Bayh-Dole Secrecy, Part 8

I guess this ends up being a little book on Bayh-Dole and secrecy. Perhaps I should have titled it “Reasons Why Bayh-Dole Should Not Be Repealed” and made it blank, but for section headings. Then it might be a best seller on Amazon and I wouldn’t have to do so much work. But alas, work it is. We are not quite done. There is one more article after this one, and then a concluding statement that wraps things up. You can wait for the wrap or read through to see how that conclusion arises.

We have looked at the primary reasons why reporting was required under the original Bayh-Dole–to deal with exclusive licenses and to worry march-in reviews. But there were other reasons as well. Until 2009, Bayh-Dole had the following paragraph at 202(a)(3):

(3) At least once each year, the Comptroller General shall transmit a report to the Committees on the Judiciary of the Senate and House of Representatives on the manner in which this chapter is being implemented by the agencies and on such other aspects of Government patent policies and practices with respect to federally funded inventions as the Comptroller General believes appropriate.

This provision required reporting on the implementation of Bayh-Dole. Invention utilization might figure in such reporting, though it is not clear that the Comptroller General produced many of the required reports. As it is, it does not appear that there is any Bayh-Dole reporting to Congress or to the President. And even if this paragraph was still in Bayh-Dole, it does not get so far as how contractors are behaving under the standard patent rights clauses, but only to how federal agencies are using standard patent rights clauses and enforcing or using or waiving the federal government’s rights under those clauses. Even where Bayh-Dole required reporting, the law was drafted to avoid reporting on the central purpose of the law–to promote the use of inventions made with federal support for public benefit on reasonable terms. Everything else is merely “tone” not “substance.” Continue reading

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Circumventing Bayh-Dole, Bonus Fitt

[updated to expand on the limits on government-side licensing once the (e) exploit is in operation–5/19/17 added account of antecedent of provisions (e), (f), and (g) in the FPR 10/6/19]

There is one more circumvention in Bayh-Dole that can be used to by-pass much of the onerous apparatus of the law. This circumvention involves an exploit of the almost totally ignored contractor license and march-in provisions in the standard patent rights clause at 37 CFR 401.14(a)(e) [as of May 2018’s renumbering silliness, 37 CFR 401.14(e)]. The march-in in (e) is not the one authorized in 35 USC 203, in which the government can march-in on assignments and exclusive licenses to require contractor licensing to meet what an agency has determined to be a need for public availability or failure to comply with the U.S. manufacturing requirement. Instead, the (e) march-in has to do with a provision under which a contractor “retains” a domestic license with the right to sublicense even when the federal government obtains title to a subject invention (and goes on to patent the invention). That is, (e) requires the federal government to grant a conditional, revocable non-exclusive license to all subject inventions, with a conditional right to sublicense. For the federal government to attempt, later, to grant an exclusive license in any given subject invention, it must first overcome the march-in barriers set up in (e).

This (e) provision has no basis in Bayh-Dole. Like the (f)(2) written agreement requirement, it is something made up in the moment perhaps because Bayh-Dole didn’t manage to set out all the things that ought to go into a patent rights clause (even if never enforced). Or perhaps (e) is there in the standard patent rights clause because it wouldn’t have made it through a Congressional review if it had been placed in the text of the statute, as one more required provision in 35 USC 202(c). Continue reading

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Circumventing Bayh-Dole, Fitt the Fourth

We have been discussing contractor-side practices to circumvent Bayh-Dole. We can finish with yet another:

4) circumvention by regulatory procedure, by which federal agencies may reduce the attraction of contractor-side exploits that don’t end up serving the public interest.

Circumvention by Regulatory Procedure

Bayh-Dole doesn’t actually dictate the patent terms of federal funding agreements. Actually, it is more of an administrative bottleneck, requiring default terms but leaving it to federal regulations to set out the actual terms for standard patent rights clauses. In fact, there are four such standard patent rights clauses (one for nonprofits, one for small businesses, one for inventors, and one for use in funding agreements involving certain weapons systems). There could be even more. Bayh-Dole permits agencies to vary from these defaults, but stipulates procedures for such changes. Thus, in a way, Bayh-Dole does absolutely nothing to assure “uniformity” or “certainty of title.” All Bayh-Dole does is to state defaults to be used in standard patent rights clauses and then make it a bother to try to change them. The regulations go further this way than does the statute, adding bother upon bother to the prospect of change, whether to the basic rights proposition or to march-in.

Oddly, Bayh-Dole has no enforcement requirements for the government side of the patent rights clauses. While Bayh-Dole makes it difficult for federal agencies to change the terms they put in a patent rights clause, Bayh-Dole makes it easy for federal agencies to then ignore any of the default terms having to do with federal–public–interest in the patent rights clause. The government does not have to require title in cases of contractor default or mis-doing, does not have to exercise its rights under its non-exclusive license to practice and have practiced, does not have to march-in, does not have to be bothered by exclusive licenses that are assignments, does not have to be bothered by exclusive licenses in the US that don’t require US manufacturing, does not have to worry about preferences for small business, does not have to watch how nonprofits spend licensing income, does not have to require reports on the use of subject inventions. Really, doesn’t have to do a darn thing. Continue reading

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Circumventing Bayh-Dole, Fitt the Third

We have been discussing circumventions of Bayh-Dole. The first set of circumventions are decidedly un-legal but universities do them anyway. Those of the second set, done with attention to detail, are allowed by Bayh-Dole and free university patent licensing practice from the public covenant of subject inventions and most of the fussy administrative overhead of Bayh-Dole’s standard patent rights clause. Now let’s look at circumventions to the faux Bayh-Dole Act–to the practices that university patent brokers say Bayh-Dole is supposed to be used for, but which Bayh-Dole doesn’t bother to come out and authorize, so the patent brokers have to act as Speakers for the Dead, as it were, and bring into the open these unstated purposes of Bayh-Dole. You know, like Bayh-Dole is a vesting statute, that it mandates commercialization, that it exists for exclusive licenses, and that universities can use royalties for most anything they want because anything they do is “education” in some sense.

Let’s use Bayh-Dole–entirely compliantly–to do things that the faux Bayh-Dole advocates want to suppress. Let’s circumvent the circumventions!

3) circumvention by practice to upset the premises of Bayh-Dole while complying with the terms of the standard patent rights clause.

Continue reading

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Circumventing Bayh-Dole, Fitt the Second

Circumventing Bayh-Dole is easy. University administrators have been circumventing Bayh-Dole since the law became effective in 1981. Consider next

2) circumvention by exploit–to use Bayh-Dole’s limitations to end up with the best deal under Bayh-Dole and avoid public covenant requirements.

Circumventing Bayh-Dole without Noncompliance 

Our next circumvention is distinctive because it does not involve a failure to comply with Bayh-Dole. Instead it exploits the architecture of the Bayh-Dole apparatus. Under Bayh-Dole, universities have no obligation to take assignment of inventions made with federal support. Even if a university implements the (f)(2) written agreement requirement in the standard patent rights clause–which makes most any invention otherwise within scope of a federal funding agreement also a subject invention–the university does not have to own the invention.

If the university does not own a subject invention, then a different invention rights clause comes into play, that of 37 CFR 401.9. That invention rights clause instructs federal agencies to treat inventors as small business contractors but with even fewer restrictions than normal small business contractors. Under 401.9, inventors have no restrictions on assignment or use of income from licensing, don’t have to prefer small businesses, and even might not have to grant the government a royalty-free license. The inventor patent rights clause is the most advantageous of all the patent rights clauses that have been created under Bayh-Dole’s authority. Continue reading

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Circumventing Bayh-Dole, Fitt the First

Circumventing Bayh-Dole is easy. University administrators have been circumventing Bayh-Dole since the law became effective in 1981. Let’s look at three sorts of circumvention:

1) circumvention for non-compliant convenience–to make Bayh-Dole do even better what people claim Bayh-Dole was intended to do;

2) circumvention by exploit–to use Bayh-Dole’s limitations to end up with the best deal under Bayh-Dole and avoid public covenant requirements; and

3) circumvention by practice to upset the premises of Bayh-Dole while complying with the terms of the standard patent rights clause.

These are all contractor-side practices. We can finish with yet another:

4) circumvention by regulatory procedure, by which federal agencies may reduce the attraction of contractor-side exploits that don’t end up serving the public interest.

Circumvention by Non-compliant Convenience

Rather than implementing the written agreement requirement in (f)(2) of the standard patent rights clause, university administrators instead created the idea that Bayh-Dole vested ownership of inventions with the universities that hosted federally supported research. And when the Supreme Court in Stanford v Roche ruled that the law did not support such vesting by research hosts (who are not necessarily even legitimate employers), university administrators switched to requiring “present assignments” for any and all future inventions, patentable or not. They’d rather do what they want to do than to do what the standard patent rights clause requires them to do, which is to implement the (f)(2) written agreement clause.

If one wanted to put this practice as a quip, Bayh-Dole’s standard patent rights clause stipulates that universities give inventors the choice of assigning to the federal government or to a non-federal patent broker, but university administrators fear such a choice and instead prevent it from ever operating, in defiance of the standard patent rights clause. Continue reading

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Bayh-Dole Secrecy, Part 7

The story so far: Bayh-Dole’s secrecy provision regarding reports of invention use was changed in 1984 to make it appear that federal agencies had no discretion in the matter, and that they “shall” treat all information in invention use reports as “commercial and financial” information and as “privileged and confidential” and as exempt from FOIA disclosure. In turn, the implementing regulations impose an additional requirement, that agencies agree not to disclose this information “outside of the agency” or “outside of government” unless with the contractor’s permission (meaning, the contractor must be consulted before any such disclosure by the government–even if information in the report is otherwise public).

Having beaten this matter beyond death, we looked at FOIA in more detail and in particular the exemption at (b)(4), which Bayh-Dole’s amended secrecy provision depends upon, and at the court’s reasoning in the Public Citizen case from 2002, involving a request under FOIA to release NIH royalty rate and income information. The court there found that the requested information was exempt under (b)(4), both because release would cause substantial competitive harm and because release would impair the government’s licensing program. The court found–and I argue expressed a general truth regarding Bayh-Dole, not just with invention use reports but with all matters of public oversight–that “in balancing the public interest in disclosure against the private interest in withholding information, the private interest prevails.”

The Department of Justice, in discussing FOIA’s exemption (b)(4), considers the issue of whether information that is exempt from FOIA is still available to be disclosed by the government. Just because FOIA does not require disclosure, can the government then disclose the information anyway, on its own time, so to speak? Here, things gather some interest. We turn to the federal Trade Secrets Act, 18 USC 1905. Continue reading

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Bayh-Dole Secrecy, Part 6

Bayh-Dole makes information regarding the use of subject inventions a government secret. It does this in a roundabout way by requiring federal agencies to treat those reports as confidential and as the sort of information that is exempt from FOIA disclosure and on top of that requires federal agencies to agree in each funding agreement not to disclose this information, at least to the extent required by Bayh-Dole.

All this secrecy apparatus is silly. Bayh-Dole could have just specified that invention use reports are not to be publicly disclosed. Bayh-Dole does just this for reports of subject inventions and patent applications in 35 USC 205. It’s no big deal to do. Bayh-Dole could just as easily have included invention use reports there in 35 USC 205, or could have stated simply and clearly at 35 USC 202(c)(5):

Provided, That any such information shall not be disclosed by the Federal agency.

One way to read the silly secrecy apparatus is of course just this way–that all that language and layers of requirements with their inconsistencies and uselessnesses just amount to this simple clear statement. I’m sure many people do read things this way. Another way to read this apparatus, however, is that the intent of Congress was not this simple clear way and the apparatus is evidence of a different intent–if Congress had wanted to write something simple and clear, Congress surely had the capacity to do so. Well, surely may be a bit much.  Continue reading

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The Bayh-Dole government license (and Grinches)

The federal government has five methods to deal with the exploitation of federally supported inventions. Let’s list them and make a few points, ending with a discussion on the value of the government’s license to “practice and have practiced” subject inventions.

  1. Bayh-Dole’s policy and objective limiting the scope of patent property rights
  2. The standard patent rights clause
  3. Exceptional circumstances modifying the patent rights clause
  4. March-in procedures for nonuse, public needs, regulatory needs, U.S. mfg
  5. Government “practice and have practiced” license

Let’s work through these.

Bayh-Dole’s policy

Bayh-Dole starts with a statement of policy and objectives at 35 USC 200. This is more than simply a statement of legislative purpose, as evidenced by the presence of the term “policy.” The policy set forth replaces the executive branch policy that governed federal agency contracting requirements for nonprofits and small businesses. But Bayh-Dole is part of federal patent law, and the policy also changes the scope of the patent property right for inventions made with federal support. Bayh-Dole defines a new category of patentable invention–the “subject” invention. Patent law states that patents have the attributes of personal property, “subject to the provision of this title” (35 USC 261). And for subject inventions, the provisions of the title include Bayh-Dole, which is part of patent law. Continue reading

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Exclusive License and Assignment

I have discussed in a number of articles the issue of exclusive license and assignment for inventions. The distinction matters under Bayh-Dole because Bayh-Dole’s standard patent rights clause (37 CFR 401.14(a)(k)(1)) forbids nonprofit contractors from assigning subject inventions other than to an organization that has as a primary function the management of inventions unless it gets federal agency approval, and even then the assignment must carry with it the nonprofit obligations of the standard patent rights clause–including sharing royalties with inventors and using any profits after expenses for scientific research or education–things that might be nice, but not the things that most for-profit organizations are willing to do with their profits from a subject invention.

A transaction becomes an assignment when the patent owner conveys “all substantial rights” in an invention to another. One way to do this is by assigning “title” to the invention. Another way, however, is to exclusively license the rights to make, use, and sell–the substantial rights in the invention.

A slide deck by Joshua Rawson and Thomas Rayski on “Critical Mistakes to Avoid in Intellectual Property Licensing” [since removed from the Dechert site;Wayback Machine archived version here] provides a useful slide that lays out the situation. I’ve messed up their slide by circling the key categories. Continue reading

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