Interpharmaceutical Settlement Clearance Request Withdrawal

Pharmaceutical manufacturing company Celgene and generic drug companies Juno and Natco have withdrawn their application to the ACCC for clearance for the terms of a settlement and license agreement. The companies sought permission from the ACCC to settle a patent dispute in the Federal Court of Australia.

The withdrawal of the application for authorization responds to the proposed decision of the ACCC and terminates the consideration of this question by the ACCC.

ACCC clearance provides protection from legal action for arrangements that risk violating competition law.

Withdrawal of authorization does not preclude plaintiffs from resolving patent litigation or entering into a licensing agreement on terms that are not likely to violate competition laws.

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

Background

Celgene is Celgene Corporation and Celgene Pty Ltd (together, Celgene), a Switzerland-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 certain blood cancers. Celgene holds several patents relating to each of these products.

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

Natco is Natco Pharma Ltd, a pharmaceutical manufacturer based in India, which operates in countries like Australia for the purpose of selling and distributing pharmaceutical products manufactured by Natco.

The Petitioners sought clearance for certain provisions of the Settlement and License Agreement because they believed there was a risk that the Agreement might contain provisions that raised concerns under the antitrust provisions of the Competition Act and consumption.

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