Let’s review where we have got to in this dive into the history of nicotine patches. The UC did not transfer technology in the nicotine patch case. Ciba-Geigy did not need the UC technology–it seems to have wanted the patent to disrupt a competitor prepared to offer a beneficial product. If the company had wanted the technology, it had two years to exercise its UC option to license the invention and let that option lapse. Ciba-Geigy did not need exclusive rights to justify investing in the development of commercial product based on the UC nicotine patch invention–it needed ownership of the invention so it could sue Alza.
Meanwhile, Alza was taking fire from all directions. Elan Pharmaceuticals acquired Pharmetrix’s patch patent and used it to sue Alza for infringement. Pharmetrix represented in its patent filing that its invention was a subject invention under Bayh-Dole, though the documentation for this claim is just as sketchy as was UC’s claim. Under Bayh-Dole, selling its patent to Elan to be used to suppress innovation runs directly against Bayh-Dole’s statement of policy at 35 USC 200. Something that should not happen, but it did. Here’s what Alza had to say when it filed a counter claim against Elan:
Plaintiffs’ suit against defendants and their request for interim injunctive relief were designed: (a) to prevent or disrupt defendants’ scheduled introduction to the relevant market of defendants’ product, known as NICODERM; (b) to gain a competitive advantage over defendants in, or to exclude defendants from, the relevant market; and (c) to injure defendants as competitors of plaintiffs in the relevant market, all in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1.
It was all out patent war. Ciba-Geigy also sued Elan. Everyone was suing everyone else, mostly with patents acquired from organizations receiving federal funding–UC and Pharmetrix. Federal funding it seemed had been used to create legal weapons rather than new and useful technology. Welcome to Bayh-Dole practice.
To his credit, Alfred M. Wolin, the judge presiding at the Ciba-Geigy v Alza trial, denied Ciba-Geigy’s motion for a preliminary injunction. Wolin reasons that the public return on any federal investment in nicotine patches is that the public gets a choice of product, not a patent monopoly used to suppress choice:
By my denial of this preliminary injunction the public will have the benefit of competing products at potentially lower prices, without giving an unnecessary advantage to a single market entrant. If the products are substantially different from one another, the public will make their choice and not the Court. If the patents are held invalid and/or not infringed, the public will have had the benefit of more than one product at the earliest possible time. Moreover, it would not be uncommon for federal funds to have been awarded and used in the development of a patch that has the capacity to reduce smoking and thereby save lives. If this premise is true, then the public receives the appropriate return on its investment – a choice of product with the potential to span the full spectrum of medical need. And this benefit to the public is in no way lessened merely because a corporate infringer may ultimately have to respond in damages for its knowing risk and calculated gamble in presenting its infringing product to the market.
Alza also prevailed in its counter-claim against Ciba-Geigy, but it would take years to get there. In 1984–more than a year before UC filed its patent application for a nicotine patch–Cecil Fox published a letter in Nature in which he proposed using a nicotine patch on the model of the Alza patches for motion sickness and angina. This letter contained about as much idea about a nicotine patch as did the UCLA inventors’ claim to conception. That was enough to invalidate UC’s patent claims. Because of the timing of Fox’s letter, UC’s patent was invalidated but Etscorn’s patent was within the grace period and–had UC not used its patent position to go after Etscorn–Fox’s “prior art” would not have invalidated Etscorn’s patent. Isn’t life strange.
We can then fill in some more conclusions:
UC’s invention was not, it turns out, a patentable invention. At best it represented a minor variation on what the industry–especially Alza–was already developing without federal funding. Federal money arrived late, chasing the fire engines, as it were. Whatever the UC-claimed “invention” was, it was made at the VA using VA resources. It was not a Bayh-Dole invention, despite UC’s claim. The license agreement UC made regarding it didn’t transfer the technology and Ciba-Geigy does not appear to have used that “technology.” Ciba-Geigy acquired the patent position and used it to beat on its competition, to suppress their health products. None of this is what universities lead the public to imagine when they report the “success” of their patent licensing programs.
But there were other problems with nicotine replacement therapy. Here’s Ciba-Geigy’s take on the situation:
One problem with transdermal nicotine patch sales was that the product created a self-defeating market: if the treatment worked, patients would eventually end the therapy; if the patches were ineffective, smokers would not buy them.
But in one sense, Ciba-Geigy’s market analysis was wrong. Smokers would buy treatments, even if they didn’t work, so long as there were statements made that they did work. In retrospect, a number of studies have been published that argue that nicotine replacement therapy generally–whether gum or patches–does not work so well. Clinical trials showed that after three weeks of use, smokers using nicotine patches have mostly stopped smoking. So far so good. But if one ran the timeline out to six months or two years, many of the smokers were back to smoking again. There was no difference between use of a nicotine patch and simply going cold turkey.
Dan Hurley, writing in Discover magazine, is blunt about it:
In fact, the one purpose for which nicotine has proven futile is the very same one for which it’s approved by the Food and Drug Administration, sold by pharmacies over the counter, bought by consumers and covered by many state Medicaid programs: quitting smoking. In January 2012, a six-year follow-up study of 787 adults who had recently quit smoking found that those who used nicotine replacement therapy in the form of a patch, gum, inhaler or nasal spray had the same long-term relapse rate as those who did not use the products. Heavy smokers who tried to quit without the benefit of counseling were actually twice as likely to relapse if they used a nicotine replacement product.
Frederique Behm, wife and research collaborator of UC nicotine patch Jed Rose, in 2019 was candid about nicotine replacement therapy:
Nicotine replacement works to a certain extent. But that was never quite the solution for the true hard core smokers who really need to light up a cigarette in the morning, and go on to smoke a pack a day.
It’s an old game, to run a clinical trial short, publish data that supports optimal beneficial effect, and close up shop. That’s what happened in the clinical trials used to support the use of antibiotics to treat middle ear infections. It’s not just that the research showing that antibiotics did not help middle ear infections, but that the federal funding was inadequate to complete the work, and once pharmaceutical companies were supporting the work, the clinical outcomes could be cherry-picked. It took a whistleblowing researcher fifteen years to fight the university and the companies. In the case of UC, no one blew the whistle, and why would they, given they would be up against not only big pharmaceutical companies but also the University of California, which had aligned itself, under a fake heading of technology transfer, with the companies.
In fact, the one purpose for which nicotine has proven futile is the very same one for which it’s approved by the Food and Drug Administration, sold by pharmacies over the counter, bought by consumers and covered by many state Medicaid programs: quitting smoking. In January 2012, a six-year follow-up study of 787 adults who had recently quit smoking found that those who used nicotine replacement therapy in the form of a patch, gum, inhaler or nasal spray had the same long-term relapse rate as those who did not use the products. Heavy smokers who tried to quit without the benefit of counseling were actually twice as likely to relapse if they used a nicotine replacement product.
So maybe the nicotine patch works for “light” smokers, at least some of them, for a time–long enough to sell to many smokers a health product that for many of them won’t work. That’s a time honored approach–long used by the “patent” medicine industry. It’s that now universities have moved into the patent medicine business, using the similar methods, but now exploiting the cover of the academic reputations of the universities to pull one over on the public. It’s not that patent administrators aren’t sincere about their desire to benefit the public–it’s that they don’t bother to connect up what they do in practice with their sincerity.
What do we learn, then, in this deep dive into nicotine patch patents? The UC claim to have invented the nicotine patch is mostly not true. The UC claim that their nicotine patch has helped millions of smokers is also, apparently, mostly not true. The UC claim that its patenting was instrumental to bringing the nicotine patch to market is generally not true at all. The claim by AUTM that the UC nicotine patch is a technology transfer “success” story is not true. The claim by the Bayh-Dole Coalition that UC’s nicotine patch success was enabled by Bayh-Dole also isn’t true.
In the place of these illusory narratives, we are led to an instructive sense of a dominant university IP practice. University research may chase after developments made years before outside of academic research. Federal funding may be used to aid in this chase. University patent administrators then use patent positions derived from the academic research to push into lines of technology use and development to extract a payout or to pit one company against the others, or a startup that turns troll against an entire industry. It doesn’t have to be this way, and at some universities, it’s not. But as we see here, at the University of California, which ought to be a leader by example, the nicotine patch shows how a university can sell out its research standing and its technology for the money, so long as it has a plausible cover.