Further Developments Of The Law Relating to SPCs

The Medeva reference –the final act

One of the CJEU decisions reported previously concerned the Medeva reference to the CJEU by the UK Court of Appeal. The case concerned the granting of an SPC directed to a combination of active ingredients based on a patent that explicitly disclosed only one of those active ingredients. The CJEU decided that an SPC may not be granted “relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”.

In light of this, the UK Court of Appeal subsequently resumed the original proceedings in order to arrive at a final verdict. Given that the CJEU’s decision was based on the facts of this Medeva case, it was predicted that the UK Court of Appeal proceedings would be relatively straight-forward.

Nevertheless, Medeva attempted to convince the UK Court of Appeal that they should be granted their SPC despite the CJEU’s decision. Their arguments were based on the uncertainty raised by the CJEU’s decision reported in the Spring/Summer 2012 issue of Inside IP, in particular what does “specified in the wording of the claims” actually mean?

Ultimately, the UK Court of Appeal dealt with the issue quickly, stating in its decision: “The ambit of “specified” may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in light of the facts of the cases in which the issue arises.”

However, the UK Court of Appeal decided that in the present case the products to which the SPCs in question relate clearly fall on the wrong side of the dividing line.

The SPC application was therefore refused. However, the Court confirmed the widely held view that the CJEU’s decision did not provide complete clarity to the situation and further references to the CJEU were perhaps inevitable.

The inevitable further referral

As it happens, we did not have to wait very long at all before further questions were referred to the CJEU in an attempt to clarify under what conditions an SPC may be granted based on a product containing a combination of active ingredients. Both the UK and Dutch courts have announced their intention to do just that. In the UK, the referral has arisen in the context of a High Court case involving Actavis v Sanofi.

Sanofi are the owners of EP(UK) Patent No. 0 454 511 claiming both irbesartan (an angiotensin II receptor blocker useful for treating hypertension) and a combination of irbesartan and a diuretic. Sanofi was granted a first SPC for the single product irbesartan (Aprovel®) which has now expired and also a second SPC for a combination of irbesartan and hydrochloridethiazide sold as CoAprovel® which is set to expire 14 October 2013. Hydrochloridethiazide (HCT) is not specifically mentioned anywhere in the patent but is a well known diuretic. Actavis challenged the validity of Sanofi’s second SPC for the combination product alleging (1) that the patent did not specify/identify a combination of irbesartan and HCT; and (2) that only one SPC is allowed per patent.

The UK judge (Mr. Justice Arnold) agreed that the criteria for granting an SPC directed to combination products were unclear and decided to refer two questions to the CJEU.

The first question to be referred is:
“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation?”

This is essentially asking for clarification regarding how the phrase “specified/identified in the wording of the claims” should be interpreted. In the opinion of Arnold J the CJEU “did not answer question 1 in the previous five references and the rulings it did make do not provide a clear test which can be applied to cases such as the present”. A number of conflicting decisions arising from national courts in France, Germany and the Netherlands are cited as evidence that this is the case. Interestingly, Arnold J offers a suggested answer to his own question “(i)n the hope that it will assist the Court of Justice to provide a clear answer this time”. He suggests that an SPC may be based on a product if it “contains an active ingredient, or combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent”. Only time will tell if the CJEU welcomes or adopts this suggestion. In the meantime, it is certain to cause further debate.

The second question to be referred is provisionally worded in the same manner as a related question referred to the CJEU by the Dutch Court:
“Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?”

The precise wording of the questions may be challenged by either party before being finalised. At the time of writing, the wording of the questions had not been confirmed.

SPCs for second medical uses

In July, a decision by the CJEU again brought into focus the significant role played by SPCs in the pharmaceutical industry. The decision derives from Case C-130/11 Neurim Pharmaceuticals relating to the protection of second/further medical uses of known active ingredients.
Until this decision, it was thought that SPC protection for second or further medical uses of known active ingredients was not allowed. However, it was often argued that this appeared to be contrary to the fundamental objectives of the SPC Regulation, namely to “ensure sufficient protection to encourage pharmaceutical research” by compensating innovators accordingly.

The opportunity to challenge this long held perception arose from a dispute in the UK involving an application by Neurim Pharmaceuticals for an SPC relating to melatonin (a naturally occurring hormone). Neurim discovered that appropriate formulations of melatonin could be used for treating insomnia (in humans). Neurim subsequently obtained a patent directed to such use and in 2007 the European Commission issued Neurim with a market authorisation enabling it to market that formulation (Circadin®). Based on the patent and the market authorisation, Neurim applied for an SPC at the UK Intellectual Property Office. However, melatonin had previously been the subject of an earlier market authorisation: for use in controlling the reproduction of sheep. The rules concerning the granting of an SPC require that an SPC may only be granted based on a first marketing authorisation. The question therefore arose: does the earlier marketing authorisation relating to reproduction in sheep prevent the granting to Neurim of an SPC based on the later marketing authorisation for treating insomnia in humans?

Neurim’s application was refused and the UK High Court agreed with the decision to refuse it. However, the UK Court of Appeal, bearing in mind the objectives of the SPC Regulation, seriously questioned the value of such a decision, stating:

 “if Neurim are wrong, then the [SPC] Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose.”

The UK Court of Appeal therefore submitted the case to the CJEU for clarification of the law.

In what was good news for innovators, in particular those involved in the search for new uses of known active ingredients, the CJEU decided that Neurim should be allowed an SPC based on their discovery of a new use (treating insomnia in humans) for melatonin. The existence of an earlier marketing authorisation relating to the use of melatonin for regulating sheep reproduction did not prohibit the granting of this later SPC application. In more general terms, the decision stated:

 “…the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC…”

The SPC would of course provide a monopoly covering, not the active ingredient, but only the new use of that product.

Although this decision will clearly have a liberalising effect on the granting of SPCs, some issues do remain. For example, before the decision many commentators raised concerns that such a decision would lead to an inevitable increase in “ever-greening” practices; e.g. the decision now potentially permits the same proprietor to obtain multiple SPCs for the same active ingredient. How effective such practices would be given the precise wording of the judgment and whether they would be allowed remain to be seen. To what extent the “new” therapeutic use must be different from the therapeutic use referred to in the first marketing authorisation is also unclear. Further case law will probably be required in order to clarify these issues.

Summary

The series of decisions handed down by the CJEU in late 2011 was expected to end a long period of speculation concerning in what circumstances SPCs directed to combination products may be granted. Although the required conditions are now a little clearer, complete clarity has not yet been achieved. It is hoped that the recent referrals announced by the UK and Dutch courts will help. At the same time, the Neurim decision concerning SPC protection for further/second medical uses appears to extend the possible circumstances in which SPC protection is available. We wait for future developments with interest.