Now for the University of California, Los Angeles. The Association of University Technology Managers (AUTM) wrote up the UC nicotine patch story with the headline “Turning Quitters Into Winners: The Nicotine Patch Success Story” as part of their “Better World Project”:
Working together with his brother and Murray Jarvik, Ph.D., then head of UCLA’s psychopharmacology laboratory, Jed Rose initiated the research and development of the nicotine patch.
After years of experimentation on hundreds of test subjects, the team, with assistance from the Swiss pharmaceutical company Ciba-Geigy, developed a skin patch that would transmit low doses of nicotine into the bloodstream through a subject’s skin at a rate corresponding to that of smoking. The patch could also be used in combination with a nicotine aerosol spray in development at the time that would mimic some of the sensations associated with inhaling tobacco smoke. The trio of researchers obtained the first of three patents on the technology in May 1990.
This account suggests that UC and Ciba-Geigy worked in a “public-private” partnership to develop the nicotine patch. But it appears that Ciba-Geigy showed up rather late to help to develop the UC invention, and it turns out, didn’t even use the UC invention in its own products. The key discovery worthy of a patent appears to be not the invention of a patch or the use of nicotine in a patch but rather providing a technical means for the nicotine to move into the bloodstream at a rate similar to that obtained by smoking. The two distinguishing elements, then, to the UC version of a nicotine patch were the “rate controlling membrane” and the use of a “nicotine containing aerosol spray” that one would pump into one’s mouth to provide a “desired sensation in the respiratory tract.”
Here’s another account, from a blog at the University of Oregon:
The nicotine patch came out of research from the University of California Los Angeles (UCLA). The technology was developed and patented by UCLA and licensed by Ciba-Geigy as a commercial product. This is a great example of university research that led to a beneficial and potentially lifesaving product for millions.
This account fits the UC work into the standard technology transfer story of basic to applied research and development. UCLA scientists discover something, develop it, and hand off their work to a company for mass production. The “great example” here amounts to little more than adding UC, a company, and a particular item–a nicotine patch–into a template about “technology transfer.”
Here is the Veterans Administration account, from the “VA research in action” web site:
VA researchers developed the nicotine patch in 1984. Researchers tested the patch on themselves, with grants from UCLA and VA, and used their own physiological responses to demonstrate that the patch was safe for human subject testing with smoking volunteers.
Here’s another, with more information, from the UCLA publication “Eureka!”:
Jarvik and Rose (then a postdoctoral fellow at UCLA) were curious about “green tobacco illness,” a malady striking tobacco farmhands harvesting the crop in the South. That led to research on the potential positive implications of absorbing tobacco through the skin, which resulted in the creation of the transdermal patch that delivers nicotine directly into the body.
After years of experimentation on hundreds of test subjects, the team, with assistance from the Swiss pharmaceutical company Ciba-Geigy, developed a skin patch that would transmit low doses of nicotine into the bloodstream through a subject’s skin at a rate corresponding to that of smoking.
And this, from a 2008 UCLA Office of Intellectual Property slide deck, under the caption “A novel idea that stops a deadly addiction and saves lives”:
For UCLA the breakthrough was rewarding. In terms of licensing fees and royalties, the nicotine patch ranked second in income in the UC system in 1992, and was still number four in 1995. It is still known as one of the more successful translations of university basic science to a product that improved the public’s quality of life.
Murray Jarvik, who had done research in the 1970s that showed nicotine blockers changed the smoking preferences of four monkeys taught to smoke, and Jed Rose–a postdoc–worked for both the Veterans Administration and for the University of California, Los Angeles. Such dual appointments are pretty typical. Jarvik and Rose (along with Jed’s brother Daniel Rose, a doctor in private practice) disclosed their invention to the VA, indicating that they had made the invention on VA time, with VA resources. It was Daniel Rose who suggested the idea of a nicotine patch, based on Alza Corporation’s new motion-sickness patch. University of California and VA officials conferred about the invention and reached a deal in which the VA would release any government claim it may have on the invention so that UC could take assignment and manage patenting, provided that UC complied with Bayh-Dole.
This part is weird, since Bayh-Dole would not apply to inventive work done by federal employees until a federal agency acquired ownership of the invention. UC obtained assignments from the three inventors and filed a patent application on April 25, 1985. This application then was divided into three separate patent applications–divisionals, each of which eventually issued as a patent.
The first of these divisional applications claimed a method of helping someone quit smoking by the combination of a nicotine patch and spraying nicotine into that someone’s mouth, to give an oral sensation almost but not entirely unlike that of smoking (filed February 19, 1988 and issued May 1, 1990 as US patent 4,920,989). This application cites five patents as prior art, and three publications. In its second divisional, filed at the same time as the first, UC claimed just the use of a nicotine patch (issued May 21, 1991 as US patent 5,016,652) without the added element of the nicotine mouth spray. This second divisional appears set up to attack Frank Etscorn’s patent with New Mexico Tech Research Foundation.
According to the iffy ipHandbook of Best Practices, Rose and Jarvik worked with Ciba-Geigy (now merged with Sandoz to form Novartis) in their development of the invention. Three months after filing its initial patent application, UC granted Ciba-Geigy an option to license their patch patent. Such options were typical of research agreements rolled into licensing agreements, but such deals later presented problems for UC in explaining how the research money in such a deal wasn’t just another form of allocating royalties–any consideration for a grant of license–for which see the Singer case.
Ciba-Geigy also obtained a series of patents on versions of transdermal patches, starting with “Multicompartamentalized transdermal patches” filed December 17, 1985 and issued May 19, 1987. The improvement claimed by this patch was that the space for containing drugs could be divided, so two distinct drugs could be used together. CG didn’t mention nicotine as one of the drugs–they focused on nitroglycerin and arecoline in dependent claims, but the general claims did not worry which drugs were used. A second patent claimed a new way of handling the adhesive layer of a patch.
Etscorn had filed a patent application on his invention in January 1985 and Alza had filed in October 1987, so Rose et al. and UC were late to the game. However, US patent law at the time was “first to invent” rather than “first to file.” So UC initiated a patent interference, claiming that Rose, Rose, and Jarvik had been the first to conceive the invention of a nicotine patch, based (apparently) on the story Jed Rose told of his brother Daniel suggesting a patch in 1981. Given what was known about transdermal nicotine, its role in efforts to help people to quit smoking, and transdermal patches already developed, if conception of an invention was merely “how about a nicotine patch” then it would appear to be obvious. If the inventive bit involved something particular about how to get nicotine into a patch or out of a patch into the bloodstream, then merely having the idea for a patch containing nicotine would not be conception of a patentable invention. Having an idea about what might be invented isn’t conception, for old-time patent purposes. But if you are into playing patent games, the difference is not worth pointing out.
In any event, in the ensuing battle of documentation, the timing of the Rose story beat out the timing of the Etscorn story, and UC got the first 15 claims of Etscorn’s patent canceled, leaving just 4 method claims. The Chronicle of Higher Education reported that UC and New Mexico Tech had settled their dispute, but the USPTO had invalidated the Etscorn claims. UC and New Mexico Tech spent over one million dollars on lawyers to fight for their patent positions. UC then filed a divisional from their still pending patent application and removed the nicotine spray step, leaving them with a set of claims remarkably like the ones that Etscorn and New Mexico Tech had previously held. This divisional application then issued as U.S. patent 5,016,652, on May 21, 1991, still titled “Method and apparatus for aiding in the reduction of incidence of tobacco smoking” but now with new claims directed to an apparatus–a patch containing nicotine.
It would appear that with some litigation, UC was able to displace the inventive priority of an academic inventor at another institution. But there really is karma in the world.
While the UC patent application was pending, on June 2, 1988 UC granted to Ciba-Geigy an option to license the invention. That option lapsed but then was extended for another two years, to May 31, 1992. Ciba-Geigy then licensed exclusively from UC on October 29, 1991. Just over a month later, Ciba-Geigy sued Alza Corporation, its former strategic partner in drug delivery, and Alza’s reseller Merrell Dow, for infringement of the UC ‘652 patent, which had issued in May 1991 with the new apparatus claims. The result of the suit was that Alza and Merrell had to delay the introduction of their Nicoderm product, which had just been approved by the FDA in November. UC’s use of its patent rights, through its proxy Ciba-Geigy, was to suppress a potentially beneficial health product from reaching the market. Is that what we expect of a public university?
Now there’s something to consider with regard to the Bayh-Dole Act. Bayh-Dole’s statement of policy asserts that the patent system should be used to “promote the utilization of inventions arising from federally supported research or development” (35 USC 200). This statement is not merely a bundle of desires, but as a part of federal patent law rather works as a limitation on the patent property rights of holders of patents on subject inventions. Federal patent law at 35 USC 261 provides that “Subject to the provisions of this title, patents shall have the attributes of personal property.” Bayh-Dole is part of “this title.” For inventions within the scope of Bayh-Dole, the attributes of personal property in patent rights are constrained by Bayh-Dole’s statement of policy. If owners of Bayh-Dole subject inventions must use the patent system to promote the utilization of inventions, then how could the UC come to support Ciba-Geigy in a patent enforcement action to suppress the use of UC’s invention? Luckily for UC, its claim wasn’t true that the nicotine patch inventions were subject inventions under Bayh-Dole.
There’s an important lesson here. If UC’s invention had been a Bayh-Dole subject invention, and had been patentable (which–spoiler–it was not), then UC had no business setting up Ciba-Geigy to block the introduction of a competing health product that had been developed without any need for a patent monopoly based on UC’s invention nor even a license under which to receive any non-public technical information that it lacked. There was no need for a patent monopoly, and no need even for “technology transfer.” UC used its patent, coarsely, to receive money in exchange for allowing Ciba-Geigy to sue Alza and Merrell Dow for infringement so Ciba-Geigy could be first to market with a nicotine patch–one that did not even use the UC invention. It’s difficult to see how Congress intended universities to use patents on subject inventions in this way. 35 USC 200 limits the use of the patent system to the “promotion” of use, and it takes a peculiar twist of logic to expand promotion of use to include the suppression of use. If anyone bothered to follow Bayh-Dole, enforcement of patent rights in subject inventions would require first a showing that enforcement by suppressing use will promote use and improve availability on reasonable terms.
Ciba-Geigy exercised its option to an exclusive license to UC’s nicotine patch patent–and a couple of months later used the licensed patent to sue Alza Corporation for infringement in an attempt to block Alza from introducing its nicotine patch, Nicoderm, which had received the first FDA approval for a nicotine patch.
Here is Alza, responding to Ciba-Geigy’s suit for infringement using the UC’s ‘652 patent:
Moreover, it was Alza—not Ciba-Geigy—who pioneered development of transdermal drug delivery devices. In contrast, the ‘652 Patent was merely licensed Ciba-Geigy in late October 1991 as leverage, to protect the market for its own Habitrol patch–a patch which apparently is not covered by the ‘652 Patent. There is no public interest in allowing Ciba-Geigy to use the ‘652 Patent to gain an advantage with respect to Habitrol.
According to Alza–and it appears that this is the case–Ciba-Geigy did not use the UC invention in its own patch. Rather, it used the UC patent position to attack Alza’s patch. There’s then a disconnect between the UC invention and the UC patent. UC did not “transfer” the “technology” but rather set Ciba-Geigy up to use the patent right that arose from the claim of invention. Lesson: the mere fact of a license does not mean that the technology under that license has been “transferred.” By not distinguishing between licenses that transfer technology and licenses that make available a patent monopoly to harass others, AUTM encourages administrative corruption and deceives the public about what is going on. At least AUTM stays on task in this way.