UK court looks for more help from ECJ

In a judgment that echoed with resentment over the opacity of several recent Court of Justice of the European Union (ECJ) decisions in the area of supplementary protection certificate (SPC) law, the Hon Mr Justice Arnold of the UK High Court has decided to refer two questions back to the ECJ, saying in effect “try again"! (Actavis Group PTC EHF v Sanofi Pharma Bristol-Myers Squibb SNC.)

The first question asks what the ECJ meant when it recently held that for an SPC to cover a medicinal product, the active ingredient(s) of that medicinal product must be specified (or identified) in the wording of the claims of the supporting patent. This is one of the questions that experts have recently been batting around, without success, in search of an answer that accommodates both SPC law and common sense.

The second question is in response to recent opinions and judgments in which the ECJ has made comments suggesting that you can get only one SPC based on any single patent. These comments have taken everyone by surprise (the widespread practice was that you could obtain SPCs for different products all based on the same patent), so the judge has asked the ECJ to confirm if there really is a “one SPC per patent” rule.

Sanofi was granted a European Patent (0454511) with claims covering an anti-hypertensive drug known as irbesartan. Sanofi obtained a first SPC for irbesartan (marketed as Aprovel) based on this patent and a first set of European marketing authorisations, and then subsequently obtained a second SPC (the “combination SPC”) for a fixed dose of irbesartan and hydrochlorothiazide (HCT) (marketed as CoAprovel) based on the same patent and on a second set of marketing authorisations.

The claimants (collectively, “Actavis”) intended to market generic versions of Aprovel and CoAprovel, the latter of which would have infringed the combination SPC if valid. Actavis contended that this combination SPC is invalid under Articles 3(a) and 3(c) of the SPC Regulation.

How specifically must an active ingredient be identified in a claim?
Article 3(a) states that an SPC may be granted if the product for which SPC protection is sought is protected by a basic patent in force. In its recent Medeva and Georgetown judgments, the ECJ ruled that Article 3(a) must be interpreted as precluding the grant of an SPC relating to active ingredients which are not “specified in the wording of the claims of the basic patent”. In Daiichi and Queensland, the ECJ repeated this interpretation but substituted “identified” for “specified”.

However, the UK judge considered the meaning of “specified (or identified) in the wording of the claims” to be unclear, and noted that the ECJ has failed to provide a clear test despite numerous references being made to the court.

In the present case, claim 20 of the basic patent recited “A pharmaceutical composition containing a compound according to any one of claims 1 to 7 [which includes irbesartan] in association with a diuretic”. The judge accepted Sanofi’s argument that the skilled person would know from his or her common general knowledge that HCT is one of the most commonly used diuretics for the treatment of hypertension and would therefore think of combining irbesartan and HCT. However, he also accepted Actavis’s counter-arguments that neither claim 20 nor the specification as a whole mentions HCT; many other diuretics fall within the scope of claim 20; claim 20 is not limited to diuretics for the treatment of hypertension; and claim 20 is not inventive over and above claims 1 to 7.

The lack of consensus on the application of the ECJ’s “specified (or identified) test” is highlighted by divergent decisions in parallel cases in France, Germany and the Netherlands.

On this point, the judge therefore referred the following question to the ECJ: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation?”

Taking an unusual step (although apparently one meant with the best of intentions in the hope of helping the ECJ to provide a clear answer this time), the judge offered a solution to this vexing problem, noting that the court had failed to do so the last time it was asked. In this respect, he said that the test might be that “it is necessary, but not sufficient, that the marketing of the product by someone other than the proprietor (or licensee) of the basic patent would infringe the basic patent” (as held, implicitly, in Medeva). Secondly, he said that it was necessary that “the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent”. In addition, “where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent”. 

The judge considered this test to be consistent with the object of the regulation to encourage invention by compensating inventors for the delay in exploiting their inventions due to the need to obtain regulatory approval.

Can you get more than one SPC per patent?
Article 3(c) of the SPC Regulation requires that the product has not already been the subject of an SPC. The judge summarised the advocate general’s opinion in Medeva as being that:

only one SPC could be granted for the active ingredient or combination of active ingredients covered by the basic patent, however many medicinal products, including combinations with other active ingredients, the patented active ingredient or combination of active ingredients might become part of."

The UK Court of Appeal has held that although the Medeva judgment does not explicitly repeat this viewpoint, the judgment’s conclusions are consistent with the advocate general’s view. The judge also speculated that the advocate general may not have considered the case where a patent discloses and claims two distinct inventions, each of which subsequently embodies different medicinal products.

The Dutch Patent Office has interpreted Medeva as prohibiting the grant of more than one SPC per patent, regardless of the number of products claimed in the basic patent, whereas the UK IP Office has adopted the opposite view of accepting one SPC per product per patent.

In the light of these divergent views, the judge proposed a second question to the ECJ (which has previously been referred to the ECJ by the Dutch courts in Georgetown University v Occtrooicentrum Nederland):

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 judge noted that if the ECJ follows his proposed test for Article 3(a), then Article 3(c) should be interpreted as allowing two SPCs to be granted for a patent which discloses and claims two inventively distinct active ingredients (or combinations of active ingredients).

The innovative pharmaceutical industry will surely be hoping for confirmation from the ECJ that multiple SPCs can be obtained based on a single patent, whereas generics companies will seek the opposite result. However, in light of the ECJ’s recent history of dealing with Article 3(a) referrals by way of reasoned order, a major question is whether the ECJ will agree to give a complete answer to the judge's questions.

The correct test under Article 3(a) is also of significant interest to the industry. Interestingly, the proposed test requires inventive step to be considered when examining SPCs, which the national patent offices are not expected to like. While it has long been tricky to forecast what the ECJ will decide in SPC cases, it would be surprising if the test proposed by the UK judge survives as the ultimate outcome of this case.

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