Learning from Latker’s 1984 “Federal Initiatives for Innovation” Talk, 2

Let’s return to Norman Latker’s talk from 1984, “Federal Initiatives for Innovation.” Keep in mind, Latker drafted the IPA master agreement, the Bayh-Dole Act, Reagan’s 1983 memorandum that displaced the Kennedy and Nixon patent policies, the 1984 amendments to Bayh-Dole (after S. 2171 failed), among other policy instruments. Latker is not peripheral to federal invention policy–he is central to it, he is the focus. When Senators Bayh and Dole argue for what they did or didn’t intend with Bayh-Dole, they argue for what they understand Latker intended.

Latker argues that the federal government funds much of the research going on in the U.S., and that Japan objected to the “Dole Bill” (S. 2171) on the grounds that it would deny Japan easy access to inventions arising in U.S.-funded work. Latker followed this up–to a lot of laughter, apparently–with the claim that denying foreign access to inventions made in federally supported work was indeed the intent of the Dole Bill, and by implication, Bayh-Dole as well.

If this is the case, then we might think of Bayh-Dole first and foremost as a law regarding foreign policy pertaining to inventions that might be exported, as it were, for use in other countries. Damp down such invention export, so the argument goes, and the federal government will be able to deny citizens of other countries the benefits of federally supported research, returning the U.S. to a position of technology domination, with all the economic benefits that must go with such a position.

This, too, makes no sense, except as fantasy. Continue reading

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Senator Nelson on the problem of “public interest” in federal patent policy, 2

The federal public policy for inventions made in federally funded work then becomes “whatever the contractor that hosts the work chooses to do, so long as the contractor files a patent application.” In Bayh-Dole, there’s no federal review of a contractor’s policies or licensing practices. The contractor has sole discretion whether to license or not, license exclusively or not, assign (including by exclusive license of all substantial rights), or release the invention open access. Bayh-Dole makes a government secret all the contractor’s reports on its efforts to achieve practical application, and the terms of its exclusive licenses. Courts have even found reason to prevent the disclosure of the terms of exclusive licenses granted by federal agencies. In Public Citizen Health Research Group v. National Institutes of Health (2002), the court ruled

While the Court is extremely cognizant of the mandate underlying the Freedom of Information Act for public disclosure, in conducting the balancing of private and public interests, the Court determines that the private interests favoring withholding the information dominate the balancing. The licensees would likely suffer substantial competitive harm if this information was released.

The Court found that if the NIH had to release the terms of the exclusive licenses (and assignments) that it granted, “the effectiveness of Defendant’s [NIH’s] licensing program would be impaired.” The Court bases its opinion largely on the claims made by Maria Freire, that “the NIH would cease to be an attractive or viable licensor of patented technology.” While the Court tosses at every turn Public Citizen’s contention that licensees would not refuse to adopt NIH-owned inventions if the terms were made public, the Court accepts uncritically Friere’s claims. And Friere’s claims are pretty much the same ones made by most every university licensing office in the country–that if the public knew what the deals looked like, or even that there were not that many deals anyway–then the companies that the universities were dealing with would refuse to take the exclusive licenses (and assignments) on offer. Continue reading

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Senator Nelson on the problem of “public interest” in federal patent policy, 1

The “public interest” plays an important role in federal invention policy. In 1963, President Kennedy announced a policy that permitted nonprofit organizations to request to retain title to inventions made in federally funded work, providing that

Where the commercial interests of the contractor are not sufficiently established to be covered by the criteria specified in Section 1(b), above, the determination of rights  shall be made by the agency after the invention has been identified, in a manner deemed most likely to serve the public interest as expressed in this policy statement . . .

There’s more, but first let’s look at what the policy statement has to say about public interest. Under “Basic Considerations,” after noting that the government spends “large sums” on research and development, producing inventions, and these inventions “constitute a valuable national resource,” the policy moves to a list of concerns:

The use and practice of these inventions and discoveries should stimulate inventors, meet the needs of the government, recognize the equities of the contractor, and serve the public interest.

Ah, there it is again. But there’s help in the next paragraph:

The public interest in a dynamic and efficient economy requires that efforts be made to encourage the expeditious development and civilian use of these inventions.

Developing inventions expeditiously for civilian use then is one element of the public interest. Continue reading

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Learning from Latker’s 1984 “Federal Initiatives for Innovation” Talk

In 1984 Norman Latker, who as NIH patent counsel drafted the Bayh-Dole Act on the sly, gave a talk (“Federal Initiatives For Innovation“) to the American Intellectual Property Association. At the time, Latker worked for the Department of Commerce, and Sen. Dole got Bayh-Dole amended that year to shift control over its regulations to Commerce so Latker could continue to work the law into something he wanted it to be.

In his talk, Latker makes a case for contractor ownership of inventions made in federally supported work. But the case simply doesn’t hold up. And in failing at his logic, Latker reveals deeper problems with federally supported research, the administrative concept of “technology transfer,” and American industry that any hoo-haw about Bayh-Dole obscures.

Continue reading

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Congressional Intent and Bayh-Dole reasonable terms

We have looked at the idea of Congressional intent in the Bayh-Dole Act and contrasted this intent with the claims of enemies of Bayh-Dole who argue that they have secret inside knowledge of the true intent that should govern the interpretation of the law. That secret true intent only they know. That intent is not made apparent by the law, nor by the legislative history where the law is ambiguous, nor by reference to the common usage of words where words might be ambiguous. Instead, claim the happy enemies of Bayh-Dole, the true intent of Bayh-Dole is whatever they say it is, drawing from their secret reservoirs of intent. As the court in the Shaw v Regents of the University of California put it, with regard to a contract embedded in a government policy (which is pretty much what Bayh-Dole is, at the federal level):

Where contract language is clear and explicit and does not lead to absurd results, we ascertain intent from the written terms and go no further.

The true intent of a contracting party is irrelevant if it remains unexpressed.

The enemies of Bayh-Dole would turn all this on its head and argue that the true intent is whatever they say it is, and whatever the words of the law would seem to say, however not absurd, cannot possibly be the intent of Congress–the words must be interpreted to be consistent with their secret, unexpressed intent. Of course, they do express what they want “the intent of Bayh-Dole” to be–it’s just that this intent is not in the law. Very shoddy of these folks. Continue reading

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Congressional Intent and Bayh-Dole’s government license

Some folks who claim to advocate “for” Bayh-Dole, but actually are the law’s worst enemies, argue using the line “Bayh-Dole was never intended . . . .” They leave out the part about who they mean has been doing the intending. Norman Latker? Bob Dole? Joe Allen? A bunch of university IP managers who have never read or grasped the law? Their often poorly trained in IP lawyer buddies? One would think that the intention that counts is that of Congress–Bayh-Dole is a statute, after all.

When the Supreme Court was asked to interpret Bayh-Dole in Stanford v Roche, the court set aside all those university attorneys’ opinions of what they thought “was intended”–and even set aside Senator Bayh’s argument about what he “intended.” Instead, the justices looked at the common meaning of words that carried no special definition, looked at the words that Congress had gone out of its way to define, such as “subject invention,” and then looked for Congressional intention. They did not need Sen. Bayh telling them what to think about the law. The court concluded that if Congress had intended such a sweeping change in the law as the university folks and Sen. Bayh claimed, then Congress would have gone out of its way to make that clear. Congress would have marked its intention to make a change:

It would be noteworthy enough for Congress to supplant one of the fundamental precepts of patent law and deprive inventors of rights in their own inventions. To do so under such unusual terms would be truly surprising. We are confident that if Congress had intended such a sea change in intellectual property rights it would have said so clearly—not obliquely through an ambiguous definition of “subject invention” and an idiosyncratic use of the word “retain.”

It’s clear that what the Bayh-Dole enemies mean when they assert “was never intended” is something very different from what Congress intended. They mean–though they don’t say this–that some unnamed someone never intended for the intention behind the law to be that of Congress. Senators Bayh and Dole, say, or Norman Latker, or Howard Bremer. These folks, apparently, never intended Bayh-Dole to reflect the intention of Congress, but rather, apparently, their personal intention, not expressed in the words of the law, but rather in regulatory rewriting of the law, statements they made later about the law, claims they made about the history of the law. In short, the enemies of Bayh-Dole argue that Bayh-Dole should be a law of personal caprice–a coterie of unelected officials should dictate to the executive branch and to the courts what they want the law to mean. “It was never intended that the law we claim to support should be read in the manner of standard federal law,” but rather Bayh-Dole must be interpreted according to the statements later of what people involved in drafting the law claim that they thought they were doing.

Well, poop on that, and on them. Let’s consider how all this plays out with a simple approach to a fundamental policy issue. I’ll point out that I am going to be coarsely simple, and that won’t sit well with those readers who demand nuance and qualification and sophistication. There’s a time for that, of course, but there’s also value in being, well, coarsely simple. Continue reading

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Another Question on RE: Does a subject invention have to be enabling?

A new question showed up in the RE search queue: “does a subject invention have to be enabling?” How to unwind this one? We can try. Another way to put it might be, “when does something new–an idea, an insight, some hunch, a prototype that accidentally works in an unexpected way–become subject to Bayh-Dole as an invention? Is it when an otherwise qualifying invention is created, or when the invention is anticipated, or when the invention is properly documented?

An “enabled” invention is one that meets the 35 USC 112 requirements for the specification of an invention in a patent application:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

If the specification of a patent application fails this standard, then the invention has not been “enabled” and the application will be rejected. Just because a patent application is rejected, however, does not mean that the subject invention that it claims is no longer patentable. It just means that whoever did the drafting of the application did a bad job. In this sense “enabled” means that everything claimed in a patent application is clearly taught–full, clear, concise, and exact–so that someone with skill in the art can make and use the invention. Continue reading

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Making Bayh-Dole March-in and Government License Work

There’s a lot of stirrings about using Bayh-Dole’s march-in procedure to address the high price of drugs in the United States. Under march-in, a federal agency has the right to require a federal contractor (or anyone who is an assignee or exclusive licensee–which also become contractors under the obtuse definitions of the law) to grant licenses under their patents on subject inventions–inventions the contractor has acquired, and which were made in work receiving federal funding–if the contractor has not achieved timely “practical application” of a subject invention. Bayh-Dole defines practical application as use of the invention such that the “benefits are available to the public on reasonable terms.”

The terror among the folks that exploit Bayh-Dole to speculate on the value of patents obtained on public interest inventions–patent folks at universities, especially–is that the courts, if not federal agencies all on their ownsome, might agree that “reasonable terms” does include “reasonable price.” Surely it does. Thus, pure terror. For a group that has been lying about Bayh-Dole for forty years, there’s really no where else to go–they can’t turn their lying up to 11 and make any difference. March-in can also be used if health needs are not satisfactorily met. More terror for the patent speculation crowd. This is all set out in 35 USC 203. Continue reading

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The Faculty Stack, 4: Frontiers Science and Other Science

We are working toward the faculty stack. To get there, however, we need context. We started with Vannevar Bush’s problem–how to connect federal resources to the free play of free intellects to expand the frontiers of science. The new awareness gained then could be used by skunk works teams drawn out of institutional research–industry, government–to develop and demonstrate prototypes outside what institutions would set as their objectives or would be willing to fund. An authoritative person–CEO status, such as a Director of a national research foundation with solid tech credentials–could then present the prototype for institutional use.

The new science would come from unexpected places. Computer science might inform telecommunications. Atomic physics might inform medicine. Thus, there was little purpose in identifying social or industry or military areas of need and conducting research on them. Need is nice, but it is already embedded in an institutional matrix of expectation and plausibility. Some years ago, I was contacted by a technology scout working for the military. “I’d like to come out to the university for a visit,” he said. “Sure,” I responded, “what would you like to see?” “That’s the problem,” he replied. “If I tell you what I’m interested in, then you will show me stuff that’s like what I’m already thinking about. Show me what you don’t think I’m interested in.” And that’s what I did. End of day, he goes, “Whew, that just obsolesced our research in multiple areas. We will have to start over.” Continue reading

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Another question on RE: are exclusive license and assignment the same thing?

Here’s another question on RE: “is an exclusive license of technology and an assignment the same thing?”

Answer: yes and no.

Let’s talk exclusive license and assignment of inventions rather than technology. An assignment expressly conveys title to an invention. An exclusive license, if it transfers all substantial rights in an invention, functions effectively as an assignment. Otherwise, it’s just an exclusive license. So, no and yes.

Continue reading

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