Summary of Federal Laws
Research
The Bayh-Dole Act of 1980 (Patent Rights in Inventions Made with Federal Assistance)
35 U.S.C. § 200-212; 37 C.F.R. Part 401
Purpose: Establishes a uniform policy for the disposition and licensing of rights to patentable inventions discovered in the course of federally-funded research. The definition of a subject invention is intellectual property that is either conceived or first actually reduced to practice in performance of a government-funded project. This Act gives grantee/contractor organizations first rights to title of a subject invention stemming from federally-funded research, provided the federal funding agency is notified of the invention within 60 days, receives a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention, the federal agency support is acknowledged in any related patent application, and commercialization is actively pursued. In certain instances, the university may retain title to inventions made with the assistance of federal funding.
Obligations of Grantee/Contractor Organizations:
Establish and implement an employee invention reporting policy.
Report all subject inventions to the federal funding agency within 60 days after the inventor discloses the invention to the university.
Elect title (or waive title) within two years.
File for a patent within one year of electing title, or public disclosure, whichever comes first (patents not required for biological material). The university must, within 10 months of the U.S. filing, notify the agency wither it will file foreign applications.
Provide a confirmatory license to the government.
Acknowledge federal government support in the patent application.
Notify the federal agency of any decision not to pursue patent rights (or licensing).
Submit an annual utilization report for all patented and licensed inventions.
Submit a final invention statement and certification within 90 days of the end of the project period.
Ensure that sponsored research agreements preserve the freedom for academic researchers to select projects, collaborate with other scientists, determine the types of sponsored research activities they wish to participate in, and communicate their research findings at meetings and by publication and through other means.
Ensure that the timely dissemination of research findings is not adversely affected by the conditions of a sponsored research agreement. A delay of disclosure of findings of 30 -60 days is generally viewed as a reasonable amount of time for the industrial sponsor to secure intellectual property rights. Recipients should not enter into sponsored research agreements that permit a sponsor to tie up the development of a technology by acquiring exclusive licensing rights to the product of given research results before deciding whether or not it will actively develop and commercialize that product.
There is a requirement that products developed with federal funds and used and sold in the U.S. be substantially manufactured in the U.S.
Ensure that the rights to inventions made with federal funding are not assigned without federal agency approval, that royalties are shared with the inventors, with the balance going to the support of scientific research or education, and that reasonable efforts are made to attract licensees of subject inventions that are small business firms.
USPTO Examination Guidelines for Determining Obviousness,
Notice, 72 Fed. Reg. 57526 (Oct. 10, 2007)
This notice for determining obviousness under 35 U.S.C. 103 was issued in view of the Supreme Court Decision in KSR International Co. v. Teleflex Inc. The guidelines are effective Oct. 10, 2007.
Rev. Proc. 2007-47
This revenue procedure modifies and supersedes Rev. Proc. 97-14 by providing special rules for federally sponsored research. These special rules provide that the rights of the Federal Government and its agencies mandated by the Bayh-Dole Act will not cause research agreements to fail to meet the requirements of section 6.03 of the Revenue Procedure. Under the stated conditions, such rights themselves will not result in private business use by the Federal Government or its agencies of property used in research performed under research agreements. These special rules do not address the use by third parties that actually receive more than non-exclusive, royalty-free licenses as the result of the exercise by a sponsoring Federal agency of its rights under the Bayh-Dole Act, such as its march-in rights. See IRS Releases Guidance on Federally Sponsored Research Agreements.
Joint Statement on Licensing University Technology
A statement/paper issued in March 2007 by 11 schools and the AAMC and WARF, that contains suggested guiding principles for university technology transfer agreements.
The Edison System: The Edison system uses Web technology to allow grantee/contractor organizations to report and monitor their invention reports to the NIH, USDA/CSREES, EPA, NOAA, FDA, USAID, CDC, ATSDR, and NSF in an electronically secure environment.
This site also provides users with instructions for complying with government regulations. The long-term goal of NIH is to become fully automated and dispense with paper document invention reporting.
GAO Review: Review by the General Accounting Office on Bayh-Dole compliance is likely to focus on the following:
USPTO: Changes to information disclosure statement (IDS) requirements, Notice of Proposed Rulemaking, 71 Fed. Reg. 38808 (July 10, 2006)
This Proposed Rule revises IDS requirements, allowing patent examiners to provide more timely, higher quality service by enabling them to focus on the relevant portions of the submitted information at the very beginning of the examination process.
The USPTO proposes changes related to submissions of IDSs by patent applicants and owners. Before a first Office action on the merits, the Proposed Rule requires additional disclosures for (1) English language documents over twenty-five pages in length; (2) foreign language documents of any length; and (3) applications where more than twenty total documents are cited.
The mandatory additional disclosures include (1) specification of additional information such as features, showings, or teachings that caused a document to be cited in the IDS and where in the document the information can be found; and (2) a correlation of the specific information to related patent claim language.
Selected Case Law
Campbell Plastics v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004)
Write up courtesy of Harold J. Evans, Williams & Anderson PLC
The court in Campbell Plastics v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004), held that "a contractor's piecemeal submissions of progress reports and drawings disclosing features of invention developed pursuant to its contract did not satisfy requirements of Federal Acquisition Regulations (FAR) incorporated into contract that required inventions to be disclosed in a single, written report within two months after invention was disclosed to contractor personnel for patent matters, entitling government to take title to the invention under the FAR." We (attorneys representing higher education institutions) have often worried about federal agencies exercising their "march-in rights" but agencies actually have less discretion to exercise such rights as noted by NIH in In re Norvir last year. Now, however, it appears that agencies have considerable discretion in deciding whether or nor to take title to an invention if it is not disclosed within two months of its reporting to an institution's research or tech transfer office.What follows is advice by Attorney Evans to higher education attorneys on the above case: Diligence is highly recommended. Many of you may have already done this but, if you have not, I believe that each of you should inform your research and tech transfer offices about the recent federal circuit decision which strictly interpreted the invention disclosure requirements of the Bayh-Dole Act. (dated Feb. 2005)
Resources
U.S. Patent and Trademark Office
IP Watchdog Web page on Patents
updated 6/7/09 by mlo to add related policy
compliance box links updated 6/10/09 rab
Last Revised 10-Jun-09 02:07 PM.
