Dana-Farber Scientists Win Checkpoint Inhibitor Patent Lawsuit
Two researchers, Gordon Freeman and Clive Wood, were recognized as the co-inventors on a series of cancer immunotherapy patents that had been previously issued to a Japanese researcher and Japanese drug company. U.S. District Court Chief Judge Patti B. Saris ordered that the immunotherapy patents be corrected to name Freeman and Wood as inventors.
The patents, which describe a method of cancer treatment blocking the PD-1/PD-L1 pathway, had been assigned to Ono Pharmaceutical Company, Ltd. and Tasuku Honjo of Kyoto University. The three scientists had published a joint research study in 2000 that announced the discovery of the protein PD-L1 (programmed cell death 1 ligand 1). The paper showed that PD-L1 exerts an inhibitory effect on T cells by binding to the T cell co-receptor PD-1 that then signals the T cell to not instigate an immune system response. Freeman noted in his research that PD-L1 is expressed on healthy cells, as well as some cancer cells. The PD-1/PD-L1 pathway played a key role in cancer cells being able to hide from the immune system. By blocking the pathway, the body’s immune system can then respond and attack the cancer cells. Pharma companies have hinged many cancer treatments on this concept. Checkpoint inhibitors like Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo have become a centerpiece of immunotherapy. The increased use of those drugs has garnered billions of dollars of annual revenue for pharma companies.
During the trial, Honjo argued that he received no significant help from his Dana-Farber colleagues. According to WBUR, testimonies focused on the “exchange of biological materials and unpublished data between the American and the Japanese researchers in 1999 and 2000.”
In her decision, Saris wrote that “Dana-Farber has presented clear and convincing evidence that Dr. Freeman and Dr. Wood are joint inventors” of the six patents that had been at the heart of the case. Saris said the Dana-Farber scientists, as well as Kyoto University’s Honjo, were simultaneously working on blocking the PD-1/PD-L1 pathway in the early 2000s.
In her ruling, Saris found that all three scientists deserved to be named on the patents. She said they were working toward a shared goal. The court found that the “conception of the inventions in the Honjo patents was the result of the collaboration of all three scientists.”
In a statement, Freeman said he was “delighted” that the court recognized the contributions he and Wood made toward the discovery. While Freeman noted that he and Wood were the winners of the three-week-long court case, cancer patients are the ultimate winners due to the increased responses from the drugs that inhibit the pathway.
The decision, which is likely to be appealed, will enable Dana-Farber to license the technology to companies looking to develop checkpoint inhibitors, the cancer institute announced. The license for those patents is currently held by BMS, WBUR reported. Laurie Glimcher, president and chief executive officer of Dana-Farber, said research is collaborative by design and the institute is gratified the court affirmed the contributions of Freeman and Wood.
“Our focus now will continue to be on the best ways to get new therapies to patients as quickly as possible,” Glimcher said in a statement.