Dana-Farber Says It Co-Owns Cancer Immunotherapy Patents

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By John T. Aquino
Oct. 1 — A U.S. cancer institute asserted Sept. 25 in federal district court litigation that two U.S. researchers are co-inventors of cancer immunotherapy patents that are a result of the collegial exchanges of ideas and draft manuscripts with a Japanese researcher (Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd., D. Mass., No. 1:15-cv-13443, filed 9/25/15).

The complaint filed by Boston-based Dana-Farber Cancer Institute (DFCI) in the U.S. District Court for the District of Massachusetts contended that DFCI researcher Gordon J. Freeman and Clive R. Wood of the biotech the Genetics Institute, which is based in Cambridge, Mass., made contributions to five patents that show Tasuku Honjo and three colleagues at Kyoto University in Japan as the inventors. The DFCI asked the court to order the Patent and Trademark Office to correct the patents' inventorship to include Freeman and Wood.

As assignee of Freeman and Wood's patent rights, DFCI would become co-owner of the five patents: U.S. Patent Nos. 7,95,048; 8,168,179; 8,728,474; 9,067,999; and 9,073,994.

Related Antibody Litigation

The lawsuit could have implications for two antibody products and another lawsuit.

Honjo and Ono Pharmaceutical are the assignees of the five patents in DFCI's litigation and have licensed their rights to Bristol-Myers Squibb, New York, and Squibb, Princeton, N.J. In 2014, the Food and Drug Administration approved two antibodies for treating advanced melanoma that block the proteins that are the focus of the five patents: Opdivo (nivolumab) , which was developed by BMS and Squibb, and Keytruda (pembrolizumab), which was developed by Merck.

BMS sued Merck on July 9, alleging that Keytruda infringes the ‘994 patent, for which BMS claims it has the exclusive license (9 LSLR 781, 7/10/15).

Collegial Exchanges

According to DFCI's complaint, cancer immunotherapy is a way to unleash the body's own disease-fighting cells—the immune system's T lymphocytes, or “T cells”—for a sustained attack on cancer cells. In the course of his research at DFCI, Freeman, who is also a professor of medicine at Harvard, discovered that the protein PD-L1 helps cells avoid being attacked by the immune system's T cells by interacting with a complementary protein on the surface of T cells called PD-1 (PD meaning “programmed cell death”).

When the PD-L1 on a normal cell binds to PD-1 on a T cell, it inhibits the proliferation of T cells, as well as the T cells’ expression of certain immune proteins called cytokines. The PD-1/PD-L1 interaction prevents an individual's T cells from launching an immune response against his or her own normal cells, providing a critical checkpoint against autoimmune disease.

Freeman and Wood began collaborating in the 1990s, and Wood introduced Freeman to Honjo in 1999. Thereafter, the three men shared samples under material transfer agreements, exchanged data and collaborated on a scientific paper.

U.S. Researchers Contributed

In 2009, the Patent and Trademark Office issued the ‘048 patent, titled “Method for Treatment of Cancer by Inhibiting the Immunosuppressive Signal Inducted by PD-1,” which claims priority to the Japanese Patent Application 2002-194491, from July 3, 2002. The ‘048 patent is co-assigned to Honjo and Ono and names as inventors Honjo and the three Kyoto University colleagues, Nagahiro Minato, Yoshiko Iwai and Shiro Shibayama. The ‘179, ‘474, ‘999 and ‘994 patents followed, with the same inventors and assignees.

According to the complaint, listing the four Kyoto researchers as inventors is an incorrect assertion that the idea of blocking the PD-1/PDL-1 pathway to allow T cells to attack cancer cells was their sole invention.

The complaint said, “Th[e] experiments [cited in the patents] depended on and grew out of Honjo's collaboration with Freeman and Wood, in which they privately shared with Honjo Freeman's discovery of the PD-L1 and PD-L2 ligands to PD-1; their discovery of the biological function of the PD-1/PD-L1 pathway; their experimental data, including Freeman's data that showed the expression of PD-L1 on various tumors; and Freeman's idea that the PD-1/PD-L1 pathway would be an attractive target for treating cancer.”

The complaint, which was filed against Ono, Honjo, BMS and Squibb, requested that the court determine that Freeman and Wood are joint inventors of the ‘048, ‘179, ‘474, ‘999 and ‘994 patents; order the PTO to correct the inventorship of the patents; and determine that the case is exceptional under 35 U.S.C. 285 and award DFCI its reasonable attorneys’ fees and costs.

The complaint was filed by Foley Hoag LLP, Boston.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com
To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com