Opinion leaves open questions on SPCs in pharma patent claims

The opinion concerns EU laws on SPCs and the criteria pharmaceutical patent holders must meet to benefit from an SPC.

SPCs serve to extend the life of a patent by up to a maximum of five years with respect to products which are authorised under the relevant regulatory framework in the field of medicinal and plant products. SPCs are granted under EU regulations which are directly applicable across the whole of the EU, although they have to be applied for separately in each EU country.

The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy approval process. Patent protection lasts 20 years but it often takes drugs companies around a decade to develop new medicines and gain marketing authorisation.

Under the SPC Regulation, SPCs can only be granted if, in the EU country in which the application is submitted, the product is protected by a basic patent in force and a valid authorisation to place the product on the market as a medicinal product has been granted. The product must not already have been the subject of an SPC and the authorisation must be the first to place the product on the market in the EU.

The requirements of the SPC Regulation in respect of products composed of several active ingredients were further clarified in EU case law in 2018 after the High Court in London asked the Court of Justice of the EU (CJEU) to clarify what criteria need to be satisfied for an SPC to be said to cover a product that is 'protected' by a basic patent, under the terms of the legislation.

The CJEU ruled in July last year that, in accordance with previous CJEU case law, the combination of active ingredients do not need to be expressly mentioned in the claims of the basic patent if those claims relate necessarily and specifically to that combination.

However, it clarified that the combination of the active ingredients must, first, necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent. Secondly each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

This two-part test must be applied through the eyes of a "person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent", the EU court said.

In two new cases being considered by the CJEU, including one referred by the Court of Appeal in London, the EU court has been asked to clarify whether the two-part test applies only to cases where pharmaceutical products are composed of several active ingredients, or if the test applies to products involving a single active ingredient and in other circumstances too.

Advocate general (AG) Gerard Hogan issued an opinion on these cases on Wednesday. Hogan's views are non-binding but the CJEU often follows elements of the opinions adopted by its advocate generals when it comes to issue formal judgments.

According to AG Hogan, the two-part test should apply, and must be satisfied, in every circumstance where an active ingredient in an SPC is not expressly mentioned in the claims of the basic patent. This includes where just one active ingredient is involved, he said.

The two-part test is technologically neutral, AG Hogan said, and so it also applies in cases where the patent claims describe the product using the function it performs or use Markush formulae, which enable large classes of chemically similar compounds to be claimed in patents, without the need to specify each compound.

In a bid to "elucidate" the two-part test in these circumstances, AG Hogan said that the requirement that the product must 'necessarily' fall under the invention would be satisfied if "the product to which the claims of the basic patent relate is a ‘specification’ required for the solution of the technical problem disclosed by that patent".

He further said that the requirement that the product must be 'specifically identifiable' in light of all the information disclosed by the basic patent does not require an express mention of the product. However, he added that this requirement will not be met "where in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question”.

AG Hogan said his attempt to elucidate the test should not be read as an "attempt to graft further conditions onto the two-part test", and confirmed that it is for national courts to apply the two-part test when considering challenges lodged against the validity of SPCs.

The advocate general further dismissed claims that an active ingredient needs to embody the "core inventive advance" of the underlying patent in order to be said to be 'protected' by the basic patent, and therefore eligible for an SPC.

Krishna Kakkaiyadi of Pinsent Masons, the law firm behind Out-Law, said AG Hogan's opinion leaves more issues unsettled for the national courts to resolve.

"Although the advocate general has rejected the applicability of the 'core inventive advance' test to determine if a product is protected by a basic patent in force, in his view, this requirement would be met if the product 'to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent'," Kakkaiyadi said. "Arguably, this test is not overly different to what might be construed as the 'core inventive advance' of the basic patent. Therefore, it appears left to applicants to work out how best to specify or characterise potential future medicinal products in their patents and for national courts and patent offices to assess whether such products 'fall under the invention' of the patent when considering SPCs."

"In addition, there is no further guidance in this opinion on the issue of how specifically an active ingredient needs to be identified in the patent to comply with the two-part test. It will be another issue for national courts to determine on a case-by-case basis whether active ingredients are 'specifically identifiable', having regard to all the individual facts and circumstances of the dispute before them," he said.

The case referred to the CJEU by the Court of Appeal in London concerned a medicinal product covered by a Markush formula in the patent. "It is noteworthy that the advocate general said that he cannot accept that every Markush formula would constitute an express mention of the active ingredients of a pharmaceutical product without further examination because of the millions of compounds that can be covered in a Markush formula," Kakkaiyadi said.