Paclitaxel: when Design Examination Certificates are not enough

Our attention has been drawn to a very recent decision of the UK Intellectual Property Office (IPO) on 6 October: it's BL O/466/15 Angiotech & UBC, a decision of Hearing Officer Dr L. Cullen.

According to the IPO's summary (to which we have added some handy links and emboldened text):

Paclitaxel

EC Design Examination Certificate no. ID 60004045 0001, dated 21 January 2003, was filed in support of SPC applications, SPC/GB/14/030 for the product “Taxol®” and SPC/GB/14/031 for the product “Taxol®-eluding stent”. These SPC applications concern the use of paclitaxel (referred to by its trade mark, Taxol®) for preventing restenosis. The stent prevents restenosis by physically keeping the blood vessel open while a paclitaxel coating on the stent hinders cell division so preventing the formation of new blood tissue that would block the open blood vessel. The applicant argued that the procedure for obtaining an EC Design Examination Certificate under Directive 93/42/EEC for this device is sufficiently identical to the procedure under Directive 2001/83/EC for the approval of a medicinal product for human use and, as such, it can be used in support of an SPC application under article 3(b) of the SPC Regulation.

The Hearing Officer (HO) reviewed the SPC regulation, the relevant parts of the Medical Devices Directive (Directive 93/42/EEC) and of the Medicinal Products Directive (Directive 2001/83/EC). He took account of the purpose and the actual procedure that is being assessed under both Directives, as well as relevant guidance on both Directives. He reviewed relevant CJEU case law including the recent decision in Laboratoires Lyocentre, C-109/12 and also considered the relevance of previous IPO decisions concerning medical devices Cerus (BL O/141/14) and Leibniz (BL O/328/14). The HO concluded that the SPC Regulation does not provide for all products which have to have some form of authorisation before being placed on the market as being worthy of an SPC but only those authorised under the directives referred to in Article 2 of this Regulation, including Directive 2001/83/EC. He did not consider that the assessment criteria used to obtain an EC Design Examination Certificate under Directive 93/42/EEC is the same as that to obtain a marketing authorisation under Directive 2001/83/EC. The objectives of both of these systems are different given the differing uses of medicinal products and medical devices and the different means used to approve their use in humans. As a consequence, the SPC applications were found not to meet the requirements of the SPC Regulation and were rejected under Article 10(2) of this Regulation.

This is the third decision of the IPO since March 2014 on whether an SPC can be obtained based on the approval for a class III medical device. Of interest here is that fact that there was a significant difference between the date when the device was approved and the date when the patent was granted. This made it necessary to consider which was the relevant version of the legislation with regard to approval of medical device or approval of medicinal products: was it the version in force when the device approval was granted or the version in force when the patent was granted for a medical device?

The decision also considered the relevance of CJEU Case C-109/12 Laboratoires Lyocentre where the CJEU was asked whether the classification of a capsule as a medical device under Directive 93/42 in some Members States prevented it being classified as a medical product under Directive 2001/83 in others.

More pay-days for pharma patents, thanks to Seattle Genetics ruling

Today, in a very short judgment of just 41 paragraphs, the Court of Justice of the European Union (CJEU) confirmed the Advocate General’s Opinion in Case C-471/14 Seattle Genetics Inc, by holding that:

Article 13(1) of Regulation (EC) No 469/2009 concerning the SPC for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.

And that is to the provision is to be interpreted as meaning the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

Many thanks go to Axel Paul Ringelhann for being the first of our readers to spot the ruling.

An early press release from London-based law firm Bristows observes that the ruling will be welcomed by innovative (= patent-owning) pharmaceutical companies, explaining the decision like this:

The issue concerned the duration of supplementary patent protection afforded to the innovative pharmaceutical industry. EU legislation provides the possibility of a supplementary protection certificate (“SPC”) to compensate a patent holder for the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation (“MA”). In the EU, no medicinal product may be commercially exploited before the relevant authority has issued an MA.

However, there was confusion as to how the duration of an SPC should be calculated. EU legislation provides that the SPC is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. But what constitutes the date of the first MA? Is it the date when the decision granting the MA is adopted by the relevant authority? Or, is it the date on which the applicant is notified of the decision?

Following a preliminary reference from Austria, the CJEU has cleared all confusion: the relevant date is the date on which the decision is notified to the applicant.

Why will the decision benefit the pharmaceutical industry?

Not only has the CJEU’s ruling put an end to the uncertainty faced by both the innovative and generic pharmaceutical industries regarding the duration of effective patent protection afforded to medicinal products, the additional two to five days typically seen between grant of an MA and notification to the applicant can be of significant commercial value. This is particularly so as the market for a medicinal product will often reach its peak towards the end of the patent term. Taking this into consideration, the additional days per product, in every member state in which the product is marketed, potentially multiplied by several products is not insignificant!

Furthermore, although the SPC regime is harmonised throughout the EU, patents remain a national right and SPCs are granted by national patent offices. Following the CJEU’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation of the SPC term allowing patent holders to be certain of a uniform SPC duration throughout the EU and, similarly, allowing competing generic companies certainty as to when patent protection will expire.

There follows a quick word from Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, who was clearly quite chuffed by the decision:

“The CJEU’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJEU on this matter”.

Representing Seattle Genetics, Marie Manley (Partner and Head of Bristows' Regulatory Practice added:

“This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product. As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire”.