Pharmaceutical manufacturing group,
Litigation background
On
The companies subsequently discontinued the proceedings after reaching a settlement on commercial terms which included Celgene granting Juno and Natco licences to the Celgene patents. This would allow Juno and Natco to supply generic versions of Celgene's blood cancer drugs Revlimid and Pomalyst before the expiry of the respective patents.
Authorisation application
The parties submitted an application to the ACCC for authorisation in respect of the settlement agreement reflecting concerns that certain provisions within the agreement might fall foul of
Pharmaceutical patent settlement arrangements have been widely subject to scrutiny by competition regulators in the EU and US (often in a 'pay for delay' context). This is the first time that this issue has come before the ACCC following the removal of the IP licensing exemption from the Competition and Consumer Act in 2017.
Draft Determination
On
One of the key issues for the ACCC was the perceived lack of information supporting the applicant's views on the public benefits of the agreement.
While the ACCC proposed to deny authorisation, ACCC Commissioner
Withdrawal
On
The withdrawal of the application meant that the ACCC was not ultimately required to provide its final view on the application and as a result, the process has provided little insight into how the ACCC might treat patent settlements in the pharmaceutical sector.
However, it is clear that the ACCC will require a significant amount of evidence to be satisfied that such an agreement is, in all the circumstances likely to result in a benefit to the public which would outweigh the detriment.
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