Tiotropium - Ireland

On Jul 26, 2017, High court of Ireland issued judgment in favor of Boehringer Ingelheim in inhalation capsule patent litigation. This capsule is used in Spiriva (Tiotropium) Handihaler device.

The capsule is used in an inhalation device which has generated worldwide sales of more than €3.5 billion. Norton (Waterford) Ltd, trading as Teva Pharmaceuticals Ireland, sought the revocation of the “EP1379220 patent” issued in Ireland in 2002 to Boehringer Ingelheim International GMBH under which it produces “Spiriva” medication used with its “Handihaler” device.

Teva argued none of the claims of the patent related to a “patentable invention” in that it did not involve an inventive step obvious to a person skilled in the art, and having regard to the state of the art at the time it was patented. Teva also claimed the specification of the patent did not disclose the alleged invention “clearly and completely enough for it to be performed by a person skilled in the art”. Boehringer denied all the claims. It said, among other things, that Teva’s objective in seeking revocation was to ensure it (Teva) could make or market a product which would compete with the Spiriva Handihaler. It also said this would mean Teva, as a generics company, would be able to compete without having had to carry out research and development work.

Mr Justice Max Barrett of High court said the challenge failed in its invalidity claim that the specification of the ‘220 patent did not disclose the invention clearly and completely enough for it to be performed by a person skilled in the art, or what is called the “insufficiency challenge”. The claim by Teva that the patent was invalid because the invention protected was obvious in light of prior publications in this area also failed, he said. It also failed in its claim that the patent was invalid because the invention protected was obvious for lack of technical contribution to this particular art. None of the grounds put forward by Teva was accepted by the court and the judge therefore declined to grant the order sought.

The said patent issue was also litigated in other European jurisdictions such as Germany, UK & Netherland. By judgment in Germany (12 January 2016), Netherlands (7 September 2016) & UK (16 December 2016) the EP’220 patent was revoked.