Comedienne Joan Rivers often began her monolog by asking ” Can we talk?”. Her purpose was to prepare her audience for some plain talk about a touchy subject. So channeling Joan, today I am asking readers “Can we talk? ”
Having worked around legislative bodies for almost 50 years, I am appalled when a client (or worse, a lobbyist) says ” Let’s not spend our “chits” on this or that.” It’s as though their congressional member was keeping score by counting your university’s “chits,” (whatever they are ). With the knowledge that TTO research commercialization capacity may not always be your university’s highest priority, it is essential to obtaining federal research grants and therefore critical to your university’s research mission. Commercialization is in danger and thus is well worth discussing with your home state delegation members. We appreciate that the political environments within universities can be complicated. Respectfully, communicating with Congress is not. University leadership frequently views communications with Congress as similarly nuanced and complex. However, it’s not rocket science. Members want to hear from their home state universities.
Henceforth herein I will refer to your university as “you” and the congress person or staffer with whom “you” communicate as “member” or ” she/her.”
She is not keeping score with you. Her reelection’s likelihood is of paramount importance. She is keeping score solely with her next vote count. You are an important and influential constituent. You often are one of the state’s largest employers. You contribute to in-state economic growth and development. You can favorably recognize her with awards, highly visible head-table location and athletic event seating, and you can even name buildings after her. She, therefore, wants to please you as much, and as often as possible. In today’s communication world, virtually every vote leaves a permanent trail and thus requires careful calculation. If that vote happens to coincide with your wishes, she will credit you with having convinced her — whatever her real reason. What members dislike most is being unaware of where you stand on an issue that affects you big or small. They appreciate communication because, a. they are hearing and learning from a credible constituent and, b. they want attention, not neglect. Connecting with them flatters their egos. As long as it is respectful, you cannot too often give your views on any issue that affects you.
Continue reading Congressional “chits”?
I recently joined Robert Sterne, Judge Paul Michel, Peter Detkin, Damon C Mateo, Paul Evans and Paul Stone on a panel at the Advanced Patent Law Institute’s annual presentation at the USPTO. Kevin Madigan begins his summary the conference’s opening presentation with the paragraph below. It is a useful overview of a presentation to an audience of advanced patent experts with Director Lee (USPTO) seated in the front row.
“Last month, the United States Patent & Trademark Office (USPTO), along with the University of Texas Law School and Antonin Scalia Law School, George Mason University, hosted the 12th annual Advanced Patent Law Institute in Alexandria, Virginia. The program featured a distinguished panel of patent experts discussing “current issues around patenting, licensing, enforcing, and monetizing patents in the U.S., and look[ing] at what the UK, EU, and China are experiencing and the impact on U.S. patent practice.” Titled The Current Patent Landscape in the US and Abroad and focusing on the economic factors that spur invention, the consensus was that dramatic changes to the US patent system are driving investment in research and development outside the country and threatening the future of American innovation.”
You can read Kevin Madigan’s excellent article in its entirety here.
In his excellent IPWatchdog post, Bruce Berman discusses Jonathan Taplin’s new book, “Move Fast and Break Things.” In his post, Bruce sagely states, ” It would be difficult for many people and businesses to live without Amazon, Google, YouTube and Facebook, but it is becoming virtually impossible for those who produce intellectual property to live with them.” If you missed it, his entire post and Taplin’s book are both worth reading.
But today’s must-read is a joint op-ed the Sunday Washington Post by MIT President Eric Lander and Alphabet’s (Google’s) Eric Schmidt. In their short well-crafted plea to the Trump Administration and Congress, the two Erics praise our nation’s underfunded R&D supported innovation ecosystem, referring to it as, “The Miracle Machine that needs refueling.” They explain the fundamental difference between investable and curiosity-driven basic scientific research saying “its fruits are typically too unpredictable, too far from commercialization and too early to be patentable. That’s where government comes in. While investing in basic research at universities usually doesn’t make sense for business, it has been a winning strategy for our nation. ” They then list its commercialized economic benefits including Google’s 40,000 domestic employees, then close by saying, “The Miracle Machine has been astoundingly successful. The problem is that too few people — in government or the public — know how it works. As a result, we’ve been letting it fall into disrepair. If we don’t change course and invest in scientific research, we risk losing one of America’s greatest advantages. To our lasting detriment, we may wake up to find the next generation of technologies, industries, medicines, and armaments pioneered elsewhere.”
Continue reading Miracles Can Happen
As usual Paul Morinville, (joined this time by his good colleagues) is right-on. State universities and their affiliates have been given a “get out of PTAB card ” by the University of Florida decision because of their 11th Amendment sovereignty. It may be that other research universities are not so blessed. But the patents as property issue he details affects everyone. Paul’s IPWatchdog piece is, therefore, essential reading for all. The difference between the juridical “liability” and “property” theories is how research universities were punished by eBay in 2006 and ever since. Now its “Public Rights Vs Property Rights,” and that debate not only affects everyone it affects the very survival of our patent system. Paul explains it well enough to help readers tell it to their congressional delegation. To read their excellent and detailed explanation, please visit our IPStrategic.com website.
Basic science funding was partially restored in this weekend’s deal to avert a government shutdown. But don’t think for a moment that life science commercialization will easily survive the administration’s anti-science budget stance. The fight to stave off R&D starvation has just begun.
Mosquito-borne Zika has no respect for national borders nor will it enjoy a summer recess. New shared development strategy to spread the rising costs and risk of developing much-needed anti-viral drugs has changed the drug development game into a shared enterprise for pharmaceutical companies. But fresh tactical approaches to vaccine development have not altered the old thinking of price-based B-D march-in crusader KEI’s Jamie Love and his Senate spokesman Bernie Sanders. They objected to an award of shared financial support to vaccine-maker Sanofi to help underwrite two-stage clinical trials that could produce concrete evidence of a potentially safe, effective and investible Zika vaccine by June. If Phase II testing is successful, NIH’s Dr. Fauci says the vaccine’s Phase III trials would require massive support from a yet unnamed drug company partner.
The US Army Office of Research and Technology Applications (ORTA) issued a letter last week reporting that the Army would pay much of this trial’s bill. The letter implied that granting Sanofi an exclusive license was a reasonable and necessary means to harness the capital and expertise needed to win FDA approval for an unproven technology. Sanofi was the only company interested in pursuing this collaborative Phase II research agreement.
Love and Sanders rottenly complained that an exclusive Phase II award might lead later to Sanofi’s charging for the vaccine “whatever astronomical price it wants.” What Love and Sanders fail to say is how they propose to defend against a baby-maiming virus creeping up our nation’s coast. Worse, what they never seem to understand is that unless this new vaccine’s later stage development can attract private sector investment capital, there will be no such vaccine. Continue reading Doing “What Works” Is Working
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
Are infringed patent holders entitled to remediation as owners of the personal property? Or do valid as violated patents protect their subject matter with ill-defined”liability” theory with “attributes” derived from their structure, owner identity, or developmental stage in the stream of commercial development.? The debate depicted by this false “choice” is economically and legally debilitating. It is undermining the centuries-old reliability of US patents. With SCOTUS benches filled again our patent system’s future now depends upon reversing the 2006 eBay detour from our patent system’s history and original purpose. SCOTUS must act soon or it will be too late to save US based innovation. The Court should return our patent law to the Lockean definition our founding fathers relied on while drafting our Constitution. It is time to recall Abe Lincoln’s famous phrases about investors’ “fuel of interest” in inventors’ “fire of genius”. The fuel of investors’ interest is running low. Our innovation ecosystem is sputtering. Investment in commercializing university basic research is shrinking. For some institutions such investment public and private investment funding it is an existential issue.
eBay and its concurring opinion by Justice Kennedy signaled SCOTUS’ surrender to the misdirection of a congressional and amicus brief “bait-and-switch” campaign by big ICT tech. Its “bait-and-switch assertions have since been proven wrong. Whatever merit they once had have been appropriately addressed. Big techs’ strategic goal was to protect themselves from the remedial consequences of their “efficient infringement”, an economically fruitful but systemically amoral business model they feel compelled to continue. Sadly they conned the Courts into killing injunctions for everyone but themselves. Big tech’s tactical rhetoric is what infected eBay. Ever since it has contaminated SCOTUS jurisprudence. It has also led to sanctioning PTAB’s intrusive elimination of statutory presumptive validity and its unconstitutional obliteration of trial by jury. Injunctions may be commercially disruptive, but the Blackberry injunction scare never happened and besides is ancient history.
Judicially framing patent infringement remediation theory with vague “liability” theory instead of “property “theory corrodes our patent system by degrading patent value. Our ICT patent community colleagues have been selfishly pursuing “liability theory” for more than a decade. Junk science academic accusations of a “tax on innovation”, speculative theories about patent “holdups”, “thickets” and “royalty stacking” and phony litigation and troll crises are over. Global markets moving up the value chain are signaling it’s time for the US to revalue patents as investors redirect their support to China and the EU. Talented researchers and students are headed there as well.Unless our new Court changes its direction, US innovation’s competitive advantage will follow them.
Continue reading Time to Undo eBay
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?