The Hill newspaper has just featured an op-ed by former Senator Evan Bayh, son of Bayh Dole’s co-sponsor. He reiterates many self-inflicted harms recently affecting US innovation especially their adverse impact on lesser-resourced independent inventors and small business that supply new US jobs. In his closing paragraph, he underlines the importance of strong patents to the development of future jobs.
“Ultimately, people and organizations innovate because they expect to reap the financial rewards associated with doing so. America thrives thanks to startups, creative ideas and novel technologies. Thankfully, we can still take steps to restore our patent system to protect patent owners and encourage invention. We need a system that will attract investment, generate jobs, and create a level playing field for companies across the United States. It’s vital for our future and, historically, what America has always done.”
Add to this the new looming harm to life science commercialization promised by enactment KEI’s price-based Bayh-Dole march-in amendment campaign in full swing on Capitol Hill and its is easy to see why to preserve commercialization we must counter this anti-patent activity soon. He also refers readers to the STRONGER Patents Act, a summary of which is reprinted below. Continue reading Evan Bayh OpEd and STRONGER Patents Summary
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. Continue reading More March-In Whack-A-Mole
Political support for congressional curbs on abusive drug pricing is traditionally balanced by congressional R&D support to create innovative drugs to cope with new challenges like super bugs, new vaccines and older ailment cures for the likes of Alzheimer’s, cancer, and other presently incurable maladies. Moreover, the drug industry provides many US jobs and university related economic development. This duality balance is reflected in political issue manifestos released today by the leading Democrats Senator Schumer and Representative Pelosi. Each of their statements takes careful aim at abusive drug pricing but also reflects the need to preserve our globally significant economic and medical advantage in US drug development and manufacture.
Accordingly, the abusive conduct of “vulture capitalists” referenced in today’s NYT statement by Schumer is rebalanced by reference to “egregiously” raising the prices of lifesaving drugs “without justification.”
“Right now, there is nothing to stop vulture capitalists from egregiously raising the price of life-saving drugs without justification. We’re going to fight for rules to stop prescription drug price gouging and demand that drug companies justify price increases to the public. And we’re going to push for empowering Medicare to negotiate lower drug prices for older Americans.”
Similarly. Rep. Pelosi’s talking points stress putting “an end” to unjustified price gouging but allow for the transparent procedure to “justify cost increases.”
“Aggressive action to lower the cost of prescription drugs – putting an end to outrageous and unjustified prescription drug price gouging, leveraging the power of Medicare to negotiate lower drug prices, and forcing drug manufacturers to open their books and justify cost increases.”
There certainly is a need to curb drug pricing abuse. But there is something familiar about recent and admittedly bad actor drug abuse and the DC practice of interests with unrelated objectives to exploit such abuse by pushing their agendas. We have experienced it before with the anti-patent originators’ use of their troll narrative. And while the drug issue is more politically compelling, the hijacking pattern is much the same. Like the infringer lobby’s efforts to dismantle our entire patent system presumably to curb patent trolls, the Bayh-Dole priced-based march-in lobby led by KEI’s Jamie Love is leveraging recent drug pricing abuse to convert B-D’s reasonable “availability” march-in language into congressionally unintended reasonable “pricing.” Having successfully persuaded Senator King to secure his march-in amendment after failing to pass one in the House, they are trying anywhere and everywhere else in DC to install price-based B-D march-in. Read on for a recent news item depicting Love’s distortions at the FDA.
Continue reading King Amendment will KO Bayh-Dole
Mother Nature sometimes creates strange, even horrifying creatures. One of these is the Hag Fish which with its eel-like body enters the mouth of larger sick, weakened fish and once inside eats its way out. Our life science patent system has been weakened. This hag fish amendment will weaken it more. Here’s why.
A Senate Committee Report on a key bill that will eventually pass in both bodies includes an amendment misinterpreting the Bayh-Dole Act as authorizing price-control march-in. This is the B-D distorted interpretation repeatedly promoted by KEI. It has been consistently rejected by NIH and more recently by DoD. Why hag fish? Because once this misinterpretation of BD enters the congressional legislative records, it is established and can eat its way through the entire life science research innovation ecosystem by adding more uncertainty to predictable ROI on investments in commercialization partnerships.
With a unanimously-supported Senator Angus King amendment to its Report for the National Defense Authorization Act, the Senate Arms Services Committee directs the Department of Defense (DOD) to use two provisions of the Bayh-Dole Act (P.L. 96-517, as amended) to issue compulsory licenses for any drug arising from DOD-funded research, if such drug is priced “higher in the United States than the median price charged in the seven largest economies that have a per capita income at least half the per capita income of the United States. With this rigid directive in the Report, DoD will feel compelled to comply with incalculable endpoint pricing applicable to life science product price-controls “arising” from DoD-funded research. It is only a matter of time before its interpretation eats its way into to all federally supported life science grants. In light of Committee Chair McCain’s regrettable physical condition, the Committee’s floor consideration of Defense Authorization may be delayed for a while, but it will pass in this form unless we loudly register research university objections to the Report language with our home state delegations.
Continue reading Hag Fish Amendment Crisis