Authorisation request for proposed settlement between pharmaceutical companies withdrawn

The pharmaceutical manufacturing company Celgene and generic drug companies, Juno and Natco have withdrawn their application to the ACCC for an authorisation for the provisions of a settlement and licence agreement. The companies sought ACCC authorisation to settle a patent dispute before the Federal Court of Australia.

The withdrawal of the request for authorisation follows the ACCC's draft determination and ends the ACCC's consideration of this issue.

ACCC authorisation provides protection from legal action for arrangements that risk breaching competition law.

Withdrawing the authorisation does not prevent the applicants from settling the patent dispute proceedings nor from agreeing to a licence agreement on terms that do not risk breaching competition laws.

Further information is available on the ACCC's Public register here: Juno Pharmaceuticals Pty Ltd & Ors.

Background

Celgene is Celgene Corporation and Celgene Pty Ltd (together, Celgene), a Swiss-based global biopharmaceutical company that develops and manufactures pharmaceutical products, with a particular focus on cancer and immunology-related diseases. Celgene Pty Ltd is a wholly owned subsidiary of Celgene Corporation which is a wholly owned subsidiary of Bristol-Myers Squibb.

Celgene is the manufacturer of Revlimid® (active ingredient lenalidomide) and Pomalyst® (active ingredient pomalidomide) which are immunomodulatory drugs for the treatment of some blood cancers. Celgene owns several patents in relation to each of these products.

Juno is Juno Pharmaceuticals Pty Ltd (Juno), a Victorian-based supplier of marketing and distribution services to pharmaceutical manufacturers that specialises in post-patent pharmaceuticals (i.e. generic products). Juno distributes generic pharmaceutical products obtained from third party manufacturers. It does not manufacture pharmaceutical products itself.

Natco is Natco Pharma Ltd, an Indian-based pharmaceutical manufacturer, which operates in countries including Australia for the purpose of selling and distributing Natco-manufactured pharmaceutical products.

The applicants sought authorisation for certain provisions of the settlement and licence agreement because they considered there was a risk that the agreement contained provisions which raise concerns under the cartel provisions of the Competition and Consumer Act.

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