Publications

While the ethical and legal debate over investigator’s interpretation and publication of clinical study data is likely to continue for some time, as suggested by the Immune Response dispute and the ensuring public interest in the dispute, it is imperative that pharmaceutical and biotechnology companies that engage universities and institutions to perform research and clinical studies take appropriate measures to best protect their confidential information and trade secrets. Since publication of confidential information may serve as a statutory bar to patent protection and result in loss of trade secret protection, particular focus must be paid to the publication clause of all research agreements.

Publication clauses should always provide the sponsor with the prior opportunity to review and comment on any public disclosure (including any publication, poster session, abstract, manuscript and grant application) related to the research or study to: (1) afford the sponsor with an adequate opportunity to file patents on any patentable material that may be contained in the proposed publication, and (2) ensure compliance with the agreement’s confidentiality provisions by permitting removal of sponsor’s trade secrets from the proposed publication.

Under the United States’ patent laws, an inventor will be denied a patent if, more than twelve months before filing the patent application, the inventor disclosed the invention in a printed publication in the United States or foreign country. Other countries do not grant the inventor a grace period following disclosure for filing the patent application.

The sponsor’s rights to review publications must extend to presentations because the delivery of a speech at an academic conference may constitute or result in a printed publication. In addition, the sponsor should have the right to review any manuscripts, abstracts, poster sessions and hand-outs for teaching purposes that relate to the research study, and any other dissemination of the invention that may be accessible to the public, including information that may be accessible to the public through the Freedom of Information Act, such as grant proposals. Since dedication of an invention to the public is the basis for the publication bar of the Patent Act, disclosure of the knowledge of an invention to another without securing a commitment of confidentiality may be considered dissemination of the invention to the public because the inventor no longer controls the knowledge of the invention.

The sponsor should request a copy of the patent and publication policies of the university or institution and thoroughly consider the impact such policies may have on the agreement’s confidentiality and publication provisions; particularly if the agreement is “subject to” such policies. Reasonable patent policies generally provide for a short delay in the publication of research result for patenting purposes and sponsor’s review of confidential information, but the university will be reluctant to agree to any provision the permits suppression of the publication or the sponsor’s right to impose substantive changes in the publication.

Finally, the sponsor should take all appropriate measures to limit public disclosure of its trade secrets and proprietary information, including clinical data, by: (a) limiting access to only those investigator’s who have a need to know; (b) discussing confidentiality at the outset with each clinical investigator; (c) requiring that each investigator sign a confidentiality agreement or ensuring that each investigator have a written agreement with the university or institution; (d) prohibiting the photocopying of proprietary documents, including, except to the extent necessary to conduct the study, study data; (e) monitoring access by maintaining logs of the nature and scope of disclosure; (f) limiting the scope of proprietary information to only that information that is necessary for the individual investigator or researcher to perform the contract services: and (g) marking documents as “proprietary” or “confidential”.

A well-drafted publication clause will strike a fair balance between the sponsor’s interest in protecting its patentable information and trade secrets and the university’s general commitment to openness in research and publication of results.

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