Wednesday 26 February 2020

Extra Protection for the Bayh-Dole Act Needed in the United States?

Bayh-Dole 40 is a new coalition of supporters of the landmark legislation concerning technology transfer—the Bayh-Dole Act.  The Bayh-Dole 40 has an attractive website with information concerning the history of the Act and its impact.  The press release states: 

Today, a diverse group of research and scientific organizations, as well as those directly involved in commercializing new products, launched Bayh-Dole 40, a coalition that will celebrate and protect the University and Small Business Patent Procedures Act of 1980, better known as the “Bayh-Dole Act.”

The Bayh-Dole Act has empowered universities, small businesses, and nonprofits that have received federal grants to retain ownership of any patented inventions — and license those patents to private firms, who then turn promising ideas into real-life products that improve peoples’ lives. Thanks to Bayh-Dole, the public and private sectors have worked together to translate basic scientific research into life-saving drugs and medical devices, internet and GPS technologies, rechargeable lithium-ion batteries, and countless other innovations.

“Bayh-Dole made the United States the engine of global innovation,” said Bayh-Dole 40 founder and executive director Joseph Allen, who helped enact the law as a member of Senator Birch Bayh’s U.S. Senate Judiciary staff. “The Act reinvigorated research and development in America, spawning breakthrough discoveries ranging from high-yield crops to advanced medicines.”

Thanks to Bayh-Dole, over 200 new therapies — including drugs and vaccines — have been created since 1980. The legislation has also bolstered U.S. economic output by $1.3 trillion, supported 4.2 million jobs, and led to more than 11,000 start-up companies.

Bayh-Dole 40’s founding members include AUTM, Biotechnology Innovation Organization, BioHealth Innovation, Council on Governmental Relations, Information Technology and Innovation Foundation, Licensing Executives Society, and PhRMA, spanning the entire U.S. innovation ecosystem. The coalition will educate lawmakers to ensure the Act is utilized in the way Senators Birch Bayh and Bob Dole envisioned.

“Misusing Bayh-Dole to undermine the existing framework for public-private technology transfer and development, as some lawmakers are suggesting, would jeopardize the future of U.S. life-sciences innovation,” said Stephen Ezell, Vice President of Global Innovation Policy at the Information Technology and Innovation Foundation. “We look forward to engaging Congress on these issues to ensure the United States remains a life-sciences R&D powerhouse.”

About Bayh-Dole 40: Bayh-Dole 40 is a coalition of research and scientific organizations, as well as those directly involved in commercializing new products, dedicated to celebrating and protecting the University and Small Business Patent Procedures Act of 1980, better known as the “Bayh-Dole Act.” The coalition was formed to educate policymakers about Bayh-Dole’s positive impact on medical innovation and defend the Act against imminent threats during its 40th anniversary year.

Bayh-Dole 40’s members include the Association of University Research Parks, AUTM, BIOCOM, BioHealth Innovation, Biotechnology Innovation Organization, California Life Sciences Association (CLSA), Columbia Technology Ventures (CTV), Council on Competitiveness, Council on Governmental Relations, Fuentek, Information Technology and Innovation Foundation, IPWatchdog, Lehigh University Office of Economic Engagement, Licensing Executives Society (LES), Licensing Executives Society (LES) Silicon Valley Chapter, National Venture Capital Association, Pharmaceutical Research and Manufacturers of America, Pristine Surgical, STC.UNM, the IDEA Center at the University of Notre Dame, Wisconsin Alumni Research Foundation, and the Yale Office of Cooperative Research.

It is interesting that the existence of the coalition is necessary to protect the Bayh-Dole Act.  There is some polling to support that U.S. Senator Bernie Sanders could defeat President Trump in an election, but I wonder if anyone really believes that polling (besides Sanders supporters) after the results of the last Presidential election. Maybe the concern will be what happens in the election after this one.  

High Level of Emotional Intelligence of Management Leads to More Creativity by Workers?

In a new paper titled, Supervisor Emotionally Intelligent Behavior and Employee Creativity, published in the Journal of Creative Behavior, Zorana Ivcevic, Julia Moeller, Jochen Menges and Marc Brackett, find a relationship between essentially the level of supervisor emotional intelligence and factors associated with creative behavior.  Basically, emotionally intelligent supervisors may impact the creativity of their employees in positive ways.  Based on their findings, the authors state: 

First, supervisors who aim to encourage and enable creativity in their employees should acknowledge that creativity is refilled with emotion, from the anxiety when facing an open-ended problem and associated uncertainty or risk, to frustration of obstacles, to excitement of initial idea generation, and pride of final achievement. Supervisors who acknowledge that emotions matter in the creative process will be more likely to be mindful of employee emotions and create an environment in which employees experience opportunities to grow and develop their skills. Second, organizations should acknowledge the important role of supervisor EIB for employee creativity and innovation. 

Interestingly, I was reading a book on management about five years ago (Of course, I can’t remember the title right now.), but one of the main points of the book was that Chinese men raised in China make better leaders in business than men raised in the West.  The main reason for the author’s assertion was that being raised in Chinese culture led to a higher level of emotional intelligence than in the West.  Notably, emotionally intelligence can be taught to some extent.  Moreover, this may have strong implications for creativity in the workplace. 

Friday 21 February 2020

GLS Capital Raises $345 million US for Litigation Fund

GLS Capital, based in Chicago, has raised $345 million US for a litigation fund, which will include intellectual property litigation.  It appears investor interest in IP litigation is high again.  Here is the press release

CHICAGO--(BUSINESS WIRE)--GLS Capital, LLC today announced the completion of fundraising of its inaugural litigation finance fund, GLS Capital Partners Fund I, LP. Together with its affiliates, the Fund has investor commitments totaling more than $345 million.

GLS Capital raises $345 million for litigation finance fund. Trio of industry veterans launch fund to finance commercial and intellectual property litigation. . . .

The Fund’s diverse institutional investor base includes global financial institutions, endowments, foundations and family offices.

GLS invests in complex situations involving commercial litigation and arbitration, as well as intellectual property disputes in both the technology and pharmaceutical industries. The firm will structure creative and flexible solutions for businesses and law firms that are looking to better manage litigation and balance-sheet risks.

“We are excited to launch our first fund in a growing and dynamic asset class,” said David Spiegel, Managing Director of GLS. “Our fundraising significantly exceeded our initial target size, reflecting a high level of investor interest in our ability to be successful.”

Spiegel and his co-founders, Adam Gill and Jamison Lynch, stand out as an experienced and tested team in litigation finance. They previously executed and managed more than $400 million in investments at two of the world’s largest litigation finance providers.

Before entering litigation finance, they were litigators at elite international law firms. Lynch also served as the co-head of global patent litigation at a leading pharmaceutical company.

The firm intends to harness the deep experience of its founders to efficiently evaluate investment opportunities and streamline the underwriting process. The founders form GLS’ investment committee and have full investment authority.

About GLS Capital

Formed in 2018, GLS Capital is one of the world’s largest private investment firms focused on legal and regulatory risk. We provide bespoke financial solutions to meet the unique needs of each investment opportunity. For more information, please visit:

Artificial Intelligence to Identify New Antibiotics

A very promising use of artificial intelligence to identify new antibiotics has recently been published in Cell on February 20, 2020.  The article, A Deep Learning Approach to Antibiotic Discovery, by lead authors Johnathan M. Stokes, MIT, and Kevin Yang, Broad Institute of MIT and Harvard, (there are nine coauthors), details how the researchers used artificial intelligence to relatively quickly find new antibiotics.  Importantly, this paper provides some hope in the antibiotics field, which has seen few new developments and likely lacks adequate incentives to discover and produce new antibiotics.  The paper is available, here

Tuesday 18 February 2020

The Regulation of Technology Companies and Data: Is IP the Answer?

In a Brookings Institute Report titled “How to Regulate Big Tech,” Anwar Aridi, World Bank, and Urška Petrovčič, VP Criterion Economics and Fellow at the Hudson Institute, review the differences between U.S. and EU competition law and the purported impact of those distinctions on EU policy development concerning technology companies and data usage.  Notably, they frame the question for EU policy makers as whether to ease the EU’s regulatory scrutiny over technology companies to develop national champions or to continue existing regulatory scrutiny to develop an even-handed approach (another idea is to ratchet up scrutiny or develop new regulations).  They seem to favor the even-handed approach.  The framing of the issue is an interesting one.  Clearly, China has taken a very different approach that was relatively protectionist in nature.  And, what has happened?  China has fought off U.S. company dominance in their market—many may argue unfairly—and has some powerful and innovative technology companies: Baidu, Alibaba and Tencent. (affectionately or maybe not so affectionately known as BAT in China).  Moreover, China has a platform that is rivaling U.S. platforms in the U.S. market, particularly amongst youth—Tik Tok.  The development of powerful non-U.S. based platforms may be what ultimately leads to increased regulation of all platforms in the United States, including more antitrust enforcement.  However, I question whether incorporating additional values into antitrust analysis, such as national security, will be a good idea. National security as a value in antitrust analysis may be very difficult to cabin-in.  Indeed, there are also other laws available to police national security.  

Dr. Kai-Fu Lee, in his book, “China, Silicon Valley and the New World Order,” makes the case that the battle over artificial intelligence systems and data will be won by China over the United States—the advantage is China’s ambitious and win-at-all costs entrepreneurs that have had to operate in a Chinese system where the weak perish quickly and the Chinese are willing to part with their data.  Is there a way to check behavior that antitrust regulators are having difficulty with keeping up with in the fast-moving technology environment?  Perhaps the answer is private enforcement of intellectual property laws—with those laws structured to protect new entrants, and small and medium-sized companies to deter efficient infringement by large, entrenched companies.  That’s perhaps still too slow.  New state laws to protect privacy interests may be helpful as well—Facebook recently settled a case concerning violation of a state bioinformatic law for around $550 million. 

Monday 17 February 2020

State of California and Others to Manufacture Generic Drugs

In a bid to lower drug prices in California, Governor Gavin Newsom has proposed that the state of California create its own generic drug label and enter into partnerships to have generic drugs manufactured on behalf of the state.  The details are located in the new proposed budget:

A group of health insurers in the United States also plan to manufacture generic drugs:

The Blue Cross Blue Shield Association (BCBSA), 18 independent and locally-operated Blue Cross and Blue Shield (BCBS) companies and Civica Rx (Civica, Inc.) announced today their partnership to create a new subsidiary dedicated to lowering the cost of select generic drugs. The subsidiary is being formed in response to the impact of high drug costs on the health of Americans and the overall affordability of health care. Other health plans, employers, retail partners and health care innovators who share the belief that patients and their needs come first are invited to join the initiative.

“We believe everyone should have access to health care, no matter who they are or where they live,” said Scott P. Serota, president and CEO of BCBSA. “Through this partnership, we will push toward the vital objective of providing greater access to much-needed medications.  As BCBS companies and Civica embark on this important work, we hope others will join us to achieve the change Americans want to see in the health care system.”

 Bringing together the brand that invented health insurance more than 90 years ago and an innovative nonprofit company that has already seen success helping to stabilize drug supplies within hospitals, the groundbreaking partnership between BCBS companies and Civica will expand on Civica’s mission by focusing on the affordability of generic medications outside of the hospital setting. 

BCBS companies have decades of collective experience providing health insurance to members in every ZIP code across the country. As champions of health care affordability, the Blue companies continue to drive solutions that will increase access and improve health for their members and for the health of all Americans.

Nonprofit Civica was formed in 2018 by three philanthropies and numerous health care organizations in an effort to combat drug shortages and price spikes in hospitals. 

“Civica’s mission is to make quality medicines available and affordable to everyone,” said Martin VanTrieste, Civica president and CEO. “Serving patients is our privilege and our responsibility—one that we are proud to share with BCBS companies who are committed to tackling one of the most important health care challenges of our time. Numerous studies confirm that medication costs can dictate whether individuals fill or ration their generic prescriptions. Together with BCBS companies, we are taking action to put patients first.” 

In the partnership, BCBSA and BCBS companies are committing the capital to bring select high-cost generic drugs to market for consumers. The subsidiary will acquire and develop Abbreviated New Drug Applications (ANDAs) for select generic drugs and partner with Civica and manufacturing partners to bring more affordable generic drugs to uncompetitive markets in exchange for aggregated volume and multiyear purchasing commitments. Initially, several generic medications identified as having high potential for savings will be prioritized by the partnership and will evolve into a platform that can be used to enhance competition for additional generic drugs.

This partnership will result in meaningful savings for individuals and families, with the first generic medications becoming available by early 2022. The new partners welcome further participation from others in the health care industry who are united with their goal of promoting competition to spur production of affordable, quality medications.

“Civica is already bringing value—in quality, supply and price—to the in-patient hospital market and with BCBS will expand that mission to reach individuals and families buying generic prescriptions in hospitals and pharmacies,” said Dan Liljenquist, Civica board chairman. “Combining Civica’s mission with the commitment BCBS companies show to their members places us in a position to make a significant impact on lowering drug costs.” 

More information is available, here