Nothing more. Why (f)(2) isn’t an assignment requirement, and can’t be.

NIST proposes to “clarify” the (f)(2) clause of the standard patent rights clause authorized by Bayh-Dole to turn it into an assignment clause. This is wrong. I will explain.

1.  Bayh-Dole does not require an assignment clause. Bayh-Dole gives no authority for a standard patent rights clause that requires assignment. If NIST places an assignment requirement in the standard patent rights clause, it exceeds its authority under Bayh-Dole. It is a misrepresentation of the law and the standard patent rights clause to argue that (f)(2) is an assignment clause.

2. The Supreme Court in Stanford v Roche was asked to determine if Bayh-Dole vested title in or otherwise required the assignment of subject inventions to the contractor. The Court ruled that Bayh-Dole did not disturb the common law ownership of patentable inventions.

Nowhere in the Act is title expressly vested in contractors or anyone else; nowhere in the Act are inventors expressly deprived of their interest in federally funded inventions.

The Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have.

The Act’s disposition of rights—like much of the rest of the Bayh-Dole Act—serves to clarify the order of priority of rights between the Federal Government and a federal contractor in a federally funded invention that already belongs to the contractor. Nothing more.

The “Nothing more” is telling. Continue reading

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Bayh-Dole all but mandates Government practice of subject inventions

The Bayh-Dole Act requires contractors retaining ownership of subject inventions to grant a non-exclusive license to the government. Commonly–and very wrongly–this license is depicted as a requirement that commercial vendors sell product based on subject inventions to the government “royalty-free”–meaning that the commercial vendor must discount each product by the amount the vendor would otherwise pay to the patent owner. Often the royalty is under 6%, and frequently under 2% in some industries. When the royalty is a fixed amount or an equity stake or involves upfront fees and milestone payments, then there’s no good way to calculate, for any given product, what portion of its price is reflected in a payment obligation to a patent licensor. The discounts available are tiny if incalculable.

But all of this is deeply silly. That’s not what the government license is all about. It has nothing to do with what the government purchases and everything to do with what the government can practice. If we take a look at the Bayh-Dole Act in context, the scope of the government license becomes evident. I’ll argue that Bayh-Dole does more than grant a license to the government–scope to be explained. Bayh-Dole also creates a federal mandate to act on the rights the government has. If Bayh-Dole is a do WTF you want law, that characteristic also applies to both the federal government and state governments.

Let’s start with the Kennedy patent policy and work forward. Continue reading

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Federal patent policy for the 21st Century, Part 3

What’s funny (funny “strange” not funny “funny”) is that universities could implement the core of this version of the law themselves, right now, no politics necessary. Yes, there is still all the wasted paperwork to throw around under the current Bayh-Dole Act, but other than that, there’s is still the 35 USC 202(d) to 37 CFR 401.9 pathway that allows inventors to own their inventions and have only limited restrictions on what they can do with any patents they obtain.

Universities could work this approach without a whole lot of effort or expense. First, there’s the usual invention reporting overhead. The university gets a report of a subject invention and dutifully passes that along to the federal agency that funded the work. But instead of demanding assignment from the inventor(s), the university sends a notice to the federal agency that the university will not elect to retain title if the federal agency agrees to permit the inventors to retain title (which they still have at this point), subject only to the standard patent rights clause at 37 CFR 401.9.

That clause reads:

Agencies which allow an employee/inventor of the contractor to retain rights to a subject invention made under a funding agreement with a small business firm or nonprofit organization contractor, as authorized by 35 U.S.C. 202(d), will impose upon the inventor at least those conditions that would apply to a small business firm contractor under paragraphs (d)(1) and (3); (f)(4); (h); (i); and (j) of the clause at § 401.14(a).

Let’s unwrap the requirements: Continue reading

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Federal patent policy for the 21st Century, Part 2

In Part 1, I proposed a new law governing federal patent policy for public interest research conducted at universities–research to advance science and technology, or to address matters of public welfare. That new law carried with it public covenants that ran with each patent on a subject invention, created commons for research and public use, and limited exclusive licensing in ways imagined by the original Bayh-Dole but amended away by the conniving forces of university bureaucrats with power lust and no desire for accountability. But all of this is predicated on the policy position that the federal patent system on its own is inadequate to meet the needs of advancing science and technology and all that, and so there has to be a second set of requirements falling on all patents made in public interest research at universities.

That has been federal policy since 1947, at least. The Kennedy patent policy expanded it. The Institutional Patent Agreements bowed to it at least (while doing their end-run). Bayh-Dole incorporates it (though walks it back everywhere it can, and where it can’t walk it back, it gets amended away a few years later, and in the meantime, everyone misrepresents the law and ignores compliance so that when amendments are proposed they appear to track “best practice” and therefore are only “clarifications.” Right NIST?) Just “clarifying” that (f)(2) requirement in the regulations to make sure that Bayh-Dole “requires” assignment when the law does nothing of the sort and the Supreme Court was crystal clear on the point. But will anyone at NIST care?

So the law proposed in Part 1 captures the social requirements that attend to a patent law “tuned” to the expectations of public science, public technology, and public interest research. Continue reading

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Federal patent policy for the 21st Century, Part 1

How about a new Dole/Bayh Act? Of course, it will have different names attached to it. How about a law that tracks what Vannevar Bush recommended for scientific frontiers, nearly 75 years ago, in Science the Endless Frontier? One that puts inventors first. But now with protections against predatory institutions and patent brokers–something not in vogue back then. And still retaining the idea that public funding should alter the patent monopoly rights available to researchers who have chosen to work at universities. If a publicly funded invention should result in patent that ought to be worked, ought not be trolled, ought to be limited in its exclusivity, and ought to result in new use faster and at lower price than what an ordinary patent might do or not exist at all–if these are the policy aims, then Bayh-Dole is no longer a meaningful approach.

Keep it short and sweet. Restrict the new law to federal funding agreements with universities and to research to advance scientific and technological knowledge, and to address matters of public welfare. Don’t conflate federal purposes involving university research with procurement of deliverables for government use. Arrangements with other organizations can be federal procurements–follow a different policy for those. Uniformity that doesn’t track purpose is merely arbitrary or indifferent or blind (take you pick). Or, if organizations want to receive grants that otherwise would go to faculty at universities, then those organizations will have to treat their own research talent as if it were faculty–released from employment duties, publishing results for general use–and allow their inventors to own their inventions (“free” inventions, not “service” inventions). All involved must recognize the purposes and limitations on public purpose patents that might result from such research.

In this new law, electing to retain title and reporting aren’t necessary, so we will have low administrative costs–no more of the Bayh-Dole useless paper shuffling. Continue reading

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Exclusive licensing in Bayh-Dole, Part 2: The Lost Requirements

Part 1 of this two-part series discussed the difference between exclusive license and assignment, and why Bayh-Dole’s wording on the one remaining restriction on exclusive licensing was worded as it was–“exclusive right to use or sell.” Let’s look at how things were at the start, before the 1984 amendments. When Bayh-Dole was first passed, the statement of policy and objective had the following:

It is the policy and objective of the Congress . . .

to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise . . . .

There used to be a portion of Bayh-Dole that was specifically responsive to this statement of policy and objective, at least for nonprofit organizations–that had to do with exclusive licensing. When Bayh-Dole was passed into law, it required that the standard patent rights clause must, for nonprofit organizations, contain:

(B) a prohibition against the granting of exclusive licenses under United States Patents or Patent Applications in a subject invention by the contractor to persons other than small business firms for a period in excess of the earlier of five years from first commercial sale or use of the invention or eight years from the date of the exclusive license excepting that time before regulatory agencies necessary to obtain premarket clearance unless, on a case-by-case basis, the Federal agency approves a longer exclusive license.

This represents a fundamental limitation on the term of exclusive licenses, at least for nonprofits. As typical with Bayh-Dole, there is also a trailing walk-back: Continue reading

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Evidence-based federal research patent policy

The Commission on Evidence-Based Policymaking is holding a public hearing in Chicago in January for “any interested stakeholders” to provide input. Given that the commission’s statutory mandate is more toward database access and security, I’m not sure that the lack of data pertaining to Bayh-Dole is all that close to their interests. Here’s what I’d present to the Commission. Maybe I’ll submit something for the West Coast meeting.

*****

The federal government provides $40 billion per year to fund research at American universities. The Bayh-Dole Act, a part of federal patent law, governs the disposition of patentable inventions made in the course of this research. Such inventions, defined as “subject inventions” by Bayh-Dole, represent a significant portion of the research output of federally sponsored university research. It is important that the federal government has the ability to assess the effects of the Bayh-Dole Act. Continue reading

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Exclusive licensing in Bayh-Dole, Part 1: Licenses and Assignments

Here is what Bayh-Dole says about exclusive licenses:

Notwithstanding any other provision of this chapter, no small business firm or nonprofit organization which receives title to any subject invention and no assignee of any such small business firm or nonprofit organization shall grant to any person the exclusive right to use or sell any subject invention in the United States unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States.

That’s from 35 USC 204. An exclusive license to use or to sell in the U.S. requires substantial U.S. making as well. And even that gets walked back immediately. There are two points to make here. The first concerns the meaning of “the exclusive right to use or sell.” The second has to do with the fact that the only limitation on exclusive licenses is here, in 35 USC 204, when originally Bayh-Dole had an extensive limitation on exclusive licenses specific to nonprofit organizations, at 35 USC 202(B)–don’t look there for it now, as the clause has been relettered, as it were, into oblivion.

exclusive right to use or sell

any products embodying the subject invention or produced through the use of the subject invention

This is odd wording. Why not just require any exclusive license in the U.S. to require U.S. manufacture? Why just single out “use” and “sell”? And why is there an “or” between the two words? And what is that limitation on products doing? Why not just any products covered by a claim of a patent on a subject invention?

Let’s expand the wording: Continue reading

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Turning (f)(2) into an assignment clause violates Bayh-Dole

When I first looked through the proposed revisions to Bayh-Dole’s implementing regulations, it appeared that they applied to inventions made by federal employees and extended implementing regulations to include large businesses, consistent with a presidential executive order that does the same thing. But I missed the following:

18. Clarify the requirement in § 401.14(a)(f)(2) for a contractor to require its employees to assign rights in subject inventions to the contractor and in order for the contractor to file patent applications on subject inventions developed under the contract;

This will be a huge change in the practice of the law, especially after the Supreme Court ruling in Stanford v Roche. In essence, it creates a work-for-hire provision in the standard patent rights clause for all inventions made with federal support. The inventor does not own anything–the employer does, regardless of the terms of employment.

Bayh-Dole pre-empts all other federal laws on the procurement of patent rights in federally supported research involving small businesses and nonprofits. Bayh-Dole must also pre-empt regulations implementing Bayh-Dole that don’t have any standing. If there’s no statutory authority in Bayh-Dole to require contractors to require assignment of inventions, no regulation has standing to require such a thing anyway. (f)(2) was drafted to be consistent with Bayh-Dole. Bayh-Dole does not provide any mandate for federal agencies to require small business and nonprofit contractors to require they obtain assignment of subject inventions. There is therefore no statutory authority for NIST to revise (f)(2) to turn Bayh-Dole into a vesting statute by requiring small businesses and nonprofits to require in the standard patent rights clause assignment of subject inventions.

This proposed change reflects a fundamental misunderstanding of Bayh-Dole–one that is of course a desired misunderstanding by folks intent on ensuring that universities in particular gain ownership to most anything that faculty or others might make in the course of research. And of course, they want ownership to ensure that they have work trying to make money licensing patents to monopolist interests. So far, they have reduced the commercialization rate from 25% to 5% to 0.5% over the course of forty years.
Continue reading

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Boiling away “Why Bayh-Dole”

The basis of the patent system is individual inventor rights. Bayh-Dole strips these in favor of institutional exploitation. Bayh-Dole is inventor loathing.

The results are terrible. Commercialization rates are 1/1oth what they were before Bayh-Dole. Bayh-Dole has created tens of thousands of unworked patents. Bayh-Dole is anti-innovation.

Bayh-Dole exists so that pharma can get monopoly rights to federally supported drug discoveries and charge monopoly prices. Bayh-Dole enables a market to exploit suffering.

Bayh-Dole grants private rights in patents in exchange for limited rights in those patents. But universities ignore the limits and go for the money. Federal agencies turn a blind eye. Bayh-Dole is never enforced.

Bayh-Dole should be repealed. It’s been a terrible 35 years. Nothing would be better.

If the U.S. government paid for prescription drugs the most favorable price those drugs were offered anywhere in the world (or even in any developed country), then we’d have enough money to fund most everyone’s basic health care needs. Bayh-Dole steals basic health care in favor of speculator profits.

Bayh-Dole, what a killer.

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