Bayh–Dole Act

The Bayh–Dole Act or Patent and Trademark Law Amendments Act is United States legislation dealing with intellectual property arising from federal government-funded research. Adopted in 1980, Bayh-Dole is codified in -212, and implemented by 37 C.F.R. 401. Among other things, it gave U.S. universities, small businesses and non-profits intellectual property control of their inventions and other intellectual property that resulted from such funding. The Act, sponsored by two senators, Birch Bayh of Indiana and Bob Dole of Kansas, was enacted by the United States Congress on December 12, 1980.

Perhaps the most important change of Bayh-Dole is that it reversed the presumption of title. Bayh-Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government.

Recipient requirements
Small businesses and non-profit organizations can retain the title in a federally funded "subject invention." In exchange, the organization is required to
 * Report each disclosed invention to the funding agency
 * Elect to retain title in writing within a statutorily prescribed timeframe
 * File for patent protection
 * Grant the federal government a non-exclusive, non-transferable, irrevocable, paid-up license to practice or have practiced on its behalf throughout the world
 * Actively promote and attempt to commercialize the invention
 * Not assign the rights to the technology, with a few exceptions
 * Share royalties with the inventor
 * Use any remaining income for education and research
 * Give preference to U.S. industry and small business

Subject inventions
A subject invention is defined as "any invention of the contractor that is conceived or first actually reduced to practice in the performance of work under a funding agreement." In Stanford v. Roche, the US Supreme Court made clear that "of the contractor" means "owned by or belonging to the contractor." Thus, subject inventions represent a subset of all inventions that may be made under a federal funding agreement; namely, those for which the contractor has obtained ownership:

"The Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have.... Only when an invention belongs to the contractor does the Bayh-Dole Act come into play."

The CFR addresses the relationship between federal funding and other funding that may supplement the federally supported research. If an invention is made outside the research activities of the federally funded research "without interference with or cost to the government-funded project," then the invention is not a subject invention. Similarly, an invention is not a subject invention if it arises in closely related research outside the "planned and committed activities" of the federally funded project, and the closely related research does not "diminish or distract from the performance" of the federally funded project.

Many institutions have assumed that where federal funds have been used anywhere in a lab, a subject invention exists.

History
Prior to the enactment of Bayh-Dole, the U.S. government had accumulated 30,000 patents. Only approximately 5% of those patents were commercially licensed.

After World War II, the government began spending a great deal of money to support public research in military, defense and medical technologies (through the newly founded National Science Foundation). However, the government did not have a unified patent policy. At one point, those interested in government intellectual property were faced with dealing with 26 different agency policies.

The government's steps towards unification began in 1963 with Jerome Wiesner, President John F. Kennedy's science advisor, and culminated in 1971 under President Richard Nixon. Nevertheless, all these policies directed title to the agencies and not to the public.

Many non-profit organizations, led by the University of Wisconsin–Madison, sought even more favorable policies. In 1968 and 1973, the University successfully lobbied for agencies to enter into Institutional Patent Agreements (IPA), which, among other things, allowed universities and non-profits with approved patent policies to retain title to their inventions. Although agreed to by only two agencies, the Health and Human Services (HHS) and National Science Foundation, the IPA laid the groundwork for enacting Bayh-Dole less than 10 years later.

Legal proceedings and case law
There has not yet been a considerable amount of case law covering the Bayh–Dole Act. However, in February 2011, the Supreme Court heard arguments in Stanford v. Roche on whether a university's right under the Act "can be terminated unilaterally by an individual inventor through a separate agreement".

Disclosure of subject inventions
Only one case has discussed the implications of disclosing subject inventions. In Campbell Plastics Engineering & Mfg., Inc. v. Les Brownlee, 389 F.3d 1243 (Fed. Cir. 2004), 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.

Extent of the government's license
In a footnote in the famous experimental use case, Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002), the court mentions Bayh-Dole. There is ultimately very little treatment of the topic. Instead the 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."

Bayh-Dole and patentability
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 curiæ, 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."

Petitions for march-in rights
The government's march-in right is one of the most contentious provisions in Bayh-Dole. It allows the funding agency, on its own initiative or at the request of a third party, to effectively ignore the exclusivity of a patent awarded under the act and grant additional licenses to other "reasonable applicants." This right is strictly limited and can only be exercised if the agency determines, following an investigation, that one of four criteria is met. The most important of these is a failure by the contractor to take "effective steps to achieve practical application of the subject invention" or a failure to satisfy "health and safety needs" of consumers.

Though this right is, in theory, quite powerful, it has not proven so in terms of its practical application — to date, no federal agency has exercised its march-in rights. Four march-in petitions have been made to the National Institutes of Health, however, and pharmaceutical companies occasionally instruct their legal departments to evaluate the risk of march-in prior to negotiating contracts for drugs licensed under Bayh-Dole. March-in petitions for inventions funded under the NIH are heard by the NIH Office of Technology Transfer.

In In Re Petition of CellPro, Inc., CellPro first argued that The Johns Hopkins University and Baxter Healthcare failed to take reasonable steps to commercialize certain patented stem cell technologies and that Johns Hopkins should be forced to license Cellpro the patent necessary to keep its machine on the market. The NIH denied this claim citing: The NIH also denied Cellpro's claim that it needed Johns Hopkins's patents to keep its device on the market for health and safety reasons. The NIH also mentioned the adverse effects that a march-in decision would have on federal efforts to encourage firms to commercialize federally funded research.
 * Johns Hopkins's licensing of the subject invention
 * Baxter's use, manufacturing, and practice of the subject invention
 * Baxter's application to the Food and Drug Administration (FDA)

In In the Case of NORVIR, the NIH received a request from Essential Inventions, supported by the public and members of the United States Congress, to exercise march-in rights for patents owned by Abbott Labs covering the drug ritonavir, sold under the trade name Norvir, a prescription drug used in the treatment of AIDS. Abbott had recently raised the price of Norvir 400% for U.S. customers (but not for consumers in any other country), and had refused to license ritonavir to another company for purposes for providing protease inhibitors coformulated with ritonavir. The NIH denied the petition finding no grounds to exercise its march-in rights. The NIH cited:
 * The availability of Norvir to patients with AIDS
 * That there was no evidence that health and safety needs were not adequately met by Abbott, and
 * That the NIH should not address the issue of drug pricing, only Congress.

In In the Case of Xalatan Pfizer's glaucoma drug was sold in the United States at two to five times the prices in other high income countries. Essential Inventions asked the NIH to adopt a policy of granting march-in licenses to patents when the patent owner charged significantly higher prices in the United States than they did in other high income countries. The NIH held that “the extraordinary remedy of march-in was not an appropriate means for controlling prices.”

In In the Case of Fabrazyme patients with Fabry disease petitioned on August 2, 2010, for march-in rights in response to Genzyme's inability to manufacture enough Fabrazyme to treat all Fabry patients. In 2009, Genzyme rationed the drug to less than a third of the recommended dose as a result of manufacturing problems and FDA sanctions but did not anticipate being able to meet the market needs until late 2011. The patients had a return of their symptoms and were put at greater risk of morbidity and mortality at the mandatory reduced dosage. The petitioners contend that where a licensee of a public invention has created a drug shortage, the public health requirements of the Bayh-Dole act are not met and other manufacturers should be allowed to enter the market.

On November 3, 2010, the NIH denied the petition for March-in stating that the current FDA drug approval process would take years of clinical testing to bring a biosimilar of Fabrazyme to market. Because of the long delay in the approval process even if March-in were granted, the NIH contends that the problem would not be solved. In a deviation from prior March-in requests, the NIH also stated that it would continue to monitor the situation and if Genzyme could not meet its production deadlines, or if a third party licensee requested a license, the March-in request would be revisited. NIH additionally required regular updates from Mount Sinai School of Medicine, the patent holder, which agreed to not seek injunctions for potentially infringing products being sold during the shortage.