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Data Access CRE Analysis 11. The proposed revisions to OMB Circular A-110 would have a negative impact upon industry-university-government partnerships. Comment by American Association of Medical Colleges CRE Response: The threat to cooperation between public and private researchers and the continued viability of these joint research partnerships has been much debated. Regrettably, confusion over the law has even led some members of industry to favor recent legislative initiatives that would undermine the new data access law. CRE continues to believe that this confusion arises from an inadequate understanding of the protections granted under FOIA exemption 4 (discussed elsewhere) and two other statutes, both of which are referenced in the comments of the American Association of Medical Colleges. The Technology Transfer Act protects companies engaged in Cooperative Research and Development Agreements ("CRADAs") with federal agencies. Under CRADAs, the government is granted certain rights to use inventions or other intellectual property of the private party. Pursuant to the National Technology Transfer Act of 1995, the non-disclosure provisions of FOIA exemption 4 apply to these agreements. The Technology Transfer Act, which amended the Stevenson-Wydler Technology Innovation Act of 1980, provides that where the government exercises its license to use an invention: the Government shall not publically disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of [FOIA exemption 4], or which would be considered as such if it had been obtained from a non-federal party. 15 U.S.C. § 3710a(b)(1). A separate provision of the Stevenson-Wydler Act states the matter even more plainly: No trade secrets or commercial or financial information that is privileged or confidential, under [FOIA exemption 4], which is obtained in the conduct of research or as a result of activities under this chapter from a non-Federal party participating in a cooperative research and development agreement shall be disclosed. 15 U.S.C. § 3710a(c)(7). The protections afforded under the Bayh-Dole Act are not affected by the new data access law. That statute provides protections against disclosure of confidential information pertaining to the subject invention while the university or other federal researcher is pursuing a patent. Section 205 of the Bayh-Dole Act states in part:
Federal agencies are authorized to withhold from disclosure to the public information disclosing any invention in which the Federal Government owns or may own a right, title, or interest (including a nonexclusive license) for a reasonable time in order for a patent application to be filed. 35 U.S.C. § 205. Once a patent application is filed, patent office regulations promulgated under the Patent Act, 35 U.S.C. § 122, explicitly grant secrecy to pending information contained therein. 37 C.F.R. § 1.14a. The Bayh-Dole Act also provides that federal agencies shall not be required to release copies of any document which is part of an application for patent filed with the United States Patent and Trademark Office or with any foreign patent office. 35 U.S.C. § 205. Significantly, the Bayh-Dole confidentiality provisions above are wholly unaffected by the passage of the new data access law. Unlike FOIA exemption 3 (5 U.S.C. § 552(b)(3)), which defers to the non-disclosure protections of other statutes, the Bayh-Dole Act contains its own statutory trump card. Section 210 provides:
Precedence of chapter 35 U.S.C. § 210 (emphasis added). In that the Shelby Amendment neither references the Bayh-Dole Act nor states that the confidentiality provisions above shall be overridden, the new data access law can hardly be said interfere with the intellectual property protections of the Bayh-Dole Act. In addition to these statutory protections, additional protections assuring the continued viability of private-federal joint research can and will invariably be secured as individual agencies adopt conforming regulations to implement OMB's revisions to Circular A-110.
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