Nab paclitaxel - the UKIPO decision

Not a direction to steal some drug, but rather the full name of the active in this UKIPO decision, considering inter alia the requirements of Article 3d.

The UKIPO's summary is below and the link to the case here: 

The product for which a Supplementary Protection Certificate (SPC) was sought is defined in the application as “paclitaxel formulated as albumin bound nanoparticles” - referred to as “nab paclitaxel”. Article 3(d) requires that the supporting marketing authorization is the first authorization for the product in the EU. Article 1(b) defines a product as “the active ingredient or combination of active ingredients of a medicinal product”. The examiner considered that paclitaxel, a well-known anti-cancer drug, was the sole active ingredient in the product and therefore the application did not comply with Article 3(d) as it had been previously received marketing authorisations in the EU.

The hearing officer considered that the application was in line with the purpose of the Regulation and had circumstantial and consequential parallels with the SPC held to be valid by the Court of Appeal in Re. Generics UK Ltd v Daiichi Pharmaceutical Co Ltd; Daiichi Sankyo Co Ltd EWCA Civ 646 [2009].

The applicant submitted that nab-paclitaxel represented a new single active ingredient. The hearing officer accepted a range of clinical and in vitro evidence showing that nab-paclitaxel is more effective and safer than paclitaxel, for example in treating breast tumours and in treating non-small cell lung cancer and pancreatic cancer in combination with other drugs. He also accepted that nab-paclitaxel is transported across cell membranes and remains intact inside tumour cells. However, he considered on the basis of the evidence before him that albumin did not play an active role in killing tumour cells but that it functioned as a carrier, which is regarded as a conventional function of albumin. He held that nab-paclitaxel was not a new single active ingredient but a combination of two ingredients and that the albumin component of nab-paclitaxel did not have a therapeutic effect on its own. Consequently, he held that nab-paclitaxel did not qualify as a combination of active ingredients, having regard to the ruling of the Court of Justice of the European Union (CJEU) in Massachusetts Institute of Technology (C-431/04). Several other authorities relating to this subject are also referred to in the decision.

The applicant contended that nab-paclitaxel was a new application of paclitaxel and therefore should be granted an SPC in light of the CJEU ruling in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (C-130/11). The hearing officer interpreted the judgment in Re. Neurim as requiring that the new application of a product should be limited to a new therapeutic application and held that nab-paclitaxel did not represent a new therapeutic application of paclitaxel. The application was refused as the hearing officer held it did not comply with Article 3(d) of the SPC Regulation having regard to the definition of a product pursuant to Article 1(b). 

C572/15 (Xeloda) - SPC term calculation and EU accession

The facts in this case (link here ) are as follows.

Roche markets a medicinal product called "Xeloda" in Estonia.  The active substance is capecitabine.  Roche has a basic patent granted on 15 April 1998.  Xeloda was registered for the first time in Estonia on 8 June 2001 and was granted an SPC by the Estonian Patent Office.  

Accord obtained an Estonian marketing authorisation (MA) for a generic version of the product. Roche brought an action before the Estonian district court seeking an injunction against Accord to prevent infringement of their rights until SPC expiry, which Roche calculated to be 8 June 2016.   

Accord considered that the SPC was not valid because the first MA for Xeloda had been  granted in Switzerland in 1998, so they said the maximum 15 years of protection actually expired in 2013. 

Roche countered that the SPC duration should be 15 years from the date of the Estonian MA.  They argued that, as the SPC was issued at a time when Estonia was not a member of the European Union, then only Estonian law applied, according to which the duration of validity of the SPC depended not on the grant of the first MA in the European Union, but the grant of that authorisation in Estonia.

The Estonian Supreme Court then referred the following questions to the ECJ:

"(1) Must Article 21(2) of Regulation No 469/2009 … be interpreted as shortening the duration of [an SPC] issued in a Member State which was issued under national law before the accession of the State in question to the European Union and whose duration in relation to an active substance, as stated in the [SPC], would be longer than 15 years from the time when the first [MA] in the Union was granted for a medicinal product consisting of the active substance or containing it?

(2) If the answer to the first question is in the affirmative, is Article 21(2) of Regulation No 469/2009 … compatible with European Union law, in particular the general principles of European Union law on the protection of acquired rights, the principle of the prohibition of retroactive effect of law, and the Charter …?"

The CJEU held that, for the purpose of calculating the duration of the SPC, the relevant marketing authorisation was to be that first granted in the EU or, in the EEA, even though this was granted before Estonian accession.  

This was not considered to be a retrospective application of EU rules because an SPC took effect only at expiry of the patent, which was after the date of accession. 

The court also ruled that it had no jurisdiction to rule on the validity of Article 21(2) of the SPC Regulation.

The CJEU conclusion was as follows:

1.      The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community.

2.      Article 21(2) of Regulation No 469/2009, as amended, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union. To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate.