АҚШ-тың патент құқығы және мемлекеттік ғылыми зерттеулер туралы Bayh-Dole заңы

United States law regarding patent rights and government research

The Bayh–Dole Act or Patent and Trademark Law Amendments Act (Pub. L. 96 517, December 12, 1980) is United States legislation permitting ownership by contractors of inventions arising from federal government funded research. Sponsored by senators, Birch Bayh of Indiana and Bob Dole of Kansas, the Act was adopted in 1980, is codified at 94 Stat. 3015, and in 35 U. S. C. § 200–212, and is implemented by 37 C. F. R. 401 for federal funding agreements with contractors and 37 C. F. R 404 for licensing of inventions owned by the federal government. A key change made by Bayh–Dole was in the procedures by which federal contractors that acquired ownership of inventions made with federal funding could retain that ownership. Before the Bayh–Dole Act, the Federal Procurement Regulation required the use of a patent rights clause that in some cases required federal contractors or their inventors to assign inventions made under contract to the federal government unless the funding agency determined that the public interest was better served by allowing the contractor or inventor to retain principal or exclusive rights. The National Institutes of Health, National Science Foundation, and the Department of Commerce had implemented programs that permitted non profit organizations to retain rights to inventions upon notice without requesting an agency determination. By contrast, Bayh–Dole uniformly permits non profit organizations and small business firm contractors to retain ownership of inventions made under contract and which they have acquired, provided that each invention is timely disclosed and the contractor elects to retain ownership in that invention. A second key change with Bayh–Dole was to authorize federal agencies to grant exclusive licenses to inventions owned by the federal government.

There is a growing body of case law on Bayh–Dole.

Stanford v. Roche, was a case decided by the Supreme Court that held that title in a patented invention vests first in the inventor, even if the inventor is a researcher at a federally funded lab subject to the Bayh–Dole Act. The judges affirmed the common understanding of US Constitutional law that inventors automatically own their inventions, and contractual obligations to assign those rights to third parties are secondary. The case arose because a Stanford employee, who was under obligation to assign certain inventions to Stanford, if Stanford was required by law or contract to own them, was sent by Stanford faculty to work at a biotech company to learn polymerase chain reaction, a proprietary technique, and signed an agreement with that company assigning his future inventions, related to the PCR method, that he learned from the company. The company was later purchased by Roche. Stanford filed patents on PCR related inventions, that the employee made, after he returned to Stanford. Roche, that purchased the startup soon thereafter, introduced the first commercially successful HIV tests, which embodied the PCR technology of the Stanford's patents. When Stanford sued Roche for infringing its patents, Roche countered, that it had an ownership interest in the patents due to the agreement that the Stanford employee had signed earlier with the startup company. Among the arguments Stanford made at the District, Federal Circuit, and Supreme Court levels, was one that stated that the Bayh–Dole Act gave grant recipients a "right of second refusal" subject to the Government's right of first refusal, based on the following language of the statute: "If a contractor does not elect to retain title to a subject invention in cases subject to this section, the Federal agency may consider and after consultation with the contractor grant requests for retention of rights by the inventor subject to the provisions of this Act and regulations promulgated hereunder." While the district court accepted that argument, both the Federal Circuit and the Supreme Court denied it, leaving the basic law of inventorship unchanged and making clear that Bayh–Dole did not give federal contractors any special right to inventions made in federally funded work. the court held that since the appellant failed to comply with the invention disclosure provisions of a contract, the court upheld the transfer of title to an invention to the U. S. Army. Specifically, the contract required, per Bayh–Dole, that an invention be disclosed to the U. S. Army through a specific form, DD Form 882s. Campbell Plastics never disclosed its subject invention through this form. Campbell Plastics argued instead that it disclosed all parts of its invention over the course of the contract, but simply never used the form. The court did not specifically address the legitimacy of the particular form, but assumed that it was sufficient. Nevertheless, the court found that the "piecemeal submissions [did] not adequately disclose the subject invention under the contract." The result was a forfeiture of the subject invention.

In a footnote in a famous experimental use case, Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002), the court briefly mentions Bayh–Dole in suggesting that experimental uses by researchers are supported under the law. Specifically, the Madey court quoted the district court as holding that where a subject invention exists and the defendant is a recipient of government funding, "in light of the Bayh–Dole Act use of the patents that has been authorized by the government does not constitute patent infringement."

In University of Rochester v. G. D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), the court rejected a claim that Bayh–Dole altered the grounds for patentability. The court, quoting an Amicus curiae, stated

no connection exists between the Bayh–Dole Act and the legal standards that courts employ to assess patentability. Furthermore, none of the eight policy objectives of the Bayh–Dole Act encourages or condones less stringent application of the patent laws to universities than to other entities.

Despite an ambiguity noted by commentators as to the effects on the public of a contractor's failure to comply with the requirements of Bayh–Dole, the courts have clarified that any such failure does not in and of itself divest an owner of title or render a patent invalid.