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: 


PROTECTION OF INTELLECTUAL PROPERTY AND USE OF TECHNOLOGY CONTROL PLANS

• 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.

. . .

INTERNATIONAL VISITORS TO CAMPUS

• 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.

EXPORT CONTROL COMPLIANCE

• 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 msmireles@gmail.com.  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. https://www.oxfirst.com/

Please use a professional email address, so we can recognize you. We were subject to spam recently. We only have space for 100 people. Places offered on a first come basis. 

Wednesday, 20 May 2020

Reflecting Forces at Work in an IP Valuation


OxFirst Ltd.

Investing wisely in IP

More than ever before, there is a need to invest wisely in technology. No matter which technology one looks at, the adequate management of the underlying IP is crucial so to commercially succeed.
An IP valuation looks at business legal dynamics from a quantitative perspective. In doing so, it allows to put substantive legal aspects in a business context and establish a bridge between law and economics. The IP department by consequence has a chance to stop being perceived as an esoteric cost centre and has the chance to become drivers of business success.

For this to happen a sort of ‘translation exercise’ needs to happen, whereby a patent right can become a patent asset. Even if it does not make the leap to be an asset and it becomes visible that it really is a patent liability, then this still has a massive business proposition. IP which bears no business proposition can be eliminated, which helps save costs.

Elements of an IP Valuation

An IP valuation is structured into three parts. An IP due diligence, a business assessment of the IP and an in-depth analysis of the role of the IP within the larger competitive environment.

The IP valuation consists of an initial due diligence followed by a strategic assessment of the various opportunities provided by the IP to maximize profits. It also helps manage costs, which many companies may find important in the current situation.

Recognizing Forces at Work in an IP Valuation

Using Professor Porter’s framework of ‘forces at work’ is a very helpful step to grasp IP from a business perspective. Translated to the peculiar features of IP law, such forces at work can consist of regulatory challenges, technology challenges, potential new market entrants, as well as competitive dynamics in the market.




Regulatory challenges may for example be Supreme Court decisions, such as the E-Bay vs Merck exchange decision in the United States, which put an end to automatic injunctions. Instead injunctions are issued after the verification of a multi factor test, which Patent Assertion Entities may find difficult to pass.

Technology challenges may pertain to the actual tech solution itself. Is this novel technology even be doable by nature? For example, is it even possible to offer a vaccine for a virus or does a virus not even respond to a vaccine?

Potential new market entrant may be in a position to offer a better market solution. They may be able to offer a faster, cheaper or more effective solution. At times, there may also be novel tech solutions, which make existing ones entirely obsolete.

Competitive dynamics in the market may pertain to issues such as vertical or horizontal integration. Does one single company operate in the same market that it also sells its tech solutions to? If so, can this have an effect on the value of its IP and that of other market participants?

The assessment of these forces at work helps determine a potential net value for the IP at stake. In doing so, it allows to establish a relationship between the IP and the business environment it is situated in. However, such analysis is not just narrative in character. The valuation of the IP allows to quantify such forces at work. This is an amazing value proposition as it helps understand potential returns and sets them in relation to risk.Unsurprisingly, this allows a firm to reorient its strategy and sets the baseline for the entire business strategy, not just the narrow circle of the IP strategy itself. A firm can be in a position to maximize revenues, while at the same time minimize its costs.


Tuesday, 19 May 2020

Why IP Valuation helps Fight the Corona Pandemic




IP Valuation helps Manage Firms
The dire need for a cure for Corona illustrates the necessity to come to grips with the valuation of intellectual property. There is neither time nor budget to waste. Ideally, a straight forward solution should be found in the next couple of months, if not even weeks.
Yet, and here lies the dilemma, markets for technology don’t work like that. Technology development is riddled with uncertainty. Risks stem from the technology itself, which may not be viable after all, as well as macroeconomic and financial risks; to name a few.
Because creative learning is central to innovation processes it is also difficult to predict how much money will be needed to create viable long-term technology solutions. Penicillin was discovered by mere coincidence and when 3M aimed at finding a glue that would stick really well, it discovered a glue that did just the opposite. Then again, there are those examples where millions are spent and in spite of that the technology is ultimately abandoned.
Intellectual Property which is adequately valued can in such contexts help. While the valuation of intellectual property can do little to prevent such risks, it can help enhance transparency. This in turn allows to better manage a firm and make enhanced investment decisions.  
Intellectual property protects various different business segments. Patents protect the technology itself, copyright helps protect code and software, trade secrets offer the protection of strategic business information and trademarks help leverage the brand of a firm. These various forms of IP are crucial for a firm to succeed. In particular, it is the congruence of different forms of IP that help a business to succeed. The valuation of IP helps shed light on the many tactics a company has at its disposal to leverage synergies. At the same time, it can help manage risk. This helps attract investments and enhance ROI (return on investment).

IP Valuation works in Practice
I have had many opportunities to show that such approaches work in the real world. Just recently I undertook the valuation of a tech start up specialized in urban mining. The firm focuses on extracting valuable materials from electronic trash. In doing so, it addresses a massive environmental challenge, while at the same time opening up previously unknown business opportunities.

The IP valuation I undertook helped the firm reorient its strategy. The IP business strategy set the baseline for a massive increase in revenues. At the same time, it helped the firm minimize its operational costs.

Quite simply, this was possible because of the immaterial nature of IP. Trading in intangible assets is a good deal more cost effective than in tangible property rights. Such approaches may also work for firms specializing in a cure for Corona. An IP valuation can help a firm save costs, increase returns and enhance its technology strategy. At the same time, an IP valuation helps investors make educated investment decisions. These advantages are immensely valuable in the age of Corona, where we need to assure every Pound is spent wisely. The path to finding a cure to the virus is invariably interlinked with an adequate analysis of the economic impact of intellectual property.



Tuesday, 12 May 2020

WIPO Has New Designated Director General


Dr Francis Gurry, who has been the Director General of the World Intellectual Property Organization, the specialized body of the United Nations for the protection of Intellectual Property, will be leaving his post after leading WIPO for twelve years as its key official.

Dr Gurry will be replaced by Mr Daren Tang, the current Chief Executive of the Intellectual Property Office of Singapore (SIPO). Mr Tang holds an LLM from Georgetown University and an LLB from the National University of Singapore. According to his C.V., his core achievement as the CEO of SIPO was to set the baseline for Singapore to thrive as an IP nation. For WIPO he has so far acted as its Chair of the Copyright Committee.

Mr Tang is the first Asian to ever hold this office. Other candidates for WIPO’s top job included long lasting insiders like Dr Edward Kwakwa, a national of Ghana and Ms Binying Wang, a national of China.

Further information can be found here:

Damages for Noneconomic Harm in Intellectual Property Law, by Thomas F. Cotter. Forthcoming with Hastings Law Journal. A Brief Review.

By Roya Ghafele, OxFirst. Email: info@oxfirst.com

Noneconomic harm, so Professor Cotter, includes (among other things) pain and suffering, emotional harm and distress, and loss of reputation. While it is difficult to quantify such harm, it is not impossible to do so. Particularly, if the plaintiff is a corporation which was confronted with the infringement of its intellectual property rights. In such circumstances one can illustrate loss of earnings caused by the infringement with reference to the firm’s financial statements. Often balance sheets of companies are used for illustrative purposes in such circumstances and the scenario one looks at is how corporate performance was affected by the noneconomic harm.

If however the injured party is not a company, but an individual, the situation is bit more complicated. How can one quantify the emotional distress of a writer who saw her work demolished?

In this article Thomas Cotter is less interested in offering a ‘cooking recipe’ how to calculate damages for such noneconomic harm, but more in discussing the overarching principles guiding damage awards for noneconomic harm.

He starts off by looking at U.S. case law and illustrates at a series of examples how, when and why Courts offered damage awards for noneconomic harm. I personally found it insightful to learn that a city cannot just simply demolish the sculptures of an artist and had to compensate the artist for such wrong doing. I was also interested to learn that a real estate developer cannot just wipe off graffiti art. Such doing, so the Court found, constituted an act of deformation and is contrary to the US copyright act. The Court found it essential ‘…to prevent any intentional distortion, mutilation, or other modification . . . which would be prejudicial to his or her honor or reputation,’. The graffiti artist subsequently received 150 K US Dollars per work. (Castillo v. G&M Realty L.P.)

Across the Atlantic, the IPR Enforcement Directive equally foresees for damages for noneconomic harm, which it describes as ‘moral prejudice.’  ‘Moral prejudice’ can include reputational harm and mental distress. Cotter describes several instances when European Courts have awarded damages under this premise. In particular in ‘Liffers v. Producciones Mandarina SL’, ¶ 17 (CJEU Mar. 17, 2016) it was recognized that moral prejudice, such as damage to the reputation of the author of a work, constitutes . . . a component of the prejudice actually suffered by the rightholder. In Liffers, the Court of Justice of the E.U. ruled that the plaintiff was allowed to obtain a royalty rate, which should be calculated in the form of a hypothetical royalty rate and that Liffers should also be entitled to a compensation for a violation of moral rights.

Factors that may guide the determination of damage awards are the ongoing significance of the infringement to the author and his reputation, the scale of the infringement, the intention of the infringer, the standing of the work and the existence of other means to undo the harm.

According to Cotter, similar considerations would be of relevance for a violation of the general right to personality, as would (under appropriate circumstances) the need to deter future violations.

In this article Cotter discusses however not only noneconomic harm in the context of copyright. He also addresses damage awards for noneconomic harm for patents and trademarks.

The article takes an interesting spin when the legitimacy of IP is not justified under the mainstream utilitarian argument. Rather than argue that IP is needed as an incentive to invest in innovation,’ Cotter argues with reference to Kant that intellectual property rights are justified because they enable IP owners to ‘expand freedom and autonomy’ and hence ‘pursue the ends they set for themselves.’

IP conceptualized as freedom rather than an incentive mechanism inspires to take this research piece to the next step and not only address the question of damage awards for noneconomic harm, but more broadly to study what other governance mechanisms for IP would be afforded if one defined the purpose of IP from a public interest rather than a mere mercantilist perspective.