University faculty often are under the impression that grant proposals or submissions to regulatory agencies remain strictly confidential. In some situations, however, a grant proposal or a submission to a regulatory agency might be considered a printed publication.
This is the seventh post in our series examining what constitutes a “printed publication.” Our first post provided an introduction and summary of the statutory basis for printed publications under 35 U.S.C. § 102; our second post examined whether patents and published patent applications can be printed publications; our third post discussed whether theses, dissertations, and other references in a library can be printed publications; our fourth post investigated under what circumstances presentations at scientific conferences can be printed publications; our fifth post considered whether technical papers, government reports, and related documents can be printed publications; and our sixth post examined whether sales catalogs and technical brochures can be printed publications. These posts can be viewed here: What Constitutes a Printed Publication – Introduction and Statutory Basis – Part 1; What Constitutes a Printed Publication – Patents and Published Patent Applications – Part 2; What Constitutes a Printed Publication – Theses, Dissertations, and other References in a Library – Part 3; What Constitutes a Printed Publication – Presentations at Scientific Conferences – Part 4; What Constitutes a Printed Publication – Technical Reports, Government Reports, and Related Documents – Part 5; and What Constitutes a Printed Publication – Sales Catalogs and Technical Brochures – Part 6
In E.I. Du Pont de Nemours & Co. v. Cetus Corp., 19 U.S.P.Q.2d 1174 (N.D.Cal. Dec. 3, 1990), the reference was an National Science Foundation (NSF) grant proposal. The NSF makes all government records, including awarded grant proposals, available to the public on request under the Freedom of Information Act (FOIA). Further, the grant proposal was listed in an index that included the title, author, institution, and grant number, but not the subject matter. The submitter of the grant proposal was a preeminent researcher in PCR thereby alerting anyone interested in the field to publications under his name. Id. at 1186. The researcher also had cited the NSF grant proposal in a journal article. Id. Based on these facts, the court found that the grant proposal qualified as “printed publication.” Id.
In Oxford Nanopore Technologies Ltd. v. University of Washington, IPR2014-00512, Paper No. 12 (P.T.A.B. Sept. 15, 2014), the references were redacted grant applications to the National Human Genome Research Institute (“NHGRI”). Id. at p. 8. The Board found that the redacted copies of the grant applications did not qualify as “printed publications.” Id. at p. 10. The Board reasoned that an opportunity existed, at all times after the grant award dates, to remove confidential proprietary information from the grant applications and that the redacted copies of the grant applications represent what was available to the public at the time of the FOIA request, not at a time before the critical date of the patent in dispute. Id. at p. 10-11. Further, there was no evidence that the grant applications were catalogued or indexed in a meaningful way and there was no prior art reference that cited the grant applications, such as described in the E.I. du Pont case. Id. at p. 11-12.
In In re Lister, 583 F.3d 1307 (Fed. Cir. 2009), the reference was a manuscript that was registered in the U.S. Copyright Office more than one year before the critical date. Id. at 1309-10. The only evidence on the record pertaining to the cataloging or indexing of the manuscript is a statement made in an Information Disclosure Statement (“IDS”) filed with the USPTO during prosecution of the patent application. Id. at 1313. The court found, inter alia, that an interested researcher would be able to gain and retain an understanding of the invention upon inspection of the manuscript and without any need to obtain a copy, id. at 1314, and that the manuscript would have been publicly accessible as of the date that it was included in commercial databases that permitted keyword searching of titles. Id. at 1316. Despite these findings, however, the court ultimately found that no evidence was presented that the manuscript was searchable in a commercial database more than one year prior to the critical date. Id. at 1316-17 (noting that no evidence of the general practice of the Copyright Office or the commercial databases with regard to database updates was presented). Thus, absent such evidence, the court found that they had no basis to conclude that the manuscript was publicly accessible prior to the critical date. Id. at 1317. Accordingly, the court vacated the Board’s decision and remanded for further proceedings. Id.
In Medtronic, Inc. v. NuVasive, Inc., IPR2014-00076, Paper No. 13, (PTAB April 8, 2014), the reference was a redacted 510(k) premarket notification submission made the by Patent Owner to the Food and Drug Administration (FDA). Id. at p. 5. The Patent Owner asserted that the Petitioner obtained the 510(k) submission from the FDA via a FOIA request after the filing date of the patent in question. Id. The Patent Owner argued that it made its 510(k) submission to the FDA confidentially and that it had a right to make substantial redactions to the submission prior to its public release pursuant to a FOIA request. Id. at p. 6. Accordingly, the Patent Owner asserted that the version of the 510(k) submission obtained from the FDA under the FOIA request did not reflect the redactions the Patent Owner would have made at the time the submission was initially available by request. Id. (arguing that what would have been confidential at the time the device was cleared for marketing, was likely no longer confidential at the time of the FOIA request). The Patent Owner argued that to hold otherwise would “be tantamount to transforming a confidential document into prior art.” Id. Accordingly, the Board concluded that the redacted version of the 510(k) submission obtained after the filing date of the patent in question did not qualify as a “printed publication.”
In Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018), the reference involved meeting materials related to an FDA advisory committee meeting. The advisory committee meeting was announced in the Federal Register, stating that the meeting was open to the public and providing a hyperlink to a FDA website where background material would be posted before the meeting, and that the meeting minutes, transcript, and slides would be posted after the meeting. Id. at 1351. The CAFC concluded that several factors supported the Board’s finding that the meeting materials were publicly accessible printed publications. Id. at 1357. These factors included that: (1) the breadth of the dissemination of the materials to persons of ordinary skill was significant; (2) the materials were available online for a substantial time (e.g., two months) before the critical date; and (3) the materials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied. Id. at 1358 (noting that indexing or searchability was not required in this case).
In Incyte Corp. v. Concert Pharm., Inc., IPR2017-01256, Paper No. 14 (PTAB Apr. 8, 2019), the reference was a prescription drug label providing indication of drug and other information, such as dosage, administration, contraindications, adverse reactions, and drug interactions. Id. at p. 11. In this case, although the FDA approved the prescription drug before the critical date, no evidence, e.g., a copy of the document from the FDA’s website, was presented that the drug label was disseminated or otherwise made available to the public. Id. at p. 13. Thus, the Board concluded that the prescription drug label was not a “printed publication” Id. at p. 15.
The key takeaway from these cases is that a grant proposal or a submission to a regulatory agency can, under some circumstances, be a printed publication. Note that upon receiving a FOIA request, the applicant has an opportunity to redact confidential information. A court will view the relevant disclosure in the redacted document as of the date of the FOIA request, which is not necessarily the same as if the document was redacted at the time of filing.
Our next post in this series is related to whether publications on the Internet and internet archives constitute printed publications: What Constitutes a Printed Publication – Publications on the Internet and Internet Archives – Part 8
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