If you are looking for new posts, you have just a bit longer to wait. Life pulls many ways! But I’ve got a number of articles drafted and more planned. When things settle down, I’ll have more time. Then things should be back to regular postings.
Much of the current, dominant narrative about patents at universities depends on looking isolating single inventions at a single institution with a single profile for use. “Inventions,” so this narrative go, will not be used or developed unless for each a patent position is established so the university grant an exclusive license to a company attracted to the incentive of that exclusionary position.” Without such an “incentive,” no company will spend the tens of millions of dollars necessary (it is claimed) to make the invention benefit the public.
Perhaps that sounds right to you, sounds normal, like there’s something to this narrative about patents. If so, but why? Is it just that’s all you’ve heard about patents at universities?
Let’s add in necessary qualifications to this narrative of the single patentable invention that should be “protected” so an exclusive licensee has an incentive that it otherwise would not have to spend money to develop the invention for public benefit. Continue reading
Norman Latker, formerly patent counsel at the NIH and chief architect of Bayh-Dole and its extension by Presidential memorandum to all federal contracting, argues that if federal inventions are not privately owned and exploited for their exclusionary and financial value, then the results of federally supported research are wasted, and the public will not benefit from federal research because companies will not adopt or invest in anything that they cannot own exclusively–or, more particularly, given that American companies at least won’t adopt much of anything made in federally supported work, that patent speculators ought to be given “incentives” of patent exclusion to put up the money to make commercial products that, when sold at whatever price the market will bear and in whatever form might be most profitable, will then serve the public interest.
Latker proposes a plausible fantasy. Fom a practice point of view, it’s nonsense. Companies adopt new technology all the time that does not come with a gift of exclusionary rights. There’s no additional uncertainty if the federal government takes ownership of inventions made in its operations and releases those inventions, uniformly, without conditions or payment requirements. Such open access amounts to a more robust public commons–a sort of federal open innovation. If the federal government had the right to deal exclusive rights in any such invention, then a company might hesitate–why should it contribute to research that could, when any invention arises, be diverted to a federal agency that could play favorites in the market, cutting out everyone else with an interest.
And that’s just what Bayh-Dole has done–by act of Congress authorized federal agencies to deal in exclusive patent rights. 35 USC 207(a)(2): Continue reading
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
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
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
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.
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
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
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
