Pharma companies withdraw authorisation request for licence agreement

Pharma News: Pharmaceutical companies have withdrawn their application for an authorisation for the provisions of a settlement and licence agreement.

Celgene, a wholly owned subsidiary of Bristol-Myers Squibb (BMS), and generic drug companies Juno and Natco, sought ACCC authorisation to settle a patent dispute before the Federal Court of Australia.

Celgene manufactures and owns patents for the drugs Revlimid (lenalidomide) which indicated in multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma, and Pomalyst (pomalidomide) which is indicated in multiple myeloma.

Celgene and Juno/Natco entered into a proposed settlement and licence agreement for Juno/Natco to supply generic versions of lenalidomide and pomalidomide from specified launch dates. The parties submitted that the agreement will enable these generic products to be supplied before the relevant Celgene patents expire.

The withdrawal of the request for authorisation follows the ACCC’s draft determination in March 2022 and ends the ACCC’s consideration of this issue.

“The competitive implications of the settlement and licence agreement are unclear,” ACCC Commissioner Stephen Ridgeway said back in March.

“The extent to which the agreement is likely to result in cost savings to the Commonwealth Government under the Pharmaceutical Benefits Scheme is uncertain,” Mr Ridgeway said. 

“There is insufficient evidence that the agreement would be likely to result in greater security of supply of lenalidomide and pomalidomide products. Further, the ACCC is not satisfied that the litigation would proceed without the agreement, and therefore cannot be satisfied there would be litigation cost savings which would result in a public benefit.

“The opportunity for other generic manufacturers to enter the market is a key driver of competition. The ACCC is concerned the agreement seeks to establish Juno/Natco as the first generic supplier on Celgene’s terms and this could result in public detriment by distorting competition between generic manufacturers,” he added.

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. It means that the applicants are not permitted to engage in cartel or other anti-competitive conduct under the agreement.

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