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Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co.

United States Court of Appeals for the Federal Circuit

July 14, 2020, Decided

2019-2050

Opinion

 [*1367]  Lourie, Circuit Judge.

Ono Pharmaceutical Co. Ltd., Tasuku Honjo, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb Co. (collectively, "Ono") appeal from the judgment of the United States District Court for the District of Massachusetts after a bench trial ordering that Dr. Gordon Freeman and Dr. Clive Wood be added to U.S. Patents 7,595,048 ("the '048 patent"), 8,168,179 ("the '179 patent"), 8,728,474 ("the '474 patent"), 9,067,999 ("the '999 patent"), 9,073,994 ("the '994 patent"), and 9,402,899 ("the '899 patent") as co-inventors. Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 379 F. Supp. 3d 53 (D. Mass. 2019) ("Decision"). Because we conclude that the district court did not err in its inventorship determination, we affirm.

Background

This appeal presents an inventorship dispute over groundbreaking [**2]  work in the field of cancer treatment. Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells.

The human immune system comprises many different cell types, but two types of those cells are relevant here: dendritic cells and T cells. Dendritic cells detect pathogens and present antigens—proteins from a pathogen or tumor—to T cells. T cells have a variety of functions but, as relevant here, are responsible for processing information to develop an immune response in the body using receptors on their surfaces. The primary receptor on a T cell, the T cell receptor, can bind to antigens to activate an immune response. But a signal sent to a T cell receptor will not activate the T cell unless a ligand binds to one of its co stimulatory receptors, such as CD28. CD28 has two ligands, B7-1 and B7-2, which are expressed in dendritic cells that have detected infection or cancer. For a T cell to activate an immune response, two things must happen: (1) an antigen on a dendritic cell must bind to the T cell receptor, and (2) a B7 ligand on the dendritic cell must bind to the CD28 receptor on the T cell. In the [**3]  absence of an infection or cancer, dendritic cells do not express B7 ligands on their surface thus blocking an immune response. B7 ligands also bind to an inhibitory receptor called CTLA-4, which is only expressed in highly activated T cells. B7 ligands bind more tightly to CTLA-4 than to CD28, so if both receptors are being expressed, CTLA-4 prevents the B7 ligands from activating the T cell through the CD28 receptor.

The discovery behind the present patents was the existence of an inhibitory receptor on T cells, PD-1, and that, when PD-1 binds to one of its ligands, either PD-L1 or PD-L2, the T cell is inhibited and does not attack the cell expressing the ligand. Expression of the PD-1 ligands in healthy cells generally shields them from attack, but some tumor cells can also express the ligands, allowing them to circumvent an immune response. The patents in this case capitalize on the discovery of the PD-1 receptor-ligand interaction. Each claim recites uses of antibodies that target either the PD-1 receptor or its PD-L1 ligand, blocking the receptor-ligand interaction. By blocking the interaction, the use of the inventions in effect stimulates the immune response against tumor cells [**4]  that would otherwise have been hidden by their expression of the PD-L1/L2 ligands.

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964 F.3d 1365 *; 2020 U.S. App. LEXIS 21704 **; 2020 U.S.P.Q.2D (BNA) 10775

DANA-FARBER CANCER INSTITUTE, INC., Plaintiff-Appellee v. ONO PHARMACEUTICAL CO., LTD., TASUKU HONJO, E.R. SQUIBB & SONS, L.L.C., BRISTOL-MYERS SQUIBB COMPANY, Defendants-Appellants

Prior History:  [**1] Appeal from the United States District Court for the District of Massachusetts in No. 1:15-cv-13443-PBS, United States District Judge Patti B. Saris.

Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 379 F. Supp. 3d 53, 2019 U.S. Dist. LEXIS 83375 (D. Mass., May 17, 2019)

Disposition: AFFIRMED.

CORE TERMS

patents, invention, tumors, inventorship, ligands, inventor, receptor, antibodies, collaboration, bind, cancer, inhibits, discovery, blocking, interaction, knockout, sequence, pathway, anti-PD-1, mice, provisional, inhibitory, dendritic, receptor-ligand, jointly, protein, mouse

Patent Law, Originality, Correction of Inventorship Errors, Joint & Sole Inventorship