Granting a Supplementary Protection Certificate (SPC) for pharmaceutical compositions mismatching active ingredients protected by the patent – the practice of the Polish courts after the Medeva case.

12 February 2015

In November 2010, the Polish Patent Office (PPO) granted Dr. Karl Thomae Gmbh (Dr. Karl Thomae) an SPC for a pharmaceutical composition of telmisartan and hydrochlorothiazide. The SPC was intended to prolong the protection conferred by a patent over a method of obtaining benzimidazoles (No. PL 169675). However, on 1 February 2013 the SPC was invalidated at the request of Krka, d.d. (KRKA) due to the SPC's non-conformity with article 3(a) of European Regulation 469/2009 (which concerns SPCs for medicinal products). KRKA argued that the basic patent did not protect the product marketed by Dr. Karl Thomae. On 15 September 2014 the Regional Administrative Court in Warsaw (WSA) dismissed Dr. Karl Thomae's appeal against the decision of the PPO (ref. No. VI SA/Wa 1900/13).

Dr. Karl Thomae had appealed to the WSA claiming that invalidation of the SPC was a consequence of changing the interpretation of art. 3(a) once the SPC was granted[AB1] . Before the Medeva judgment (C-322/10), national courts had applied two tests, i.e. infringement and literal tests. Following the judgment in Medeva, a SPC cannot be granted for active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate (thus, only the literal test should be applied).

Dr. Karl Thomae argued that claim 1 of the patent protected telmisartan and hydrochlorothiazide through the use of the wording that telmisartan may be combined with other active substances and excipients. However, the PPO's opinion was that neither precise examples nor biological tests were provided in the patent description. Additionally, the general portions of active substances [AB2] in the patent description failed to correspond with the quantity of telmisartan and hydrochlorothiazide used in the marketed medicinal product.

A patent granted in respect of [AB3] a process protects the invented process, as well as the offering, marketing or importation of products obtained directly by such a process for such purposes. Since the PPO and the WSA also considered the infringement test, the question was whether the combination of telmisartan and hydrochlorothiazide was directly obtained via the patented process. If the inclusion of hydrochlorothiazide resulted in only superficial changes to the pharmaceutical composition, the product is not materially changed and therefore derives directly from the patented process. KRKA argued that the relevant combination of telmisartan and hydrochlorothiazide could not be manufactured based on the patented process.

In general, the PPO based its decision on the Medeva case. As the relevant medicinal product was composed of two active substances (telmisartan and hydrochlorothiazide), but only one (telmisartan) was indicated in the claims of the patent, the SPC [AB4] could not be granted. The PPO and the WSA agreed that the marketed product of Dr. Karl Thomae solved a different problem than the patent since the combination of the two substances lowered the blood pressure more effectively than either component alone. Regardless of which test was applied by the courts, the result was the same since hydrochlorothiazide was not indicated in the claims of the patent (the literal test), nor was it directly obtained by the patented process (the infringement test).

In the proceedings before the PPO, Dr. Karl Thomae asked the PPO to refer to the CJEU for a preliminary ruling on the interpretation of art. 3(a) – specifically whether different criteria should be used to determine protection of a product by a basic patent when it is a patent for a process or a patent for a product and, if so, what are the criteria to be applied to a patent for a process. The PPO rejected the request, finding it irrelevant to the proceedings.

The PPO and the WSA explained that the patent protects only benzimidazoles (inter alia telmisartan) and their salts, not hydrochlorothiazide. Since it is the claims of a patent (which may be supplemented by the patent description) that provide the parameters for the scope of protection conferred by a patent, the PPO was not entitled to interpret patent claims against their literal meaning and thereby broaden the monopoly conferred by that patent upon a patentee (Judgment of the Polish Supreme Administrative Court, II GSK 1224/10).

Dr. Karl Thomae's attempt to obtain protection for a process aimed at manufacturing a product that could be combined with multiple active substances did not work on this occasion. The basic patent at issue lapsed on 5 February 2012, and the SPC was intended to prolong the period of patent protection for the product for a further five years until 4 February 2017. The SPC was invalidated on 1 February 2013 and the WSA judgment is final and cannot be appealed.

 [AB1]I referred here to the particular SPC granted to Dr Karl Thomae.

 [AB2]I meant here portions of active substances used in the patent – e.g. 10 mg of X and 20 mg of X. I did not refer to any proportions of active substances.

 [AB3]Introduction of another word i.e. method, in my opinion, may be confusing since it may indicate another patent matter.

 [AB4]I referred here to the particular SPC granted to Dr Karl Thomae.