[et_pb_section fb_built=”1″ _builder_version=”3.19.5″][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”2_5″ _builder_version=”3.0.47″ parallax=”off” parallax_method=”on”][et_pb_image src=”https://vidalquadrasramon.com/wp-content/uploads/2021/09/SORAFENIB-2.jpg” _builder_version=”3.19.5″][/et_pb_image][/et_pb_column][et_pb_column type=”3_5″ _builder_version=”3.0.47″ parallax=”off” parallax_method=”on”][et_pb_post_title comments=”off” featured_image=”off” _builder_version=”3.19.5″][/et_pb_post_title][et_pb_text _builder_version=”3.19.5″]
In the Order of 19 July 2021 (ECLI:ES:JMB:2021:2692A) Commercial Court No. 1 of Barcelona dismissed a preliminary injunction request by BAYER against four companies that launched generic medicines containing the active ingredient sorafenib in the form of its tosylate salt on the Spanish market. The decision is available here.
BAYER based its request on claim no. 12 of patent EP 2.305.255 (“EP’255”), which is directed to the said active ingredient. The defendants’ defence was based on the lack of likelihood of prevailing at trial (fumus boni iuris), considering the patent-in-suit invalid on two grounds: (i) lack of novelty, as the priority claimed by the patent was invalid and two prior art documents anticipating the tosylate salt of sorafenib came into play and (ii) lack of inventive step, derived from combining the closest prior art with the common general knowledge according to the problem-solution approach developed by the European Patent Office.
The lack of inventive step was based on two alternative attacks: formulating the technical problem as an alternative and formulating the technical problem as proposed by BAYER, i.e. an improvement of the bioavailability of the tosylate salt with respect to sorafenib free base.
However, the Order does not rule either on the issue of priority or on the attack on inventive step based on the technical problem formulated as an alternative. The dismissal of the preliminary injunction is because the Court considers that it would have been obvious to the skilled person to prepare a tosylate salt of sorafenib in an attempt to improve the bioavailability of sorafenib free base.
BAYER claimed that the tosylate salt surprisingly improved bioavailability despite not improving the absolute or intrinsic solubility of sorafenib free base.
However, the Order explains that it would have been obvious to the person skilled in the art to test the tosylate salt among the possible salts in the prior art.
To reach this conclusion it points out two important aspects: on the one hand, that the expert would have included tosylate as a possible counterion for the formation of the salt, taking into account the pka of sorafenib free base, since it is a very weak base and, therefore, has limitations in terms of the possible counterions (conjugated acids) to choose for the formation of the salt; and, on the other, he would have studied not only the absolute solubility (intrinsic), but also the dissolution rate, closely related to the absorption of the drug and, therefore, its bioavailability. Therefore, although the salt would not improve solubility, it could improve absorption (bioavailability) if it improved the dissolution rate. These teachings were part of the common general knowledge of the skilled person.
Thus, the Order concludes that the skilled person who started indistinctly from both patent application WO 00/42012 and a scientific article identified as LYONS, both disclosing the active ingredient sorafenib, would have arrived at the result of claim no. 12 of EP ‘255 in an obvious, routine manner.
As procedural aspects to highlight, the Decision states that in the case of preliminary injunctions, defendants whose defence relies on challenging the validity of the patent must allege and prove clear indicia that allow concluding, even provisionally and indicially, that the challenged claim (patent) is invalid. Thus, the Court indicates that, a priori, there are indicia that corroborate the strength of the patent: its grant with prior examination by the European Patent Office, the non-existence of oppositions and the non-filing of nullity suits during the nine years since its grant. In turn, and contrary to these indicia, in addition to the evidence presented by the defendants, it also notes the existence of a preliminary opinion issued by the German Federal Patent Court (Bundespatentgericht) in favour of the invalidity of claim no. 12 of the patent.
A final relevant aspect to highlight is that the Court did not grant the preliminary injunction ex parte despite the fact that BAYER had requested them. Although nothing is mentioned in the Decision, two of the defendants had previously filed protective letters that included arguments of non-urgency and invalidity of the claim in question. One aspect that in our opinion may have been decisive is the Court’s availability to issue a decision before the expected launch date of the generic drugs, which was communicated in those protective letters and coincided with the expiry date of the Supplementary Protection Certificate of the basic patent for sorafenib.
BAYER has filed an appeal against the Order and the defendants have filed their oppositions, so the decision is not yet final.
[/et_pb_text][/et_pb_column][/et_pb_row][/et_pb_section]