Revlimid exclusivity under threat

By Megan Brodie 3 years ago | In Companies, Legal
  • 3 years ago

22 March 2021

An attempt by Celgene (now part of BMS) to block competition for its blood cancer treatment REVLIMID (lenalidomide) based on action not yet taken and before the competitors appear on the ARTG has ramifications for the generic and innovative sectors in terms of when an innovator can move to block generic competition.

While the TGA is moving towards implementing an early notification scheme which would reveal when a company files for registration, thereby exposing potential generic competitors up to a year prior to their appearance on the ARTG, Celgene’s court action against Juno Pharmaceuticals and Natco Pharma could have achieved a similar outcome.

In a decision handed down on Friday in the Federal Court by Justice Jonathan Beach, the generics had their claim challenging the validity of one patent (779) protecting Revlimid expedited, with the trial set down for August.

A successful outcome of the August court action could result in the launch later this year of the first competitors for Revlimid, which listed on the PBS in 2009 and is reimbursed for multiple myeloma and other blood cancers.

Celgene filed a cross-claim in February arguing that if the generics are successful in their action, they would seek registration and PBS listing for the same indications as the innovator brand and hence would infringe on at least one of seven other valid patents.

“The respondent’s cross-claim is in some respects hypothetical but not sufficiently hypothetical to warrant summary disposition,” Justice Beach said.

“Now although the cross-claim concerns conduct that has not yet taken place, it is based on conduct that the applicants intend to undertake during the term of the seven patents.

“The fact that the applicants have not yet marketed their lenalidomide products does not render the cross-claim egregiously hypothetical concerning the seven patents.

“Now there is no doubt that the applicants are not currently offering lenalidomide products and cannot do so until they obtain regulatory approval. But that does not mean that they have no intention to offer those products for sale after such approval is obtained, and prior to the expiry of the seven patents. Indeed, it is clear that they do have such an intention.”

While Justice Beach expedited the case for the generics’ current action challenging the 779 patent, saying this could be resolved before October and prior to any launch, he found the issue of the other seven patents needed to be dealt with separately.

He said that action depended not only on the success of the current case but also on the indications which the lenalidomide competitors are ultimately registered for.

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