Teva Pharmaceuticals and Boehringer Ingelheim in patent dispute

Two drug companies are in dispute over the patent for an alleged invention related to an inhalation capsule used in the treatment of chronic obstructive pulmonary disease, a court has heard.

Norton (Waterford) Ltd, trading as Teva Pharmaceuticals Ireland, wants the High Court to order the revocation of a patent issued to Boehringer Ingelheim International GMBH.

The same patent protects Boehringer’s ‘Spiriva’ product which is used with its ‘Handihaler’ inhalation device, Teva claims.

Teva argues none of the claims of the patent relate 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 claims 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 denies all the claims and has filed a full defence.

Boehringer says, among other things, that Teva’s objective in seeking revocation is to ensure it (Teva) can make or market a product which will compete with the Spiriva Handihaler.

It also says this will mean Teva, as a generics company, will be able to compete without having had to carry out R&D work.

The High Court has already ruled on a number of pre-trial disclosure of document issues.

Mr Justice John Hedigan yesterday ruled confidentiality protections sought by Boehringer as part of that discovery and pre-trial phase of the case were too restrictive.

Boehringer had agreed to disclose certain documents which it intended to rely on in defending the case, he said.

It had been previously granted an order that a so-called “confidentiality club”, a group of people who will have access to the confidential information subject to certain restrictions, would be set up.

Boehringer argued that apart from Teva’s Irish and UK external lawyers and experts, just one of its (Teva’s) in-house counsel should be admitted to the “club”.

Teva argued this was too restrictive, unprecedented, and also said there should be three, rather than one, in-house counsel in the club.

Mr Justice Hedigan agreed they were too restrictive.

A further proposed restriction on the removal of copies, notes or extracts of confidential information was also too restrictive, he said.