Dana-Farber Cancer Institute, Inc. v. Bristol-Myers Squibb Co.

CourtDistrict Court, D. Massachusetts
DecidedAugust 13, 2021
Docket1:19-cv-11380
StatusUnknown

This text of Dana-Farber Cancer Institute, Inc. v. Bristol-Myers Squibb Co. (Dana-Farber Cancer Institute, Inc. v. Bristol-Myers Squibb Co.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dana-Farber Cancer Institute, Inc. v. Bristol-Myers Squibb Co., (D. Mass. 2021).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

___________________________________ ) Dana-Farber Cancer Institute, Inc.,) ) Plaintiff, ) ) Civil Action v. ) No. 19-cv-11380-PBS ) Bristol-Myers Squibb, Co., ) E. R. Squibb & Sons, L.L.C., and ) Ono Pharmaceutical Co., Ltd., ) ) Defendants. ) ______________________________ )

MEMORANDUM AND ORDER August 13, 2021 Saris, D.J. INTRODUCTION This case involves a ground-breaking, life-saving invention in the field of cancer immunotherapy. In an earlier case, plaintiff Dana-Farber Cancer Institute, Inc. (“Dana-Farber”) brought an action seeking to correct inventorship of six disputed patents under 35 U.S.C. § 256 (the “Inventorship Case”). On May 17, 2019, this Court held that Dr. Gordon Freeman of Dana-Farber and Dr. Clive Wood, formerly of the Genetics Institute, previously unnamed as inventors of the patents, were joint inventors of the six disputed patents. Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 379 F. Supp. 3d 53, 100 (D. Mass. 2019), aff’d, 964 F.3d 1365 (Fed. Cir. 2020), cert. denied sub nom. Ono Pharm. Co. v. Dana-Farber Cancer Inst., Inc., No. 20- 1258, 2021 WL 2044661 (U.S. May 24, 2021). On June 21, 2019, Dana-Farber commenced the current action against Defendants Bristol-Myers Squibb, Co.; E.R. Squibb &

Sons, L.L.C.; and Ono Pharmaceutical Co., Ltd. (collectively, “Defendants”) alleging, among other things, employment of unfair methods of competition and unfair trade practices (Count I), tortious interference with prospective business relationships (Count II), and unjust enrichment (Count III). On July 30, 2019 and August 20, 2019, the Patent Office added Drs. Freeman and Wood as co-inventors. On December 19, 2019, this Court issued an administrative stay pending the resolution of the appeal in the Inventorship Case. Docket No. 66. The Federal Circuit affirmed this Court’s decision in an opinion and judgment issued on July 14, 2020, and the mandate of the court issued on October 23, 2020. This Court

then restored the case to the active docket. Docket No. 75. Dana-Farber filed an Amended and Supplemental Complaint on January 7, 2021 which added a request for a judicial declaration regarding the inventorship of two newly disputed patents. Docket No. 82. Defendants filed their Motion to Dismiss on February 5, 2021. Docket No. 90. Dana-Farber opposed, and Defendants filed a Reply.1 Docket Nos. 97, 105. On May 5, 2021, by agreement, judgment was entered pursuant to 35 U.S.C. § 256 in favor of Dana-Farber as to Dana-Farber’s claim for correction of inventorship on these new patents. Docket No. 125. Defendants contend that the Amended and Supplemental

Complaint should be dismissed because (1) it is barred under the doctrine of claim preclusion; (2) the claims are preempted under Federal Patent Act; (3) most of the claims are time-barred under the statute of limitations; and (4) Dana-Farber has failed to plead a viable tortious interference claim. After a hearing, Defendants’ Motion to Dismiss the Amended and Supplemental Complaint (Docket No. 90) is DENIED. I. FACTUAL BACKGROUND A. The Parties Dana-Farber is a non-profit corporation which treats adults and children suffering from cancer, provides training for physicians and scientists, and develops future cancer therapies

through research. Bristol-Myers Squibb Co. (“BMS”) and its subsidiary E. R. Squibb & Sons LLC (collectively, “Bristol- Myers”) are biopharmaceutical companies that discover, develop, and deliver medicines for curing serious diseases. Ono

1 The parties also battled over sealing the licenses referred to in the Complaint. See Docket Nos. 121, 127, 128, 129, 137, 138, 139, 141, 143. Pharmaceutical Co., Ltd. (“Ono”) is a Japanese corporation also committed to pursuing the discovery and development of life- saving treatments. B. The Inventorship Case In September 2015, Dana-Farber initiated the Inventorship

Case by filing for correction of inventorship of six patents relating to methods of cancer immunotherapy administration of PD-1 and PDL-1 antibodies. Docket No. 82 ¶¶ 3, 20, 21, 22, 33. Dana-Farber alleged that its scientist Dr. Freeman (as well as another scientist, Dr. Clive Gordon) was wrongfully omitted as an inventor. Id. ¶ 3. Pfizer intervened in the Inventorship Case because it and Wyeth LLC were the parent companies of Genetics Institute, which employed Dr. Wood. In February 2019, on the eve of trial in the Inventorship Case, Defendants settled their infringement action with Pfizer. In the settlement, Pfizer obtained a license for the patents. Id. ¶ 81. Under the agreement, Defendants paid Pfizer an upfront

payment plus a share of Defendants’ future royalties and agreed to pay Pfizer a “bonus” (Dana-Farber’s word) in the event that Defendants succeeded in keeping Dr. Freeman off of the patents. Id. ¶¶ 81, 83. The agreement contained a restrictive covenant that stipulated that Pfizer not seek or obtain a license from any third party (which included Dana-Farber) even if its license was later terminated. Id. ¶¶ 81, 85. In exchange, Pfizer agreed to withdraw its inventorship claim to the patents. Id. ¶ 81. Pfizer also agreed not to support Dana-Farber “in any pending Legal Proceedings among [Dana-Farber] and the BMS/Ono Parties” and agreed that “no Pfizer consultants or advisors shall participate as witnesses (unless by operation of a valid

subpoena) or consultants or advisors in connection with any such Legal Proceeding.” Id. ¶ 83. This last-minute surprise settlement meant that Dr. Gordon did not appear to testify as scheduled, and the trial had to be briefly continued. He did eventually testify. On May 17, 2019, after a bench trial, this Court ruled in Dana-Farber’s favor, finding that Dr. Freeman and Dr. Gordon were joint inventors to the patents. Id. ¶ 23. The patents expire in either 2023 or 2024. C. Defendants’ Patent Infringement Litigation Against Merck and Other Companies

In September 2014, The U.S. Food and Drug Administration (the “FDA”) approved Merck & Co.’s (“Merck”) PD-1 blocking antibody Keytruda®. Id. ¶ 61. That same day, Defendants and Dr. Honjo, the named inventor of the patents, filed a patent infringement lawsuit against Merck. Id. ¶ 62. In 2015, Defendants filed two additional patent infringement lawsuits against Merck. Id. ¶ 67. Only Defendants and Dr. Honjo, then the sole parties with ownership rights to the patents, had standing to sue. Id. ¶ 69. Defendants subsequently filed additional patent infringement actions against Genentech, Pfizer, and AstraZeneca. Id. ¶ 79. D. Defendants’ Other Licensing Agreements Throughout the pendency of the Inventorship Case,

Defendants aggressively pursued commercial opportunities regarding the patents. On January 1, 2017, Defendants entered into a settlement agreement with Merck pursuant to which Merck obtained a license for the patents. In exchange, Merck paid Defendants an upfront fee of $625 million plus an ongoing royalty of 6.5% on worldwide sales of Keytruda®. Id. ¶ 71. Since 2017, Defendants have received more than $2 billion in royalties from Merck. Id. ¶ 74. The agreement also stipulated that Merck would (1) never seek or obtain a license of any of the patents from any third party, even if Merck’s license with Defendants were later terminated; (2) not challenge the inventorship of the patents or support a third party inventorship challenge; and (3)

not provide any attorney work-product covering incorrect inventorship to any third party. Id. ¶¶ 72, 82.

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Dana-Farber Cancer Institute, Inc. v. Bristol-Myers Squibb Co., Counsel Stack Legal Research, https://law.counselstack.com/opinion/dana-farber-cancer-institute-inc-v-bristol-myers-squibb-co-mad-2021.