Below are excerpts from an April 26 Forbes article noting an open letter from the Online, Property Rights Alliance to WIPO’s General Director urging that WIPO becomes more engaged by fighting worldwide economic abuse of IP protection. The letter is timely. WIPO’s annual commemoration World Intellectual Property Day is fine, but it is no longer enough. Significantly, it is signed by AUTM, signaling its wider engagement in defending the IP bedrock of TT commercialization not only here in the US, but throughout our global Info Age economy. From US patent weakening to international price caps on life science products worldwide, patent protected university TT commercialization capacity is under fire. Continue reading World IP Day
This week, Congressman Lloyd Doggett released the march-in letter we warned about several weeks ago. Its KEI sponsors then said they were waiting for things to “quiet down” before its release. We assume they tired of waiting. Rep. Doggett’s press release and letter (both linked below) is signed by 51 Democrat House Members and is addressed to President Trump. Misinterpreting Bayh-Dole, the letter demands presidential pressure on NIH to issue guidelines for the B-D price-based march-in order to enable compulsory licensing of prescription drugs. As Francis Collins has explained to Congress, the 1995 CRADA retraction episode conclusively proved that even the possibility of such price controls would deter the private investor research in university life science commercialization NIH needs to implement NIH’s life science mission. To prove his point Collins expressly pointed to the CRADA experience in the “90’s. Speaking at a more recent KEI conference on compulsory licensing, AUTM representative Ashley Stevens echoed Dr. Collins’ comments by emphasizing the Doggett proposal’s inevitable harm to research university education research and public benefit mission. Continue reading Rep. Doggett to Pres. Trump – Implement B-D Price-based March-in!
Our Report’s title repeats a headline in today’s “Heard on the Street” section of the Wall Street Journal. Readers may have missed it but investors won’t.
The piece suggests that despite strong polling support for prescription drug price controls, equity investors seem to be ignoring Capitol Hill where the “Improving Access to Affordable Prescription Drug Act” (The Act) was introduced last week in both the House and Senate. (Both are similarly worded and linked below) As the WSJ article emphasizes, investors in pharmaceutical stocks may think they have time to watch and wait. The WSJ says their investments may soon be significantly devalued. Why should we care?
Investment in drug stocks is conceptually no different than related higher risk investment in the promising discoveries of early stage life science research. VC’s read the WSJ. If VC investors in life science research cannot calculate projected ROI they will not invest. If the Act passes their inevitable absence will eventually end life science research commercialization because without them NIH’s cannot complete its Bayh-Dole (B-D)-directed commercialization mission. HR 1776 and its senate counterpart can soon become the beginning of the end. Perhaps its authors saw B-D’s collapse ahead. The Act initiates prize-incentivized life science research. It establishes NIH medical centers for clinical research. Many research universities depend on life science grants to attract scientific talent. For universities and medical centers that rely on access to life science grants, university engagement in the commercialization impacts of proposed drug price controls is an existential imperative. Continue reading Don’t Write Off Pharma’s Nightmare Scenario
TTO directors remember their sickening feeling when the Stanford vs. Roche sent them scrambling for legal advice about university researched invention ownership and assignment. SCOTUS held that an earlier researcher promise to assign IP to their universities was trumped by an actual assignment made later. The case stirred debate about choice of law conflicts between state contracts law and federal patents. More important it raised the question of how to reliably verbalize future pre-invention assignments. Was an assignment valid if executed pre-invention? Were assignments necessary every time an invention or discovery occurred? Some universities have focused on acknowledging a PI’s on-going responsibility to report to university TTO’s any investigative undertaking that could possibly be patentable. One of the issues now raised by the Alice/Mayo eligibility line of cases may be the narrowing meaning of “potentially patentable” in the UCSC case described below where the university focused more on the researcher’s acknowledging a dual obligation to assign and disclose patentable inventions. The relevant UCSC operable language appears to have been:
“I acknowledge my obligation to assign inventions and patents that I conceive or develop while employed by University or during the course of my utilization of any University research facilities or any connection with my use of gift, grant, or contract research funds received through the University. I further acknowledge my obligation to promptly report and fully disclose the conception and/or reduction to practice of potentially patentable inventions to the Office of Technology Transfer or authorized Licensing office.”
Continue reading Researcher Patent Assignments Redux?
The fog of war on the Hill is thick. Now chaos is the only constant. This is not your usual “dead on arrival” termed presidential budget where negotiation showmanship calls for partisan disdain. These players are all Republicans. The victim list includes almost everyone. As long as Trump’s advisors are calling the shots, Speaker Ryan’s choice is to accept Trump’s “Deconstruction of the Administrative State” or follow former Speaker Boehner’s footsteps into retirement. The disrupted atmosphere promises incapacitating injury to all non-military entities. There will be no exceptions made for the low hanging fruit of R&D’s annual $130 billion budget allocation. And as the saying goes with massive budget cuts, ” if you are not at the table, you are on the menu “. It isn’t validated yet officially but the simple math of discretionary federal budget remainders following a $54 Billion military increase and educated whispers point to the coming cut of at least 8% to10% in R&D research by Trump’s budget proposal, doubling down on the Control Budget Act’s sequester.
As we have said before, Bayh-Dole commercialization is like a bridge having an on-ramp and an off-ramp. Its off-ramp is quickly narrowing as private capital backs away from piling up uncertainties enveloping the future of patent enforcement as Congress and the courts keep moving the goal posts of patent reliability. Post development PTAB nullifications, looming life science price controls and the confused subjective analysis of Alice/ Mayo eligibility have combined to virtually defeat the prudent possibility of private investor participation in ROI-driven B-D partnerships. Now however, B-D’s protective focus is shifting to the commercialization bridges’ on-ramp entry by R&D’s basic science funding through federal grant agencies.
The federal government’s “deconstruction” is taking shape in reality not just rhetoric. The parlous consequences for universities are well described in an WSJ op-ed last December by MIT’s President Rafael Rief, who after highlighting findings of a National Science Foundation report ….. Continue reading Commercialization Bridge On-ramp “Loss is as Lethal as Off-ramp Failure”
Our last post referenced the Advanced Patent Law Institute opening Panel’s concerns about the decline of investment in commercialization caused by a precipitous decline in patent reliability and pervasive patent legal uncertainty. Life science commercialization drew extra emphasis because of the seemingly simple but complex ramifications of price controls for prescription drug products. Bayh-Dole march-in’s compulsory licensing and importation of drugs through Canada were joined last week by prominent discussion of repealing the “nonintervention” law, the statutory prohibition of direct negotiations with drug makers over the price of Medicare prescription by President Trump replacing the insurance companies and PBM’s who negotiate now.
Many believe such negotiations will lower prices. In some cases maybe yes …in others maybe no. Trump said they would save 3 billion dollars. CBO has said savings, if any, would be small. Negotiators however must be ready to disagree. Non-agreement means reducing access to certain medicines because disagreement means removal from patient formularies. While the conference was pondering the commercialization effects of price controls at the USPTO President Trump was meeting with Representatives Cummings to discuss the direct negotiations issue. Speaker Ryan could not have been pleased to see the meeting get two day’s news coverage.
On Saturday NPR commentator Scott Simon caught up with Rep Cummings to learn more about his White House meeting. Cummings said not only that the meeting went well but that Friday night he was advised by the president that he would try to insert repeal of the non-interference law into the contentious ACA repeal debate which began last week. The meeting went well for Cummings to be sure. For Trump …not so much. There is no way Cummings will support ACA’s Repeal and Replace no matter what Trump does but the meeting and its outcome added more uncertainty to the commercialization issue. When Simon asked Cummings about the meeting’s outcome this weekend Cummings, who is one of the president’s harshest critics, cleverly drew Trump back into the direct negotiations debate….
CUMMINGS: I think that we have a chance. As a matter of fact, as late as yesterday – last night – he told me that he’s going to try to get it into his bill.
SIMON: He told you this last night, Friday night.
CUMMINGS: Last night, that’s right. So we’ll see what happens. You know, with President Trump you – I think you have to wait and see. You’re going to have a good conversation. It sounds like he’s going in the direction that you’re going in, and people have told me you step out of the room and next thing you know maybe something has changed. But the conversation that we had with him was a very good one.
Earlier in his interview Simon asked why direct negotiations were not provided for during ACA’s original enactment, noting that true negotiations can only occur when one of the parties can walk away if they do not agree. In effect, he was asking if the president was ready to exclude formerly included drugs from patient formularies. Continue reading Trump is Trapped Again
The long-expected clash between Republican campaign rhetoric and the political reality of Republican control begins in the House this week. And what happens to R&D funding in the budget process is still unclear, but because of its size and future benefits as distinguished from immediate impact, its current $130+billion will not be unnoticed by a revenue-starved “controlled” Congress.
Beyond this week’s start of House committee consideration of ACA, including its repeal of revenue producers. And the administration has promised “details” this week on its $54 bn. increase in discretionary defense spending. This implies an equivalent decrease in non-military civilian discretionary spending. Discretionary spending is about a third of our entire federal budget. The remaining two thirds are mandatory paying for debt interest, and the Social Security/ Medicare entitlements Trump has vowed to leave untouched. Like the “Wall” new expenses, must be offset by future budget savings, either from future reductions in mandatory entitlements or from discretionary expenditures like the Depts. of State, EPA, and AID. Repealing small fry funding for the Arts, Head Start Americorps, and the Corporation for Public Broadcasting contribute little to the savings needed to offset Trump’s announced spending increases and tax reductions. Other spending offset sources like more revenue or increased debt have their own problems. So, to put it bluntly, R&D’s annual $130bn. appropriation which includes future basic science funding at NIH, NSA, and DOE is a very tempting offsets target. Will R&D funding it be trimmed… and if so how much? Two Trump budgets (for 2016 and 2017) must clear the House this Spring. And while the coming budget battle may be too complex to knowledgeably monitor both, for those of us who care about federally funded basic research, it makes sense to pay attention, stay alert and be ready to act if R&D funding goes on the chopping block. Here’s the problem. R&D funding invests in the future. The budget quagmire is now. If a deadlock among Republicans emerges Republicans collectively must resolve it because there is no one else to blame. They have postponed defining their actual positions for years. Will they now postpone implementation of long term investment expenditures whose beneficial effect is not immediate?
On March 9, 2017, I will be serving on a panel moderated by former Federal Circuit Court CJ Paul Michel and Robert Sterne Esq. at the USPTO. The UT Panel on the Global Patent Landscape is a well-attended, mixed assembly where patent jurists and practitioners gather to consider patent law developments and trends from a more detached and wider vantage point than daily contention with individual cases allows. Wearing my university hat, I will be joined by representative panelists Paul Evans, Paul Stone, Peter Detkin and Damon Matteo each of whom expertly exercises keystone roles in our innovation ecosystem. Sadly, although there are many pressing issues confronting the IP community our panel preparation calls have inevitably focused on one overriding issue.
Inadvertently or not, SCOTUS, Congress, CAFC and PTAB have combined to drape an iron curtain of enforcement cost and uncertainty over patent enforcement, weakening US patents to the point of risk-adjusted irrelevance. For under-resourced patent holders, a growing cohort growing larger with expanding litigation overuse of post grant process, patents’ statutory presumption of validity has become a presumption of non-enforceability. Biopharma interests may still count on patents, but incumbent ICT operating companies whose efficient infringement business model has substantially reduced patent values see their value now only as weapons to preserve global market share and/or as clubs to beat down component product pricing, daring their suppliers to assert. In short U.S. Patents are rapidly losing their critical investment attracting role within our national innovation ecosystem. The question now is what we can do about it? Continue reading Take Back the Rights
Bayh-Dole’s (B-D) commercialization of federally-funded basic research is the bridge connecting annual $130+ bn. congressional funding to its congressionally intended public benefits of jobs, economic development and scientific progress. This B-D bridge’s on-ramp is controlled by federal grant agencies, each with its own mission. Life science’s on-ramp is supervised by NIH. Its off-ramp exit is policed by the FDA. Life science’s high-risk commercialization crossing to the off-ramp is difficult, long and costly. Its chances of reaching and using the FDA managed off-ramp are statistically slim. Continue reading Elimination of Further R&D Funding