Posts Tagged: "Bayh-Dole"

A reliable and predictable patent law is more necessary than ever, for technology is a much larger part of our industrial product than ever. The recent Supreme Court attention to patent cases reflects their importance to the nation. The balances are not simple, the fresh balances among creativity, business risk, competition, trade, the creation of new knowledge, the production of industrial capital, and fairness, justice. There is no room in the United States for second best. You and we, lawyers and judges, share this responsibility.

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.

It would be a tragic mistake to blame federal tech transfer underperformance on Bayh-Dole. Bayh-Dole needs no amending. Bayh-Dole demonstrates how secure patent rights are the lynchpin to society’s getting the greatest benefit from federal research dollars.

Three events boosted our economic turnaround in the 1980’s: the passage of Bayh-Dole, which injected the incentives of patent ownership into the federal R&D system; the enactment of the Court of Appeals for the Federal Circuit, which insured the courts would apply the patent law consistently; and the Supreme Court’s ruling in Diamond v Chakraberty that living organisms could be patented. That decision stated that patents could “include anything under the sun that is made by man.” Today that quote is only ironic.

The biggest complaint about federal labs is it’s too hard to complete deals. Many federal labs must run pending agreements through byzantine departmental procedures. Companies wonder what’s taking so long and are surprised when negotiated points come back altered… One reason why universities outperform the labs is that many academic licensing officers come from the private sector. They understand the pressures companies are under to complete agreements.

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private sector partner willing and able to assume the burden of commercial development, which dwarfs the amount of money the government spent on the underlying research. This investment can only be justified if the technology has strong patent protection… There’s a reason it’s called intellectual property. Ownership of inventions in the United States of America isn’t a gift from the king but the right of a free people to securely own what they create. That’s the driver of American entrepreneurs, who with proper support will astound centralized governments run by dictators for life with what they can do when turned loose. Restoring our patent system removes the leash holding them back. After that, watch out if you’re in their way.

Secretary Ross gave an unequivocal endorsement of Bayh-Dole specifically, and more generally saying laws need to be updated to address business and technology realities of today, and to enable more companies to license federally funded technologies and take advantage of federally funded research in order to launch high-tech start-ups, create jobs, and grow the economy. “Our practices, policies, regulations, and laws all need to be updated to assure that technology transfer commercialization in the large-scale production and manufacture of innovative technologies occurs within the US,” Ross said. “We must address growing trade imbalances by producing in America the innovative products that the rest of the world needs to buy.”

A group of 16 leaders from politically conservative institutions sent a letter addressed to President Donald Trump lauding the Trump Administration’s decision last summer to initiate an investigation into Chinese trade practices regarding intellectual property. The investigation, authorized under Section 301 of the Trade Act of 1974, was aimed at identifying instances where U.S. technologies have been forcibly transferred to Chinese entities as a cost of entering the Chinese domestic market as a foreign entity… The recent letter to President Trump from conservative leaders is the latest indication that right-leaning institutions and think tanks have been more engaged with the debate surrounding the current U.S. intellectual property system.

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.

We’ve learned from experience that just because a theory’s off base doesn’t mean it won’t take root, particularly when it involves patents and medicine. “No Vaccines Before the Next Zika Outbreak?: A Case for IP Preparedness”  by Professor Ana Santos Rutshman, a faculty fellow in Health Law and Intellectual Property at DePaul University, Co-Director of the Global Healthcare Innovation Alliances at Duke University, and consultant to the World Health Organization, previews  her upcoming UCLA law review article. It could be titled “Developing Treatments Without Patents: Let’s Give it a Try.” The article blames exclusive licensing for the lack of a Zika vaccine citing the failed deal between the Department of the Army and Sanofi. The remedy: banning exclusive licensing for federally supported inventions related to specific diseases while imposing price controls on other life science discoveries. Before this bandwagon rolls, let’s look at the quality of its construction.

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.

Though aimed at certain pharmaceutical products, Sens. Angus King’s and Bernie Sanders’ potential amendments would throw the key to the Bayh-Dole Act’s success —certainty and exclusivity of the intellectual property associated with technology transfer in order to agree to attempt commercialization in the first place — into disarray beyond a single product or sector, the signatories contend.

Sen. Bernie Sanders (I-VT) introduced legislation requiring every agency and non-profit entity to include a “reasonable pricing” provision based on King’s formula for any life science invention made with government support. Apparently the colossal failure of a similar requirement forced on the National Institutes of Health (NIH) in the 1990’s which led to the collapse of industry partnerships without any reduction in drug prices is either unknown, or made no impression on Sen. Sanders. Or perhaps like his trust in socialism, he thinks that what failed in the past will somehow work by some weird magic if trotted out again.

Many were stunned to learn that Senator Angus King (I-ME) included language undermining the Bayh-Dole Act in the report of the Senate Armed Services Committee as it approved the National Defense Authorization Act. The the language “directs” the Department of Defense (DOD) to issue compulsory licenses under Bayh-Dole “whenever the price of a drug, vaccine, or other medical technology is higher in the U.S. 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 U.S.” The provision gives the Department no discretion— it must comply. Apparently no one bothered to check with DOD or anyone familiar with the law to discover that this language incorporates a long discredited theory of how Bayh-Dole operates, or of the significant damage it would do to the development of badly needed medicines and the U.S. economy. The bill is headed to the full Senate for consideration. So before that happens, let’s consider why this is such a bad idea.