Can you obtain an SPC for a new formulation of a medicine? The UKIPO considers the CJEU decisions in MIT and Neurim

25.10.2016

On 26 August 2016, the UKIPO issued its decision rejecting Abraxis Bioscience’s application for an SPC for “paclitaxel formulated as albumin nanoparticles” (“nab-paclitaxel”), the formulation of its anti-cancer drug Abraxane®. The key question in this case was whether or not the MA for nab-paclitaxel represented the first MA placing the product (active ingredient or combination of active ingredients) on the market as a medicinal product for the purpose of Article 3(d) of the SPC Regulation.
Abraxis had contended that nab-paclitaxel was, for the purposes of the definition of “product” in Article 1(b) of the SPC Regulation, a new single active ingredient, notwithstanding that earlier MAs had been granted for paclitaxel. Although the Hearing Officer of the UKIPO considered that the Explanatory Memorandum to the SPC Regulation and the Court of Appeal decision in Daiichi (EWCA Civ 646 [2009]) provided a “favourable policy backdrop” to Abraxis’ application, he was ultimately unable to accept Abraxis’ position.
Having concluded that nab-paclitaxel was a combination of substances, the Hearing Officer considered as relevant authority MIT (C-431/04), which requires that both substances have a therapeutic effect of their own for the combination to form basis for an SPC application and noted that this authority had been reaffirmed by the CJEU in GSK (C-210/13). Notwithstanding that Abraxis established that nab-paclitaxel has a distinct pharmacological activity when compared with paclitaxel and that albumin and paclitaxel are transported across the cell membrane as a single unit, the Hearing Officer concluded that Abraxis had not sufficiently established that the albumin component of nab-paclitaxel had a therapeutic effect of its own. Abraxis had not established that it functioned as more than a mere carrier for the main active ingredient, i.e. paclitaxel. It is interesting to note the level of detail at which the Patent Office carried out its assessment (even considering to a YouTube video purporting to show how paclitaxel is transported by albumin and transferred into cells by an endocytotic process mediated by the protein caveolin). It is questionable whether such analysis is consistent with the straightforward assessment that the framers of the SPC Regulation intended would be performed by Patent Offices.
The Hearing Officer further rejected Abraxis’ argument that the albumin portion of nab-paclitaxel had at least an indirect effect of its own in the treatment of the authorised conditions and that this was sufficient by virtue of the CJEU decisions in Bayer (C 11/13) and Söll (C-420/10). The Hearing Officer considered that these authorities were distinguishable on the facts and did not assist Abraxis’ submission.
Abraxis’ final position was that even if nab-paclitaxel was not a new active ingredient, it was entitled to an SPC by virtue of the CJEU decision in Neurim (C-130/11). The facts of the case in Neurim were that melatonin had been placed on the market originally as a veterinary medicinal product under the brand name Regulin® for use in the regulation of breeding patterns in sheep. The applicant subsequently obtained an MA for Circadin®, a different formulation of melatonin as a treatment for insomnia in humans. Neurim had a patent protecting Circadin with both formulation and medical use claims. Crucially, the patent would not have covered Regulin. The CJEU held that the earlier MA “does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.” Abraxis argued that the CJEU had intended that “different application” could mean either a new indication or a new formulation. However, this argument was rejected by the Hearing Officer, who took the position that “new application” should be interpreted as meaning a new therapeutic application.
It is arguable that a broad interpretation of the Neurim decision would enable Patent Offices to avoid the level of detailed consideration of the pharmacological activity of the “product” in question as described above. However, for the time being it appears that the UKIPO will adopt a narrow interpretation of the Neurim decision and it will not therefore be possible to obtain SPCs for new formulations of active ingredients which have been previously approved, even if the new formulation provides enhanced therapeutic efficacy or is the result of significant clinical expenditure. However, Abraxis has appealed this decision to the Patents Court and, if experience is anything to go by, it seems likely that this case could lead to a further referral to the CJEU. Furthermore, it is understood that the UKIPO will shortly be issuing a further decision on the subject in relation to the premature ejaculation drug Fortacin®.