Five Steps to Restoring an Effective University IP Practice, Step 3

Posted on February 11, 2022 by Gerald Barnett

We are working through five steps to restoring your university IP practice to something effective and conscionable.

The third step involves a fundamental, but again simple, change in policy. Current IP policy at most universities does not address non-exclusive and exclusive licensing, so TLOs do non-exclusive licensing when they are forced to, such as in NSF Cooperative Research Center grants, and for biomaterials and software, and default to exclusive licensing to most everything else. But policy ought to push TLOs to adopt non-exclusive practice. Policy restrictions provide a TLO with support to resist requests for exclusivity. Otherwise, a TLO will be helpless in the face of a request for an exclusive license. Getting a deal–any deal–is important in a TLO land in which deals don’t much happen. That will change if most TLO deals are non-exclusive. Continue reading →

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Five Steps to Restoring an Effective University IP Practice, Steps 1 and 2

Posted on February 10, 2022 by Gerald Barnett

Over the past couple of years, I have been involved in projects based on the idea of commons for the exchange of research and diagnostic assets. These projects have been blocked or resisted at each point by organizational technology transfer officers. In one project, it was clear that the tech transfer office vastly prefers to try to make money from patents than to let physicians share information that might help them better diagnose their patients. In another, the technology transfer officers cannot figure out how to read their own IP policy (or Bayh-Dole) and so are helpless (and courage-less) to acknowledge practices in the open source communities. Instead, they claim that they would violate policy to permit software developers to contribute to open source projects, even as they acknowledge that software developers are indeed contributing to open source projects, policy or no policy. Whether it’s open source software, or circulation of materials under a Creative Commons license, or open hardware, open wetware, BioBricks or dedication to a patent public domain or copyright public domain–or both–university administrations will have to work hard to extract themselves from the hell hole of patent monopoly rent-seeking instead of supporting effective technology transfer.

Here are five things that university officials can do to return their technology transfer programs to at least modestly effective practices–and ones that are highly aligned with academic freedoms of research and publication and with entrepreneurial initiative. Continue reading →

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Latkerstein’s Monster, 2

Posted on February 5, 2022 by Gerald Barnett

The monopoly meme argument is that no one would have ever received any cisplatin if not for an exclusive license to motivate a big drug company to “develop” the drug as a product. Left out is the idea that the federal government paid the development costs itself, including clinical trials, and could have created an industry consortium to establish a standard cisplatin platform and share data as part of developing products, or could have limited the term of exclusivity after which time, the license would go non-exclusive and others could also explore use of the invention. Actually, the exclusive license for cisplatin was time-limited, but at the end of the term, the licensee and university both petitioned for an extension. So much for open access. Continue reading →

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Latkerstein’s Monster, 1

Posted on February 4, 2022 by Gerald Barnett

I ran a Twitter thread on this topic. Here’s more of the same.

The Bayh-Dole Coalition describes Bayh-Dole as part of a “delicate balance of the university techtransfer system.” My experience differs. There is no “delicate balance.” Bayh-Dole is a botched, inept statute made of the body parts of failed regulations and patent management schemes. Bayh-Dole is a Latkerstein’s monster. University practice gives lip service to Bayh-Dole, but Bayh-Dole mostly adds bureaucracy. Well, and ruins opportunities. And takes credit for what manages to survive its requirements. Oh drat. Let me come in again.

When Norman Latker, long-time patent counsel at the NIH and former patent examiner, drafted Bayh-Dole, he claimed that he was “reversing the presumption of title” to inventions made in federally supported work under executive branch patent policy. But even his claim of what he was doing was nonsense. Executive branch patent policy did not presume title. It authorized federal agencies to contract to obtain title in certain situations–when the contractor had no capability or presence in a non-governmental market, when supervising the work of others, when the principal user or funder of the technology was the federal government and non-federal control would mess up competitive bidding, and when the research involved public health or safety. In all other situations, policy presumed that contractors could keep title to inventions that they acquired from inventors doing work involving federal funding. Even then, it was not so much a presumption as it was a recognition of the fact that inventors owned their inventions when they made them, and it was up to an employer to work out arrangements to acquire the inventions that it wanted. Continue reading →

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Nicotine Patches, 4

Posted on December 21, 2021 by Gerald Barnett

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. Continue reading →

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Nicotine Patches, 3

Posted on December 20, 2021 by Gerald Barnett

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.

Continue reading →

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Nicotine Patches, 2

Posted on December 19, 2021 by Gerald Barnett

We are working through the history of nicotine patches, to learn what we can from UC’s claim to have invented the nicotine patch, and AUTM’s claim that this is a success story, and the Bayh-Dole Coalition’s claim that this success was due to the Bayh-Dole Act.

In Sweden, in an efficient version of technology change, scientist Ove Fernö at Aktiebolaget Leo, a Swedish pharmaceutical firm that would end up owned by Pharmacia, was prompted to create a nicotine gum–Nicorette–by a suggestion from professor friends at Lund University, who noted that sailors assigned to submarines switched from smoking to chewing tobacco. Fernö filed for a patent in the UK in 1970 and in the US in 1974, including his two Lund University colleagues as co-inventors. The US patent issued in 1975. By the mid-1970s, then, it was established that nicotine could be absorbed through the mucosa–the skin of the mouth, as it were, and doing so provided a way to stop smoking, at least for a while–even if one still remained attached to a regular hit of nicotine. Continue reading →

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Nicotine Patches, 1

Posted on December 18, 2021 by Gerald Barnett

The Bayh-Dole Coalition recently posted on Twitter a claim that the development of the nicotine patch was a Bayh-Dole “success story”:

Bayh-Dole Success Story! Did you know that the nicotine patch was developed at @UCLA and commercialized via Bayh-Dole? Check out this inspiring story of scientific research helping millions kick their smoking habit from @AUTM’s Better World Project! buff.ly/33CGxvZ

Well, it’s true that the link provided connects to a “story.” And AUTM did publish the story as part of its Better World Project. And it is also true that the rights to at least two versions of the nicotine patch did claim to go “via” Bayh-Dole. But on the main points, AUTM has it wrong, and BDC uncritically repeats AUTM. They are both wrong, and their “story” misleads.

To save you lots of time, I’ll summarize: Continue reading →

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Why the NIH fuss with Moderna over inventorship doesn’t matter, but does

Posted on November 9, 2021 by Gerald Barnett

The New York Times ran a story today that Moderna and the NIH are having a spat over inventorship on a patent application covering aspects of the Moderna mRNA vaccine.

The N.I.H. had been in talks with Moderna for more than a year to try to resolve the dispute; the company’s July filing caught the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine whether a patent is warranted. If the two sides do not come to terms by the time a patent is issued, the government will have to decide whether to go to court — a battle that could be costly and messy.

From the looks of this–at least from the NYT’s account–one has to ask just what the NIH is thinking, if anything at all. It appears to be a fuss of incompetence. But then, the NYT article only gets at a bit of the problem, if it is even a problem. Let me explain.

First, the NIH has funded Moderna to do the research and development, much of the funding coming under a BARDA contract. Moderna is not a “small business” and was not in 2020, when the BARDA contract was signed. Thus, Bayh-Dole doesn’t apply directly. However, executive branch patent policy requires federal agencies to use a patent rights clause:

agency policy with respect to the disposition of any invention made in the performance of a federally-funded research and development contract, grant or cooperative agreement award shall be the same or substantially the same as applied to small business firms and nonprofit organizations under Chapter 38 of Title 35 of the United States Code.

Here, Chapter 38 is now Chapter 18–the Bayh-Dole chapter. But the policy goes on to explain that federal agencies can waive whatever of Bayh-Dole-like requirements they want, including for co-sponsored and joint research. So who knows what BARDA did with its contract–and as far as I know, the crucial bits of the patent rights clause have not been released to the public. Continue reading →

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How they screwed over Senator Long and inventors after Bayh-Dole

Posted on October 7, 2021 by Gerald Barnett

The miracle of Bayh-Dole came about, so the story is told, because Senator Long, the arch-critic of Bayh-Dole (“the worst bill I’ve seen in my life”), suddenly flipped his position to give Senator Bayh a consolation gift for losing his bid for re-election, on the condition that Senator Dole promised not to amend the bill later to extend it to large companies. “Sure, sure, absolutely not, Senator Long.” Senator Long must have got something mighty tasty in return to flip his vote on a lame-duck session bill that gutted a previous bill and added language that had already failed in the Senate and now required a unanimous vote.

But what? What was worth blowing away the community of science commons that had paced the interface between science and technology development from the 1950s to the 1970s? Given that President Carter flipped his position, too (he had backed a competing bill that covered all federal contractors, sponsored by Senator Schmitt). So had Senator Nelson from Wisconsin (home of the Wisconsin Alumni Research Foundation, which was closely aligned with Norman Latker, the former patent examiner turned NIH patent counsel who drafted Bayh-Dole). Very strange, very tasty something.

So Bayh-Dole passed in 1980, got signed by President Carter, and came into effect in the summer of 1981. Now Senator Dole had promised no amendments to the law to let big company contractors have the same right to retain ownership of inventions made in federally supported work that Bayh-Dole gave to small companies and nonprofits. What then to do to complete the agenda and not go back on the promise? Ah, play dirty politics.

Norman Latker drafted for President Reagan a “Presidential Memorandum,” picking up the language of the Kennedy executive branch patent policy published in 1963. In this new Memorandum, President Reagan turned executive branch patent policy on its head. Reagan required federal agencies to use Bayh-Dole practices for large companies. Bayh-Dole wasn’t extended to large companies. Executive branch patent policy was flipped instead to require Bayh-Dole for large companies (except where executive branch policy could not preempt federal statute, and except when federal agencies decided to give large companies a better deal than they would get following Bayh-Dole practices).

Continue reading →

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