"The Polish Supreme Administrative Court applies the definition of a “product” in the light of the CJEU’s judgments in the “Medeva” and “Georgetown” cases and Polish principles on patent claim construction
In its recently published reasoning to the judgment of 14 February 2012, the Polish Supreme Administrative Court (“SAC”) explains the grounds for upholding the judgment of the District Administrative Court in Warsaw (“DAC”), which ruled that the decision of the Polish Patent Office (“PPO”) on renouncing to grant an SPC for an antiretroviral product was correct.
Merck & Co., Inc applied for an SPC for an antiretroviral product (“Atripla”) based on Polish patent PL 176679, which encompassed a new compound I or II and one nucleoside analog. The PPO stated that the basic patent concerned a product consisting of two active ingredients, whereas an SPC application concerned a product consisting of three active ingredients: efavirenz, emtrycitabine and tenofovir dizoproxil. The PPO decided that the product cannot be identified in the basic patent and tenofovir dizoproxil is a nucleotide analog whereas the subject matter of the basic patent is nucleoside analog. Since the patent claims do not refer to nucleotide analog or nucleoside analog prodrugs, the PPO decided that tenofovir dizoproxil does not fall within the claims of the basic patent. As a result, the PPO refused to grant an SPC.
Merck challenged the argumentation raised by the PPO that patent claims, in particular in the case of inventions in the field of chemistry, may not be construed literally. Furthermore, the basic patent also covers products which consist of three active ingredients since the second ingredient specified in the patent claims has a functional character, thus encompasses any compounds which are biologically active. Claim construction applied by the PPO excessively limits the scope of the patent protection. The PPO does not take into account that patent protection encompasses not only ingredients indicated in the claims but also additional features, thus any combination of such ingredients may be considered a product qualifying for an SPC.
According to Merck the claim no. 1 of the basic patent specifies a combination of ingredients having a formula I or II (in this case – efavirenz) with nucleoside analog being a reverse-HIV-transcriptase inhibitor (in this case nucleoside analog is: emtricitabine and tenofovir disoproxil fumarate). The claim does not refer only to one nucleoside analog since nucleoside analog reverse-HIV-transcriptase inhibitor concerns a group of compounds defined functionally. When editing patent claims a singular is commonly used, which however does not limit patent protection just to a single solution. The application of a nucleotide analog in combination which, after administration to a patient, transforms into a nucleoside analog falls into claim no.1 of the basic patent. The nucleotide analog is a nucleoside analog prodrug and is an equivalent to the solution covered by the basic patent.
The DAC upheld the PPO’s decision and decided that the claims of the basic patent concern a combination of active ingredients to prevent HIV infection characterized by that it is a combination of a formula I or II or pharmaceutically acceptable salts of formula I or II, with a nucleoside analog being a reverse-HIV-transcriptase inhibitor. According to the DAC, the basic patent covered only a two-ingredient combination: a combination of formula I or formula II with a nucleoside analog reverse-HIV-transcriptase inhibitor. The three-ingredient product being a combination of efavirenz, emtricitabine and tenofovir dizoproxil does not fall within the patent claims. One cannot derive from a teaching of the patent that it should cover more than two active ingredients. Neither do patent claims contain any “nucleotide analog” or “nucleoside analog prodrugs”. As a formula I, a formula II, their salts or nucleoside inhibitor one may use different compounds expressed by a particular formula or a functional name, though there will always be only two ingredients. Tenofovir dizoproxil fumarate is an additional active ingredient which renders the product new comparing to that included in the basic patent, beyond its scope of protection.
Merck appealed the DAC’s verdict to the SAC which dismissed the appeal. According to the SAC, the scope of protection of the basic patent is determined by its claims. The Patent description and drawings should support claim construction, however, these are claims which are decisive when determining the scope of the patent protection. This means that claims should be construed literally and only what one can construe based on a patent document has a meaning. There is no basis to construe patent claims to the extent which a patent applicant did not take care of himself and seek protection which extends over the literal meaning of claims. This applies also to equivalents. It is important to remember that patent protection is not only a privilege for a patent owner but a limitation for others which should not encroach upon patent monopoly. Therefore, there must be and are limits of patent protection and this case has indicated this precisely.
Granting an SPC over a product which is not entirely protected by the basic patent would in fact be contrary to Art. 3a of Regulation 1768/92. The SAC referred at this point to the judgments of the Court of Justice of the European Union of 24 November 2011 in cases C-322/10 (“Medeva”) and C-422/10 (“Georgetown”), in which the CJEU held that Art. 3a of the Regulation precludes the PPO from granting an SPC to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application. Art. 3b of the Regulation does not preclude the PPO from granting an SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on where the medicinal product for which the marketing authorization is submitted in support of the SPC application contains not only that combination of the two active ingredients (in the “Georgetown” case, C -422/10 – “that active ingredient”), but also other active ingredients. As a result, the material patent law has not been infringed in this case when determining scope of protection of the basic patent.
According to the SAC, the subject matter of the basic patent is: a combination of two active ingredients, where active ingredient I is a particular compound I or II or their salt, and active ingredient II is a functional compound - nucleoside analog being a reverse-HIV-transcriptase inhibitor. Therefore, the second active ingredient must be from a group of nucleoside analog reverse-HIV-transcriptase inhibitors, however, one cannot derive from the claims of the basic patent that the combination may include two different nucleoside analogs, i.e. include a third active ingredient being another nucleoside analog. The basic patent did not encompass a combination of three active ingredients: efivarenz (compound indicated expressly in the patent claims), emtricitabine (nucleoside analog), tenofovir dizoproxil fumarate (nucleotide analog which transforms in a human body into another nucleoside analog). As a result, an SPC could not be granted for such a product which extends over the literal meaning of patent claims of the basic patent and thus does not meet the requirements under art. 3(a) of Regulation 1768/92".