As part of our regular updates on SPC developments in Europe, we discuss the recent Abraxis decision handed down by the Court of Justice of the European Union (CJEU) in C-443/17. A discussion on further recent SPC developments is also found below.
Abraxis in light of Neurim
On 21 March 2019 the CJEU handed down its judgement on C-443/17 (Abraxis Bioscience LLC v Comptroller General of Patents). The decision was somewhat expected to provide clarity on the extent that the earlier “Neurim” decision applies (C-130/11).
Amongst the regulatory requirements for obtaining an SPC for a medicinal product, Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (SPC Regulation) requires that the product must have obtained a valid authorisation to place the product on the market. Article 3(d) of the regulation requires that this market authorisation must be the first market authorisation obtained for that product.
The Neurim decision relates to the marketing of a melatonin medicine. The question at hand was whether a market authorisation of the active ingredient for use in controlling reproduction in sheep would preclude the grant an SPC based on a market authorisation of the same active ingredient for use in treating insomnia in humans. In other words, should the later market authorisation for use in humans be considered the “first” market authorisation despite the existence of an earlier market authorisation for use in sheep?
In the CJEU’s judgement, the CJEU agreed with the patentee that the market authorisation for use in humans should be considered the first market authorisation (noting that a new therapeutic application of a product should enable a patent proprietor to obtain an SPC). This news was well received by pharmaceutical patent holders as it provided the opportunity to obtain “second medical use” SPCs, i.e. SPCs for products that had previously received market authorisation if they obtained further market authorisation for a “new use”. However, the judgement was not without criticism and has led to divergent implementation across European national patent offices (mainly based on potential inconsistencies with earlier CJEU decisions and/or what constituted a “new use” in the later market authorisation)
For a full discussion of the Neurim decision please refer to Tim Russell’s article: https://www.vennershipley.co.uk/resources/news/2012/12/07/further-developments-of-the-law-relating-to-spcs
In light of much wanted/needed clarification, enter the Abraxis judgement:
Abraxis applied for an SPC for its medicine Abraxane (a combination of nanoparticles of paclitaxel and albumin) based on European patent no. 0 961 612. Whilst paclitaxel itself had been previously marketed (based on earlier market authorisations), Abraxis obtained the first market authorisation for the new formulation of paclitaxel: Abraxane.
The question referred to the CJEU by the UK High Court was whether an SPC should be granted based on a first market authorisation within the scope of the basic patent if the product is a new formulation of an old active ingredient.
In the judgement, the CJEU first discussed Article 1(b) of the regulation, i.e. what is the “product” in question. It was noted that the product must be an “active ingredient or combination of active ingredients of a medicinal product”. The CJEU therefore stated that the combination of paclitaxel and albumin was not a distinct product to previous paclitaxel products as albumin acts as a carrier and has no therapeutic effect itself. As such, Abraxane was considered a new formulation of an old active ingredient (rather than a new product providing improved efficacy). It should be noted that whether the carrier (albumin) does or does not provide a therapeutic effect by itself needed to be verified by the UK High Court.
The CJEU then considered whether nevertheless Article 3(d) of the regulation should be interpreted such that a first market authorisation for a new formulation of an old active ingredient should result in an SPC. The answer to this was no – a market authorisation for a new formulation should not be considered the first market authorisation if the active ingredient has already been the subject of a market authorisation as an active ingredient (regardless of whether it was the first market authorisation within the scope of the basic patent being relied upon by the SPC application in question). This narrow interpretation therefore provides some clarity regarding the requirement to have a “first” market authorisation – market authorisations for new formulations of “old” active ingredients do not count.
Whilst the Abraxis decision may provide some clarity, we note that the CJEU did not directly address all issues arising from the Neurim decision in the judgement but instead opted to distance the facts of the present case from that decision. Specifically, the CJEU stated that the Neurim decision does not relate to new formulations as in the Abraxis case (it relates instead to different therapeutic uses in sheep and humans). However, the CJEU did not go so far as to limit the teaching of Neurim to the facts of that case (which will come as a relief to pharmaceutical companies/patent proprietors).
It therefore seems that in the CJEU’s opinion the Neurim decision represents an exception to the narrow interpretation of Article 3(d) of the regulation but how narrowly the Neurim decision should be applied is still not entirely clear.
Article 3(d) of the regulation
As noted in my update of November 2018, the Abraxis referral is not the only referral attempting to clarify aspects of the Neurim decision and the scope of Article 3(d) of the regulation. Click the following link for discussion of a referral (C-673/18) from the Court of Appeal of Paris dealing with a similar issue.
In summary, the Court of Appeal of Paris has asked two questions of the CJEU which were formulated to receive clear guidelines on how the Neurim decision should be applied, i.e. how different must the “use” of the second market authorisation be to the first market authorisation such that the second market authorisation can be considered as the “first” for the purposes of Article 3(d) of the regulation. Whilst the Neurim decision suggests that a different therapeutic use in humans and animals use is a sufficient difference, the Abraxis decision clarifies that a new formulation of an old active ingredient is not a sufficient difference in use.
We await the CJEU’s decision in this regard eagerly and will report back in due course.
Article 3(c) of the regulation
On a related note, a Swedish Court has recently referred to the CJEU a question relating to the allowance of second-medical use SPCs. However, the referral in this case relates to the interpretation of Article 3(c) of the regulation which requires that a product has not already been the subject of SPC.
Essentially, the question referred is whether an SPC may be granted for a product used in a new therapeutic indication (based on a basic patent that protects that use specifically) if the applicant already has been granted an SPC for the same product used in a different therapeutic indication (being based on a basic patent that protects the product per se).
The Neurim decision (and in part the Abraxis decision) imply that a new use of an old active ingredient should be protectable by an SPC (in the context of Article 3(d) of the regulation). However, the facts of the present referral differ from those of the Neurim and Abraxis decisions in that the SPC in question is based on a new use (not a new formulation) and that the owner holds an earlier SPC for the same active ingredient.
The decision should clarify whether an earlier SPC for an active ingredient would preclude the grant of an SPC for the same active ingredient for a different use if both the earlier SPC and the SPC being applied for are owned by the same party.
We will of course report on any developments on these cases as and when they occur.
Third Party SPCs: Lilly vs Genentech
The High Court of England and Wales has recently referred to the CJEU a question relating to the common practice of filing third party SPCs (where an SPC is filed by a company other than the company that owns the market authorisation). Whilst this situation is usually because the company that filed the SPC and the company that filed for market authorisation are legally linked, currently it is unclear if there is a requirement for such a legal relationship. As such, SPCs have been filed by and granted to “third parties” relying on market authorisations granted to competitors.
In Lilly vs Genentech (where the High Court was asked to declare that Genentech’s SPC would be invalid due to lack of said legal relationship), Lilly contends that the SPC Regulation was designed to compensate research organisations for the delay caused by going through the regulatory process to obtain a marketing authorisation. As such, Lilly argues that an SPC should not be granted to a party that has not suffered this delay and resultant loss of monopoly time in which to market a product.
Genentech argues that third party SPCs are commonly granted at national offices and that there is simply no requirement in the SPC regulation that would require a relationship between the SPC filer and the market authorisation holder.
Whilst Mr Justice Arnold notes that previous CJEU decisions and commentaries support Lilly’s interpretation of the law, the situation is not clear and as such has referred the following question the CJEU:
“Does the SPC Regulation preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?”
We look forward to the CJEU’s clarification of this issue and we will of course report back when we hear more.
Swiss Paediatric extensions
Whilst paediatric extensions of SPCs are commonplace across European Union countries, Switzerland (a member of the European Economic Area but not the European Union) has only recently (as of 1 January 2019) amended its legislation to allow for such extensions.
Paediatric extensions of SPCs allow SPC holders to extend the duration of an SPC by six months to encourage pharmaceutical companies to bring drugs to market in what can be less profitable therapeutic areas.