The High Court has ordered Boehringer Ingelheim companies to disclose specified documents in two patent-related challenges brought by Norton (Waterford) Limited, trading as Teva Pharmaceuticals Ireland. Mr Justice Cregan delivered the decisions on discovery on 27 March 2015. He did not decide whether either patent or the supplementary protection certificate should be revoked.
In the first case, Teva seeks revocation of the Irish designation of European Patent No. 1379220, concerning inhalation capsules. Its pleaded objections include lack of inventive step, an alleged arbitrary selection of capsule moisture content and insufficiency. Boehringer denies the allegations.
The judge said the requested discovery had to be relevant, necessary and proportionate. He ordered discovery of the patent application file, limited to the European and Irish patent offices and the German priority application. He said he would hear the parties on the final wording and the proposed four-year time window.
He rejected as too broad Teva’s request for all documents concerning conception, development and reduction to practice. Instead, he identified internal U Reports, Spiriva project folders and specified hard-copy files in Boehringer’s UK disclosure report as proportionate documents for that part of the request. He also allowed discovery of the named inventors’ and laboratory technicians’ notebooks, documents showing consideration of pleaded prior art, and documents concerning the patent’s validity that had been shared with retained experts, consultants, in-house counsel or patent attorneys. He said these categories should be time-limited and would hear further submissions on that issue. Documents Boehringer would rely on to defend the patent were ordered forthwith.
In the second case, Teva seeks revocation of supplementary protection certificate 2002/021. Its objections concern whether products covered by the certificate were protected by the basic patent under the relevant regulation; Boehringer denies the claims. The judge described the dispute as essentially a matter of construing the patent and certificate.
He allowed discovery of the Irish and European basic-patent files and the German priority-application file, but not files from other designated states. He also allowed the inventors’ laboratory notebooks, the Irish certificate application file, documents concerning the certificate’s validity shared with retained advisers, and documents Boehringer would rely on to defend the certificate. The last category was ordered forthwith. Time limits for some categories remained for further submissions.
The judge refused broader development and correspondence requests, categories concerning a separate patent, documents about selecting the basic patent or marketing authorisation, and additional marketing-authorisation material beyond the Irish and Dutch authorisations Boehringer had offered subject to redaction and confidentiality arrangements. The judgment records discovery rulings only; it does not establish the pleaded objections or determine the validity of the patent or certificate.