BREAKING: CJEU delivers another blow to SPC owners in Abraxis Article 3(d) (or 1(b)) battle

This is getting old!  Come on CJEU, give us a decision
which leads to a valid SPC....

The AmeriKat is whiskers deep in papers at the moment, but she took a few minutes just now to have a look at this morning's latest SPC decision from the Court of Justice of the European Union in C-443/17 Abraxis v Comptroller General of Patents, which was subject to a referral made by Mr Justice Arnold on 16 March 2017 (see previous IPKat posts here).  The issue concerned Article 3(d) and of Regulation (EC) No 469/2009 (the SPC Regulation).

First, a quick SPC recap:

• By law, before a medicinal product can be placed on the market, it requires a marketing authorization (MA). 
• Getting a medicinal product to this point cant take upwards to 15 years. By the time a MA for a medicinal product is granted, much of the term of the patent that protects the product will have expired. This means that the effective protection under the patent is insufficient to cover the investment in R&D (see Article 4 of the SPC Regulation).
• For this reason, a new right - the Supplementary Protection Certificate (SPC) - was introduced by the SPC Regulation in order to address that problem. 
• SPCs provide an additional period of protection - up to a maximum of 5 years - for a product (i) subject to a valid MA at the date of the application (Article 3(b)) and protected by a patent (basic patent) in force at the date of the application (Article 3(a)).  The product cannot already be the subejct of an SPC (Article 3(c)) and the MA referred to at Article 32(b) has to be the first authorization to place the product on the market as a medicinal product.  

The provision at issue in this case was Article 3(d).   The UKIPO had refused to grant an SPC for paclitaxel formulated as albumin-bound nanoparticles (nab-paclitaxel, marketed as ABRAXANE®) on the basis that it did not meet the requirements of Article 3(d).  The point at issue being whether paclitaxel (already subject to an MA) was a different product to nab-paclitaxel (subject to a separate MA).  Abraxis said they were, as there was an important therapeutic differences between the two and thus subject to two different MAs, the latter being the "first MA" (thus complying with Article 3(d)).

Mr Justice Arnold considered there was inconsistency in the CJEU judgments as between Neurim and Pharmacia or Yissum.  He thus referred the following question:

"Is Art 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Art 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”"

The answer that came back from the CJEU this morning was "No":

"Article 3(d) 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, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient."

Where did it go wrong?  Well, in a reference about Article 3(d), it is really all about Article 1(b).  In the CJEU's words:

"30 Those considerations [in C-210/13 GSK] apply equally to a substance which, such as the albumin in the main proceedings, acts as a carrier of the active ingredient, according to the indications listed in the request for a preliminary ruling referred to in paragraph 21 of the present judgment. Since such a carrier does not have any therapeutic effects of its own – this being a matter which must, however, be verified by the referring court –, it cannot be regarded as being an active ingredient within the meaning of Article 1(b) of Regulation No 469/2009 even if it allows the active ingredient with which it is associated to exercise its therapeutic effect more effectively. Therefore, even the alliance of such a carrier with another substance which does have therapeutic effects of its own cannot give rise to a combination of active ingredients within the meaning of that provision.

31 It follows from the foregoing that Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a new formulation of an old active ingredient, which, such as nab-paclitaxel, consists of that active ingredient and a carrier which has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy.

32 In the second place, it is appropriate to determine whether an MA granted for a new formulation of an old active ingredient, such as nab-paclitaxel, may be regarded as being the first MA granted for that product as a medicinal product within the meaning of Article 3(d) of Regulation No 469/2009, in the case where that MA is the first MA to come within the scope of protection of the basic patent concerned.

33 In that regard, it must be pointed out that, according to that provision, one of the conditions to which the grant of an SPC is made subject is that, in the Member State in which the SPC application is submitted and at the date of that application, the MA obtained in respect of the product which was the subject of that application must be the first MA for that product as a medicinal product.

34 As the Advocate General noted, in essence, in point 30 of his Opinion, in the light of the definition of the scope of ‘product’, as is clear from the Court’s settled case-law, a literal interpretation of Article 3(d) of Regulation No 469/2009 presupposes that the first MA for the product as a medicinal product within the meaning of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue.

35 According to such an interpretation, only the authorisation in respect of the first medicinal product placed on the market, consisting of the product concerned, may be regarded as the first MA within the meaning of Article 3(d) of Regulation No 469/2009, as defined in Article 1(b) of that regulation (see, to that effect, judgment of 24 November 2011, Medeva, C‑322/10, EU:C:2011:773, paragraph 40).

36 It should be added that, with regard to the objective of Regulation No 469/2009, it is clear from the wording of recitals 3 to 5 and 9 thereof, as the Advocate General observed in point 50 of his Opinion, that the SPC regime has the purpose of compensating for the lack of protection conferred by a patent with respect to covering the investment put into research concerning new medicinal products and, therefore, of encouraging that research. However, it follows from recital 10 of that regulation that the legislature intended to achieve that objective so as to take into account all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector.

37 That finding, which supports a narrow interpretation of Article 3(d) of Regulation No 469/2009, is confirmed by the Explanatory Memorandum of 11 April 1990 to the Proposal for a Regulation, referred to in paragraph 26 of the present judgment, the effect of which is, as the Advocate General observed in points 52 to 55, 66 and 69 of his Opinion, that the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.

38 Such an objective would be jeopardised if, in order to fulfil the condition set out in Article 3(d) of Regulation No 469/2009, it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation."

So the CJEU agreed with Mr Justice Arnold's answer to this question (see his judgment at [63]).  They liked it so much, it seems, that they basically adopted his comment at [63] of his judgment into paragraph [39] of their decision (see below):

63. If Article 3(d) were to be interpreted in that way, it would be likely to lead to uncertainty and inconsistency as to the circumstances in which SPCs for new formulations could be obtained, as the existing case law illustrates.

39. Furthermore, such an interpretation of Article 3(d) of Regulation No 469/2009 would risk leading to legal uncertainty and inconsistencies as to the circumstances in which an SPC may be obtained, as it would be difficult to determine in which specific circumstances an MA granted in respect of a new formulation of an old active ingredient may be covered by that provision.

Further analysis on the decision and the CJEU's answer or "answer" (depending on who you ask) to Mr Justice Arnold's question regarding the inconsistency in the case law will be delved into later this evening or tomorrow by the IPKat.  But it seems to the AmeriKat that the "good" old days of a teleological approach to the SPC Regulation (such as they were) are a faint memory, and we are now firmly in the new world of narrow interpretation.  But, maybe we were never in teleological land.  Paragraph 30 of the decision rung bells with the AmeriKat in respect of the comment from the Commission representative at the 3 February 1995 meeting of national experts on the SPC Regulation which was recorded as follows, under the heading "Questions concerning the meaning of the term "product"":

"For instance, a derived product in the form of a salt or ester, by producing an activity profile quite distinct from that of the original substance, could be considered a new product; in addition to a certificate for the original active substance, a certificate for the derived form would then be granted."  

However, how narrow can and should the CJEU and national courts go in narrowly interpreting the SPC Regulation before they start risking what was the fundamental purpose of the EU introducing the SPC Regulation in the first place:  "to improve the protection of innovation in the pharmaceutical sector" and "guarantee therapeutic, scientific, economic and social progress which is indissolubly linked with the discovery and use of new medicinal products" (see paragraph 1 of the Commission's 1990 Explanatory Memorandum)?

In the meantime, let us all play everyone's favorite game "What does the CJEU decision actually mean?" - answers in the comments below, please!