Hoffmann-La Roche Inc. v. Yoder

950 F. Supp. 1348, 1997 U.S. Dist. LEXIS 51, 1997 WL 7284
CourtDistrict Court, S.D. Ohio
DecidedJanuary 7, 1997
DocketCivil Action 2-96-204
StatusPublished
Cited by8 cases

This text of 950 F. Supp. 1348 (Hoffmann-La Roche Inc. v. Yoder) is published on Counsel Stack Legal Research, covering District Court, S.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hoffmann-La Roche Inc. v. Yoder, 950 F. Supp. 1348, 1997 U.S. Dist. LEXIS 51, 1997 WL 7284 (S.D. Ohio 1997).

Opinion

OPINION & ORDER

DLOTT, District Judge.

This case presents novel questions concerning whether documents provided to a physician by a pharmaceutical company for use in connection with clinical drug trials are protected “trade secrets” under Ohio’s Uni *1350 form Trade Secrets Act. The Plaintiff, Hoffmann-La Roche, Inc. (hereinafter “Roche”) alleges that more than 550 pages of documents obtained by the Defendant in the late 1970s and early 1980s while he served as a clinical investigator for Roche constitute “trade secret” information of the company. The Defendant, Frank W. Yoder, M.D., argues that such information has been the subject of widespread publication within the medical field and thus is generally known and readily available. Dr. Yoder also argues that Roche, both at the time he received the documents and over the past fifteen years, has not made reasonable efforts to maintain the secrecy of the information provided, and thus has forfeited any claim to trade secret protection under Ohio law.

On March 20, 1996, the Court heard testimony on Plaintiff’s motion for a preliminary injunction to enjoin the Defendant from selling the documents at issue. At that time the Court granted Defendant’s motion to consolidate the hearing on the preliminary injunction with the ultimate trial on the merits, pursuant to Federal Rule of Civil Procedure 65(a)(2). The matter was continued until April 24, 1996, at which time all testimony concluded. On July 31, 1996, the Court ordered the Plaintiff to provide the Court with additional information regarding litigation in New Jersey involving Roche and the secrecy of similar documents, and to compile an index of the documents involved in this case. This matter is now ripe for final decision.

I. FINDINGS OF FACT

Hoffmann-La Roche is a duly organized corporation existing under the laws of the State of Delaware with its principal place of business in New Jersey. Roche is involved in the business of, among other things, the manufacture, sale and distribution of various pharmaceutical and medical products. In the late 1970s Roche received permission from the Food and Drug Administration (hereinafter “FDA”) to conduct clinical investigations on 13-Cis Retinoic Acid — the active ingredient in the drug currently known as “Accutane”. 1 As part of its clinical trials, Roche retained physicians from around the country to prescribe Accutane to their patients.

The Defendant, Dr. Yoder, served as one such clinical investigator for Roche from approximately 1977 to 1983. Prior to that— from 1975 to 1977 — Dr. Yoder was involved with the study of Accutane while serving as a clinical associate at the National Institute of Health (“NIH”) under the supervision of Dr. Gary Peck. Dr. Yoder left the NIH in 1977 and moved to Columbus, Ohio, where he opened his own private practice and became a Roche clinical investigator.

Roche compensated Dr. Yoder on a reimbursement basis, with approximately $1,500 allotted for each patient’s treatment. These payments lessened over time and were ultimately eliminated once the drug was approved. All of Dr. Yoder’s work for Roche was carried out at his offices. It is undisputed that at all times during the course of the Accutane trials Dr. Yoder’s primary responsibility was to his patients.

From 1977 to 1981 Dr. Dorothy Windhorst served as Roche’s Director of Clinical Research for retinoids. As such, Dr. Windhorst supervised Roche’s clinical trials relating to Accutane and was responsible for selecting, retaining, meeting and instructing the Accutane clinical investigators. As part of the clinical trials Roche provided its investigators with materials relating to Accutane, including protocols setting forth the standards and guidelines for conducting the trials and investigational drug brochures (hereinafter “IDB” or “IDBs”) outlining the results of animal and clinical studies conducted by Roche.

On January 12, 1996, Dr. Yoder sent a letter to Roche enclosing a photocopy of an advertisement indicating that he intended to sell his collection of documents relating to Accutane, including an unpublished manu-. script written by him entitled, “Accutane Induced Birth Defects — A Preventable Tragedy.” The advertisement, published in The Columbus Daily Reporter on January 4, 1996, stated in relevant part:

*1351 UNIQUE SEALED-BID AUCTION
The entire private collection of Frank W. Yoder M.D. regarding the development, use and misuse of ISOTRETINOIN (Accutane) will be sold by a sealed-bid auction. This sale includes documents relating to the original protocol, letters from European investigators, and a never before distributed or published manuscript titled, “Isotretinoin Birth Defects — A Preventable Tragedy.”
Individuals, corporations and all other serious parties are invited to participate in this unique and one time event. The minimum bid is $9.5 million dollars (U.S. Currency) and 20% of the net proceeds will be designated for the prevention of birth defects.

Pl.’s Ex. 1. A similar advertisement appeared in The Washington Post on February 11,1996. Dr. Yoder testified that the roughly 550 pages of documents at issue are important because they comprise about 20% of the footnotes and references for his manuscript. Transcript, April 24, 1996, (hereinafter “Tr. 2”) at 182-83. He stated that although he believes most of the information at issue is published elsewhere in medical literature, the information “becomes important because of what was omitted from the black book, from the IDBs, and if I don’t have that, it destroys, it weakens the manuscript that I wrote.” Tr. 2 at 183. Finally, Dr. Yoder testified that the documents at issue are only a portion of his life’s work in collecting documents relating to the development of Accutane. Tr. 2 at 158.

On February 27, 1996, Roche filed suit against Dr. Yoder, seeking an injunction to prevent Dr. Yoder from selling or disseminating “any highly proprietary, confidential and trade secret information Dr. Yoder received from Roche while he was a clinical investigator for Roche regarding Accutane” and seeking replevin of such documents. Compl. at ¶38. By letter dated March 1, 1996, the parties agreed to hold the contested documents in status quo pending the Court’s determination of whether these documents constitute protected trade secrets under Ohio law. J. Entry, March 19, 1996 (Docket No. 17).

The documents at issue in this case can be grouped into three broad categories: (1) protocols for clinical trials or materials related directly thereto, (2) investigational drug brochures, and (3) correspondence between Roche and Dr. Yoder from 1977 to 1983. 2

Roche lists as “Protocol Materials” Document Nos. 4 and 172-175. 3 A careful review of these documents, however, reveals that they are overlapping, versions of the same two protocols, Protocol 970 (Doe. No. 172) and Protocol 2109A (Doc. No. 175). 4

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Bluebook (online)
950 F. Supp. 1348, 1997 U.S. Dist. LEXIS 51, 1997 WL 7284, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hoffmann-la-roche-inc-v-yoder-ohsd-1997.