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Drug companies’ patent row reaches High Cour

Source: The Irish Times

teva-pharmaceutical-ipTeva and Boehringer in dispute over inahation capsule used to treat lung condition

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, the High Court has heard.

Norton (Waterford) Ltd, trading as Teva Pharmaceuticals Ireland, wants the court to order 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.

‘Patentable invention’

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 in a full defence to the action.

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

This will mean Teva, as a generics company, will be able to compete without having had to carry out research and development work, it is argued.

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

In a judgment on Wednesday, Mr Justice John Hedigan 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.

Confidentiality club

It had previously obtained an order for establishment of a so-called “confidentiality club” – a group of people who will have access to the confidential information subject to certain restrictions. However, there was no agreement as to who would be in this club, nor what conditions would be applied to them, the judge said.

Boehringer argued that apart from Teva’s Irish and UK external lawyers and experts, just one of Teva’s in-house counsel should be admitted to the “club”, subject to a restriction on her involvement in any other litigation involving the same matters for five years.

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

Mr Justice Hedigan agreed they were too restrictive.

He accepted Boehringer’s proposals regarding to whom the information should be provided and for a written record of the disclosure to be kept. Teva was not obliged to provide that written record to Boehringer until the conclusion of the proceedings, he said.

A further proposed restriction on the removal of copies, notes or extracts of confidential information was too restrictive, he said. In-house counsel were accepted as reputable lawyers well aware of their professional obligations, he said. They will be responsible for ensuring the security of relevant documentation and liable for any loss of it, he added.

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