BL number
O/410/16
Concerning rights in
SPC/GB09/046
Hearing Officer
Dr J Houlihan
Decision date
26 August 2016
Person(s) or Company(s) involved
Abraxis BioScience LLC
Provisions discussed
Articles 1(b) and Article 3(d) of Council Regulation (EC) 469/2009 concerning the creation of a supplementary protection certificate for medicinal products
Keywords
Supplementary Protection Certificates
Related Decisions
None

Summary

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).

Full decision O/410/16 PDF document218Kb

 
 
 
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