U.S. District Court Rules Dana-Farber Scientist is an Inventor on Six Critical Immunotherapy Patents

BOSTON–(BUSINESS WIRE)–The U. S. District Court ruled today that a Dana-Farber Cancer Institute
scientist, Gordon Freeman, PhD, and another scientist, Clive Wood, PhD,
are co-inventors on a series of cancer immunotherapy patents previously
issued to a Japanese researcher and Japanese drug company, and ordered
that the patents be corrected to name Freeman and Wood as inventors.

In her decision, Chief Judge Patti B. Saris wrote that “Dana-Farber has
presented clear and convincing evidence that Dr. Freeman and Dr. Wood
are joint inventors” of the six patents at issue.

In 2015, Dana-Farber filed suit asking the U.S. District Court in Boston
to correct the inventorship on six patents that were assigned to Ono
Pharmaceutical Co., Ltd. and Tasuku Honjo, MD, PhD, of Kyoto University.
The patents describe a cancer treatment that helps patients’ own immune
systems attack cancer cells in the body. This approach works by blocking
the “PD-1/PD-L1” pathway, the centerpiece of a mechanism that cancer
cells use to escape attack by a patient’s T cells, thereby freeing the
immune system to launch a more effective response against the disease.
The trial was held over three weeks earlier this year.

In her findings, Saris noted that the three scientists’ “simultaneous
focus on blocking the pathway to treat cancer in early 2000 shows that
they were all working toward a shared goal.” The court also found that
conception of the inventions in the Honjo patents was the result of the
collaboration of all three scientists.”

I am delighted that the court recognized our essential contribution to
these inventions,” said Freeman. “Patients are the real winners because
we have discovered a new strategy to cure cancer.”

The decision will enable Dana-Farber to license the technology, which is
currently embodied in several of the newest immunotherapy drugs, to
additional companies seeking to develop PD-1 and PD-L1 antibody
therapeutics for a wide range of cancers.

Scientific research is collaborative by design and we are gratified
that the court affirmed Gordon Freeman’s contributions to this seminal
work, which will be recognized on the relevant patents,” said Laurie H.
Glimcher, MD, President and CEO, Dana-Farber Cancer Institute. “Our
focus now will continue to be on the best ways to get new therapies to
patients as quickly as possible.”

In 2000, Freeman, Wood, and Honjo published a joint research study
announcing the discovery of the protein PD-L1 (programmed cell death 1
ligand 1). The researchers found that PD-L1 exerts an inhibitory effect
on T cells by binding to the T cell co-receptor PD-1, thereby signaling
the T cell not to instigate an immune system attack. In pursuing his
study of the PD-1/PD-L1 pathway, Freeman discovered that the PD-L1
protein is expressed not only on normal cells but also on many cancer
cells. The implication was that an agent that blocks PD-1 or PD-L1 (or a
related ligand, PD-L2) could release the brakes on the immune system’s
attack on cancer. These discoveries prompted pharmaceutical companies to
pursue the development of drug agents that block PD-1, PD-L1, or PD-L2.
A half dozen of these drugs – known as immune checkpoint inhibitors –
have received US Food and Drug Administration (FDA) approval for
treating multiple types of cancers and are being tested in the clinic
for treatment of a wide variety of other cancers.

Relevant Links:

Background
info on G. Freeman and his research

Copy
of complaint – Amended (Filed 8-10-2016)

Contacts

Ellen Berlin
ellen_berlin@dfci.harvard.edu
617-750-8884