The Opinion of the Advocate General in the case C-443/17 (Abraxis case). A lost case for second medical indication SPCs?


The Opinion of the Advocate General in the case C-443/17 (Abraxis case) was given a few days ago, but this IPKat needed a bit of time  to get her analytical paws around it.  Read it here. The Abraxis case concerns second medical indication patents and whether they fulfill the requirements for grant of  a Supplementary Protection Certificate (SPC).

The case
The High Court of Justice (UK)  asked the CJEU for an interpretation of Article 3(d) of Regulation (EC) No 469/2009  ("Article 3(d)") concerning the supplementary protection certificate for medicinal products. The dispute  was between Abraxis and the Comptroller General of Patents, Designs and Trademarks. The Comptroller rejected  the  SPC application filed by Abraxis for a combination of substances containing the active ingredient paclitaxel, marketed under the name Abraxane. Abraxane is a medicinal product indicated for the treatment of certain breast, pancreatic and lung cancers. Paclitaxel has been previously marketed under other brand names pursuant to other marketing authorizations. Abraxane is more efficient and presents better patient tolerance. Its development has been the result of both costly and lengthy research.

The question to the Court 
The UK court asks whether the condition set out in Article 3(d) is fulfilled where, although the marketing authorization relied upon in support of the SPC application is for an active ingredient that  has already been granted in  an earlier marketing authorization,  such earlier marketing authorization did not concern the new formulation protected by the basic patent and covered by the marketing authorization of the applicant for the SPC- of that active ingredient.

The Advocate General’s approach
The AG proceeds to offer a literal interpretation of Article 3(d) in conjunction with Article 1(b) of the Regulation, in particular with regards to what constitutes a “product” under the Regulation. In order to be subject to an SPC, the product must consist of an “active ingredient” or of a “mixture of active ingredients”.

In the specific case, paclitaxel is the only active ingredient in Abraxane. The AG refers to CJEU case-law in Yissum and Pharmacia Italia, providing that the definition of the term “product” is independent of the therapeutic use concerned, meaning that an active ingredient or a “combination of active ingredients” remains the same product irrespective of the different therapeutic uses this might have. Thus, the first marketing authorization, according to the AG,   will be the first one granted for the “product” in question.

The AG refers naturally to the Court’s ruling in the Neurim case. There,  the question was whether an SPC is to be granted for the new therapeutic indication in human medicine of a product already covered by an earlier marketing authorization for a therapeutic indication in a separate therapeutic area as a veterinary medicinal product. The AG questions whether the Neurim ruling has as en effect in fact that all forms of patentable inventions (all forms of second or third medical indications, dosages schemes or routes of administration) would also be granted an SPC.

The AG refers extensively to the Explanatory Memorandum (11 April 1990 (COM(90) 101 final) and states that the SPC regulation was introduced in order to protect new medicinal products and not to cover every single marketing authorization that might be granted for the same active substance. The AG underlines that in the field of second medical indication patents, the requirement set in Article 3(d)  cannot be fulfilled since the product is not placed on the market for the first time. The AG is not convinced by the argument  advanced by Abraxis, stating that the patentability of second medical indication inventions has been clarified and facilitated after the EPC 2000 revision (negotiated post-SPC Regulation). According to Abraxis, that means that even the grant of the SPC should accordingly be open for second medical indication patents.

The AG states that the SPC regime has, as its objective, to protect not all pharmaceutical research  that is sufficiently innovative to give rise to the grant of a patent and the marketing of a new medicinal product, but only research leading to the placing on the market for the first time of an active ingredient or combination of active ingredients as a medicinal product. The AG concludes that any other interpretation of Article 3(d) would entail deviating from its meaning and scope, and would jeopardize the balance between different interests in the pharmaceutical market that the SPC Regulation has wanted to achieve.

The conclusion of the AG provides the Court with two alternative proposals:
i)                 To abandon the teleological interpretation of Article 3(d) applied in the Neurim case  and return to a literal interpretation that in its turn means that the grant of an SPC would be precluded in the Abraxis cases (and in the Neurim case for that matter)
ii)                To considerably limit the scope of applicability of the Neurim case, resulting  in  its applicability only i where the second medical indication is the first placing on the market of a human medicinal product, even if  there has previously been another marketing authorization for that active ingredient (but as a veterinary product).

It's a complicated world, the world of pills...

Thoughts
The Neurim ruling was welcomed by the industry and seen as a confirmation that second medical indication patents are of central importance in pharma research and should be rewarded as such. Should the Court follow the AG Opinion in the Abraxis case, irrespective of which alternative is adopted, it will have  considerable impact on this segment of pharma innovation.

This Kat finds that several of AG:s arguments have interesting starting points: namely, (i)  that pharmaceutical innovation that is to be rewarded by means of an SPC should only cover such research that concerns completely new active substances; (ii)that applying Neurim would lead to a non-transparent SPC regime; and (iii)   that Neurim would also lead to an even more divergent national application of the SPC regulation.

What becomes clearer than ever is that the SPC regulation provides for a rather unclear and unstable legal framework that does not seem to match the modern challenges of pharmaceutical product development. High time for a change?

The Opinion of the Advocate General in the case C-443/17 (Abraxis case). A lost case for second medical indication SPCs? The Opinion of the Advocate General in the case C-443/17 (Abraxis case). A lost case for second medical indication SPCs? Reviewed by Frantzeska Papadopoulou on Sunday, December 23, 2018 Rating: 5

2 comments:

Anonymous said...

Well the author seems to have a strong opinion on this. However, where is the data that shows that pharma companies need more time than their patent rights in order to recoup investments relating to formulations rather than actual drug discovery? The latter is far more costly and time consuming - and indeed involves much more risk and wasted R&D spend on projects that do nowhere in the end due to tox issues etc. Hence, the SPC system was designed to provide assistance to fund drug discovery and the explanatory memorandum, the articles of the SPC regs and the previous caselaw all dictate that SPCs are meant to cover new active substances or combinations. I think that new legislation should indeed be required to change this - it is not the job of the court. However, there would need to be data on which to base any such new legislation. Working in the industry - it is clear to me that the costs for reformulation just cannot be considered to be anything like in the same ballpark (and thus require 5 more years of exclusivity). I would be very surprised if any convincing data to the contrary can be adduced

مرحبا said...

I think that patent practitioners have not yet realised the implications of the CJEU being part of the EU, i.e. it will interpret EU legislation according to the relevant policy objective, and not according to the what it says 'literally'. The SPC system is about protecting the finding of new drugs, and not about new ways of using known drugs in the eyes of the EU, and so we can expect CJEU decisions to mirror that. By pointing this out I am hoping to prevent my fellow European practitioners going through the same pain that US attorneys have been through in seeing the US Supreme Court using 'eligibility' to radically change what is patentable in the US. Expect the CJEU to increasingly do the same to patent law here, as per the relevant policy objective. For too long the Enlarged Board of the EPO has protected us from considering wider issues, but any Supreme Court cannot ignore them, and we are about to get a taste of that as the UPC gets up and running and the CJEU becomes an important source of patent law.

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