T 2056/17 - Co-marketing as 2nd medical use?

Key points

• Claim 1 is, arguably, a second medical use claim and reads: “"1. A pharmaceutical combination for use in the prevention, alleviation or/and treatment of epileptic seizures, which comprises a separate dosage form comprising (a) a first composition comprising lacosamide and (b) a second composition comprising levetiracetam, wherein the compositions (a) and (b) are provided in distinct preparations (separate dosage forms), which are administered simultaneously and/or subsequently, wherein said separate dosage forms are co-presented in separate packaging, or are separately packaged and available for sale independently of one another, but are co-marketed or co-promoted for simultaneous and/or subsequent administration."
• “D2 discloses a pharmaceutical combination for use in the treatment of epileptic seizures which comprises a separate dosage form comprising (a) a first composition comprising LCM and (b) a second composition comprising LVT, where the compositions (a) and (b) are provided in distinct preparations, i.e. packaged separately, and administered simultaneously and/or subsequently.”
• “Regarding the feature in claim 1 that the actives are available for sale independently of one another but are co-marketed or co-promoted for simultaneous and/or subsequent administration, the board notes the following. The effective treatment of epileptic seizures according to both claim 1 and D2 is achieved by the simultaneous and/or subsequent administration of the separate dosage forms of LCM and LVT. The fact that these dosage forms are available for sale independently of one another but co-marketed or co-promoted for simultaneous or subsequent administration does not render the therapeutic treatment in claim 1 different from that in D2. In both cases, the therapeutic effect is the same, it is achieved on patients having the same physiologic and pathologic state, using the same combination of active ingredients, administered by the same route and with the same dosage regime. In other words, claim 1 and D2 relate to an identical clinical situation which is treated with the same therapeutic measures. Therefore, claim 1 does not define a new specific use within the meaning of Article 54(5) EPC.”
• As a comment, one may ask if “are co-marketed or co-promoted for simultaneous and/or subsequent administration” is a technical feature at all. 

EPO - T 2056/17 -

Link to the decision after the jump, as well as an extract of the decision text.

https://www.epo.org/law-practice/case-law-appeals/recent/t172056eu1.html

2. Main request - novelty (Article 54 EPC)

2.1 Document D2 discloses the result of clinical trials which evaluate the effect of oral lacosamide (LCM) on concomitant antiepileptic drugs (AEDs). One of the AEDs is LVT, which in the opposition proceedings was assumed to be levetiracetam (decision, page 14, paragraph 33). The appellant did not contest this assumption (statement of grounds of appeal, page 7, line 4). The board sees no reason to differ.

The trials in D2 aimed at investigating the efficacy and safety of oral LCM as adjunctive therapy in subjects with uncontrolled, partial seizures taking one or two concomitant AEDs, including LVT. First, the plasmatic baseline of the AEDs was established during eight weeks. Then, patients were treated concomitantly with placebo, 200, 400 or 600 mg/day LCM twice daily (bid). During the first six weeks of concomitant treatment, LCM was titrated to the final dose. After that, the treatment was maintained for 12 weeks. The dose of AEDs was maintained constant during the whole trial.

The authors of D2 concluded from the trials that the concomitant administration of LCM did not affect the mean plasma concentration of AEDs and that it reduced patients' seizure frequency.

2.2 The design of the trial in D2, where AEDs constituted a baseline treatment and LCM was later added in concomitance, implies that LVT and LCM were administered in separate dosage forms. This was not contested by the appellant (statement of grounds, point 2.5.1).

2.3 Given that AEDs constituted the baseline treatment, their plasma levels had to be sufficient to provide a therapeutic effect across the whole trial. Moreover, as LCM was administered concomitantly during 12 weeks to prevent the partial seizures that AEDs could not control, AEDs and LCM had to be present in plasma simultaneously at therapeutic levels. Thus, contrary to the appellant's contention, AEDs and LCM necessarily acted in combination. Moreover, the only possible option for achieving such a combined effect was that AEDs and LCM were administered simultaneously and/or subsequently.

2.4 The appellant's arguments that D2 does not disclose a combination therapy or that AEDs and LCM in D2 were not administered simultaneously and/or subsequently are not convincing.

At the oral proceedings before the board, the appellant put forward that, rather than a combination therapy, D2 disclosed the use of LCM as adjunctive therapy. Thus, although AEDs had to be added as a baseline treatment for ethical reasons, the focus of D2 was exclusively on the individual effect of LCM. Adjunctive and combination therapy had different meanings in the context of marketing authorisations: they implied different clinical set-ups and required different experimental evidence. Therefore, D2 did not allow the reader to draw any conclusion on a combination therapy.

The board disagrees. There is no basis in claim 1 for interpreting the feature "pharmaceutical combination" narrowly or restricted to the meaning used in the specific context of marketing authorisations. As put forward above, the design of the clinical trials in D2 imply the combined effect of LCM and LVT. Thus, the separate compositions of LCM and LVT administered in D2 constituted a pharmaceutical combination within the meaning of claim 1.

This also means that the appellant's allegation (statement of grounds of appeal, point 2.4 and letter of 1 October 2021, page 6, paragraphs 2-4) that LCM and LVT could have been administered in a alternating or intermittent manner which would be different from simultaneous and/or subsequent administration, cannot succeed. It is notorious that the combined action of two actives can only be achieved if they are administered simultaneously and/or subsequently.

2.5 Hence, in accordance with claim 1, D2 discloses a pharmaceutical combination for use in the treatment of epileptic seizures which comprises a separate dosage form comprising (a) a first composition comprising LCM and (b) a second composition comprising LVT, where the compositions (a) and (b) are provided in distinct preparations, i.e. packaged separately, and administered simultaneously and/or subsequently.

2.6 Regarding the feature in claim 1 that the actives are available for sale independently of one another but are co-marketed or co-promoted for simultaneous and/or subsequent administration, the board notes the following.

The effective treatment of epileptic seizures according to both claim 1 and D2 is achieved by the simultaneous and/or subsequent administration of the separate dosage forms of LCM and LVT. The fact that these dosage forms are available for sale independently of one another but co-marketed or co-promoted for simultaneous or subsequent administration does not render the therapeutic treatment in claim 1 different from that in D2. In both cases, the therapeutic effect is the same, it is achieved on patients having the same physiologic and pathologic state, using the same combination of active ingredients, administered by the same route and with the same dosage regime. In other words, claim 1 and D2 relate to an identical clinical situation which is treated with the same therapeutic measures. Therefore, claim 1 does not define a new specific use within the meaning of Article 54(5) EPC.

The board rejects the appellant's argument that co-marketing and co-promotion of the separate dosage forms for simultaneous and/or subsequent administration belongs to the dosage regime and that it ensures the success of the therapeutic treatment. The effectiveness of the therapy lies in the fact that LCM and LVT are administered simultaneously and/or subsequently. This is the essential feature of the dosage regime, and it is present in D2. As put forward above, how the actives are co-promoted or co-marketed neither changes the clinical situation nor contributes to the therapeutic effect.

2.7 The board therefore concludes that the subject-matter of claim 1 lacks novelty, contrary to Article 54 EPC.