Cancer centre sues BMS and Ono over alleged patent exploitation
Boston-based Dana-Farber Cancer Institute is seeking a share of the $1.6 billion in licensing revenue that BMS and Ono Pharmaceutical Co have allegedly received from six immunotherapy patents.
In a lawsuit filed on Friday, June 21 at the US District Court for the District of Massachusetts, Dana-Farber claimed that the two pharmaceutical companies had “exploited” patents co-owned by the cancer centre.
The patents are directed to methods of cancer immunotherapy involving the administration of PD-1 or PD-L1 antibodies.
In May 2019, the Massachusetts court held that Gordon Freeman, a Dana-Farber scientist, is a joint inventor of the patents, and Dana-Farber is a co-owner.
But despite this ruling, BMS and Ono have allegedly held themselves out to Dana-Farber’s potential licensees as the exclusive patent owners.
“They have been able to sue their competitors for patent infringement and negotiate lucrative licensing deals with them, unjustly enriching themselves through their receipt of more than $1.6 billion in licensing revenue,” said the claim.
According to Dana-Farber, these actions have “unfairly deprived” the cancer centre of the opportunity to grant royalty-bearing licences and “robbed” the centre of the licensing revenue.
Back in 2014, the US Food and Drug Administration approved Merck & Co’s PD-1 blocking antibody Keytruda (pembrolizumab).
The same day, BMS and Ono filed a patent infringement suit against Merck, followed by two additional patent infringement suits in 2015, according to the claim.
“Defendants did not seek Dana-Farber’s consent to sue Merck for patent infringement, knowing that if they had recognised Dana-Farber as a co-owner of the asserted patent, they would not have had standing to sue Merck for patent infringement,” alleged the cancer centre.
Under US patent laws, all co-owners of a patent must join as plaintiffs to have standing to sue for patent infringement.
In January 2017, BMS and Ono obtained a settlement of the Merck litigation.
Merck received a licence to the patents in exchange for an upfront payment of $625 million plus an ongoing royalty of 6.5% on worldwide sales of Keytruda.
According to Dana-Farber, since January 2017, Merck has paid BMS and Ono approximately $1 billion in royalties in addition to Merck’s upfront payment of $625 million.
This settlement was agreed more than a year after Dana-Farber sued for correction of inventorship.
“This case stems from the pioneering work of Freeman and Clive Wood, former head of drug development at Genetics Institute, in a collaboration with Tasuku Honjo of Kyoto University that led to the development of cancer immunotherapy treatment methods claimed in the patents,” said the suit.
However, Ono allegedly filed two Japanese patent applications secretly, without informing either Freeman or Wood. The patents only listed Honjo and two of his current or former colleagues at Kyoto University as named inventors.
Then, in July 2003, Ono filed a Patent Cooperation Treaty Application, a utility application that claims priority to the Japanese Patent Applications. Honjo, his two colleagues and an Ono scientist Shiro Shibayama were named as inventors.
Beginning in 2009 and ending in 2016, the US Patent and Trademark Office (USPTO) granted the patents at issue in the suit, all of which claim priority to the Japanese patent applications.
Following the court’s decision in May 2019 that Freeman, Wood and Honjo had all made “significant contributions to the inventions”, the court ordered the USPTO to issue a certificate of correction of the patents and name Freeman and Wood as co-inventors.
Now, the cancer centre is seeking a cut of the licensing revenue, along with triple profits and damages.
Earlier this month, the pharmaceutical companies appealed against the May decision to the US Court of Appeals for the Federal Circuit.
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