The Advocate General of the CJEU proposed a narrow interpretation of Article 3(d) in the Opinion given yesterday in Abraxis Bioscience LLC v Comptroller General of Patents 13 December 2018, one that would marginalise the effect of the CJEU’s decision in Neurim (C-130/11). If followed by the CJEU, this position would be met with disappointment by the pharmaceutical industry, which continues to make significant investments in researching and developing formulations that improve efficacy and new uses of known products.
On 13 December 2018, Advocate General Saugmandsgaard Øe gave his opinion in Abraxis Bioscience (C-443/17) on the correct interpretation of Article 3(d) of the SPC Regulation (Regulation 469/2009). He proposed a return to a literal interpretation of Article 3(d) and an abandonment of the “scope of protection of the basic patent” test that had been applied by the CJEU in Neurim. This case concerned Abraxis’s cancer treatment “nab-paclitaxel” (Abraxane®), in which the previously authorised active ingredient paclitaxel was formulated as nanoparticles bound to albumin. In other words, Abraxane® was a new formulation of a known product for a known and previously authorised therapeutic use. In the AG’s opinion, Abraxis should not be able to obtain SPC protection for its product.
It was undisputed before Arnold J in the English referring court that Abraxis undertook prolonged and expensive research to develop Abraxane®, and it took significant time for Abraxis to obtain a marketing authorisation for the product. Following Arnold J’s decision that paclitaxel is Abraxane’s active ingredient and albumin is a carrier, contrary to Abraxis’ argument that nab-paclitaxel was the active ingredient, he referred the following question to the CJEU:
“Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(d) 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 AG’s opinion
In the opinion of Advocate General Saugmandsgaard Øe (the “AG”), a strict literal approach should be taken to the wording of Article 3(d), which (when read literally) precludes an SPC unless the authorisation relied upon for the SPC is the first authorisation to place that “product” (ie, active ingredient or combination of active ingredients) on the market as a medicinal product. In doing so, the AG urges the CJEU to reject the approach developed by it in Neurim (C-130/11), which permitted an SPC for a new therapeutic use if the authorisation relied upon in support the SPC was the first authorisation that fell within the “scope of the protection” of the basic patent.
If the CJEU do not wish to overturn their earlier decision, then the AG suggests that the approach should be limited to the “particular, and probably exceptional, kind of situations at issue in Neurim“, such that an SPC can be permitted for a new therapeutic indication in human medicine despite an earlier approval for a different indication for veterinary use that is outside the scope of its basic patent.
The AG is of the opinion that a strict, literal interpretation of Article 3(d) is supported by:
- The CJEU case law concerning the meaning of “product” under Article 1(b) of the SPC Regulation. That case law (Yissum and MIT) excludes from the meaning of “product” its therapeutic use or aspects of a medicinal product’s formulation that are not “active ingredients”, even those parts of the formulation impact therapeutic efficacy. This case law in the AG’s view “is difficult to reconcile” with Neurim, but is consistent with a literal interpretation of Article 3(d).
- The CJEU having no power to depart from the clear and precise wording of a provision of EU legislation where the objectives of the SPC Regulation support literal interpretation. In the AG’s Opinion, the Recitals of the SPC Regulation and its Explanatory Memorandum show that the “the intention of the legislature, in establishing the SPC regime, was to protect not all pharmaceutical research 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 a combination of active ingredients as a medicinal product“.
To further support these conclusions, the AG considers the balance of interests required when considering the objectives of the SPC Regulation of stimulating innovation and striking a balance between all the interests involved in the field of medicinal products. In doing so, he highlights that there is a debate on whether the SPC Regime necessarily favours research into innovative medicinal products in the European Union. When considering this, he refers to:
- An argument in the Max Plank Report that the SPC regime was established to address the decline in “risky innovations leading to real therapeutic breakthroughs” that require onerous pre-clinical tests and clinical trials (which he refers to as “fundamental innovations”).
- Studies by Technopolis Group and the Dutch Ministry of Health, Well-being and Sport which suggest that “the grant of SPCs on the basis of marketing authorisations for medicinal products comprising active ingredients which have all been previously authorised may amplify a tendency, observed in the pharmaceutical industry, to concentrate research efforts on safer and more marginal innovations (‘incremental innovations’)” rather than fundamental innovations.
Although the AG states that he does not take a position in this debate (which is an issue for the European legislator to address), the general compromise between the interested parties should be reflected in the wording of the SPC Regulation, such that this favours a cautious, literary approach to its interpretation. He recognised that Abraxis’s development of Abraxane® constituted a genuine therapeutic advance for which there was a significant loss of patent exclusivity due to the regulatory process (particularly as Abraxis had to make a full application for a marketing authorisation and could not rely on any “hybrid” procedure), but this did “not justify the creation by judicial decision of a test departing from the wording of Article 3(d)… and from the intention of the legislature“.
The AG suggests that the legislature used the fact that the active ingredient or combination of active ingredients was new as a ‘proxy’ to demonstrate the existence of fundamental innovations for which an SPC should be available. In doing so, he is implicitly suggesting that identifying new therapeutic uses or formulations of known compounds are not “fundamental innovations” and consequently must be “incremental innovations”. The pharmaceutical industry is unlikely to agree with this categorisation of such innovations, particularly where they make a fundamental breakthrough in the treatment of patients.
The AG concludes that even if a full application for a marketing authorisation is required for a new formulation that “the exclusion of the benefit of the SPC for such inventions appears to be inherent both in striking the overall balance sought by the legislature between the interests involved and in the functioning of the SPC regime, which the legislature intended to be simple and predictable“.
Having reached this position, the AG suggests that if the CJEU are not minded to follow him, then they should reject an approach that adopts the “scope of the protection” test from Neurim for new therapeutic uses but not new formulations, as he cannot find any arguments to justify this distinction. Although he highlights inconsistencies with the wording of the SPC Regulation and the CJEU’s decision in Pharmacia Italia, in the alternative the AG endorses the narrowest approach to Neurim in which an SPC can be permitted for a new therapeutic indication in human medicine despite an earlier approval for a different indication for veterinary use that is outside the scope of its basic patent.
We now await the CJEU’s decision in this case and to see if it follows the AG’s proposal for a literal approach to Article 3(d), or his alternative position of taking the narrowest approach to Neurim, or if it takes a different approach. In reaching its decision, the CJEU may also deal with issues arising from the pending reference to the CJEU from the French Courts on Article 3(d) in Santen (Case C-673/18).