When to disclose inventions? Part II: Bayh-Dole, 2

We are explaining why, despite widespread insistence by folks who set themselves up as experts, there’s no obligation in Bayh-Dole for inventors to disclose inventions made under a federal contract. The first point to be made is that if one looks at the statute, there’s no disclosure requirement at all for inventors, only for contractors, after inventors do disclose–and the contractor has acquired title.

The standard patent rights clause authorized by Bayh-Dole includes a provision addressing inventor disclosure that’s entirely outside Bayh-Dole (there is no statutory authority in Bayh-Dole to require inventors to disclose anything to their employers–but what’s to stop meddling?). But even the standard patent rights clause provision does not actually require inventors to disclose inventions–disclosure is conditioned on a contractor’s compliance with the contractor’s disclosure obligation, and the contractor’s disclosure obligation only shows up after an inventor has disclosed the invention to the contractor. And a contractor is not required to get disclosures. With no inventor disclosure, there is no contractor compliance problem. So the patent rights clause in Bayh-Dole totally messes things up–unless its purpose is to keep inventors free (somewhat) from bureaucrats forcing them to use the patent system or to give up their rights to inventions.

A part of my brain, at this point, tells me that those drafting Bayh-Dole simply did not have a full deck. Continue reading

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When to disclose inventions? Part II: Bayh-Dole, 1

When to disclose a subject invention under Bayh-Dole? It doesn’t matter. Really. Let me explain.

The Bayh-Dole Act applies to subject inventions. A subject invention is an invention (i) owned by a contractor (ii) that is or may be patentable (iii) and which has been made in the performance of work under a federal funding agreement. See 35 USC 201 and the Supreme Court decision in Stanford v Roche.

Bayh-Dole has this to say about invention disclosure at 35 USC 202(c)(1), in the list of things that must be in the standard patent rights clause unless a federal agency determines exceptional circumstances:

That the contractor disclose each subject invention to the Federal agency within a reasonable time after it becomes known to contractor personnel responsible for the administration of patent matters, and that the Federal Government may receive title to any subject invention not disclosed to it within such time.

Remember, a subject invention is one that the contractor has somehow acquired. Continue reading

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A century of reaping enormous profits at the expense of sickness and misfortune, 3

The Mayo doctors, having made their specific arguments with regard to salvarsan in their 1917 letter to Congress, end with a full scale plea, not only to cancel the patent for salvarsan but also for other German drugs, and for patents on drugs in general:

We beg to urge upon you that you use every influence which you can bring to bear in favor of an immediate abrogation by Congress of the patent rights on this drug and incidentally on other drugs necessary to the public health whose usefulness is curtailed by German patents.

Then their expanded plea, for a “radical revision of our patent law”:

We urge that such an abrogation shall not be merely for the duration of the war but shall be permanent, and that furthermore, there shall ultimately be a radical revision of our patent law, looking to the prevention of private monopoly of remedial agents indispensible to the public health.

The letter is signed (by my count) 86 members of Mayo Clinic including both Mayos.

What follows, then, were two bills introduced into the Senate, one that canceled the salvarsan patents (S. 2178) and the other authorized the United States to make and distribute for use any drug “that cannot be procured at a reasonable price” (S. 2363). Not quite what the Mayo doctors wanted, but something.

In this day and age, when the NIH and NIST officials claim to be confused by what “reasonable terms” might mean in 35 USC 203 of the Bayh-Dole Act, we might start with usage a century ago. Eighty plus Mayo doctors were clear on the idea–the terms that mattered for public health were quantity, quality, and price. Those are the terms that must be reasonable, or the United States should take action to make and permit the use of the “drug, medicine, or other remedy or device” and any patent or trademark owner can recover “reasonable compensation” through a court of claims. Continue reading

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A century of reaping enormous profits at the expense of sickness and misfortune, 2

Mayo’s research publication Discovery’s Edge recently ran an article on “The Power of Patents.” In the article, Mayo Clinic wonders about patent royalties from a famous past invention:

When Mayo Clinic colleagues Edward Kendall, Ph.D., and Philip Hench, M.D., along with Swiss chemist Tadeau Reichstein, won the Nobel Prize for Physiology or Medicine in 1950 for demonstrating how cortisone was capable of reversing inflammation, Mayo Clinic did not patent this discovery nor participate in its commercialization. The invention was a breakthrough in treatment for patients with rheumatoid diseases, but Mayo Clinic did not receive a share of the revenue generated by pharmaceutical companies from this innovation. If Mayo had received such funds, they could have been used to further research to benefit patients.

Mayo Clinic did not patent the invention, but Kendall certainly did, working through Research Corporation, which made a deal with Merck, all under the auspices of Vannevar Bush’s war effort to study adrenal gland extracts as a possible benefit for pilots flying at high altitudes. (See the story here).

In the Mayo Clinic article, perhaps unintentionally, is a clue to the problem of introducing a cap on income earned with respect to a patented medicine made with federal support–the “mede measureless” of the royalty income could be used for further research “to benefit patients.” The tag is telling, because most research, while it may be proposed to benefit patients, largely and most immediately benefits the organizations involved in conducting the research. The larger argument, however, is that to achieve a maximal amount of income from a “share” of sales revenue, the sales revenue itself cannot be capped. For a Mayo Clinic to get its 1%, it is essential, so the implicit logic goes, for the manufacturers to get their unlimited 99%. Continue reading

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A century of reaping enormous profits at the expense of sickness and misfortune, 1

In June 1917, the United States had just entered the first world war against Germany, and a German chemical maker through its American subsidiary Farbwerke-Hoechst held U.S. patents on salvarsan, a medicine used to treat syphilis. Along letters written on behalf of the seven hundred members of the Connecticut Society of Social Hygiene and with the Center Congregational Church of South Manchester, doctors at the Mayo Clinic wrote a letter to Congress, asking that the patents be canceled.

Mayo doctors complained that

During the course of the European war the supply of salvarsan in this country has been insufficient and precarious. The drug has been manufactured in German, imported when circumstances permitted, and doled out to the medical profession at prices which have largely prevented its use to the extent or in the type of cases which the interest of the public health demands.

The Mayo doctors pointed out that an American lab was permitted to make salvarsan by the German company for a time when importation was not possible, but “at a price dictated by their conception of commercial expediency.” Once imports resumed, the American lab was ordered to cease production. The Mayo doctors then turn to the price:

The price of salvarsan as regulated by the Farbwerke-Hoeschst Co. is a glaring example of a commercial monopoly reaping enormous profits at the expense of sickness and misfortune.

Continue reading

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“Promote” in Bayh-Dole, 4

In arguing in Public Citizen v NIH that secret exclusive deals were the only way the NIH could fulfill its public mission–or at least the mission of its patent licensing office–the NIH produced some interesting metrics. In 2000, the NIH negotiated on 43 inventions, and for only two of these inventions was there a second interested company. What do we make of that? Perhaps it is that the NIH fails to broadcast availability sufficiently broadly. Perhaps it is that because the NIH is open to secret exclusive deals, once a company shows up to request a license, the NIH shuts off announcing availability of the invention under negotiation. Perhaps more potential licensees would appear if an invention was made available non-exclusive, royalty-free. The Court has this to say:

Thus, forty-one of the applications had no competition.

Now, if one were to assess the NIH patent licensing program relative to the expectation on exclusive licenses set out in Bayh-Dole (35 USC 209(a)(4)), one would conclude that the NIH had failed to comply:

granting the [exclusive] license will not tend to substantially lessen competition

NIH, no doubt, would argue that if there was no competition for a license, then granting the license could not tend to lessen competition. Nothing from nothing leaves nothing, as the song goes. Continue reading

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“Promote” in Bayh-Dole, 3

We are working through the Public Citizen v NIH case. Public Citizen sought to make the NIH disclose key elements of its exclusive licensing practice, and NIH refused. The Court agreed with the NIH–that in the balance between public interest and private interests–including NIH’s private or at least secret interests–the private interest should prevail. There should be no public oversight of federal agency dealings in patent monopolies.

Central to the Court’s, um, reasoning involves a second-hand interpretation of Bayh-Dole and the Federal Technology Transfer Act, spun through the NIH’s representation of these laws. The NIH argued that any public revelation of the royalty rate or income received would harm its licensing program. Federal technology transfer law, so it would appear, can operate only when it operates in secret. Continue reading

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“Promote” in Bayh-Dole, 2

The meaning of “promote” in Bayh-Dole gets dealt with, though indirectly, in Public Citizen v. NIH (2002). In this case, Public Citizen, an advocacy group, sued the NIH in an effort to get the NIH to disclose certain particulars of an exclusive license the NIH had granted to Johnson & Johnson. Public Citizen wanted to know how much money the NIH had received under the license and the royalty rate the NIH had negotiated. The NIH claimed the information was protected by FOIA. The court ruled in favor of the NIH–that releasing such information would have a detrimental effect on the NIH’s licensing program.

The upshot–no public accountability for federal agencies when they deal in patents. Whatever public agencies require (or give up) in patent deals must be understood to be information coming from whomever the agency is dealing with, and to release that information–a deal whose terms are entirely in the federal agency’s control–would damage the federal agency’s ability to do more such deals. “If we cannot do secret deals, then our licensing program based on secret deals will be damaged.” Well, well, tautologies abound. Meanwhile, the public loses oversight over matters of public importance. If Bayh-Dole anticipates federal licensing in the public interest, apparently it also asserts that the public is too stupid and dangerous to be informed of what the federal government is doing in its interest. Fundamental rule of Bayh-Dole: Sucks to be the public. Continue reading

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Hormones and Patents

Graham Dutfield at the University of Leeds has published an article on the development of medical hormone products and patent law, “Patent on Steroids: What Hormones Tell Us about the Evolution of Patent Law.” The article doesn’t do as much with the evolution of patent law as its title suggests, but it does a great deal to describe how the use of patents on hormones shaped both company and non-company practices. Dutfield works through the major discoveries of the early to mid 20th century–adrenaline, insulin, cortisone, and sex hormones. German dye companies developed synthetic chemistry and transitioned into production of chemistry-based medical products–products for pain relief or fever reduction, like aspirin. In the United States, companies making medical products focused on extracting natural agents or purifying minerals.

When hormones got interesting at the turn of the 20th century, companies had to adapt. Hormones are too difficult and expensive merely to extract and purify. There must be ways to synthesize them, or make analogs. And once the hormones have been synthesized, then ways have to be found to make them in quantity and reduce the cost of doing so. Continue reading

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“Promote” in Bayh-Dole, 1

In 2002, a district court provided an implicit interpretation of a key word in the Bayh-Dole Act. No, not “of”–but rather “promote.” Let’s look at “promote” in Bayh-Dole, and then at the case.

The first section of Bayh-Dole, 35 USC 200, opens with these words:

It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations, including universities; to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery; to promote the commercialization and public availability of inventions made in the United States by United States industry and labor . . .

In all, “promote” is used four times in a single sentence. “Promote” is important to federal patent law, since the Constitution grants Congress the power to

To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;

For reminders, here is the preamble to the Constitution:

We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defense, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United States of America.

So what does “promote” mean? Here’s the first definition for “promote” in Webster’s Dictionary of 1828:

To forward; to advance; to contribute to the growth, enlargement or excellence of any thing valuable, or to the increase of any thing evil;

as, to promote learning, knowledge, virtue or religion; to promote the interest of commerce or agriculture; to promote the arts; to promote civilization or refinement; to promote the propagation of the gospel; to promote vice and disorder.

“To forward, advance, contribute to the growth, enlargement or excellence.” That makes sense of the power to “promote” the general welfare or to “promote” the progress of the useful arts. When Bayh-Dole uses “promote”–as part of federal patent law–we might expect that Bayh-Dole also means, then, to use the patent system “to advance” the utilization of inventions or “to contribute” to the conditions under which inventions may be utilized. Similarly, “to promote” collaboration must mean to create conditions that favor collaboration, so that there will be more collaboration or more excellent collaboration; and “to promote” commercialization and public availability must mean creating better conditions than otherwise under which inventions are both commercialized and are publicly available. That is, the conditions for commercialization and public availability of inventions have been advanced over those that otherwise would prevail.

Bayh-Dole’s usage for free competition is somewhat more complex:

to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery

Congress intends the law to ensure that inventions are used to promote free competition and enterprise–“in a manner” that promotes free competition and not in other manners that otherwise would be possible and legal were federal patent law not amended by Bayh-Dole. Here “promote” must mean “advances” or “contributes to the growth of” free competition and enterprise. By the manner of use of an invention, free competition is advanced. The use of inventions by nonprofits and small businesses must–ensure–follow those ways–manners–by which free competition grows, is advanced, is promoted.

We might then understand Bayh-Dole’s policy and objective to be that inventions arising in federally supported research or development are to be used, and that the particular use of these inventions by nonprofits and small businesses must advance free competition and enterprise.

A preamble by itself may be taken to be declaratory, not legally binding. Bayh-Dole, however, goes out of its way to assert that its first section states not just an objective but also a “policy.” Bayh-Dole replaces executive branch policy–and its codification as federal regulation–by a new policy. Thus, it is reasonable to expect that 35 USC 200 does in fact have statutory power–not merely to provide some general guidance on how to read what follows in the law, but itself is part of that law, limiting the patent property rights in inventions to conform with the policy of Congress (rather than the Executive branch) with regard to inventions arising in federally supported research and development. Of course, reasonable expectations mean next to nothing for a law that no one complies with, no one enforces, and for which pretty much anyone can make up anything they want to about it. What matters is how the law gets argued by lawyers before courts, and what those courts decide–and even then, it appears that folks are more than happy to ignore the courts when it suits them.

Thus, even though courts have ruled that an exclusive license that conveys all substantial rights in a subject invention–one that comes within the scope of Bayh-Dole–constitutes an assignment of the invention, no one cares that Bayh-Dole limits how nonprofits can grant such assignments nor the conditions that Bayh-Dole places on such assignments. Similarly, even though the Supreme Court has ruled that Bayh-Dole applies only after a contractor obtains ownership of an invention, and that Bayh-Dole provides no special power or privilege for a contractor to obtain that ownership, university administrators still retain their policies that make it appear that federal law gives them those special powers and privileges. It would make a heck of a difference in practice were Bayh-Dole enforced–were it that anyone cared. But Bayh-Dole is so important, so critical, so successful that no one is supposed to care.

It is worth noting, as well, that while Bayh-Dole sets out a general limitation on the use of the patent system–to promote utilization of inventions made in work with federal support–the law does not place any limitations on federal agencies that own these inventions with regard to promoting free competition and enterprise. While nonprofits and small businesses must use inventions to promote free competition and enterprise, the executive branch agencies are not under any such statutory obligation. Thus, when the implementing regulations for federal agency administration of inventions were written, Bayh-Dole’s statement of policy and objective was reduced to (37 CFR 404.2):

It is the policy and objective of this subpart to use the patent system to promote the utilization of inventions arising from federally supported research or development.

All the rest of the policy and objective go by the board. Unlike the statutory statement, which constrains the use of inventions for nonprofits and small businesses–maximum involvement of small businesses in research and development; collaboration between commercial concerns and nonprofits; use that ensures free competition and enterprise; commercialization and public availability of inventions made by U.S. industry and labor–the federal agency implementation leaves “utilization” bare naked. Who utilizes? In what manner? With what public outcome–what promotion of public welfare?

Elements of Bayh-Dole’s policy and objective, along with specific requirements of this policy and objective applicable to nonprofits and small businesses, are re-introduced in regulations pertaining to the licensing of federally owned inventions (for which, see 37 CFR 404.5), but as licensing requirements, these are now substantially changed into administrative matters that restate what ought to be obvious–if there’s an agreement for U.S. manufacturing, then that agreement should be in the license. Woah.

Let’s take it, then, that it is reasonable to expect that “promote,” as used in Bayh-Dole, means “to forward, advance, contribute to the growth of.” And that the primary objective for anyone that owns an invention arising in federally supported research or development is to use the patent system to promote the use of the invention. The outcome of the activities authorized under Bayh-Dole starts with a greater growth in the use of inventions than would be had otherwise–as a matter of general welfare, or as Bayh-Dole has it in the definition of practical application, use that can be established with benefits of the inventions available to the public on reasonable terms.

Bayh-Dole mandates a practical application of federal inventions when owned by contractors or federal agencies better than would otherwise happen. Bayh-Dole works only if the law promotes–advances, contributes to the use of the specified inventions.

Does that meaning of “promote” make sense? Are you willing to stick with this meaning through thick and thin? Let’s see.

 

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