The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic products’ before expiry of the patent or SPC, in practice, according to Italian courts, it seems that the product must be covered by a valid SPC in order to block such reimbursement. A recent Judgement of the Administrative Court of Lazio (TAR Lazio), published on 19 January 2018 in the case Medac Gesellschaft Für Klinische Spezialpraeparate Mbh (Medac) vs. Doc Generici S.r.l. (Doc), seems to confirm that conclusion – but all hope is not lost.
Article 11 (1-bis) of the Law Decree no 158 of 13 September 2012 (so-called “Balduzzi Decree”) essentially states that patents and SPCs block generic products from pricing and reimbursement, until the patent or the SPC expires. To date, the Italian Patent Office has been publishing a list of SPCs with indication of the medicinal products concerned and the expiry date. Accordingly, reimbursement is usually not granted by the Italian Medicines Agency (AIFA) until the relevant SPC has expired.
Earlier case law
That said, the provision of the Balduzzi Decree also makes reference to patents that may cover the generic medicinal product, but which are not encompassed by the above mentioned list. In a few instances, patent owners brought the issue before the administrative court (TAR), appealing reimbursement decisions of generics where the generic was still covered by a patent (but not by a SPC). None succeeded as the TAR consistently held that the reference to patent protection in the Balduzzi Decree should be regarded as concerned with patents covering the active compound.
In 2014, however, the Supreme Administrative Court (Consiglio di Stato) acknowledged that under particular circumstances other patents could also be relied upon for preventing the reimbursement of generics, as long as the patent covers a product that “has a significantly different therapeutic efficacy other and additional in respect of [the earlier product] … so that the patent […] may be assimilated to a patent on the active compound to the purpose of its listing in the transparency list”. However, in the case at hand, the patent was eventually held not to meet such requirement.
Medac vs. Doc: formulation patents are in the scope
In the Judgement Medac vs. Doc., the TAR of Lazio returns to the possibility of invoking a patent in order to prevent the reimbursement of generic products, when the patent does not cover the active compound.
Medac is the patent owner of a European patent covering the medicinal product Reumaflex® (methotrexate sodium), which is marketed in Italy for the treatment of some inflammatory autoimmune diseases (in particular: psoriasis and rheumatoid arthritis). The patent is concerned with a particular use of methotrexate, subcutaneous, in a concentration of 50 mg/ml. On October 19th, 2016, Reumaflex® was inserted in the transparency list along with the generic medicinal products having the same active ingredient, meaning that reimbursement was limited to that of the products with the lowest price. According to the patent owner, Reumaflex® would have been different from the products already on the market (and belonging to the same category in the transparency list), since it would contemplate different dosages and have a specific concentration of the active compound (50mg/ml) which the competitors’ product did not make available. Thus, the patent owner argued that the patent would cover a product formulation having an additional and specific benefit as compared to the competitors’ products, regardless of the active compound being the same.
The TAR of Lazio drew a distinction between product and process patents. The former including not only the patents covering an active compound but also those concerned with a particular formulation of a product. For example, formulations that may allow a retarded release of the active ingredient in the human body after the administration of the medicinal product would be acceptable. No mention was made of patents covering other aspects of a medicinal product, as a new therapeutic indication.
So far so good, but the TAR of Lazio went a step further clarifying that not all the patents covering a formulation may justify the refusal of reimbursement. To that purpose, the Court drew a further distinction between “marginal” innovation, which would confer an additional benefit to a known substance, as against disruptive innovation, i.e. formulations “with a particular efficacy and therapeutically innovative”. The Tar of Lazio further pointed out that:
(a) the patent owner shall provide “serious and rigorous evidence of the actual innovation”, as the exclusion from the reimbursement would be an exceptional derogation to the rule that the relevant patents are only those for the active compound;
(b) the assessment eventually rests on the AIFA, whose discretionary opinion may be challenged only if clearly erroneous, aberrant or based on a misinterpretation of the facts. In the case at stake, the TAR of Lazio held the view that the claimant did not prove that the patented product was clearly innovative vis à vis known compounds, as neither the commercial success of the medicinal product, nor the expert opinions filed by the patent owner were deemed sufficient to that purpose. In addition, AIFA’s technical committee came to the conclusion that the different concentration of the active ingredient was not material to the efficacy of the product.
The Judgement at stake is not final. The decision of the TAR of Lazio is in line with the earlier case law vis à vis the application of the exclusion from reimbursement only to products covered by a product patent. However, the distinction between product patents covering an active compound and those concerning a formulation seems to be inadequate to encompass all the possible inventions that may concern a medicinal product. In particular, the decision and the earlier case law leave unaddressed whether second medical use patents may be invoked to prevent reimbursement. Indeed, a new and inventive therapeutic indication of a known substance should be regarded as qualifying the compound as a completely different medicinal product.
On a different note, the importance attached to the degree of innovation that should be associated to the relevant patent seems questionable. On one hand, when a patent is granted, an independent assessment has already been carried out in that respect by an independent and specialised body (the Patent Office). On the other hand, the burden of proof that is imposed on the patent owner, who should prove that the patent is highly innovative, as opposed to marginally beneficial, is not an easy one to discharge. After all, innovation is very rarely achieved from scratch and frequently based on an existing state of the art.