Posts Tagged: "National Institutes of Health"

University discoveries are recognized as critical national assets because Bayh-Dole gave academic institutions the ability to own and manage inventions made with federal funding. The law helped lift the economy out of the doldrums of the 1970’s, re-establishing America’s leadership in every field of technology…. While the critics argue that Cohen-Boyer would have had the same impact without patent protection, there are other more likely scenarios. It could have languished on the shelf as did many other published, but not patented, discoveries. It took a lot of work from Reimers before U.S. companies recognized its potential. That effort would not have been made to promote a scientific paper.

I was just thinking how often someone teaching intellectual property law leads the attack on the patent system when “Racing for academic glory and patents: Lessons from CRISPR” appeared. It sounds a dire warning that “overly broad patents must be reined in” as the passage of the Bayh-Dole Act “invoking patents as a mechanism for promoting commercialization of federally funded research” set off an “often socially wasteful race…for glory in academic research and in the patent sphere.” What’s particularly striking is that neither the paper nor the articles hyping it provide any evidence the CRISPR patents are restricting research or blocking commercial development. Indeed, most signs point in the opposite direction… Doesn’t a finding by NIH that there’s no evidence of any problems with how universities are licensing their CRISPR patents deserve to be mentioned? It seems like a pretty important point.

Most assaults on public/private sector R&D partnerships are launched by those who believe patents are inherently bad and that through some undefined magic publicly funded inventions will be developed if they were only made freely available.  However, every couple of years attacks come from another, more threatening direction — claims by well placed, but inexperienced “experts” that if their pet theories were adopted technology transfer from the public sector would sky rocket. One idea being promoted is that universities should double or triple the number of their inventions to justify continued federal funding, thus triggering a spike in commercialization rates. In reality the only  spike would be in patenting dubious inventions to pad the numbers, leading to depressed licensing rates as portfolios were filled with junk.

The old arguments that patents inhibit innovation, and non-exclusivity with compulsory licensing leads to a brave new world are now in vogue. We’ve stood at this fork in the road before. It requires courage to reject the easy path downward and restore the system which created our prosperity. If we lack the will, we have no one else to blame as we plunge deeper into the mire. That’s the last place anyone wanting to drain the swamp while growing the economy should go.

Being an entrepreneur isn’t easy. While it is a tough road for anyone, it’s particularly tough if you’re in the public sector and threatened by politicians… Rather, the march in provision is intended to insure that good faith efforts are being made towards commercialization and that sufficient quantities of resulting products are available to meet public health or safety needs. If the government is ever pressured to misapply the law for price control, the bottom would fall out of our public technology transfer system. Such a change would not be restricted to drugs but to any product commercialized under Bayh-Dole. What company would commercialize a federally funded invention if an agency could retroactively apply a completely arbitrary standard of fair pricing to justify taking the technology away through compulsory licensing? The answer is easy to guess.

Earlier today, by a vote of 94 to 5, the United States Senate overwhelmingly passed the 21st Century Cures Act. Having passed in the House, the Cures Act now goes off to the White House for the President’s signature, where it will receive a warm reception. “I’ll sign it as soon as it reaches my desk, because like a lot of you I’ve lost people I’ve loved deeply to cancer,” President Obama said in his weekly address on December 3, 2016, as he called upon Congress to act swiftly to pass the legislation and send it to the White House.

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more fundamental than advocates acknowledge. The long-term price of exercising these exceptional prerogatives could include creating a crisis in confidence over use of federally funded research discoveries, dried-up private investments where basic research has federally funded fingerprints, hesitation to commercialize university research, and a corresponding drop in start-ups, new products, economic development and technological advancements. March-in could effectively repeal Bayh-Dole.

At the time of an NIH study in 2011, algae-based biofuel production costs using conventional technologies were anywhere from $300 USD to $2,600 USD per barrel, much higher than the production costs of petroleum, which have since dropped dramatically in recent years. The economic disincentive associated with algae exploration when compared to petroleum is very real, but not the only challenge. Challenges preventing increased biofuel production from algae resources include the need to find more efficient algae harvesting techniques, more cost-effective oil extraction and effective use of land and water. Conquering these challenges should reduce the cost per barrel, but much research is still to be done. Despite the challenges that lie ahead, scientists and innovators remain optimistic.

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

Earlier this week the National Cancer Institute (NCI), which is part of the National Institutes of Health, announced a Blue Ribbon Panel of scientific experts, cancer leaders, and patient advocates that will work to inform the scientific direction and goals for Vice President Joe Biden’s National Cancer Moonshot Initiative. “Thanks to advances in science, we are now in a historically unique position to make profound improvements in the way we treat, detect, and prevent cancer,” said NIH Director Francis S. Collins, M.D., Ph.D. He is correct, and here is why.

Secretary Burwell and Director Collins are facing formidable pressure to reinterpret the Bayh-Dole Act for the compulsory licensing of costly drugs arising from federally supported research. And the pressure just increased another notch. On March 28, Senators Bernie Sanders, Elizabeth Warren, Al Franken, Patrick Leahy, Sheldon Whitehouse and Amy Klobuchar joined the leaders of the House Democratic Task Force on Prescription Drug Pricing urging Burwell and Collins to hold a meeting “to allow the public to engage in a dialogue with the Department of Health and Human Services and NIH in order to better understand its position on the use of march-in rights to address excessive prices.” If NIH joins in pursuing the swamp gas illusion that Bayh-Dole was intended to regulate drug pricing, we’ll quickly learn that it’s a lot easier getting into this morass than getting back out.

England isn’t the only part of the world where embryonic gene editing research has been finding a foothold. In early 2015, researchers out of China published a paper reporting experiments in using CRISPR-Cas9 to edit a specific gene in an embryo’s genetic code responsible for a potentially life-threatening blood disorder. The research team found serious obstacles that need to be addressed before CRISPR-Cas9 can be used to edit genetic code in an embryo on a wide scale; these issues include low retention of genetic material and unintended mutations when a Cas9 enzyme misses its target.

The new year was hardly underway before Representative Lloyd Doggett (D-TX) and 50 of his House colleagues sent a letter to Health and Human Services Secretary Sylvia Burwell and NIH Director Francis Collins urging them to “march in” under the Bayh-Dole Act to control prices for drugs developed under the law. While the high cost of drugs is a legitimate concern, attempts to address the problem through technology transfer statutes would only guarantee that we will have fewer new drugs, not that they will be cheaper. The march-in provision is intended for instances when a licensee is not making good faith efforts to bring an invention to market or when national emergencies require that more product is needed than a licensee is capable of making, not to fix drug prices.