‘Darunavir’ CJEU referral withdrawn - Article 3(a) of the SPC Regulation

At the end of September, we reported here on the publication of AG Hogan’s Opinion on the joint referrals from the German Bundespatentgericht (case C-650/17) for Merck’s sitagliptin product and from the English Court of Appeal for Searle’s darunavir product (case C-114/18).

Following the AG Opinion, it is understood that the darunavir reference has been withdrawn, and so the case will no longer be passed to the CJEU for a final ruling. The sitagliptin referral remains pending before the CJEU.

Background

Both the sitagliptin and darunavir referrals sought clarification of the SPC requirements under Article 3(a) of the SPC Regulation, specifically that an SPC may be granted if the authorised active ingredient or combination of active ingredients is “protected” by a patent.

With regards to the darunavir case, the UK High Court and Court of Appeal agreed that darunavir was in fact specified in the basic patent in line with Article 3(a), despite only being represented by a general Markush formula. Both Courts were unsure whether a correct interpretation of Article 3(a) had been applied, and so the referral to the CJEU made.

In his Opinion, AG Hogan considered that Article 3(a) should be interpreted based on the two-part test from Teva v Gilead (C-121/17), i.e. that i) 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, and ii) the skilled person would have been able to derive the product in question on the basis of the prior art at the filing/priority date and in light of all the information in the patent in question.

The next stage was a final ruling from the CJEU.

Referral Withdrawn

If the darunavir referral has been withdrawn, the CJEU will not need to give a final ruling on Searle’s SPC eligibility in this case.

The withdrawal of this reference may not alter the impact of the CJEU decision that follows AG Hogan’s Opinion. If the CJEU wishes to follow the Advocate General, it is unlikely that it would do so in a way that expressly adopts his reasoning for the functional claims of the Royalty patent whilst also excluding the application of the Teva test to Markush claims. Therefore, even without a decision on the facts of the darunavir referral, the CJEU ruling in the sitagliptin case should give some degree of guidance as to how patentees with Markush claims can argue SPC eligibility.

Comments

Although we will not get a final decision on this case, the sitagliptin referral is still pending and so we should get guidance from the CJEU on the interpretation Article 3(a) and whether the Teva two-part test really is the key. Notwithstanding the withdrawal, the CJEU could well still confirm the universal applicability of the Teva test across all types of patent claims and protected subject matter.