Monday 29 June 2020

Gilead Sciences Releases Letter on Pandemic Pricing of COVID-19 Treatment

The Chairman and CEO of Gilead Sciences, Daniel O’Day, has released an open letter concerning the pricing of the COVID-19 treatment remdesivir with apparent price differences between developed and developing countries.  The transparency concerning pricing is welcome.  Notably, it appears that developed countries will pay about the same amount which is set at around what the developed country with the least ability to pay could pay.  There is a difference for private insurers in the United States.  The letter references the cost savings of reduced hospitalization from usage of the treatment in the United States.  Developing countries will apparently pay a price that should allow wide access, but it is unclear whether that price will vary amongst countries or within different populations in those countries.  The letter could be read to mean that the developing countries will all essentially pay one price similar to the developed countries.  The price is also tied to continued research and development concerning remdesivir itself as well as future treatments.  The letter states, in part: 

As with all our actions on remdesivir, we approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been our compass point throughout, from collaborating to find rapid answers on safety and efficacy, to scaling up manufacturing and donating our supply of remdesivir through the end of June. In each case, we recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as we transition beyond the donation period and set a price for remdesivir, the same principle applies.

In normal circumstances, we would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 showed that remdesivir shortened time to recovery by an average of four days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. Even just considering these immediate savings to the healthcare system alone, we can see the potential value that remdesivir provides. This is before we factor in the direct benefit to those patients who may have a shorter stay in the hospital.

We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.

Part of the intent behind our decision was to remove the need for country by country negotiations on price. We discounted the price to a level that is affordable for developed countries with the lowest purchasing power. This price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. At the current price of $390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems.

In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.

Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS) whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation.

In the developing world, where healthcare resources, infrastructure and economics are so different, we have entered into agreements with generic manufacturers to deliver treatment at a substantially lower cost. These alternative solutions are designed to ensure that all countries in the world can provide access to treatment.

Our work on remdesivir is far from done. We continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the course of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies. As we accumulate more data from global clinical trials and initiate many additional studies, we will understand more about the full value of remdesivir over time. Our teams also remain focused on increasing supplies to meet the high global demand. By the end of this year, we expect our investment on the development and manufacture of remdesivir to exceed $1 billion (U.S.) and our commitment will continue through 2021 and beyond.

In making our decision on how to price remdesivir, we considered the full scope of our responsibilities. We started with our immediate responsibility to ensure price is in no way a hindrance to ensuring rapid and broad treatment. We also balanced that with our longer-term responsibilities: to continue with our ongoing work on remdesivir, to maintain our long-term research in antivirals and to invest in scientific innovation that might help generations to come. As with many other aspects of this pandemic, we are in uncharted territory in pricing remdesivir. Ultimately, we were guided by the need to do things differently. As the world continues to reel from the human, social and economic impact of this pandemic, we believe that pricing remdesivir well below value is the right and responsible thing to do.

Tuesday 23 June 2020

Legislation Introduced in United States Concerning Semiconductor Manufacturing and Innovation

The Creating Helpful Incentives to Produce Semiconductors Act (CHIPS Act) has been introduced in Congress to reinvigorate U.S. chip manufacturing and innovation, particularly by pushing chip manufacturing back to the United States because of national security concerns.  Steve Blank summarizes and discusses the current situation in the United States concerning national security, China and chip manufacturing, here.  A press release sets forth the main provisions of the CHIPS Act as follows: 

The CHIPS For America Act: 

  • Creates a 40-percent refundable ITC for qualified semiconductor equipment (placed in service) or any qualified semiconductor manufacturing facility investment expenditures through 2024. The ITC is reduced to 30 percent in 2025, 20 percent in 2026, and phases out in 2027. 

  • Directs the Secretary of Commerce to create a $10 billion federal match program that matches state and local incentives offered to a company for the purposes of building a semiconductor foundry with advanced manufacturing capabilities.

  • Creates a new NIST Semiconductor Program to support advanced manufacturing in America. The program’s funds will also support STEM workforce development, ecosystem clustering, U.S. 5G leadership, and advanced assembly and test.

  • Authorizes funding for DOD to execute research, development, workforce training, test, and evaluation for programs, projects, and activities in connection with semiconductor technologies and direct the implementation of a plan to utilize Defense Production Act Title III funding to establish and enhance a domestic semiconductor production capability.

  • Requires the Secretary of Commerce to complete a report within 90 days to assess the capabilities of the U.S. industrial base to support the national defense in light of the global nature of the supply chain and significant interdependencies between the U.S. industrial base and that of foreign countries as it relates to microelectronics.

  • Establishes a trust fund in the amount of $750M over ten years to be allocated upon reaching an agreement with foreign government partners to participate in a consortium in order to promote consistency in policies related to microelectronics, greater transparency in microelectronic supply chains, and greater alignment in policies towards non-market economies. To incentivize multilateral participation, a common funding mechanism is established to use this fund to support the development of secure microelectronics and secure microelectronics supply chains. A report to Congress is required for each year funding is available. 

  • Directs the President to establish, through the National Science and Technology Council, a Subcommittee on Semiconductor Leadership responsible for the development of a national semiconductor research strategy to ensure U.S. leadership in semiconductor technology and innovation, which is critical to American economic growth and national security, and to coordinate semiconductor research and development.

  • Creates new R&D streams to ensure U.S. leadership in semiconductor technology and innovation is critical to American economic growth and national security:
    • $2 billion to implement the Electronics Resurgence Initiative of the Defense Advanced Research Projects Agency.
    • $3 billion to implement semiconductor basic research programs at the National Science Foundation.
    • $2 billion to implement semiconductor basic research programs at the Department of Energy.
    • $5 billion to establish an Advanced Packaging National Manufacturing Institute under the Department of Commerce to establish U.S. leadership in advanced microelectronic packaging and, in coordination with the private sector, to promote standards development, foster private-public partnerships, create R&D programs to advance technology, create an investment fund ($500M) to support domestic advanced microelectronic packaging ecosystem, and work with the Secretary of Labor on establishing workforce training programs and apprenticeships in advanced microelectronic packaging capabilities.

Monday 22 June 2020

U.S. Universities and Foreign Researchers: Guidance from the AAU and APLU

The Association of American Universities (AAU) and Association of Public and Land Grant Universities (APLU) has released a document entitled, “University Actions to Address Concerns about Security Threats and Undue Foreign Government Influence on Campus.”  The document is a response to increased concerns in the United States concerning intellectual property theft by foreign students, researchers and professors.  The document focuses on how U.S. universities can exercise additional care in vetting visitors and guests as well as ensure that data and intellectual property is adequately protected.  The document is an attempt to achieve those goals and assuage some that adequate measures are being taken.  The prospect of universities in the United States completely losing technical expertise as well as tuition dollars is not an attractive option.  The Trump Administration is rumored to release an executive order severely limiting certain visas and the Optional Practical Training program soon [UPDATE: Here is the Executive Order.  Apparently, it doesn't touch the Optional Practical Training Program].  Here are some provisions on visitors to campus, intellectual property and export controls: 


• Development and use of faculty disclosure requirements for intellectual property (IP) protection. Institutions routinely require faculty disclosure of intellectual property with commercialization potential, with the intent of ensuring that such IP is secured by quickly applying for the appropriate patent protection. Institutions also protect and restrict access to specific information on university invention disclosures, patent applications, and license agreements.

• Use of Technology Control Plans (TCPs) and non-disclosure agreements. Institutions regularly establish TCPs and other risk-mitigation initiatives to ensure the security of research and protection of intellectual property and to maintain compliance with federal regulations, laws, and contract directives. In instances where proprietary research is being conducted, institutions regularly make use of non-disclosure agreements.

. . .


• Development and use of requirements for vetting and securely hosting foreign visitors while on campus. Institutions have developed policies requiring faculty to alert university officials, often through their export control, research compliance, or international affairs offices, when they plan to have foreign visitors come to visit campus and/or tour their laboratories. The hosting faculty member may be required to fill out a brief questionnaire and/or form for each visitor. Some institutions use software solutions such as Visual Compliance or Amber Road, which search numerous continually updated restricted parties lists, to screen for restricted or denied parties. Other institutions have implemented measures for securely hosting and escorting foreign visitors and avoiding unauthorized information gathering. Some institutions are also now choosing to screen all visiting foreign scholars, which previously may have been limited to scholars in visa categories requiring screening under export control regulations.

• Implementation of visitation control plans and visiting scholar handbooks. Some institutions and departments have created plans to detail specific measures the host will take to prevent unauthorized access to export-controlled data and areas where export-controlled research is performed. Submitted plans often include a list of visitors, who they meet with, the duration and campus location of their visit, and the purpose of their visit. Institutions have also provided detailed handbooks with guidance on how to successfully invite and host a visiting student researcher or a visiting scholar on campus including details on how visitors should be onboarded.

• Development of resource documents on foreign engagements and visitors to campus. The Academic Security and Counter Exploitation Working Group (ASCE) produced a paper, “Steps and Considerations for Effective Foreign Visitor Review Process in an Academic Environment.” The paper suggests a checklist for foreign visitor review processes including: determining the level of risk proposed by the visitor, reviewing the visitors background and reason for visit, preparing an official university invitation, managing the onboarding process and oversight while visitor is on campus, and completing the departure process for the foreign visitor. ASCE also includes a list of suggested interview questions that institutions could use for foreign visitors. COGR produced a “Framework for Review of Global Engagements in Academic Research” to provide an underlying structure to support an institution’s analysis of global research engagements, assess potential risks, and develop strategies for mitigation. The U15 Group of Canadian Research Universities also developed a paper, “Mitigating Economic and/or Geopolitical Risks in Sensitive Research Projects: A Tool for University Researchers,” to assist with identifying and mitigating risks with research collaborations and projects, and provides a checklist for building a strong project team, assessing non-academic partners, and reviewing use of research findings.

The Australian Group of 8 has also produced “Guidelines to Counter Foreign Interference in the Australian University Sector” to help manage and engage with risk to deepen resilience against foreign interference in the university sector.


• Use and strengthening of policies and programs to ensure full compliance with federal export control requirements. Institutions have in place clear, visible, and comprehensive policies regarding whether and how they will undertake export-controlled research activities. This includes applying for export control licenses when required and creating TCPs to protect technology from unauthorized access when export-controlled technologies are involved and/or classified work is being conducted.

• Employing university staff with specific export control compliance expertise. Most AAU and APLU institutions have one or more staff members with specific responsibility for ensuring compliance with export controls. Many of these individuals belong to the Association of University Export Control Officers (AUECO), a national association of more than 270 university export control officers, whose mission is aimed at exchanging information and sharing knowledge and effective university policies and procedures to advance university compliance with U.S. export, import, and trade sanctions laws and regulations. Institutions conducting classified research also have specially trained Facility Security Officers (FSOs), who oversee security specific to this research.

There are also provisions on data control.  The document can be found here.

Thursday 18 June 2020

Free Colloquium -- "Technological Progress, COVID-19 and the Future of Globalization"

VIT University Law School in Chennai, India is hosting a Zoom colloquium titled, “Technological Progress, COVID-19 and the Future of Globalization” on June 22 at 6:30 pm Indian Standard Time (6:00 am PST (California); 3:00 pm GMT+2 (Belgium) 9:00 pm GMT+8 (China)). The colloquium participants will offer their preliminary thoughts concerning issues ranging from intellectual property access to vaccine development and manufacturing to investment and the World Trade Organization.  Given the nature of the colloquium, we will not cover all potential issues.  However, a follow-up conference exploring these and additional issues in depth is tentatively scheduled for the Winter of 2020 or Spring of 2021 in Chennai. 

The participants in the Zoom colloquium include: Dean Gandhi Manimuthu (VIT Law); Mark Lemley (Stanford Law); Jim Chen (Michigan State Law); Martin Husovec (Tilburg University); Kirsten Schmalenbach (Univ. of Salzburg Law); Stephan Kirste (Univ. of Salzburg Law); Henrik Andersen (CBS Law); Liu Lina (Xi’an Jiaotong University); Prabash Ranjan (South Asian University); James Nedumpara (Indian Institute of Foreign Trade); Ana Rutchsman (St. Louis Law); Patrick Warto (Univ. of Salzburg Law); and Mike Mireles (Univ. of the Pacific, McGeorge Law).   If you are interested in participating via Zoom, please contact Mike Mireles at  There are limited spots available.  Thank you!

Wednesday 10 June 2020

Damages for Noneconomic Harm in Intellectual Property Law

FREE Webinar

                              June 23, 2020 15:00 PM- 16:00 PM British Standard Time

Damages for Noneconomic Harm in Intellectual Property Law

By Professor Thomas Cotter

Hosted by OxFirst.

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