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词条 Government patent use (United States)
释义

  1. Applications of section 1498

     Night-vision goggles (1990s)  Antibiotic ciprofloxacin (2001)  Software (2009)  Green bullets (2014)   Direct-acting antivirals (2015) 

  2. See also

  3. References

  4. External links

Government patent use law is a statute codified at 28 USC § 1498(a)[1] that is a "form of government immunity from patent claims."[2][1] [https://en.wikisource.org/wiki/United_States_Code/Title_28/Chapter_91/Section_1498 Section 1498] gives the federal government of the United States the "right to use patented inventions without permission, while paying the patent holder 'reasonable and entire compensation' which is usually "set at ten percent of sales or less".[2][5][2] This statute "allows federal agencies and thirdparty government contractors to manufacture and/or use any invention without authorization from the patent holder. The federal government's rights are without an obligation for prior negotiation."[3] Although Congress has the right to waive sovereign immunity for alleged patent infringement claims under the 'government patent use' statute, there are limits to the patent holder's recourse in the United States Court of Federal Claims.[4][5][6]

Applications of section 1498

{{quote|Under the Patent and Trademark Law Amendments Act of 1980 (commonly known as the Bayh-Dole Act), patents granted on inventions developed with the use of government funds can be exclusively licensed to promote their commercialization, but the government retains the ability to 'march in" if the patented technology is not made available to the public on reasonable terms.}}

Night-vision goggles (1990s)

The United States Department of Defense began developing night-vision goggles in 1987. They purchased thousands for Operation Desert Storm alone. Gargoyles Inc. acquired the patent for protective eyewear from Pro-Tec Inc in 1988. They "commenced an action under 28 U.S.C. § 1498 for "reasonable and entire" compensation for direct infringement of the patent by the United States. Gargoyles lost their 1996 appeal.[2][7]

Antibiotic ciprofloxacin (2001)

Faced with the anthrax threat of anthrax as a chemical weapon, Tommy Thompson, the 19th Secretary of United States Secretary of Health and Human Services (2001-2005) organized the stockpiling of the treatment, the antibiotic ciprofloxacin brandname Cipro which was manufactured by Bayer. When Bayer refused to lower prices, Tommy Thompson, threatened to invoke import generics under section 1498. In response Bayer guaranteed an adequate supply of Cipro at a 50 percent discount.[8][2]{{rp|794}}

Software (2009)

The United States Department of the Treasury used it to "purchase software without regard to patents" held by Advanced Software Design Corporation.[2] In Advanced Software Design Corp. v. Federal Reserve Bank of St. Louis the court expanded the statute's interpretation to give immunity from liability to private companies as well as persons who are performing work on behalf of the government.[9]

Green bullets (2014)

In 2010 the United States Army completed the development of a green bullet, the M855 A1, which was part of its lead-free initiative begun in the 1990s.[10] Liberty Ammunition Inc sued the United States claiming they were the owners of the patent. The United States Department of Defense invoked section 1498.[2][11][10]

Direct-acting antivirals (2015)

In a May 18, 2016 letter to Secretary Robert McDonald The United States Department of Veterans Affairs, Senator Bernie Sanders (I-VT) suggested that the Secretary "utilize federal law, specifically 28 USC § 1498, to break the patents on these drugs to authorize third parties to manufacture or import them for government use" through section 1498".[21] to "address the funding shortfall that has resulted from the high demand for, and high cost of, direct-acting antivirals."[2][12]

Amy Kapczynski, a Yale University law professor, and Aaron S. Kesselheim, Harvard Medical School associate professor of medicine, proposed that the federal government "invoke section 1498 to make important new high-cost therapies widely available to patients who need them."[13]{{rp|792,793}} By July 2017, Louisiana's health secretary—Rebekah Gee—who described Louisiana as Americas's "public-health-crisis cradle", was investigating the use of the "government patent use" as a strategy.[14] to make Sofosbuvir, a highly effective treatment for hepatitis C which cost $84,000 for a treatment in 2016.[15] Gilead's CEO John Martin has been questioned by Congress on the prohibitive pricing.[16][16][17][18] Louisiana and other states were forced to ration Sofosbuvir by delaying treatment of Medicaid hepatitis patients until the liver presented more severe damage.[14]

See also

  • [https://en.wikisource.org/wiki/United_States_Code/Title_28/Chapter_91/Section_1498 Wikisource]

References

1. ^1 {{cite web |url=https://www.gpo.gov/fdsys/pkg/USCODE-2011-title28/pdf/USCODE-2011-title28-partIV-chap91-sec1498.pdf |format=PDF |date=2006 |title=United States Code, Supplement 5, Title 28 - Judiciary and Judicial Procedure |number=Y 1.2/5}} [https://www.law.cornell.edu/uscode/text/28/1498 Section 1498]. Patent and Copyright cases. Title 28, Judiciary and Judicial Procedure, Part IV. Jurisdiction and Venue. [https://www.law.cornell.edu/uscode/text/28/part-IV/chapter-91 Chapter 91] United States Court of Federal Claims.
2. ^Decca Limited v. United States, 225 Ct. Cl. 326 (1980)
3. ^{{cite journal |last=Love |first=James |title=Non-voluntary use of patents for drugs to treat the hepatitis C virus in the United States: mechanisms available to the federal government, state governments and private actors |location=Washington (DC) |work=Knowledge Ecology International (KEI)|date=July 18, 2014 |series=KEI Policy Brief |number=2014:1|url=http://keionline.org/sites/default/files/Non-voluntary_use_HCV_patents_USA.pdf |format=PDF |access-date=July 4, 2017}}
4. ^See Gray v. Bell, 712 F.2d 490, 507 (D.C. Cir. 1983).
5. ^United States v. Mitchell, 445 U.S. 535, 538 (1980)
6. ^Price v. United States, 174 U.S. 373, 375-76 (1899)
7. ^1 [https://caselaw.findlaw.com/us-federal-circuit/1098010.html Gargoyles, Inc., and Pro-Tec, Inc., v. United States], 113 F.3d 1572 (Fed. Cir. 1997).
8. ^{{cite journal |last=Love |first=James |title=Non-voluntary use of patents for drugs to treat the hepatitis C virus in the United States: mechanisms available to the federal government, state governments and private actors |location=Washington (DC) |work=Knowledge Ecology International (KEI)|date=July 18, 2014 |series=KEI Policy Brief |number=2014:1|url=http://keionline.org/sites/default/files/Non-voluntary_use_HCV_patents_USA.pdf |format=PDF |access-date=July 4, 2017}}
9. ^{{cite web |url=https://caselaw.findlaw.com/us-federal-circuit/1492506.html |title=Advanced Software Design Corp. v. Federal Reserve Bank of St. Louis 583 F.3d 1371 |agency=Federal Circuit Court |date=2009}}
10. ^1 {{cite web |url=https://www.mwe.com/en/thought-leadership/newsletters/2016/09/ip-update-september-2016 |series=Patents Claim Construction |title=Army Ammunition Goes Green and Infringement Free |first=Rita J. |last=Yoon |date=September 2016}}
11. ^Liberty Ammunition, Inc. v. United States, 119 Fed. Cl. 368 (2014).
12. ^1 {{cite web |title=Senator Asks Department of Veteran Affairs to Break Patents on Hepatitis C Drugs|work=Patent Docs|date=May 18, 2015 |url=http://www.patentdocs.org/2015/05/senator-asks-department-of-veteran-affairs-to-break-patents-on-hepatitis-c-drugs.html |access-date=July 4, 2017 |first=Donald |last=Zuhn }}
13. ^1 2 3 4 5 6 7 {{cite journal |url=https://law.yale.edu/system/files/documents/faculty/papers/kapcyznski_govpatentuse.pdf |format=PDF |title='Government Patent Use': A Legal Approach To Reducing Drug Spending |first1=Amy |last1=Kapczynski |first2=Aaron S. |last2=Kesselheim |doi=10.1377/hlthaff.2015.1120 |journal=Health Affairs |date=May 10, 2016 |access-date=June 4, 2017 |volume=35 |number=5791 |pages=791–797}}
14. ^1 {{cite news |url=https://www.washingtonpost.com/business/economy/louisiana-considers-radical-step-to-counter-high-drug-prices-federal-intervention/2017/07/03/456b99f6-4a59-11e7-a186-60c031eab644_story.html?tid=sm_tw |title=Louisiana considers radical step to counter high drug prices: Federal intervention |first=Carolyn Y. |last=Johnson |date=July 3, 2017 |access-date=July 4, 2017 |location=Baton Rouge, Louisiana }}
15. ^{{cite journal|last1=Hill|first1=A|last2=Simmons|first2=B|last3=Gotham|first3=D|last4=Fortunak|first4=J|title=Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C.|journal=Journal of virus eradication|date=1 January 2016|volume=2|issue=1|pages=28–31|pmid=27482432|pmc=4946692}}
16. ^1 {{cite web | url=https://www.bloomberg.com/news/articles/2014-03-21/gilead-s-84-000-treatment-questioned-by-congress | title=Gilead's $84,000 Treatment Questioned by U.S. Lawmakers | publisher=Bloomberg | date=21 March 2014 | accessdate=27 October 2015 | author=Armstrong, Drew}}
17. ^{{cite web | url=http://www.pppmag.com/article_print.php?articleid=1637 | title=The Increasing Impact of High-Cost Specialty Therapies | volume=12 | number=2 | date=February 2015 | publisher=Pharmacy Purchasing & Products Magazine | accessdate=4 December 2015 | author=Lucio, Steven | deadurl=yes | archiveurl=https://web.archive.org/web/20151208051829/http://www.pppmag.com/article_print.php?articleid=1637 | archivedate=8 December 2015 | df= }}
18. ^{{cite web | title=New expensive treatments for hepatitis C infection | work=JAMA | date=2014 | pages=593–594 | author1=Brennan, T. | author2=Shrank W. | volume=312 | number=6}}

External links

  • U.S. Code Title 28, via United States Government Printing Office
  • [https://www.law.cornell.edu/uscode/html/uscode28/usc_sup_01_28.html Text of Title 28 of the U.S. Code at Cornell's Legal Information Institute]
{{USCTitles}}

5 : Titles of the United States Code|United States federal judiciary legislation|United States Court of Federal Claims|Federal sovereign immunity in the United States|Government procurement in the United States
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