The recent European Court decision in Case C-130/11 Neurim Pharmaceuticals1 has caused excitement among pharmaceutical companies because of the potential to receive additional supplementary protection certificates (SPC) on second medical use patents. However, while this may increase the length of patent protection, it could also trigger the obligation to carry out paediatric studies under the Paediatric Regulation.2 The Paediatric Regulation requires such studies to be carried out for previously authorised medicinal products only if they are protected by an SPC or by a patent which qualifies for an SPC. Therefore, by extending the scope of SPC protection, the Court may also have extended the scope of the obligations under the Paediatric Regulation. This advisory highlights the need for a coordinated approach when considering applying for SPCs for “old” active substances.
Case C-130/11 Neurim Pharmaceuticals
The SPC Regulation3 provides that an SPC shall be granted if four criteria are met: (1) the product is protected by a basic patent in force; (2) a valid authorisation to place the product on the market as a medicinal product has been granted; (3) the product has not already been the subject of a certificate; and (4) the authorisation is the first authorisation to place the product (active ingredient) on the market as a medicinal product.
Neurim considered the last criterion. Neurim had obtained a patent for the use of melatonin in the treatment of insomnia, and obtained a marketing authorisation for its use to treat sleep disorders in humans. However, melatonin had been previously authorised as the active ingredient in two medicinal products for veterinary use.
Until recently, it was generally believed that the applicant for an SPC had to refer to the earliest authorisation of the active ingredient in the EU, even if the earlier authorisation related to a different use in a different species. Therefore, although the prior uses of melatonin were unrelated to insomnia in humans, the UK Intellectual Property Office refused to grant an SPC. Neurim challenged this refusal, and the case was ultimately referred by the Court of Appeal to the Court of Justice of the European Union.
The European Court agreed with Neurim, and construed the criterion as being limited to the first authorisation for a medicinal product authorised for a therapeutic use protected by the patent. Therefore, where a patent is limited to certain uses of an active ingredient, the relevant marketing authorisation is the first to cover those uses, which is not necessarily the first to cover that active ingredient itself (or other uses).
As a result, it is now possible for patents for a second medical use of an active substance to be eligible for an SPC. This has led many companies to re-evaluate their patent portfolios and consider filing additional SPC applications.
The Paediatric Regulation
The Paediatric Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population by ensuring that appropriate studies are carried out. This is primarily done through the agreement of a Paediatric Investigation Plan (PIP) with the European Medicines Agency.
The Paediatric Regulation requires any application for authorisation of a new medicinal product to include the results of all studies in compliance with an agreed PIP (unless a deferral or a waiver has been granted). The same obligation applies to applications for new indications for authorised medicinal products, but only for products that are protected by an SPC or by a patent that qualifies for an SPC.
The cost and time required to agree a PIP and conduct the studies within it can be significant, as the PIP must cover all existing and new indications and formulations. Although a 6 month extension of the SPC may be available as a “reward”, companies with existing medicinal products need to consider carefully whether any PIP could be completed in time, and if so, whether the reward will justify the investment.
In light of the European Court’s decision in Neurim, patent groups in many pharmaceutical companies are applying for SPCs where it was previously thought not to be possible on the basis “what is there to lose?” The answer to the apparently rhetorical question is that making such applications could trigger obligations to carry out expensive paediatric studies if the company wants to seek approval for new therapeutic indications for the product.
Timing may be critical. SPC applications must be filed within six months of the later of the grant of the patent or the grant of the regulatory authorisation. However, similarly strict timing does not apply to national patent offices that consider SPC applications (not to mention any subsequent appeal or reference to the European Court), meaning that the applications may still be pending when the next regulatory filing is made. Therefore, even if the SPC application is ultimately rejected, in the meantime the company may have been prevented from filing for new regulatory approvals without carrying out paediatric studies.
The limitations of the Court’s decision in Neurim have not yet been tested, but the interpretation of “first authorisation” certainly opens the door for companies to apply for an SPC on novel grounds. However, such applications should not be made without careful consideration with internal regulatory groups, to ensure that the potential additional protection of the SPC is balanced against the potential cost of paediatric development or delayed grant of new therapeutic indications.