Outline of the federal framework for the disposition of inventions

Here is an outline of the federal framework for inventions. I have included links to various documents. Lots more to be said, and the brief account here is more gist than deep summary, but perhaps you find it helpful. Plenty of additional documents out there, such as the PHS revised patent policy of 1962 (discussion in the Harbridge House report here). A number of policies and reports are compiled in a 1977 report. The big picture–things in the federal land of regulation of inventions made in federal research and development is not, shall we say, straight forward.

Attorney General’s Report on Government Patent Practices and Policies

For many years, the framework for federal agency disposition of inventions. 

Issued in 1947, lead author David Lloyd Kreeger. Recommends that federal agencies fund development of inventions in which they determine they have an interest, that federal agencies should not take a financial interest in licenses granted to federally owned inventions, that agencies should not grant exclusive licenses, and should not set up to police exclusive license agreements or to enforce patents against US citizens and US companies.

Executive Order 10096

Basis for federal claims of ownership on inventions made by federal employees. 

Issued by President Truman in 1950, EO 10096 creates the authority for federal agencies to claim ownership of inventions made by federal employees. Codified at 37 CFR 501. Authority for  federal agencies to take ownership of (or release claims to) inventions made by federal employee inventors. Addresses Dubilier. A number of revisions.

Kennedy and Nixon Patent Policies

Statement of executive branch patent policy from 1963 until replaced in 1983.

Kennedy (1963) and Nixon revisions (1971) established when federal agencies should allow contractors to retain rights to inventions made in federally funded work, and when agencies should require assignment of inventions to the government. The general frame was that companies with technical capability and non-governmental markets should own inventions; otherwise the government should own unless a federal agency decided otherwise. There were four categories of exceptions to contractor ownership, including research directly concerning public health. These policies form the default position of the federal government in research and development contracting for two years under Bayh-Dole. Essentially, there were two patent rights clauses potentially in play–one for inventions with a scope defined by the Federal Procurement Regulation and one for subject inventions within the scope of Bayh-Dole’s patent rights clauses, which took precedence.

2 CFR 200

2 CFR 200 codifies administration of grants with universities and other nonprofits. In present form/numeration in 2013. Many changes over the years. Formerly OMB Circular A-110, initially issued in 1976, with inventions at _.36. Then 2 CFR 215. Now at 2 CFR 200, with inventions  addressed at 2 CFR 200.315 and .316.

Stevenson-Wydler Act

Basis for disposition of royalties received by federal laboratories and patent clauses in CRADAs and cooperative research center agreements. 

15 USC  Chapter 63. Passed in 1980. Establishes a number of programs pertaining to technology transfer from federal laboratories. Basis for Secretary of Commerce to use patent rights clauses as desired, federal cooperative research centers, and CRADAs. Takes precedence over Bayh-Dole, but some provisions later amended to conform to Bayh-Dole practices. Basis for disposition of royalties received by federal laboratories.

The Bayh-Dole Act

Basis for nonprofit and small business contractors conditionally to retain ownership of inventions that they acquire and which are made in federally funded work.

35 USC 200-212. Part of federal patent law. Passed in 1980, effective July 1, 1981. Original version here. Major revision in 1983. A number of changes since, but most of the attempts at change have come via changes to the CFR.

Requires federal agencies to use standard patent rights clauses in federal funding agreements with small businesses and nonprofits unless they can justify some other rights clause. Contractors that obtain title to an invention made in federally funded work may retain that title, subject to various conditions to protect the public from nonuse, unreasonable terms, and failure to satisfy public health or regulatory needs.

Authorizes federal agencies to deal in exclusive patent licenses, to take a financial interest in patent licenses, and to enforce patent rights or authorize private companies to enforce patent rights on behalf of the government.

Replaces a portion of the Kennedy/Nixon patent policy.

Reagan Presidential Memorandum

Basis for federal agencies to use Bayh-Dole like provisions with large company contractors. 

Memorandum issued by President Reagan in 1983. Replaces the rest of the Kennedy/Nixon patent policy. Authorizes all federal agencies to use Bayh-Dole-like contract provisions with any contractor for research and development work.

Executive Order 12591

Authorizes royalty sharing for federal employee inventors. 

President Reagan Executive Order 12591 issued in 1987. Authorizes federal agencies to promote commercialization. Authorizes federal agencies to create royalty sharing programs for federal employee inventors. Incorporates the 1983 Memorandum by reference. Would be no royalty sharing but for Bayh-Dole’s authorization for federal agencies to receive royalties.

37 CFR 401

Bayh-Dole delegates administration of the statute to the Department of Commerce, which has further delegated oversight to NIST.  Finalized in 1987. 37 CFR 401 codifies the portion of Bayh-Dole dealing with federal contracting for research or development (202-204), restating the statute, providing specific guidance, adding provisions not in Bayh-Dole, and establishing three standard patent rights clauses, at 37 CFR 401.14 [for nonprofits], 37 CFR 401.14 (minus paragraph (k)) [for small businesses], 37 CFR 401.9 [for inventors, as small businesses].

37 CFR 404

Codifies the portion of Bayh-Dole (35 USC 207, 209) dealing with federal for agency invention licensing. Finalized in 1985. Notably restates only the Bayh-Dole policy objective of promoting utilization.

Federal Acquisition Regulation (FAR)

Finalized in 1983. Codified at 48 CFR. Restates Bayh-Dole at 52.227-11, with five alternative clauses; a patent rights clause for large companies that differs in significant ways from 37 CFR 401.14 is at DFARS 252.227-7038. The FAR displaced the Federal Procurement Regulation (1975), which codified the Nixon version of the Kennedy patent policy. Restated with agency-specific customizations at various places in the CFR.

Stanford v Roche

In 2011 the US Supreme Court ruled in Stanford v Roche that Bayh-Dole does not vest invention title with contractors or give them any special right to take title, rejecting claims made ubiquitously by university patent administrators and related lobbying organizations, including AUTM.

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ChatGPT’s Response to a Question Regarding Bayh-Dole Enforcement

Here’s another ChatGPT response, this one to “What are the key provisions of the Bayh-Dole Act that federal agencies fail to enforce?” It’s sort of a trick question, and ChatGPT fails to recognize that. Given that ChatGPT must use extant literature on Bayh-Dole as its training set, ChatGPT’s response is a nice, broad depiction of what’s out there in the wild. What is impressive, then, is how closely ChatGPT’s response tracks the language used by law firms and university licensing offices in discussing Bayh-Dole compliance. In the technical sense of “having no regard for the truth,” as Harry Frankfurt has it, both ChatGPT and the university crowd, excel at “bullshit.” It is just that ChatGPT can have no regard for the truth–at least, it does not appear to be algorithmically capable of doubt, skepticism, evaluation of sources, evaluation of evidence and argument offered by those sources–but the other folks, the humans, the non-artificial intelligences should have these  capabilities but apparently have largely turned them off.

Here we go. ChatGPT is in italics.

The Bayh-Dole Act is a federal law that allows organizations to retain ownership of intellectual property (IP) developed using federal funds.

The summary repeats common stuff found on-line–and chronically wrong. Bayh-Dole is specific to inventions and plant varieties, so “intellectual property” is inappropriately broad. What does it matter? Because, for one, there’s a different federal regime for copyright. And copyright is at the heart of academic publishing, and so the idea that Bayh-Dole also controls copyright runs over into the idea that Bayh-Dole also gives universities some rights in faculty and student articles and lab notebooks and the like. Bayh-Dole does not do that.

We also see a repeat of the “developed using federal funds” which is inappropriately narrow. Inventions made in work receiving federal funding, “made under contract”– where “made” has an expressly defined meaning (“conceived or first actually reduced to practice”–wording drawn from a now obsolete part of patent law dealing with establishing priority of invention, not scope of interest), as does “contract” (a funding agreement–grant, contract, or cooperative agreement–but not anything not sorted into one of these three categories). Not inventions “developed”–development comes after making, if development is necessary. “Development,” too, is a defined term in federal procurement. And the use of federal funds to develop an invention after having made it is irrelevant to a determination of whether Bayh-Dole applies to the invention itself. Just doesn’t matter. What matters is the scope of the work for which a contractor has petitioned or bid for federal support for at least some of that work. If federal funds support at least a portion of that work, then any invention made in that work, whether that is the federal portion of the work or not, becomes, when it is acquired by the contractor, a subject invention under Bayh-Dole. What matters is the work as a whole, not necessarily just the portion of the work that federal funds have been used to pay for. Work, some supported by federal funds? Invention made in scope of work? Contractor acquires? Bingo.

“Developed using federal funds” is just so wrong–and yet you will find this usage all over the internet, which should give you pause for the competence of the folks writing this way. “Developed using federal funds” is not just a loose, easier to understand shorthand–it’s just stupidly, stubbornly wrong.

“Any invention conceived or reduced to practice with the assistance of the Federal funding is subject to the Bayh-Dole Act.” Law firm “information” on compliance

“to determine ownership rights of an invention developed using federal funds” Law firm discussing Stanford v Roche

“to acquire ownership of inventions developed with such funding” North Dakota State University (Bayh-Dole doesn’t “allow” acquisition, it allows retention following acquisition–huge difference, really)

“are permitted to elect title to federally funded inventions” University of Virginia (research or development is federally funded, not inventions; “elect” title is wrong–elect to retain title that they got in some non-Bayh-Dole way)

“The University is entitled to retain ownership of any inventions created as a result of federal funding” Drexel (and wrong about “entitled”–nonsense)

“made under the auspices of federal funding” Rice (“made under contract” would work, as would “made in performance of work under contract,” but not “auspices”–goofy)

Some get this bit right, for instance:

“resulting from federally-funded research” Michigan (but they are wrong about “allows . . . ownership rights”)

“inventions made under federally sponsored research” Delaware (though “federally sponsored funding agreement”) would be better, and even better would be pointing out that “made” has a special not so obvious meaning).

We continue with ChatGPT:

This law applies to organizations that receive funding from federal agencies, such as universities and businesses.

Bayh-Dole applies principally to federal agencies, not to contractors. The one provision directed at contractors is 35 USC 202(a). That’s it. The rest is focused on what federal agencies must do in contracting and licensing. It is by federal contract–compliance with Bayh-Dole by federal agencies–that most of Bayh-Dole applies to universities. By breaching a patent rights clause, a contractor does not violate Bayh-Dole, the statute. In fact, given that 35 USC 202(a) simply offers contractors a right, there is nothing in Bayh-Dole that a contractor can violate. All contractor problems arise in the patent rights clauses.

And of course, Bayh-Dole addresses only nonprofits and small businesses–not all businesses. Executive branch patent policy–EO 12591, incorporating Reagan’s 1983 Memorandum–authorizes Bayh-Dole-like provisions for large companies. And the “funding” must come in the form of a “funding agreement,” which has an express definition in Bayh-Dole–in particular, the funding has to be for research or development. If it’s for education, procurement, investment, or anything else, it falls outside Bayh-Dole’s scope. Federal agencies use this workaround all the time, with “other transactions” (don’t call them contracts), and with contracts that specify a purpose other than research or development, even if the primary activity will be research or development.

There are several key provisions of the Bayh-Dole Act that federal agencies may fail to enforce, including:

This part is rich–federal agencies don’t enforce much of anything other than proper format of invention disclosures–they don’t even review disclosures for documentation to back determination of proper identification of funding scope.

1. The requirement that organizations disclose any IP they have developed using federal funds within a certain period of time after the development of the IP.

This bit misstates the disclosure requirement. Not “any IP” but rather subject inventions, only. You know now to see “developed using federal funds” is flat wrong. And “after the development of the IP” is just gibberish; try “within a reasonable time after it becomes known to contractor personnel responsible for the administration of patent matters” 35 USC 202(c)(1). The Bayh-Dole disclosure requirement kicks in when a contractor’s patent personnel have received a conforming disclosure from the inventor and the invention has been acquired by the contractor–contractor acquisition of an invention is necessary for an invention to be a subject invention under Bayh-Dole. Bayh-Dole originally required contractors to disclose subject inventions (ones they had acquired, made under contract) within a reasonable time. That would have required contractors–universities especially–to actively monitor inventive activity. It would be on the tech transfer office to go out and monitor federal grant work for inventions and timely report them. But in 1983, two years after Bayh-Dole went into effect, university-affiliated patent officers got the law changed so that they didn’t have to do anything until an inventor properly disclosed an invention to them. Cozy, but slack.

2. The requirement that organizations make a reasonable effort to license any IP they have developed using federal funds to potential users, in order to promote the use and dissemination of the technology.

This requirement does not exist. It is fantasy. There is no “reasonable effort” bit in Bayh-Dole or in the patent rights clauses. There is also no “incentive” stated there to license, and it would be dumb to put in either a requirement or an incentive to license because small companies–a key focus of the law–don’t have any obvious reason to license the inventions they acquire. They can just practice them, to grow their companies (or sink into bankruptcy, inventions as they often are). There is also no requirement to try to “commercialize” inventions. That’s also fantasy. Bayh-Dole’s primary focus throughout is “utilization”–and in particular, “practical application,” which is utilization with benefits available to the public on reasonable terms” (that is, terms that would be expected if there were competition, even if patents are used to suppress competition). Where “commercialization” is used in Bayh-Dole–and the law does anticipate commercialization as one way to achieve utilization, collaboration with industry, and US manufacturing goals–there’s also “public availability.” That is, a contractor can either use an invention or license it. Doesn’t much matter. No requirement to do one or the other, no incentive to do one or the other.

The “reasonable effort” fiction comes from attempts to prevent federal agencies from protecting the public from lack of availability, nonuse, and unreasonable terms by using the compulsory licensing authorization of 35 USC 203. The “march-in” provisions authorize federal agencies to request that contractors grant licenses if they have not timely achieved practical application of a given subject invention. Here’s the key bit (203(a)(1):

has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use

The “is not expected to take” part might be rebutted by a showing of effort–perhaps even “reasonable effort”–but the standard is an expectation to take “effective steps” in a reasonable time. Nothing here about reasonable effort. The reasonable effort idea is just made up nonsense serving as political spin to try to shut down the public interest part of the Bayh-Dole bargain. Might say that nonsense is, well, corrupt.

Bayh-Dole does not give contractors a pass if they “try.” As Yoda has it, “Do or do not. There is no try.” Come to think of it, Yoda probably could do better at restating Bayh-Dole than either ChatGPT or a gibber of university licensing administrators.

3. The requirement that organizations share any royalties or other income they receive from licensing their IP with the federal agency that provided the funding for the development of the technology.

The royalty sharing requirement is limited to nonprofits. See 35 USC 202(c)(7)(B). Bayh-Dole distinguishes royalties from “income earned . . . with respect to subject inventions.” Royalties must be shared, but not other income earned. But all of this is beside the point! The royalty sharing is with inventors. There is no royalty sharing with the federal agency. This is just totally wrong. Drafts of other bills–Thornton, Schmitt–anticipated royalty sharing with federal agencies (a hugely bad idea, just like allowing federal agencies to have a money interest–a secret money interest at that–was and is a hugely bad idea). But Bayh-Dole does not do that. Here, ChatGPT is totally wrong. And of course “development of the technology” is off-base. Not “development,” not generally “technology,” not “funding for.” All gibberish.

4. The requirement that organizations provide the federal government with a royalty-free license to use any IP they have developed using federal funds for government purposes.

Okay. Bayh-Dole does require federal agencies to require a non-exclusive, royalty-free license. But the scope of that license is “to practice and have practiced.” The wording here comes from the Kennedy patent policy and the Institutional Patent Agreement master contract. There, “practice” is defined as “to make, to use, and to sell”–that is, the substantial rights one may have in an invention. The license, then, is not merely “to use” an invention, but to practice it–all the rights are available to the government but for the right to exclusively license or assign the entire interest in an invention or to enforce the patent. The restriction “for government purposes” does not show up in Bayh-Dole, though “Governmental purpose” is used in the Kennedy patent policy. The Bayh-Dole license to the government is general, broad, unlimited. Anything the federal government can do, that’s the scope of the license the contractor grants.

In general, federal agencies are responsible for enforcing these provisions of the Bayh-Dole Act . . .

Nope. Federal agencies are responsible for the management of patent rights clauses in individual funding agreements. The Department of Commerce is responsible for the administration of the implementing regulations and patent rights clauses (and making a slobbering mess of that). But there is no enforcement specified for Bayh-Dole. No oversight. In the most positive spin, self-regulating. What could go wrong with that?

. . . to ensure that organizations are complying with the law

Nope. Here, it should read “to ensure that contractors are complying with their patent rights clauses.” But even so, at crucial points Bayh-Dole gives federal agencies the power to ignore requirements (such as contractor reporting on utilization), waive them (such as US manufacturing), or walk away even after determining non-compliance (as for anything that involves the march-in procedure–see 37 CFR 401.6(h)). As the 1995 GAO report found, there’s no oversight. Federal agencies leave it up to universities to comply, and universities are hopelessly inapt and inept at compliance. As one director of a licensing office told me, point blank, in response to a question regarding Bayh-Dole, “We will do that if and when a federal agency makes us do that.”

. . . and that the government is able to benefit from the IP developed using its funds.

This part looks like a well constructed English clause, but it makes no sense it context. We are talking about enforcement, and the sentence starts out that federal agencies are responsible “enforcing these provisions to ensure that” [contractors are complying] and [the government is able to benefit]. It just doesn’t work. If contractors comply, then they grant the government its license. The government then benefits however federal agencies choose to exploit the government’s right under that license. Bayh-Dole has nothing to say, expressly, about how federal agencies go about practicing (including having practiced) any given subject invention. There is nothing to enforce. And federal agencies have a tough time enforcing on themselves what they don’t care to do. It just doesn’t work. Here, looks good, is gibberish. Sadly, it’s not just what one would expect from an AI text generator. It’s just like what one expects from university licensing offices and the law firms selling services to them and to companies dealing with them.

However, it is possible that some federal agencies may not always adequately enforce these provisions, potentially leading to organizations not complying with the requirements of the law.

Well, yes! Spot on. Perhaps “it is possible” is a bit timid, but let’s go with that.

As for the list ChatGPT generated, it’s bland to the point of useless. The problems of enforcement extend from failure to accurately cite federal funding in patent applications to misallocation of royalty income to failure by agencies to determine exceptional (not extraordinary or rare) circumstances and a blind eye to nonprofit assignment of subject inventions and march-in for nonuse (lots of nonuse), unreasonable (non-competitive) pricing, and lack of availability (including availability in alternative forms and combinations). There is nothing in the ChatGPT write up that would even spark a discussion regarding whether Bayh-Dole lacks necessary oversight, auditing, and enforcement, and where agency or contractor noncompliance might be harming the public. Just bland, often wrong, sentences that look great but are, well, off, sometimes way off, way wrong.

Continue reading

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ChatGPT’s Garbled But Expectable Version of Bayh-Dole

I asked ChatGPT for “the key points of the Bayh-Dole Act.” Here’s the first response:

The Bayh-Dole Act is a United States federal law that was passed in 1980. It allows businesses, universities, and other organizations to retain ownership of patents on inventions that are developed using federal funding. This means that these organizations can choose to license the inventions to other companies or to produce the inventions themselves, rather than having the patents automatically assigned to the federal government. The act was intended to encourage innovation and to stimulate economic growth by providing a financial incentive for organizations to invest in research and development. Some of the key points of the Bayh-Dole Act include:

  1. It allows organizations to retain ownership of patents on inventions developed using federal funding.
  2. It provides a financial incentive for organizations to invest in research and development.
  3. It encourages innovation by allowing organizations to license their inventions or produce them themselves.
  4. It stimulates economic growth by making it easier for new technologies and products to reach the marketplace.
  5. It allows the federal government to use patented inventions for government purposes, such as national defense, without requiring the organization that owns the patent to grant permission.

Let’s work through this. Continue reading

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A Bayh-Dole Quicker Read Made Much Longer!

Here’s an even shorter version of Bayh-Dole, with some paraphrasing

[now made much longer with comments to show why these quick things matter.]

Use the patent system to promote the use of inventions.

[This is a restriction. The Constitutional mandate is to promote the progress of the useful arts, where “progress” means “dissemination.” To restrict the use of patents to promote utilization of inventions is oddly interesting, given that the basic right of a patent holder is to suppress the practice of an invention. Think on the Congressional intent here. The restriction also works within federal patent law, of which Bayh-Dole was made a part, now Chapter 18 of Title 35. The patent law at 35 USC 261 stipulates that

Subject to the provisions of this title, patents shall have the attributes of personal property.

Bolding added. Bayh-Dole is among the provisions of “this title.” Bayh-Dole places restrictions on the use of the patent system. Those restrictions then follow through to the “attributes” of patents on inventions subject to Bayh-Dole, and restrict the personal property rights in those patents. See? Get it? Yes, of course!] Continue reading

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A look at recent startups at Duke

A recent tweet called out the Duke University technology transfer program for starting 12 companies so far in 2022. That’s a good number of startups for a university. We should applaud. But the tweet went on to attribute the startups to Bayh-Dole:

#BayhDole makes all of this possible, getting the research from the lab to the consumer.

We should note that (i) Bayh-Dole does not make starting companies associated with universities possible, (ii) that starting a company does not mean that a product based on a licensed subject invention will ever get to “the consumer”, and (iii) that utilization in the form of practical application, not consumer products, is the stated purpose of Bayh-Dole’s restrictions on patent property rights for inventions made in federally supported work.

But given these observations, I thought I’d spend an afternoon of my mortal existence taking a look at Duke’s startups. Duke has a nice web page that lists a bunch of them. The information there could use a refresh and an edit but it can give us a rough estimate of the place of Bayh-Dole. Continue reading

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Mixing Two Governments’ Funding

Here’s an interesting statement of government rights in a University of Arizona patent, 9239453 B2. (I’d link to the USPTO patent server, but since the change in search software, it’s not obviously possible.):

GOVERNMENT RIGHTS (1) This invention was made with government supports under contract numbers 0644446 awarded by the U.S. National Science Foundation, 60827003 awarded by the National Natural Science Foundation of China, and 2009AA01Z308 awarded by the Hi-Tech Research and Development Program of China. The U.S. and Chinese governments have certain rights in the invention.

The invention is assigned jointly to the University of Arizona and Beijing Institute of Technology. There must be a technology administration agreement somewhere behind this patent, dealing with such things as who pays for the patent work and how the invention (patent) will be exploited.

Here’s your Bayh-Dole problem. Bayh-Dole requires that for any subject invention exclusively licensed in the U.S. to use or to sell, product must be manufactured substantially in the U.S. See 35 USC 204. Now how is that going to work with not only a Chinese university involved, but also Chinese government rights in the invention?

It would seem that Bayh-Dole’s national (protectionist?) manufacturing requirements are easily circumvented simply by mixing NSF funding with funding from another government. This can be as simple as collaborating with a researcher from whatever country one wishes to advantage, so long as that researcher is operating under his or her own national interest requirements.

In any event, collaboration with a researcher working under the funding requirements of another country, or accepting money from that country directly, offers a rather different patent management practice.

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The failed Bayh-Dole bargain, 4

Finally, we reach Xtandi. The authors provide the pricing of $156,000 per year, but don’t point out that generic manufacturers have offered to produce Xtandi for $3 per pill–or about $4,300 per year. There’s a claim that Astellas has spent $1.4 billion on development, but there’s no supporting documentation for this claim. Give that UCLA exclusively licensed the series of compounds of which Xtandi was one to Medivation, who then contracted with Astellas for development on a non-exclusive basis (dividing up the world into a non-US market and a US market to avoid the US manufacturing requirement in Bayh-Dole), and that both UCLA and Medivation have sold out their interest in Xtandi in the Pfizer/Royalty Pharma transactions, what Astellas has put into development really has no bearing on march-in. There’s nothing in march-in that says “you can charge unreasonable prices if you spent a lot of money.” The standard of what is reasonable does not depend merely on what one has spent, but also on what one has made, and what one would make if there were, say, competition, even if there’s not because of the patent situation. Continue reading

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The failed Bayh-Dole bargain, 3

We are working through a new article on Bayh-Dole march-in, written by two PhD patent attorneys. In its way, the article is more puff piece than law review, drawing its frame from the sources chosen, not much looking at the law itself, but also not much looking at the policy implications of using the pathway of march-in to create competition to restore reasonable terms for public access, especially to new medicines based on discoveries made in federally funded research.

In the big picture, the federal government could fund the “development” of new medicines that its research has discovered and then could produce and distribute those medicines directly, or contract with others to do so on its behalf. What sort of pricing would we expect if the government contracted for production and distribution? Perhaps cost of production plus a “reasonable” margin for contractors? If a company wanted to compete with this arrangement,  having open access to the invention, what pricing would we expect from it? If higher than the government version, on what basis? Higher quality? additional functionality? more readily available? Any of that might make reasonable sense. Continue reading

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The failed Bayh-Dole bargain, 2

We are working through an article about the possibility that the federal government might use march-in to address unreasonable pricing for Xtandi. The case for march-in is as strong as any could be. But to get at this issue, our authors choose to frame things as a matter of what’s “uniform” about Bayh-Dole. The implication is that Bayh-Dole is supposed to make federal policy “uniform” and since march-in for Xtandi would not be uniform, well, then, there’s your implicit answer.

Now let’s look at Bayh-Dole. Is Bayh-Dole “uniform”? Hardly. The law suffers from a host of defects with regard to “uniform.” First, exceptions are baked into the law. The primary exception is for DOE nuclear research and development. The DOE fought to have its “non-standard” default reflected in the Bayh-Dole’s implementing regulations. There were then two default patent rights clauses–at the old 37 CFR 401.14(a) and (b). The design idea in presenting these clauses as (a) and (b) was that as agencies identified other “exceptional circumstances” under 35 USC 202(a), these could be codified at 401.14 as (c), (d), and the like. Exceptions were anticipated. Non-uniformity was anticipated. Second, Bayh-Dole goes out of its way to pre-empt any federal statute that dictates an invention ownership policy at odds with Bayh-Dole. Except that Bayh-Dole does not pre-empt the Stevenson-Wydler Act. Again, not uniform. Furthermore, Bayh-Dole provides that Congress can pass laws that also pre-empt Bayh-Dole, provided such a law cites Bayh-Dole and expressly indicates that the new law takes precedence. Not uniform. Continue reading

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The failed Bayh-Dole bargain, 1

Dr. Rebecca McFadyen and Dr. Tara Nealey–both working for an IP law firm–have published an article “Will old Bayh-Dole be taught new tricks?” Me, Dr. Barnett–not working for an IP law firm–thinks they have got it wrong. Consider:

Before 1980 the US government did not have a uniform IP policy with respect to all federal granting institutions that funded research or technology transfer to the private sector.

This is not particularly meaning-full prose. What is a “federal granting institution”? Are we talking federal agencies and the Department of Defense or something else? And what is this about funding “technology transfer”? Bayh-Dole certainly doesn’t anticipate funding “technology transfer”–though universities have figured a way to do this, sort of, sometimes, from licensing income, even if they have to violate Bayh-Dole’s patent rights clauses here and there to do it. No matter, federal agencies uniformly decline to enforce the patent rights clauses in any of their substantive terms, so there is that.

But the article is out there, and ought to be read, regardless of the garbled bits. Let’s put a stick in this mess and swirl it around a bit, and see what we’ve got here. Continue reading

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