On September 16, 2016, the Department of Health and Human Services ("HHS") published a new rule ("Final Rule") expanding the clinical trial information published to the ClinicalTrials.gov database. On September 16, 2016, the Department of Health and Human Services ("HHS") published a new rule ("Final Rule") expanding the clinical trial information published to the ClinicalTrials.gov database. ClinicalTrials.gov is a public registry for clinical trial information maintained by the National Institutes of Health ("NIH").1 The Final Rule clarifies certain requirements for registration and disclosure. Further, it expands the clinical trial disclosure requirements by:
- Requiring the submission of results information for unapproved drugs, biologics, and device products;
- Requiring the submission of the full protocol and a statistical analysis plan (although some redaction is permitted)2; and
- Expanding the requirements for submission of adverse event information.
These rule changes increase the amount and type of information that will be made accessible to the public. This poses the risk of placing otherwise patentable subject matter in the public domain, and/or making it available as prior art that may be cited by an examiner during prosecution of a patent application and/or used as a basis for alleging invalidity of patent claims in the context of a litigation or post-grant proceeding. This Commentary provides a summary of some of the key new requirements under the Final Rule.
Prior Art and Public Accessibility
The Patent Act provides that: "A person shall be entitled to a patent unless ... the invention was patented or described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention." 35 U.S.C. § 102(a)(1) (AIA). This statutory "bar is grounded on the principle that once an invention is in the public domain, it is no longer patentable by anyone." SRI Int'l, Inc. v. Internet Sec. Sys., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (citation and internal quotation marks omitted). 35 U.S.C. § 102 "serves as a limiting provision, both excluding ideas that are in the public domain from patent protection and confining the duration of the monopoly to the statutory term." Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).
In order for a reference to qualify as a "printed publication" under Section 102, it must be accessible to the public. See In re Wyer, 655 F.2d 221 (CCPA 1981) (citation omitted). "Accessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to." Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1568 (Fed. Cir. 1988). A reference may be deemed "publicly accessible" if it:
has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.
In re Wyer, 655 F.2d at 226; see Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006).3
Download >> NIH Publishes New Clinical Disclosure Rules: Changing Scope of "Publicly Accessible" Information
Footnotes
1 A similar policy was recently released by the European Medicines Agency ("EMA"), whereby clinical data submitted by pharmaceutical companies in their request for market authorization are published.
2 Clinical Trials Registration and Results Information Submission, 81 Fed. Reg. 64981, 64982 (Sept. 21, 2016) (to be codified at 42 C.F.R. Part 11), § 11.48(a)(5) .
3 Publication of data and protocols on ClinicalTrials.gov and by the EMA may also present similar prior art and validity issues for patents and patent applications filed outside the United States.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
