On 9 July 2015, the Voivodeship Administrative Court in Warsaw (VAC) (ref. No. VI SA/Wa 285/15) ruled that a marketing authorisation (MA) granted for a combination product, the original API of which had already received an MA, should be regarded as a first MA within the meaning of Article 3(d) of the Regulation No. 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation).
Merck Sharp & Dohme Ltd, the US pharmaceutical company (Merck), is the owner of patent No. PL 196278 protecting sitagliptin used in the treatment of diabetes mellitus (the Patent). The Patent application was filed on 5 July 2002, and the original products containing sitagliptin (sold under the brand names Januvia and Xelevia), were granted MAs in the EU on 21 March 2007.
Pursuant to Article 13(1) of the SPC Regulation, the duration of an SPC (which extends the patent protection for a particular product) is equal to the period lapsed between the date of filing of the application for the basic patent, and the date of the first MA to place the product on the market in the EU, reduced by a period of five years. In the case of Januvia and Xelevia, no additional market exclusivity would have been granted once patent protection expired, because less than five years had passed between the date of patent application filing and the date of the MA.
Merck subsequently put a new medicinal product on the market, which was a combination of sitagliptin and metformin, under the trade name Janumet. The MA for Janumet was granted on 16 July 2008. When calculating the SPC period from this date, Merck would benefit from over one year of additional market exclusivity.
Metformin was specified in the Patent at claim 16, which provided that sitagliptin may also include a pharmaceutically acceptable salt thereof, or optionally it can be combined with metformin. In addition, in therapeutic indications for Januvia and Xelevia, metformin was recommended in a dual oral therapy with sitagliptin; this dual therapy was used when diet and exercise plus metformin therapy alone was unable to achieve adequate glycaemic control. Following the Medeva case (C-322/10), a basic patented product combined with an additional active ingredient specified in the patent claims could benefit from SPC protection.
However, the Polish Patent Office (PPO) refused to grant an SPC for the Patent because in its view the first MA in accordance with Article 3(d) of the SPC Regulation had been granted on 21 March 2007 for Januvia and Xelevia. The PPO argued that Janumet was not a new medicinal product because the combination of sitagliptin and metformin was already commercialised in a combined therapy.
In the PPO's view, this combination did not provide any difference in the use of the patented product, and thus could not form the basis for an extension of patent protection.
In considering Merck's appeal from the PPO's decision, the VAC held that, contrary to the PPO's position, the first MAs for Januvia and Xelevia should not be taken into account. This was because the meaning of MA, in the sense of Article 3(d) of the SPC Regulation, concerns a particular product, not any product protected by the patent. In the VAC's view, Januvia and Xelevia were different "products" to Janumet within the meaning of Article 1(b) of the SPC Regulation.
As a general rule, an SPC can extend patent exclusivity up to 15 years at most to reward investment into pharmaceutical research and the time spent on acquiring the patent and MA. In the case at hand, patent exclusivity was extended to 16 years from when the first patented product was put on the market. The VAC court ruling is final and must be followed by the PPO when reconsidering the case on granting the SPC for Merck's product, Janumet.