Another King-type amendment, offered this time by Rep. Marcy Kaptur at a House hearing regarding HHS, was rejected in committee. Marcy Kaptur has been our heroine in the patent wars. Her willingness to stand up to the Megatech has been courageous and is greatly appreciated.
But as reported by KEI itself, Committee Chair Tom Cole spoke against it.
“Opposition during the Committee’s debate came from Rep. Tom Cole (R-OK), who urged a no vote on the amendment. Rep. Cole stated that while he appreciated the concern of Rep. Kaptur, he thought the amendment would run the risk of upsetting the relationship between the National Institutes of Health and private industry. Rep. Cole also stated that the amendment would be “complicated to implement, as there’s no way to measure to what extent a particularly federally funded study played in the discovery of a new drug.” (KEI Report linked below.)
Tom Cole is correct. This time he prevailed, but KEI will persist. Its warped interpretation of Bayh Dole resulting in the B-D lethal price-based march in can be expected to pop-up repeatedly whack-a-mole fashion unless KEI is “marched-out” of Hill hearings by home state universities. They must act now by conducting a concerted effort to support NIH’s mission to promote commercialization of promising results of its funded basic research. If price based march-in amendment can take hold anywhere on the Hill, universities who fail to voice their opposition will have only themselves to blame. KEI’s strategy is clear. They will persist. Each time the legally erroneous notion that availability triggers B-D march-in at a “reasonable price” rather than “available” in satisfactory quantity spreads to a new committee KEI attracts new converts to its misdirected legal interpretation of the march-in’s triggers.
There are two important points embedded in Rep Cole’s sound response.
- Basic and applied research are two different animals. B-D interpretation contortionists base their funding recoupment and price control arguments on conflating the two different kinds of research. Basic research is important but is curiosity-driven and commercially uninvestable. Private sector development is voluntarily conducted by profit-driven entities willing to risk many times the cost of a federal basic research grant to create a therapy that may be FDA approved and may then made available to the public. Pricing was never mentioned when the law was enacted. It is not and cannot be allowed to become part of the equation now.
- The commercialization mission of NIH is utterly dependent on commercializing promising results of its congressionally funded research by attracting voluntary profit-driven private sector funding willing to assume the high risk and high cost of its development. CRADA investments in basic research were deterred when a reasonable price condition was inserted into the process. It was repealed in 1995 at the request of NIH itself. NIH cannot carry out its commercialization mission through Bayh-Dole partnerships when private investors are deterred by price controls.
It may well be that just as FTC unfair and deceptive enforcement oversight to curb bad actor patent troll abuse conduct is the best way to curb patent trolls. Maybe curbing bad actor price-gouging conduct as recently urged by the Democrats is a sound approach to drug trolls. Democrat Marcy Kaptur has endorsed targeting patent trolls’ abusive conduct while opposing the Innovation Act’s hobbling of all patent enforcement. She would thus understand that drug-maker bad actors should be similarly targeted and that B-D as now interpreted by NIH is not only what the B_D law says but how it must be interpreted to preserve our nation’s existing life-science innovation ecosystem and the innovative therapies and jobs it produces. But good folks like Marcy Kaptur need to hear this from their home state universities. KEI is hard at work. https://www.keionline.org/node/2839. Are we?