Here Comes the Sun: Here Comes 2021!

For those of us on the East Coast of the US in the Northern Hemisphere, Winter Solstice is at Dec 21 at 5:20 am EST, when the Sun reaches its southernmost point in the sky as part of the longest night of the year. But each day after that the days get a bit longer. The Sun is returning.

The Economist Magazine, not known for idle puffery, called this ‘one of the most inspired pieces of legislation in the past half century’. The legislation? The Bayh-Dole Act. 
 
The 1980 Bayh-Dole Act helped to unlock the inventions in laboratories across the US that were made with taxpayer money. Before the Bayh-Dole Act was put into law, of the 28,000 patents owned by the US government, less than 5% were licensed to industry.  These technologies were lying on the shelf as the government negotiation process was complex, time-consuming and frustrating for industry. By giving incentives to universities and other entities to take title to patents funded by government research, the legislation created a whole new industry of technology intermediaries at universities and companies to help push the tech transfer process. 
 
Before the Bayh-Dole Act, few universities had tech commercialization offices, and fewer still had tech incubators, research parks or innovation districts to bring together public-private partnerships to fuel economic growth in the US.   The success of California's Silicon Valley and Massachusetts’ Kendall Square, but also places like North Carolina’s Research Triangle Park and the University of Arizona’s Tech Parks would have been inhibited, if not for robust university tech commercialization policies undergirded by Bayh-Dole. 
 
Unfortunately, some policymakers on both the left and right have seized on a provision in the Bayh-Dole Act in an attempt to control medical drug prices. March-in Rights under Bayh-Dole allows the federal government to take back patents if universities or companies have not made good faith efforts to commercialize the underlying technology. But this provision was never intended to be used as a price control mechanism for consumer drugs.  Previous administrations have rejected invoking march-in rights as a price control mechanism, and it would be especially detrimental to smaller biotech companies in our parks. Large pharmaceutical companies would survive but creating uncertainty for biotech patents owned by small companies would hurt bringing in needed capital to create new health therapies.
 
This year, as we celebrate the 40th Anniversary of the passage of this path breaking legislation, during the 2020 AURP International Conference (Nov 2-6), AURP is honored to have Joe Allen, one of the Act’s principal architects, leading a special panel looking at the history and policy emulation across the globe. www.aurp.net
 
Other changemaker keynoters include, entrepreneur and venture capitalist Steve Case, on Revolution and Rise of the Rest, along with BIO’s new CEO and President, Dr. Michelle McMurry-Heath.  Both the biotechnology industry and venture capital would look very different if the Bayh-Dole Act had not passed back in 1980, stimulating the growth of startup companies and new bio technologies in the US. 
 
Let’s celebrate the amazing success of the Bayh-Dole Act, and ensure it remains a force for innovation and new technologies for the next 40 years. Continue the discussion on our Blogger.

Consider the lowly horseshoe crab. East Coast beach walkers can see these creatures, early in the morning, sometimes stranded upside down in the sand. It isn’t a crab, but more closely related to the spider family. Not well known is that the blood from horseshoe crabs play a critical role in ensuring the safety of vaccines and other drugs. The crab’s milky-blue blood provides a substance that can detect a deadly containment called endotoxin that can contaminate vaccines and other drugs during manufacturing. Fortunately, we have a sufficient natural supply of horseshoe crabs to supply the country’s immediate needs, even with a surge of a COVID19 vaccine production.  But what about other drugs and medical supplies? If drug manufacturing isn’t taking place in the US, how do we know our medical supply lines won’t be disrupted when the next pandemic arrives?

Earlier this month AURP hosted a webinar on reshoring bio and pharma manufacturing to ensure health for our citizens. The COVID-19 Pandemic vividly demonstrates the need for rethinking ways to manufacture biological materials and create sustainable medical product supply lines.