product already has such a plan. The interchangeability of biosimilars with their reference medicinal products is also better recognised based on accumulated scientific experience with such medicinal products. In addition, the act provides an incentive for repurposing off-patent, added value medicinal products. This supports innovation, resulting in a new therapeutic indication that offers significant clinical benefit in comparison with existing therapies. Taken together, these measures will facilitate earlier market entry of generics and biosimilars, thus increasing competition and contributing to the objectives of promoting affordability of medicinal products and patient access.“
Reading the Proposal, it is hard to believe that it comes from the same source as the 1997 complaint filed by the European Communities and their Member States before the World Trade Organization (“WTO”) against Canada for having approved a Bolar provision that, according to the complainants, was in breach of, inter alia, articles 28 and 30 of the TRIPS Agreement.
The so-called “Regulatory Review Exception” introduced by Canada had a narrower scope than the Bolar provision now proposed by the European Commission:
“Section 55.2(1) provides as follows:
It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.”
The Canadian law also introduced a “Stockpiling Exception” that read as follows:
“Section 55.2(2) of the Patent Act, which is referred to as “the stockpiling exception”, reads as follows:
It is not an infringement of a patent for any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) to make, construct or use the invention, during the applicable period provided for by the regulations, for the manufacture and storage of articles intended for sale after the date on which the term of the patent expires.”
The complaint led the WTO to establish a panel (a quasi-judicial body composed of three members) to resolve the case. In par. 4.4 of its report of 17 March 2000, the WTO panel summarized the arguments of the complaint as follows:
“4.4 The European Communities and their member States argued that Section 55.2(1) of the Canadian Patent Act allowed all activities related to the development and submission of information required to obtain marketing approval for pharmaceutical products carried out by a third party without the consent of the patent holder at any time during the patent term, notwithstanding the exclusive rights stipulated in Article 28.1 of the TRIPS Agreement. These activities were completely unlimited in quantity and extent and included the acts of offering for sale and selling, at least insofar as any manufacturer of the patented product or process could invoke this right, if only the final purchaser of the product had the intention to use the product for “[…] uses reasonably related to the development and submission of information required under the law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.
Therefore, Section 55.2(1) of the Canadian Patent Act had to be considered to be incompatible with the provisions of Article 28.1(a) and (b) of the TRIPS Agreement.”
Canada, in its statements of defence, denied these allegations and alleged, in short, that article 30 of the TRIPS Agreements allows limited exceptions to patent rights such as those set forth in its Patent Act.
In relation to the “Stockpiling Exception”, the European Communities and their Member States alleged, among other arguments, that this exception was contrary to articles 28 and 30 of the TRIPS Agreement because it resulted in substantial curtailment of the exclusionary rights that must be granted to patent owners under Article 28.1 of the TRIPS Agreement. The panel agreed and found the “Stockpiling Exception” to be contrary to articles 28.1 and 30 of the TRIPS Agreement.
Moving to the “Regulatory Review Exception”, the following paragraphs of the panel’s report are of particular interest:
“7.44. In the previous part of this Report dealing with the stockpiling exception of Section 2(2), the Panel concluded that the words “limited exception” express a requirement that the exception make only a narrow curtailment of the legal rights which Article 28.1 requires to be granted to patent owners, and that the measure of that curtailment was the extent to which the affected legal rights themselves had been impaired. As was made clear by our conclusions regarding the stockpiling exception, the Panel could not accept Canada’s contention that an exception can be regarded as “limited” just so long as it preserves the patent owner’s exclusive right to sell to the ultimate consumer during the patent term.
7.45. In the Panel’s view, however, Canada’s regulatory review exception is a “limited exception” within the meaning of TRIPS Article 30. It is “limited” because of the narrow scope of its curtailment of Article 1 rights. As long as the exception is confined to conduct needed to comply with the requirements of the regulatory approval process, the extent of the acts unauthorized by the right holder that are permitted by it will be small and narrowly bounded. Even though regulatory approval processes may require substantial amounts of test production to demonstrate reliable manufacturing, the patent owner’s rights themselves are not impaired any further by the size of such production runs, as long as they are solely for regulatory purposes and no commercial use is made of resulting final products.”
As readers will have noted, the “Regulatory Review Exception” was found to be in accordance with articles 28 and 30 of the TRIPS Agreement “[a]s long as the exception is confined to conduct needed to comply with the requirements of the regulatory approval process“.
The question, then: is the new Bolar provision proposed by the European Commission confined to conduct needed to comply with the requirements of the regulatory approval process? Even its authors know the answer.
All in all, in view of the clear tension between some of the aspects, of the broadened Bolar provision proposed by the European Commission, such as acts relating to price and reimbursement, with articles 28 and 30 of the TRIPS Agreement there is a possibility that the European Commission and its Member States may end up swallowing their own TRIPS medicine.
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