The Catholic University of America

Summary of Federal Laws

Research

Compliance Partners

Associate Provost for Research

Related Policies

Patent Policy

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.

Changes To Implement the First Inventor To File Provisions of the Leahy-Smith America Invents Act, Final Rule, 78 Fed. Reg. 11023, Feb. 14, 2013
The rule revises the rules of practice in title 37 of the Code of Federal Regulations to implement, and to address the examination issues raised by, section 3 of the Leahy-Smith America Invents Act (AIA), which, inter alia, converted the U.S. patent system from a “first to invent” to a “first inventor to file” system. These changes in section 3 of the AIA are effective on March 16, 2013.


Examination Guidelines for Implementing the First Inventor To File Provisions of the Leahy-Smith America Invents Act,
78 Fed. Reg. 11059, Feb. 14, 2013
The USPTO is providing the examination guidelines to assist in the implementation of the “first inventor to file” provisions of the Leahy-Smith America Invents Act (AIA), and to clarify certain aspects of the law in response to public comment. The guidelines will be effective as of March 16, 2013.

 

Changes To Implement Derivation Proceedings, Final Rule, 77 Fed. Reg. 56067, Sept. 11, 2012. Effective March 16, 2013.

Changes to Implement the First Inventor to File Provision of the Leahy-Smith America Invents Act, 77 Fed. Reg. 43742, July 26, 2012, Proposed Rule. The Leahy Smith Act amends the patent laws by converting from a first to invent system to a first inventor to file system. For an article summarizing (and critiquing) the changes see the New York Times article titled "Inventor Challenges a Sweeping Revision in Patent Law", posted August 26, 2012.

Examination Guidelines for Implementing the First Inventor to File Provision of the Leahy-Smith America Invents Act, 77 Fed. Reg. 43759, July 26, 2012.

The USPTO is publishing proposed examination guidelines concerning the “first inventor to file” provisions of the Leahy-Smith America Invents Act (AIA), which converted the U.S. patent system from a “first to invent” system to a “first to file” system. These Guidelines will assist the Office in, and inform the public of how the Office is, implementing the “first inventor to file” provisions of the AIA.

 

Changes To Implement the Supplemental Examination Provisions of the Leahy-Smith America Invents Act and To Revise Reexamination Fees; Proposed Rule, 77 Fed. Reg. 3666, Jan. 25, 2012
The supplemental examination provisions permit a patent owner to request supplemental examination of a patent by the USPTO to consider, reconsider or correct information believed to be relevant to the patent.

Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act, Proposed Rule, 77 Fed. Reg. 442, Jan. 5, 2012
The proposed rule would implement miscellaneous post patent provisions of the America Invents Act, including expanding the scope of information that parties may site in patent file to include written statements made by a patent owner before a Federal court or the USPTO.

Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act, Proposed Rule,  77 Fed. Reg. 448, Jan. 5, 2012
The proposed rule would change the rules of patent practice to provide a mechanism for third parties to submit to the USPTO any patents, published patent applications, or other printed publications of potential relevance to the examination of the applications.

Changes To Implement the Inventor's Oath or Declaration Provisions of the Leahy-Smith America Invents Act; Proposed Rule, 77 Fed. Reg. 982, Jan. 6, 2012
The proposed rule would revise and clarify the existing rules of practice regarding the inventor’s oath or declaration, including reissue oaths or declarations, assignments containing oath or declaration statements from inventors, and oaths or declarations signed by parties other than the inventors. The proposed rule would also revise and clarify rules of practice for power of attorney and prosecution of an application by a designee.

 

 

Leahy Smith America Invents Act, HR 1249, signed by President on Sept. 16, 2011. A chart of the effective dates of the legislation is posted on the USPTO web page. This bill was supported by higher education and medical schools, and effects an overhaul of patent law. The law changes the system from a first to invent to a first to file system.

See the Press Release issued by the White House as well as the Congressional Research Service Summary.

See the Stanford v. Roche case below for how to draft agreements with researchers.

Commercialization of University Research, Request for Information, 75 Fed. Reg. 14476, March 25, 2010 The White House office of Science and Technology Policy and the National Economic Council are interested in answers to the following questions: What are some promising practices and successful models for fostering commercialization and diffusion of university research? What is the evidence that these approaches are successful? How could these promising practices be more widely adopted? RFI Guidelines: Responses to this RFI should be submitted by 11:59 p.m. Eastern Time on April 26, 2010. Responses to this RFI must be delivered electronically as an attachment to an e-mail sent to NEC_General@who.eop.gov with the subject line "Commercialization of University Research.''

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:

  • whether there is sufficient training to secure full compliance and implementation of the Act;

  • how universities determine when research should become a reportable invention;

  • how universities decide whether to patent inventions;

  • how universities comply with the requirements for small business preferences;

  • how universities monitor their licensees' progress to reach milestones set forth in the license agreements; and

  • whether the Bayh-Dole Act has had the affect of turning faculty away from basic research to more commercial ventures.


    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

Stanford University v. Roche Molecular Systems, U.S. Supreme Court, June 6, 2011. Case No. 09-1159
In a case that highlights the importance of drafting, the U.S. Supreme Court, in a decision (7-2) authored by the Chief Justice, held that an inventor who was a research fellow at Stanford but who also conducted at research at Cetus (with Roche Molecular later acquiring certain Cetus assets relevant to this case) had not signed away his rights to an invention that is used to quantify blood borne levels of the HIV virus. The Court held the Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions, and that patent law is unique and the basic idea that inventors have the right to patent their inventions has not changed "in the 220 years since the first Patent Act." 

The agreement the inventor signed with Stanford stated the inventor "agreed to assign" to Stanford his right title and interest resulting from his employment at the University. In contrast, the agreement he signed at the Company Cetus stated he “will assign and do[es] hereby assign” to Cetus his “right, title and interest in each of the ideas, inventions and improve-ments” made “as a consequence of [his] access” to Cetus."

See the SCOTUS blog for background  documents and analysis of the case.For an excellent article on the case see "The Supreme Court's Decision in Stanford v. Roche: Important Implications for Research Institutions. by David W. Burgett and J. Trevor Cloak,  Medical Research Law and Policy Report, 10 MRLR 435, 6/15/11, BNA, Inc.

Bilski v. Kappos, No. 08-964 US Supreme Court, decided June 28, 2010
In this case the court held that the claims were not patentable becase they recited abstract ideas, and did not meet the "machine or transformation" test. See the Hogan Lovells write up of the case.

Association for Molecular Pathology et al. v. USPTO, et al. (S.D. New York) March 29, 2010 (09 Civ. 4515)

Question presented was are isolated human genes and the comparison of their sequence patentable? The court answered that genes isolated from the DNA sequence are not patentable.

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

Higher Education Association Comments (Oct. 15, 2014) to the USPTO on Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, and Natural Products. **

NACUA Notes: The Leahy-Smith America Invents Act (May 15, 2012)

U.S. Patent and Trademark Office

 

 

 

updated 10-31 to add comments on Guidance

CCR updated CFR links 5/18/15