Summary
On 3 December 2021, the ACCC received an application for authorisation from Juno Pharmaceuticals Pty Ltd (Juno), Natco Pharma Ltd (Natco), Celgene Corporation and Celgene Pty Ltd (together, Celgene) (altogether, the Applicants).
The Applicants sought authorisation to enter into, and give effect to, certain operative provisions of a settlement and licence agreement that would enable Juno and Natco to bring to market generic versions of Revlimid® and Pomalyst® from a specified launch date for each drug. The Applicants sought authorisation until 2 August 2027, when the last of the relevant Celgene patents is due to expire.
The Applicants sought authorisation to settle a patent dispute before the Federal Court of Australia.
On 23 March 2022, the ACCC issued a draft determination proposing to deny authorisation.
On 27 May 2022, the date by which the ACCC must make a final determination was extended, with the agreement of the Applicants, until 29 July 2022.
On 29 July 2022, the Applicants withdrew their application for authorisation. Please see the ‘Applicants to ACCC re Withdrawal of Application’ document below for further details.
Applicant(s)
- Juno Pharmaceuticals Pty Ltd
- Celgene Corporation
- Natco Pharma Ltd
- Celgene Pty Ltd
Authorisation number(s)
- AA1000592-1
Applications
| Document title | Date | |
|---|---|---|
| Celgene re ACCC media release ( PDF 117.31 KB ) | 5 Aug 2022 | |
| Applicants to ACCC re Withdrawal of Application ( PDF 115.19 KB ) | 29 Jul 2022 | |
| Application Received ( PDF 10.11 MB ) | 3 Dec 2021 |
Decisions
| Document title | Date | |
|---|---|---|
| Applicants to ACCC re Extension of Statutory Timeframe ( PDF 980.26 KB ) | 27 May 2022 | |
| ACCC to Applicants re Extension of Statutory Timeframe ( PDF 151.2 KB ) | 27 May 2022 | |
| Draft Determination - Summary ( PDF 161.9 KB ) | 23 Mar 2022 | |
| Draft Determination ( PDF 665.1 KB ) | 23 Mar 2022 | |
| Show all documents (1 more) | ||
Consultations
| Document title | Date | |
|---|---|---|
| ACCC to Interested Parties re Draft Determination ( PDF 162.69 KB ) | 23 Mar 2022 | |
| ACCC to Interested Parties re Consultation Process ( PDF 179.54 KB ) | 15 Dec 2021 |
ACCC correspondence
| Document title | Date | |
|---|---|---|
| ACCC to Celgene re request for further information ( PDF 432.56 KB ) | 21 Jun 2022 | |
| ACCC to Juno and Natco re extension of statutory timeframe and request for further information ( PDF 656.05 KB ) | 6 Jun 2022 | |
| ACCC to Celgene re extension of statutory timeframe and request for further information ( PDF 556.24 KB ) | 6 Jun 2022 | |
| ACCC to Applicant's re request for information ( PDF 1015.69 KB ) | 16 Dec 2021 | |
| ACCC to Celgene re request for information ( PDF 131.2 KB ) | 16 Dec 2021 | |
| ACCC to Juno and Natco re request for information ( PDF 136.72 KB ) | 16 Dec 2021 | |
| Show all documents (3 more) | ||