Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products.
The decision concerns interpretation of EU Regulation 469/2009, which created a supplementary protection certificate (SPC) scheme to tackle a lack of protection for new products which was perceived to be penalising pharmaceutical R&D. SPCs are granted to cover the period that elapses between the filing for a patent for a new medicine and and its marketing authorisation.
"The fundamental objective of Regulation 469/2009 is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health," the EU justices noted, in their initial ruling given yesterday.
The case involves Medeva BV, which holds a European patent concerning the preparation of vaccine against whooping cough and sought to use it with other active ingredients to produce a multi-disease vaccine for children. The firm filed five SPC applications with the UK Patent Office, primarily seeking supplementary protection for vaccines covering diphtheria, tetanus, whooping cough, poliomyelitis and meningitis. The Office refused to grant the SPCs, stating that in four of the applications more active ingredients were specified than in the wording of the claims of the basic patent, and that the fifth related to medicinal products containing nine active ingredients, not all of which were specified in the SPC application and in the patent claims.
Medeva’s appeal against this decision was turned down by the UK High Court, but the firm then turned the Court of Appeal, which asked the CJEU for guidance.
Delivering their ruling yesterday, the European justices stated that an SPC can only be granted for the active ingredients specified in the claims of the basic patent and that only one SPC can be given per patent.
The EU rules must be interpreted as precluding EU patent authorities "from granting an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application," said the CJEU.
The justices also ruled that patent authorities may grant an SPC for a product which combines two active ingredients covered by the basic patent plus other active ingredients.
Commenting to Pharma Times, the Association of the British Pharmaceutical Industry (ABPI) said the ruling will mean "greater patent protection for medicines developed by the pharmaceutical industry, which in turn will encourage the research and development of new treatments for unmet clinical need. Specifically, companies involved in the development and sale of products that contain multiple active ingredients, we trust will benefit from the ruling," said a spokesman.
The ABPI is consulting on certain aspects of ruling, including those dealing with the number of SPCs per patent. "The details of this in the ruling are currently unclear and we will be following developments closely," the spokesman added.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) told Pharma Times that the Court's interpretation of the rules "takes us back to the original intent of the SPC scheme - to stimulate innovation. The much narrower interpretation by the UK disregarded the fact that components that are patented, such as one part of a combination vaccine, should be protected also when used in combination."
A leading intellectual property expert said that while the Court's decisions give life sciences companies welcome clarification that it is legitimate to have SPCs for combination products and multiple active ingredients, they also give “an unequivocally stark reminder that there can be only one SPC for each relevant patent."
This "cuts direct across current patent office and industry practice across Europe," and its consequence will potentially be an increase in litigation in national courts seeking to cancel existing multiple SPCs, warns Jonathan Radcliffe, partner in the intellectual property group at Mayer Brown LP in London.
In the longer term, these cases will have a significant effect on how companies craft their patent life cycle strategies, says Mr Radcliffe. "We can expect to see much attention being given at the granular level to how patents are written to maximise the types of SPC that may subsequently follow, to the choice that has to be made between keeping or abandoning active ingredients or combinations for SPCs, and to how marketing authorisations can be best deployed to boost the position," he forecasts.