post-medeva
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20 June 2014BiotechnologyJaap Mannaerts

The post-Medeva SPC saga: what about biologicals?

In a long series of judgments and orders, starting with the Medeva case, the Court of Justice of the European Union (CJEU) has given guidance on the exact requirements for the grant of supplementary protection certificates (SPCs) for medicinal products in the EU. It seems that the matter is finally settling after last December’s judgments in the Actavis, Georgetown II and Eli Lilly cases, in a manner that appears generally acceptable, but that may not be the case when it comes to biologicals.

Background

With the Medeva (C-322/10) judgment, the CJEU caused turmoil by ruling that an active pharmaceutical substance could be considered protected by a basic patent only if it was ‘identified in the wording of the claims’. The case arose out of a situation where a patent had been obtained for certain antigens that had been developed into a vaccine containing additional antigens.

The Medeva judgment also contained a conspicuous obiter dictum on Article 3(c) of the SPC Regulation (EC 469/2009), to the effect that just one SPC could be granted per patent, which seemed contrary to national practices throughout the EU. In the Actavis (C-443/12) as well as in the Georgetown II (C-484/12) judgments, the CJEU shed further light on the latter issue and effectively required that a further certificate could be granted for a further product only if it was also protected as such by the basic patent.

In the Actavis case, the CJEU did not specifically answer the question concerning interpretation of the Medeva test. In the Eli Lilly (C-493/12) case that was pending at the same time, the CJEU did consider this matter again, although it may still not have provided the further clarification sought after. The CJEU ruled that, for a product to be considered protected by the basic patent, it must be possible to reach the conclusion that the claims of the basic patent relate at least implicitly, but necessarily and specifically, to the active ingredient in question.

This might be interpreted as an indication that the Medeva principles had to be seen in the specific context of the combination product issues, although some commentators have suggested that the CJEU really intended to depart from the principle laid down in Medeva altogether.

Resulting situation

Whatever the case may be, it seems fair to conclude that last year’s judgments suggest an overall approach by the CJEU largely in line with Mr. Justice Arnold’s suggestions in the referring decision in the Actavis case, as well as with the decision by the Hague Court of Appeal in the ‘equivalent’ case in the Netherlands. Such an approach would come down to the principle that one SPC would be available per patented invention.

For this purpose, what is decisive is not necessarily the literal disclosure in the claim but a finding that the drug substance is part of the inventive advance for which the patent in suit has been granted. Thus, a company inventing a drug substance can get an SPC based on the first marketing authorisation (MA) for a medicinal product containing that drug substance, regardless of whether it is the sole active ingredient or part of a combination.

Under this approach it would not matter whether the actual substance was disclosed in the claims literally or ‘merely’ belonged to the group of substances (defined using, eg, a Markush structure) for which the patent was granted. Furthermore, if a certain combination containing that drug substance proves to constitute a further patentable invention per se (and only then) a further SPC might be available.

Such an approach would seem to fit in with the overall scheme and objectives of the SPC Regulation. Furthermore, it is an approach that complements normal patent practice, rather than one that changes it. This approach, in particular, would belie the idea that eligibility for an SPC could be dependent on the way the basic patent is drafted and prosecuted, rather than on its substance.

What about biologicals?

Although this approach would seem to work quite well for virtually any known ‘small molecule’ case, this author is aware of more than a few examples of biological drug substances where it is still very questionable whether the result would be fair. One common characteristic of these examples is that the biological drug substance was not the result of just a single invention by a single company or institution, as is usually the case with the classical small molecule drug substances, but of several ‘partial inventions’ that were all individually patented, often by different companies and/or institutions.

"The consequence is that significant pharmaceutical research essential to the development of new biological drug substances will often prove to be ineligible for supplementary protection."

Typically in such cases, most of the ‘early’ patents would not be suitable basic patents as the claims did not (and could not) identify the biological drug substance eventually developed in any degree of specificity or ‘relate to it, at least implicitly, but necessarily and specifically’. As the Dutch IPO has often put it in cases like these: if further inventions are needed for the skilled person to be able to produce the actual drug substance, the respective patent can not be a suitable basic patent.

With the CJEU judgments on the issue in mind, it may have become difficult to contend that this approach would be very far off the mark. The consequence however is that significant pharmaceutical research essential to the development of new biological drug substances will often prove to be ineligible for supplementary protection. This result, in many such cases, will be difficult to reconcile with the objectives of the SPC Regulation. The situation probably illustrates that the SPC Regulation was drafted by the legislator and interpreted by the CJEU based primarily on conceptions derived from ‘classical’ drug development.

As there is no indication that it really was intended to exclude such ‘partial inventions’ in more complex situations, such as those arising in the biotechnology field, and in view of the constant emphasis on purposive interpretation and application of the SPC Regulation, it would seem unavoidable that (further) attempts are going to be made in the future to find an acceptable resolution for this apparent deficit.

With the criterion of infringement having been ruled out definitively, however, straightforward and workable solutions are hard to envisage. In any case, as it should be, this will become the battle of those involved in SPC practice and not of those involved in the drafting and prosecution of the relevant patents.

Jaap Mannaerts is a European patent attorney and partner at NLO. He can be contacted at: Mannaerts@nlo.nl