ES – Janssen v. Teva – Galantamine / Interim Injunction Appeal
Posted: November 16th, 2009
Janssen Pharmaceutica NV & Janssen-Cilag, S.A. v.Teva Genéricos Española, S.L., Court of Appeal (28th Section), Madrid, Spain, 16 November 2009, Docket No. 184/09
Section 28 of the Court of Appeal of Madrid has recently confirmed the first instance decision ordering Teva Genéricos Española (Teva) to temporarily refrain from commercializing in Spain generic drugs with the active compound galantamine for the treatment of Alzheimer and related diseases.
Janssen had brought legal actions against Teva for the infringement of the SPC no. C 20010009, which, expiring on 15 January 2012, had been granted over the basic patent EP 236684, validated in Spain as ES 2000428. Said patent (and accordingly its SPC) protects the use of the compound galantamine, or a pharmaceutically acceptable acid addition salt thereof -which is the active compound of Janssen's Reminyl® product- to prepare a medicinal product for the treatment of Alzheimer and related diseases.
The complaint was filed when Teva had already obtained administrative authorization to market in Spain several generic products with the active compound galantamine for the treatment of Alzheimer, and, beyond that, when said company had already applied to the health authorities for the granting of reimbursement price for the authorized generics, being thus their launching imminent. For this reason, Janssen also requested the Court to adopt an interim injunction to avoid those generics to be launched into the Spanish market and, due to the imminence of said launching, it requested those injunctions to be adopted inaudita (ex) parte, without hearing Teva. The first instance (Commercial) Court extraordinarily agreed to Janssen’s urgent petition and ordered Teva not to temporarily market galantamine generics.
Teva challenged in the appeal stage the interim injunctions adopted, alleging the invalidity of the SPC and the invalidity of the basic patent for lack of inventive step and insufficient disclosure, which could not justify the interim measures ordered against them, as the invalidity of the right invoked leads to the dismissal of the infringement arguments.
The alleged invalidity of the SPC was founded on the fact that the first marketing authorization for the Reminyl® product within the EC territory was not granted after 1 January 1985 –as alleged in the SPC application, referring to the authorization granted in Sweden on 1 March 2000-, as required by Article 19 of the EC Regulation 1768/1992. On the contrary, Teva defended that the active compound galantamine had already been authorized in Austria and in Germany, in 1963 and 1978 respectively, to be marketed as a drug under the brand name Nivalin®.
However, the Court of Appeal has dismissed this line of reasoning on the grounds that Article 19 of the EC Regulation 1768/1992 is not applicable to those Member States (such as Spain) that did not allow for patenting of pharmaceutical products on 1 January 1990, as set forth by Article 21 of that same EC Regulation.
Next to that, Teva argued that the SPC was ineffective pursuant to Article 13 of the EC Regulation 1768/1992, establishing that the SPC is enforceable for a period equal to the period that elapsed between the date on which the application for a basic patent was filed and the date of the first authorization to place the product on the market in the EC, reduced by a period of five years. If the first authorization was granted in 1963 –Teva alleged- then that protection period was ineffective.
Again, the Court of Appeal discarded Teva’s argument, by saying that the EC Regulation 1768/1992 requires that the first marketing authorization was granted in accordance with the Directive 65/65/EEC on the approximation of legislation relating to medicinal products, not having Teva demonstrated that the Austrian or the German original authorizations were granted pursuant to any proceedings equivalent to that one set fort in the Directive 65/65/EEC.
Concerning the lack of inventive step of the basic patent, the Court of Appeal rejects Teva’s argument on the grounds that the technical evidence submitted by said company reflects an ex post facto analysis when assessing the obviousness of successfully treating the Alzheimer disease with a drug prepared with the active compound galantamine. On the contrary, the Court asserts that there were no indicia in the state of the art leading in an obvious manner to that solution, which could even be deemed surprising.
The argument of the insufficient disclosure also fails in the opinion of the Court of Appeal. In this regard, the Court makes reference to the EPO Boards of Appeal case-law according to which it is not always necessary to provide the data resulting from clinical trials on the date when the patent application is filed, being enough for the purposes of sufficient disclosure that the application contains some information on the effects of the claimed compound over a metabolic mechanism involved in the disease. If that relative information is contained in the patent/application, then the evidence published afterward could be taken into consideration to support the disclosures in the patent (EPO Boards of Appeal Decision T 0433/05 dated 14 June 2007).
For all these reasons, the Court of Appeal of Madrid has understood that Teva did not provide enough evidence on the possible invalidity of the SPC and the basic patent, at least to destroy the presumption of validity of these rights in a sufficient extent that could make believe that the infringement action on the merits would not succeed, maintaining thus the interim interdiction to market galantamine generics in Spain.
Read the judgment (in Spanish) here.
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