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.



Thursday, 7 May 2020

The Pandemic Anti-Monopoly Act to be Introduced in US Congress


U.S. Representative Ocasio-Cortez and Senator Warren will introduce the “Pandemic Anti-Monopoly Act” (Act.)  The Act would apparently halt some mergers and acquisitions during a time when many small and medium sized companies may be struggling financially.  Many commentators have already asserted that too many anti-competitive mergers and acquisitions have been approved by regulators.  The fear is that some large companies may try to take advantage of the crisis.  

Some mergers and acquisitions may result in increased innovation.  Interestingly, one provision appears to target companies with a patent relating to the COVID-19 issue.  A merger or acquisition could be necessary for commercialization.  The Press Release for the Act states, in part:


The Pandemic Anti-Monopoly Act would: 

  • Impose a moratorium on risky mergers and acquisitions until the Federal Trade Commission (FTC) unanimously determines that small businesses, workers, and consumers are no longer under severe financial distress. The moratorium includes all mergers and acquisitions that involve:

o    Companies with over $100 million in revenue or financial institutions with over $100 million in market capitalization;

o    Private equity companies, hedge funds, or companies that are majority-owned by a private equity company or hedge fund;

o    Companies with an exclusive patent that impacts the crisis, like personal protective equipment; and

o    Transactions that must otherwise be reported to the FTC under current law.

  • Pause all waiting periods and deadlines imposed on antitrust agencies during the moratorium.

  • Direct the FTC to engage in rulemaking to establish a legal presumption against mergers and acquisitions that pose a risk to the government's ability to respond to a national emergency. 

New U.S. Legislation Introduced to Address COVID-19-related Pharmaceutical Manufacturing


U.S. Senator Warren, has introduced legislation titled, “COVID-19 Emergency Manufacturing Act” (Act).  The Act gives the federal government the power to manufacture certain goods, including pharmaceuticals needed to address the Covid-19 issue.  The Press Release states: 


Washington, DC - Today, United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Committee on Health, Education, Labor, and Pensions, and Representative Jan Schakowsky (D-Ill.), Chair of the Energy and Commerce Consumer Protection and Commerce Subcommittee, introduced the COVID-19 Emergency Manufacturing Act to publicly manufacture personal protective equipment, prescription drugs, and other medical supplies necessary to combat the COVID-19 pandemic. The legislation authorizes the federal government to manufacture medical products, including by contracting with existing manufacturers, to ensure the nation has an adequate supply of critical materials to avoid rationing during this unprecedented crisis. It will also help the nation begin to prepare for the approval of a COVID-19 vaccine by dramatically increasing our capacity for development and distribution 

In 2018, Senator Warren and Representative Schakowsky introduced the Affordable Drug Manufacturing Act to radically reduce drug prices through public manufacturing of prescription drugs and re-introduced it in 2019. The COVID-19 Emergency Manufacturing Act of 2020 builds off of the lawmakers' original public manufacturing bill to ensure that the federal government harnesses its full manufacturing, contracting, and coordinating capacity during the pandemic. 

The legislation builds on an existing model in which the federal government contracts with private manufacturers to produce drugs critical to national security, and for which there is often a limited or non-existent commercial market. 

. . . The COVID-19 Emergency Manufacturing Act will:  

  • Establish an Emergency Office of Manufacturing for Public Health to ensure an adequate supply of drugs, devices, biological products, active pharmaceutical ingredients, and other supplies necessary to diagnose, mitigate, and treat COVID-19 and to address shortages in products used to treat non-COVID conditions and illnesses.
  • Require the Office to manufacture, or enter into contracts to manufacture, COVID-19 products and other critical drugs and medical devices in shortage. The Office will be required to provide COVID-19 products at no cost to federal, state, local, and tribal health programs and to sell COVID-19 products at cost to international and other commercial entities. The Office will be required to sell the additional products it manufactures at a transparent and reasonable price to domestic and international entities.
  • Direct the Office to begin manufacturing, or enter into contracts to manufacture, PPE, diagnostic test materials, COVID-19 treatment drugs within one month of the Act's passage. The Office will prioritize production of items that have most impact on public health and the economy, that address shortages, and that alleviate demographic disparities in COVID-19.

  • Direct the Office to begin constructing, or enter into contracts to construct, vaccine and therapeutic manufacturing facilities to ensure the immediate production, at-scale, of COVID-19 vaccines when such vaccines become available.
  • Provide transparency into the Office's activities by mandating Inspector General reviews of all of the Office's contracts, requiring periodic reports to Congress, and forcing the Office to publicly post its prices for COVID-19 and other products as well as any licensing agreements. 

Friday, 1 May 2020

Brookings Institute Article on Regulating the Internet (with a nod to antitrust enforcement)


Tom Wheeler at the Brookings Institute has published an interesting article titled, “COVID-19 has Taught Us that the Internet is Critical and Needs Public Interest Oversight.”  Even before COVID-19, the regulation of internet platforms has been a very hot issue in the United States and in other countries.  For example, India recently announced a new regulator for Internet commerce.  In Mr. Wheeler’s article, he discusses why Internet regulation is different from Industrial Age type regulation and proposes four helpful suggestions for moving forward: 


First, do not pretend these challenges can be shoehorned into industrial era regulatory structures. . . .

Second, digital companies should have a seat at the table in the development of the rules rather than having them force-fed. . . . There should be a new federal agency that convenes, oversees, and approves a public-private process that establishes an agency-enforceable Digital Code.

Third, this new Digital Code is not a substitute for antitrust enforcement. The Digital Code is about the behavior of the companies in the services they offer to the public. If a company behaves in an anticompetitive manner, including mergers, that should be the jurisdiction of antitrust enforcers and the Code should not include antitrust exemption.

Fourth, the regulatory oversight needs to be principles-based and agile. Industrial production was a rules-based linear process where each person on the shop floor followed rules for a specific task. Industrial regulation followed the same rigid pattern. In contrast, modern digital products are never finished (think how your smartphone is always updating its software). Digital products are constantly adapting to the changes in their environment. This agile development needs to find its equivalent in agile regulation. Heavy-handed industrial “do this or else” needs to give way to “this is how technology is changing and business practices must evolve as well.”

The full article is available, here.  COVID-19 may speed things up a bit. 

American Antitrust Institute Adds Voice to Criticism of Lax Competition Law Enforcement in the United States


The American Antitrust Institute has released a report titled, “The State of Antitrust Enforcement and Competition in the United States” (Report).  The Report takes the Trump Administration as well as prior administrations to task for a relatively low level of merger and acquisition scrutiny.  The Report also points out that numerous current policy proposals are essentially underdeveloped.  The following is a list of the major conclusions of the Report: 


•  DECLINING COMPETITION PRESENTS A POLITICAL-ECONOMIC DILEMMA IN THE U.S.: The cumulative effects of decades of lax antitrust enforcement, coupled with a step-down in enforcement under the Trump administration, poses fundamental challenges for markets and the democratic values that undergird them. Long-term inaction has compromised the effectiveness of the U.S. antitrust laws, presenting a significant political-economic dilemma around the role of antitrust in solving the broader public policy problem of declining competition.

•  ANTITRUST ENFORCEMENT HAS DECLINED UNDER THE TRUMP ADMINISTRATION: Key metrics indicate a decline in cartel enforcement under the Trump administration, as well as a falloff in second requests and merger challenges. And despite a few high-profile cases, there is no meaningful invigoration of monopolization enforcement. Recent agency actions to block some mergers involving highly concentrated markets reflect “emergency” merger control of the most egregiously anticompetitive transactions.

•  POLICY PRIORITIES AT THE ANTITRUST AGENCIES ARE MARKEDLY DIFFERENT: The Trump DOJ has introduced major changes in government policy surrounding cartel and merger enforcement, the intersection of competition and intellectual property, and competition advocacy. Many of these policies could work against the interests of competition and consumers. The FTC has taken a more pro-active approach, with continued efforts to challenge the expansion of intellectual property to achieve anticompetitive objectives in pharmaceutical markets.

•  SHIFTS IN AGENCY ADVOCACY REFLECT MORE FEDERAL INTERVENTION BY DOJ IN PRIVATE ANTITRUST CASES: The important role of antitrust agency advocacy has shifted markedly under the Trump agencies. The FTC’s competition advocacy, embodied in comments before federal and state agencies and amicus briefs, has fallen off dramatically. In contrast, the DOJ’s competition advocacy has increased but often stakes out positions that work against the interests of competition and consumers.

•  PRIVATE ENFORCERS CAN TAKE UP SOME OF THE SLACK IN FEDERAL UNDER-ENFORCEMENT AND SPUR POLICY CHANGE, BUT THEY FACE SIGNIFICANT CHALLENGES: Key private antitrust cases have had positive impacts by obtaining compensation for victims, deterring future violations, and spurring public debate and state legislative reform. There are also opportunities for private challenges of consummated mergers that have harmed consumers and workers. But challenges remain, with tightening judicial standards for showing collusion and other impediments that make it more difficult to bring, litigate, and win cases.

•  STATE ATTORNEYS GENERAL ARE BECOMING MORE ACTIVE BUT LIMITATIONS PERSIST THAT WILL DEFINE HOW MUCH THE STATES CAN DO IN RESPONSE TO FEDERAL INACTION: State Attorneys General are stepping up efforts in response to weak federal enforcement. These include independent lawsuits to block illegal mergers and confront price fixing, a proactive stance on strengthening federal merger settlements, and investigations into the competitive practices of large digital technology companies. Resource limitations and a change in the tenor of coordination between the DOJ and the states, however, pose challenges.

•  LEGISLATIVE ANTITRUST REFORM IS NEEDED BUT PROPOSALS THUS FAR LACK A COMPREHENSIVE AND COORDINATED APPROACH: Legislative efforts to reform the antitrust laws have accelerated in the 116th Congress and are at levels not seen since the early 1990s. These include comprehensive reform proposals and narrower initiatives targeting specific antitrust issues and particularly vulnerable sectors. Legislative reform is needed to strengthen and clarify the antitrust laws, but these efforts require a coordinated response to ensure that they promote enforcement, not inadvertently weaken it or cause confusion in the courts.

• REVERSING DECLINING COMPETITION IS A PROBLEM THAT WILL REQUIRE A PUBLIC POLICY SOLUTION: Change in the way the U.S. promotes competition and protects the market system is badly needed. Strengthening antitrust to promote more vigorous enforcement of the antitrust laws is part of a broader solution that should be complemented through the use of other tools, including social and economic regulation, standard-setting and interoperability, labor policy, and intellectual property law.

The Report notably discusses the intersection of competition policy and intellectual property, particularly efforts concerning SEPs and pharmaceuticals.  On SEPs, the Report states, in part, that: 


Under the Trump administration, the DOJ has unilaterally reversed course on patent holdup issues. For example, in 2018, the Antitrust Division withdrew from its 2013 Joint Policy Statement with the Patent & Trademark Office on Remedies for Standard Essential Patents (SEPs). The Policy Statement had endorsed sensible limits on court-ordered injunctive relief and the International Trade Commission’s issuance of exclusion orders, which ban imports of products into the U.S. if the products infringe a U.S. patent. It cautioned against such injunctions and orders when the alleged infringer’s products are compliant with industry standards and the patent holder has voluntarily committed to an SSO to license the patent on FRAND terms.

In December 2019, the Antitrust Division issued a new Policy Statement downplaying the concerns and ignoring the public policy justifications against injunctions and exclusion orders on products alleged to infringe SEPs.62 The new Policy Statement offers no tailored rules or meaningful guidance, and it signals increased scrutiny of SSOs rather than SEP owners. The new Policy Statement warns that such heightened scrutiny could result in an investigation or enforcement action when SSO’s take certain steps to clarify their patent policies and procedures to mitigate the risks of hold-up and disputes over licensing terms, whereas the previous statement had encouraged SSOs to make appropriate clarifications to that end.

The Report is available, here

Thursday, 30 April 2020

University of Michigan Spin-off Company Develops Covid-19 Test


A University of Michigan spin-off company has developed a promising Covid-19 antibody test.  The press release states: 


ANN ARBOR—COVID-19 antibody testing that’s portable, fast, cheap and highly precise—four attributes that are usually mutually exclusive—could be possible with a microfluidic device invented at the University of Michigan and developed by U-M startup Optofluidic Bioassay.

A microfluidic device, or “lab on a chip,” shrinks multiple lab functions onto a single chip just millimeters or centimeters in size. The technology enables faster results with smaller sample sizes.

The new system is believed to be the first microfluidic approach to a gold standard testing protocol known as “enzyme-linked immunosorbent assay,” or ELISA. The U-M researchers have previously published results showing that their device can work as well as the slower, larger, standard ELISA setup. They are currently validating it for use on COVID-19 antibodies.

They have demonstrated that they can detect synthetic COVID-19 antibodies and they’re working with researchers at a hospital in New Jersey on experiments with human blood from COVID-19 patients.

University and industry labs around the U.S. are clambering to develop better antibody tests. The U-M approach is different in that it centers on a device, rather than the chemical mixtures, or reagents, to detect COVID-19 markers.

“We are unique because we are a hardware company,” said Xudong (Sherman) Fan, U-M biomedical engineering professor and co-founder of Optofluidic Bioassay. “Anyone working on COVID-19 antibody tests can use their reagents in our device.”

Why we need antibody tests

Rapid and accurate antibody tests could play an important role as governments, medical workers, scientists and private citizens alike continue to navigate the pandemic, the researchers say. Antibody tests can reveal who has already been exposed to the virus and developed immunity, at least temporarily, and can safely go back to work. If done in a widespread way, they could show the true scale of the pandemic and its death rate.

And the U-M researchers say their particular approach could give doctors critical, near-real-time insights into how a patient is responding to treatment, or a vaccine once one is developed.

Small-scale antibody testing has been done in some countries. Research projects are underway in the U.S. and while kits are beginning to materialize on the market here, they’re not yet widely available.

Antibody, or “serology” tests are different from the “PCR” tests being used to diagnose COVID-19. Rather than screen for the virus itself, serology tests detect antibodies—proteins the immune system manufactures to fight it.

Microfluidic ELISA in the landscape of COVID-19 antibody tests

The majority of labs working on serology kits are making a particular type called “rapid diagnostic tests” that give a yes or no reading. These are quick, but they have drawbacks. False positives can be a problem. And because they don’t give a lot of information, they aren’t useful in monitoring the immune system’s response during treatment.

A handful of labs are making ELISA tests. These are typically quantitative and accurate, showing the concentration of antibodies. That makes them more reliable and less prone to false positives than the rapid diagnostic tests. But standard ELISA results take several hours, and the machines that provide them are the size of refrigerators. In addition, the sample needs to be sent to the test lab for analysis.

But microfluidic ELISA can give a quantitative and accurate result in just 15 minutes, with a finger-prick’s worth of blood. This combination of attributes, plus the fact that it’s portable, could make it a powerful tool.

“Our approach offers the best of both worlds. We can achieve the quickness and simplicity of the rapid diagnostic test with the accuracy of the standard ELISA quantitative measure,” Fan said.

“Because our device generates such sensitive and quantitative measurements, we believe its use goes beyond identifying recovered patients. Antibodies begin to show up a few days after infection, so we could use this approach to monitor patients’ immune response to infection, treatment and vaccination.”

The microfluidic ELISA is rapid, portable and low cost.

“The estimated cost of testing is a few dollars per test of two to three different antibodies, making this a very viable option for use in hospitals, doctors’ offices, field clinics and potentially even pharmacies,” said Xiaotian Tan, a doctoral student in biomedical engineering who is working on COVID-19 antibody testing with Fan.

The machine can be the size of a microwave, and can test multiple simultaneous samples of little more than a drop of blood from a fingertip in less than 20 minutes.

It was invented at U-M several years ago and developed by Optofluidic Bioassay, which was founded by Fan and former research investigator of biomedical engineering, Maung (Malcolm) Khaing Oo, who now serves as the company’’ chief technology officer. Fan and Maung Khaing Oo are co-founders of and have an equity interest in Optofluidic Bioassay. The researchers plan to eventually apply for FDA Emergency Use Authorization.

Saturday, 25 April 2020

American Antitrust Institute Materials on Competition Issues in the Healthcare Supply Chain


The American Antitrust Institute has released a collection of materials on competition issues with respect to the health care supply chain.  The Press Release states: 


The current COVID-19 public health crisis highlights the critical competition, public policy, and security issues relating to the healthcare supply chain. At a time when some functions within the healthcare system are temporarily immunized from the antitrust laws, it is essential to emphasize the importance of vigorous antitrust oversight and the benefits of competition for the welfare of consumers, healthcare workers, and innovation.

AAI has produced legal, economic, and institutional analysis of healthcare competition issues for over two decades. This evidence-based analysis touches on all aspects of the supply chain, including the adverse effects of consolidation at the provider, insurer, and intermediary levels; the debate around bargaining power; and the importance of diversity and redundancy on the stability and safety of the supply chain.

Below is a sampling of key healthcare supply chain issues for which AAI has generated research, education, and advocacy to inform and engage the antitrust enforcement and competition policy communities. This body of work also serves in a vital role to inform longer term responses to the current public health crisis and to suggest the importance of a broader public policy framework for ensuring competition in this critical sector. Note: AAI resources on competition in the pharmaceutical sector can be located separately under “Health & Pharmaceuticals” section of our website.

The resources can be found, here

Friday, 24 April 2020

USPTO Report on Patent Eligible Subject Matter: Greater Certainty Achieved?


The United States Patent and Trademark Office (USPTO) has released an eleven page report titled, “Adjusting to Alice: USPTO Patent Examination Outcomes After Alice Corp. v. CLS Bank International,” on the impact of Patent Office changes on patent eligible subject matter.  U.S. patent eligible subject matter law has been described by some as a “mess,” which breeds uncertainty and may impact incentives to innovate and patent.  To address the apparently conflicting and confusing state of the law, the Patent Office has worked hard to provide guidance to examiners and applicants concerning the application of the law.  The USPTO report notes that recent guidance provided by the Patent Office has had a positive effect on predictability and certainty concerning the doctrine.  Of particular interest, the guidance provided by the Patent Office has a positive impact on Alice-effected technologies.  The full report is available, here.  The Press Release states: 


WASHINGTON - The United States Patent and Trademark Office (USPTO) today published a report authored by its Chief Economist titled, Adjusting to Alice: USPTO patent examination outcomes after Alice Corp v. CLS Bank International. The report highlights how recent actions undertaken by the USPTO have brought greater predictability and certainty to the determination of patent eligibility in the technology areas most affected by the decision.

“We have heard anecdotally from both examiners and applicants across the entire spectrum of technologies that our 2019 guidance on Section 101 greatly improved the analysis in this important area of patent law,” said Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. “The Chief Economist’s report now confirms this general perception, especially with its critical finding that uncertainty decreased by a remarkable 44%.” 

The report’s analysis by the USPTO’s Office of the Chief Economist found that one year after the USPTO issued its January 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), the likelihood of Alice-affected technologies receiving a first office action with a rejection for patent-ineligible subject matter had decreased by 25%. Likewise, uncertainty about determinations of patent subject matter eligibility in the first action stage of patent examination for the relevant technologies decreased by 44% over the first year following publication of the 2019 PEG compared to the previous year.

“The primary economic function of the patent system is to provide an incentive for greater innovation,” according to Dr. Andrew Toole, Chief Economist of the United States Patent and Trademark Office and principal author of the report. “Using an evidence-based approach, our report highlights the significant impact of the Supreme Court’s Alice decision on patent examination outcomes and the important stabilizing role played by the USPTO. This is what innovators and investors need to confidently promote entrepreneurship, create jobs, and advance science and technology.”

Director Iancu added, “I have long said that in order to ensure that the United States remains the global leader in the technologies of the future, our patent system must move beyond the recent years of confusion and unpredictability on subject matter eligibility. It is now clear that our recent guidelines mark a significant step in that direction, and I ask all involved in our treasured patent system to come together and solve, once and for all, this fundamental issue.”

Saturday, 18 April 2020

U.S. Army Receives Remdesivir at No Cost

Back in March, the U.S. Army signed a deal with Gilead Sciences to receive Remdesivir at no cost to treat Covid-19.  This is especially important given the recent study demonstrating Remdesivir as a potential effective treatment for Covid-19.  The Military Times discusses the deal as well as work on a vaccine which started in January, here.  

Friday, 17 April 2020

Relecura Offers Platform for Coronavirus Innovation and Patent Research for Free


Patent and innovation analytics firm, Relecura, is offering its platform for Coronavirus research for free for a period of time.  Here is a description of its platform:


Relecura Enterprise Platform

Derive smarter insights and power your decisions throughout the innovation life-cycle with Relecura’s Enterprise-wide customizable Platform

How do you manage complex data across various units and functions and use it to propel your business interests? Relecura Enterprise Platform helps you customize and automate workflows, combine data from a number of resources, quickly extract insights from it and collaborate across teams and functions to multiply the impact. Obtain powerful analytics and attain scale across the enterprise with a single platform. 

The offer is available, here. 

Monday, 30 March 2020

Novartis, the Good Samaritan

As discussed in a previous post, the Covid-19 pandemic is an excellent opportunity for the pharmaceutical industry to demonstrate its commitment to serving the world through philanthropy.  Novartis recently stated that it will “donate up to 130 million doses” of a generic drug which may be a good treatment for coronavirus.  The Press Release further outlines Novartis’ other efforts to combat Covid-19.  Notably, Gilead Sciences received a significant amount of criticism for its attempt to get a potential treatment for Covid-19 orphan status under U.S. law—which it has since withdrawn.  Professor Lisa Larrimore Ouellette has an excellent analysis of the situation, here.  The Novartis Press Release states, in part:


Basel, March 20, 2020 - Novartis announced today its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials.

When supported for use in COVID-19 infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. The company is also exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.

Novartis Sandoz division currently only holds a registration for hydroxychloroquine in the U.S., and will pursue appropriate regulatory authorizations from the U.S. FDA and the European Medicines Agency. Novartis will work with stakeholders including the World Health Organization to determine the best distribution of the medicine to ensure broad access to patients most in need of this medicine globally. The company aims to ensure that patients currently depending on this medicine are not impacted by the donation.

The commitment announced today builds on the previously announced commitments of a USD 20 million Novartis COVID-19 Response Fund, drug discovery collaboration efforts, support of clinical trials for existing Novartis medicines, and the Sandoz commitment to maintain stable prices on a basket of essential medicines that may help in the treatment of COVID-19.

Novartis intends to work closely with other manufacturers to scale up production of hydroxychloroquine as necessary to support global supply, and encourages industry, governments and international institutions to ensure adequate global supply of medications to treat COVID-19 patients.

Saturday, 28 March 2020

US FTC and DOJ, Antitrust Division Modify Antitrust Procedures in Light of Coronavirus


The Federal Trade Commission and the U.S. Department of Justice, Antitrust Division have modified procedures for antitrust review and provided direction for businesses addressing the coronavirus.  The Press Release from the FTC states, in part: 


The Federal Trade Commission and the U.S. Department of Justice Antitrust Division today issued joint statement detailing an expedited antitrust procedure and providing guidance for collaborations of businesses working to protect the health and safety of Americans during the COVID-19 pandemic.

The expedited procedure notes, for example, that health care facilities may need to work together in providing resources and services to assist patients, consumers, and communities affected by the pandemic and its aftermath. Other businesses may need to temporarily combine production, distribution, or service networks to facilitate production and distribution of COVID-19-related supplies.

Under the expedited procedure for COVID-19 public health projects, the agencies will respond to all COVID-19-related requests, and resolve those addressing public health and safety, within seven calendar days of receiving all information necessary to vet these proposals. The statement sets out the instructions for businesses wishing to take advantage of this procedure.

The expedited COVID-19 procedure offers quicker review than existing FTC and Justice Department programs that are designed to provide guidance to businesses concerned about the legality of proposed conduct under the antitrust laws. The FTC’s “Staff Advisory Opinion” procedure and DOJ’s “Business Review Letter” procedure allow any firm, individual, or group of firms or individuals to submit a proposal to the agencies and to receive a statement advising whether the agencies would challenge the proposed activity under the antitrust laws.

“Under these extraordinary circumstances, we understand that businesses collaborating on public health initiatives may need an expedited response from U.S. antitrust authorities,” said FTC Chairman Joe Simons. “We are committed to doing everything we can to help with these efforts, while continuing to aggressively enforce the antitrust laws.”

“The Antitrust Division recognizes the importance of providing clarity expeditious clarity on any antitrust obligations in this challenging time,” said Assistant Attorney General Makan Delrahim of the Department of Justice’s Antitrust Division. “Our expedited Business Review Letter procedure will help facilitate businesses that want to work quickly to address the urgent public health and economic needs associated with COVID 19.”

The antitrust laws accommodate procompetitive collaborations among competitors. In their joint statement, the FTC and the Department of Justice listed several types of collaborative activities designed to improve the health and safety response to the pandemic that would likely be consistent with the antitrust laws.

At the same time, the agencies also stressed that they will not hesitate to hold accountable those who try to use the pandemic to engage in antitrust violations. In addition, the Department of Justice will criminally prosecute conduct such as price-fixing, bid-rigging, or market allocation.

The expedited procedure requires that an applicant provide the FTC or Justice Department a written description of the proposal, including the parties that would be involved in the effort or activity, and the name and contact information of a person from whom the agencies could obtain additional information. This expedited procedure is for use solely for coronavirus-related public health efforts and may be invoked at the option of the requestor, in lieu of the agencies’ standard procedures for handling requests for advice.

The agencies also committed to expedite requests under the National Cooperative Research and Production Act for flexible treatment of certain standard development organizations and joint ventures. 

The statement also notes that the FTC and the Justice Department are addressing actions by individuals and businesses to take advantage of COVID-19 through other fraudulent and illegal schemes. Anyone with information or concerns about this sort of conduct, or other COVID-19-related complaints, should contact the FTC’s Consumer Response Center at 1-877-382-4357 or the National Center for Disaster Fraud Hotline (1-866-720-5721) or e-mail (disaster@leo.gov). More information on the FTC’s guidance on potential fraud, deceptive practices, and scams is available here, and to report a complaint go to www.ftc.gov/complaint.

Saturday, 21 March 2020

Is it Time to Increase Funding to Universities for Research and Development in the United States?


In a document released by the Association of American Universities (AAU), Mary Sue Coleman, president of the organization, discusses Vannevar Bush’s report, “Science, the Endless Frontier” in a short essay titled, "Celebrating the Government-University Partnership's 75th Anniversary."  Notably, in light of the report, she explains how issues with respect to climate change and Covid-19 only highlight why government should continue to invest in university research.  Unfortunately, the Trump Administration continues to push for less funding for research and development at universities in terms of real dollars.  One of the Democratic presidential candidates who consistently appeared to support university research and development was Tom Steyer.  If former Vice President Biden is elected, hopefully he will consider Tom Steyer for a position in Biden's administration.  If President Trump is reelected, I hope he reconsiders his position regarding funding university research and development.  The AAU document provides, in part: 


. . . 

Famously titled “Science, the Endless Frontier,” the influential report had been requested the previous year by then-President Franklin D. Roosevelt, whom Bush served as chief scientific adviser. As World War II increasingly appeared winnable – in no small part due to the scientific research enterprise that Bush’s office led – Roosevelt was looking to the future. He asked the MIT-trained Bush to file a report addressing four questions:

1. “What can be done, consistent with military security, and with the prior approval of the military authorities, to make known to the world as soon as possible the contributions which have been made during our war effort to scientific knowledge?”

2. “With particular reference to the war of science against disease, what can be done now to organize a program for continuing in the future the work which has been done in medicine and related sciences?”

3. “What can the Government do now and in the future to aid research activities by public and private organizations?”

4. “Can an effective program be proposed for discovering and developing scientific talent in American youth so that the continuing future of scientific research in this country may be assured on a level comparable to what has been done during the war?”

Bush took this brief set of questions and delivered an expansive report with recommendations that have informed U.S. science policy ever since. Calling basic scientific research “the pacemaker of technological progress,” Bush recommended a significant and ongoing partnership between the federal government and universities to conduct research to benefit the nation.

Bush’s report noted that government support for basic research could continue to bolster not only the nation’s security, but also its economic prosperity. “New products and new processes do not appear full-grown,” he wrote. “They are founded on new principles and new conceptions, which in turn are painstakingly developed by research in the purest realms of science!”

Bush’s recommendations led to the creation of the National Science Foundation, the National Institutes of Health and other federal agencies. These agencies conducted and funded the research that sent humans to the Moon, gave us the Internet and smartphones, ended polio and a host of other diseases, and made HIV infection manageable -- more akin to diabetes than a death sentence.

I recently participated in a National Academies of Sciences-sponsored symposium exploring the legacy of this important report and forecasting the future of the government-university partnership. As Vannevar Bush realized 75 years ago, wartime is not the only time for the government to invest in the science that makes us safer and more prosperous. Leading scientists, government officials, and academic researchers at the symposium agreed that – as emerging threats like the COVID-19 virus and the climate crisis make clear – the United States should double down on investments in the government-university research partnership. In fact, in a 2018 article I wrote for Change: The Magazine of Higher Learning, I describe in detail how we must continue pressing toward that “Endless Frontier.” Our prosperous and healthy future absolutely depends on vigorously pursuing this journey.