Saturday, 1 August 2020

Will Trump Win the Presidential Election in November?

A common general inquiry I get from friends who are not Americans is “what is going on in the United States with respect to Trump—will he be reelected?”.  My answer is, “I don’t know.”  This may surprise some because they see Biden as the obvious winner.  Here are my imperfect and half-baked thoughts on the subject: 

1)      My guess is that we’ll get good news about a vaccine before the election.  It may even be distributed before the election to some in the United States.  My guess is that Trump’s biggest concern with mail in voting is that it’ll occur before the “best” news possible about a vaccine to COVID-19. 

2)     What about Trump’s handling of COVID-19?  This seems to look bad, but see above on point 1.  Also, Trump put the lock-down decisions in the hands of state and local government.  Could Trump have done more earlier?  Yes, I think he could of done more.  The Chinese apparently knew that masks were effective in slowing the spread.  Why didn’t we move faster on that?  But, see state and local government.  And, please don’t forget that many are suffering badly economically because of lock-downs. 

3)     What about Trump’s handling of race-related issues, including the George Floyd horror and BLM?  I think Trump’s botched this badly.  However, please remember that before the last election we had serious BLM protests.  I am concerned that Trump voters have become even more concerned about so-called “law and order issues.”  This means that turn-out amongst the concerned may be strong.  Hopefully, turn-out amongst BLM supporters will be strong.  Please remember one of President Obama’s relatively quick responses to the protests: Be sure to get out and vote in local elections. 

4)     What about the polls?  I haven’t looked closely at this, but my understanding is that the polls are not that far off from where Hilary Clinton was in the last election in battleground states—she had quite a nice lead.  I think Biden has a better lead now.  We’ll see if it holds up.  Also, please don’t forget one of the supposed reasons the last election defied the polls—people didn’t want to admit they were voting for Trump.  That effect may be even stronger now. 

5)     What about the debates?  I am quite worried about this.  I think Trump is going to blast Biden on any supposed mistakes concerning the Obama/Biden administration.  This time Biden is fully on the hook as VP: 1) Opioid Crisis; 2) Crappy Economy in Some Battleground States (goodness, AOC actually is attacking Opportunity Zones); 3) Bad Trade Deals; 4) Skyrocketing Health Care Costs; and 4) the China Relationship.  Finally, Trump doesn’t have to worry about how he looks debating a woman.  He is going to fully unload on Biden.  Biden also does not always present well in debates.  He sometimes looks befuddled.  If Trump is sharp, he may come out as the winner.  Biden needs to hammer Trump on his immigration disasters.  

6)      More stimulus is on the way.  More money directly into the pockets of Americans.  If the Senate Republicans were thinking, they’d continue the $600 unemployment benefit and push up the stimulus.  People are suffering economically.  When was the last time the economy was very good--when Trump was president.  Also, Trump just issued executive orders on pharmaceutical pricing and access--he's fulfilling campaign promises (see debates). 

7)      The most important issue concerning American politics is likely turnout.  If your people don’t turnout, then you’ve got a serious problem.  Will the lack of big-time rallies hurt Trump?  Maybe.  However, I fear the continuing protests in Portland and elsewhere are going to push some Trump protesters to vote.  What about young people?  Are they going to be pissed about Tik Tok?  Well, they need to register to vote.  Guess who won’t be on campus where a lot of voter registration efforts happen?  Young people.  What about Biden’s VP choice?  That may help with turnout for him, but may help the other side as well.  And, don’t forget, the possibility of a Supreme Court vacancy(ies) soon should be a good motivator to turnout.  That’s going to seriously be on the minds of members of both parties—it really should for Dems especially given the age and health of Dem Supreme Court Justices.  

What’s the answer?  I don’t know, but this election cycle is fascinating and the result is going to be devastating to one side.  What impact on IP and Innovation?  Whoever wins the impact will be huge--from USPTO appointments and policy to FTC/DOJ appointments and policy to court appointments to trade. 

Tuesday, 14 July 2020

Act Now! Listerine Royalty Share Available for Purchase!


This is absolutely fantastic!  An opportunity from Royalty Exchange to purchase at auction a share of the royalties from the famous Listerine mouthwash contract.  The Listerine case is one that is still taught in IP classes in the United States as a BEWARE case.  You only have three hours left to bid and it's over $300,000!  Details are below.



Starting Price:
$180,000


Bidding Increment:
$1,500
End Date:
Jul 14, 2020, 3:00 PM MDT
Dollar Age:
139 Years
Last 12 Months' Royalties:
$32,040
Investment Term:
Perpetual (See Note Below)
Distributors:
Johnson & Johnson
Rights Included:
Sales Royalties (See Note Below)
Interests Included:
Royalty Holder (World)
First Distribution (paid 30 days from receipt):
July 15, 2020
Distribution Frequency:
Monthly
Buyer Fees:
1% of closing price or $500 (whichever is greater)‡§



Investors placing the opening bid on any listing pay no buyer fee if they win the resulting auction, a savings of 1% off the final price (minimum $500). All Access members who already receive this discount will be rewarded with a cash rebate equal to the buyer fee.

§ Become a Royalty Exchange All Access Investor to waive auction fees and enjoy additional exclusive benefits.

Description

Up for bid is a very unique asset with a nearly 140-year earning history, generating monthly payments for the lifetime of the brand.

It’s an opportunity to collect royalty income derived from what has been called one of the most remarkable business transactions in U.S. business history. As the winning bidder, you’ll own a royalty interest in the gross global sales of Listerine Antiseptic mouthwash. 

LISTING HIGHLIGHTS:

  • 139-Year Dollar Age
  • Monthly Payments
  • Perpetual investment term, as long as Listerine is sold

FINANCIAL HIGHLIGHTS:

Annual earnings for this asset have remained remarkably consistent over the past 5 calendar years — averaging just over $30,000/year from 2015 to 2019. What’s more, looking at the last three years of monthly payments, there is a very low variance year to year. 

U.S. generated royalties are paid monthly, based on the prior months’ sales. Royalties from sales in all other countries are paid on a quarterly basis. 

As a result, you’ll notice a spike in payments in the first month of every quarter (January, April, July, and October) due to those quarterly foreign royalty payments.

ABOUT THE ASSET:

The history of Listerine brand royalties is one of contract law legend. 

In 1881, Dr. JJ Lawrence invented Listerine and licensed the secret formula to J.W. Lambert and Lambert Pharmaceutical Co., ultimately settling on a royalty based on the number of ounces sold, to be paid to him and his “heirs, executors, or assigns” for as long as Listerine was sold.

For the next 75 years, the Lawrence family collected these royalties, with the ownership stake splintering between various heirs, some of whom sold portions of their stake to additional owners (such as New York real estate broker John J. Reynolds, who acquired half of the share of these royalties from the Lawrence heirs in 1950). 

After Lambert Pharmaceutical merged with Warner-Hudnut in 1955, the newly merged management contested the $1.5 million a year they were paying in royalties in court… a case they famously lost in a decision that remains cited in contract law cases and classes today. 

As a result of this decision, the Listerine royalty payments will remain in force for the lifetime of the brand, paid to whoever owns a share. Today, those entities include not only the heirs of the Lawrence family, but also various pension funds, universities, hospitals, and multiple individuals. 

This is your chance to be part of this exclusive group. 

Key Drivers

Consumer Staple. The royalty interest being sold is derived from an 1881 agreement between the inventor of the Listerine formula and the original distributor of the Listerine product. The royalty agreement calls for a flat rate royalty based on the ounces of Listerine sold worldwide, for as long as Listerine is sold. 

According to Statista, Listerine is the leading mouthwash/dental rinse brand in the U.S., with 2018 sales of $354 million. That’s nearly twice that of the second-place brand.

It's important to take into consideration that this income stream will only continue to pay out for as long as the Listerine Antiseptic mouthwash is sold. 

Dollar Age. This asset has a Dollar Age of 139 years, with payments made consistently since 1881. A high Dollar Age like this suggests stability and longevity.

What’s more, this asset has already survived a landmark court case contesting this royalty payment. In 1959, a federal court ruled that Listerine’s distributor— Warner-Lambert Pharmaceutical—must continue to abide by the original 1881 royalty agreement despite the fact that Listerine’s formula had previously been made public. 

So unlike music royalties, the copyright for which lasts the lifetime of the last surviving author plus 70 years, these royalties will pay in perpetuity for as long as Listerine is sold.

Monthly Payments. These sales royalties are calculated on the gross sales of Listerine Antiseptic and paid on a monthly basis (for U.S. sales) by Johnson & Johnson. This is something noteworthy to prospective investors, as you’ll continue to collect income from this asset each month.

WHAT IS BEING SOLD?

A royalty interest in gross sales of Listerine Antiseptic. The royalty interest is derived from an 1881 agreement between the inventor of the Listerine formula and the original distributor of the Listerine product. The royalty agreement calls for a flat rate royalty on each gross of Listerine sold worldwide, for as long as Listerine is sold. The agreement has been in effect since 1881, and in 1959 its perpetual nature was upheld in U.S. federal court.

About the Royalty Distributor

Johnson & Johnson is an American multinational corporation founded in 1886 that develops medical devices, pharmaceutical, and consumer packaged goods. The corporation includes some 250 subsidiary companies with operations in 60 countries and products sold in over 175 countries. Johnson & Johnson's brands include numerous household names of medications and first aid supplies, including the Listerine brand. 

Free U.S. Judicial Panel on Halo, Alice and FRAND


Winston and Strawn are cohosting a free webinar titled, “Judicial Panel: Grappling with the Uncertainties Created by Halo, Alice and Frand” on July 28, 2020 at 3:00 pm EDT.  The description and registration information follows: 


Please join Kathi Vidal, managing partner of Winston & Strawn’s Silicon Valley office, the Federal Circuit Bar Association, and the Berkeley Center for Law and Technology in cooperation with The Sedona Conference® for a panel discussion on the hard topics confronting the patent system today.

Sign up for this event here.

Federal Circuit Appellate Judge Kathleen M. O’Malley and Federal District Court Judges Alan D. Albright (TXWD) and Cathy Ann Bencivengo (CASD) will join The Sedona Conference Patent Litigation Working Group Chairs Matt Powers and Eric Hutz for an engaging discussion on the current state of play for willfulness, patent eligibility, FRAND, and ways to manage the uncertainty of each.

Topics of discussion may include: 

  • How should Halo be applied at the pleading stage, at summary judgment and at trial?  
  • Is 101 the best way to weed out weak patents early, efficiently, and accurately? 
  • Are U.S. courts ceding global FRAND determinations to courts of other countries?

A webinar is a complimentary interactive seminar offered by Winston & Strawn LLP over the Internet. You'll watch and listen to the presentation at your own computer.

Winston & Strawn LLP is an accredited CLE provider in California, Illinois, New York, and Texas.

Friday, 10 July 2020

New US $1 Billion Fund to Finance Development of Antibiotics


The Biotechnology Innovation Organization has issued a press release announcing the creation of essentially a US $1 billion fund to finance the development (particularly late stage) of antibiotics.  The press release states: 


Today more than 20 leading biopharmaceutical companies announced the creation of an estimated $1 billion fund to help support the pipeline for new antibiotic treatments. The AMR Action Fund was launched as the threat of antimicrobial resistance, or AMR, continues to grow and claim more lives. In response to today’s launch of the fund, BIO issued the following statements celebrating the news:

“Antimicrobial resistance is one of the largest and looming public health threats we face today,” said BIO President and CEO Dr. Michelle McMurry-Heath. “Even as the world’s scientists work tirelessly to fight COVID-19, we must not ease up on our battle against antimicrobial resistance. Just as we’ve seen our industry step up during the pandemic, I applaud these biopharmaceutical leaders and partners for committing to the development of new antibiotics. The AMR Action Fund will provide critical support for the development of new medicines, but it is up to policymakers to enact the long-term changes needed to support healthy, sustainable markets for the future development of new and effective antibiotics.”

“For years, we’ve watched antimicrobial-resistance infections rapidly rise around the world, while the market has slowly shrunk for new medicines to fight them,” said Greg Frank, Director of Infectious Disease Policy at BIO & Director of the Working to Fight AMR campaign. “Today’s new AMR Action Fund will have a tremendous impact on the development of new antimicrobials, but we still need government to implement new policies and incentives so companies can successfully develop, test, and launch new antimicrobial products.”

Biopharmaceutical companies and foundations supporting the fund are:

Almirall, Amgen, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, Lundbeck, Menarini, Merck, MSD, Novartis, Novo Nordisk, Novo Nordisk Foundation, Pfizer, Roche, Shionogi, Takeda, Teva, and UCB

For more details on the AMR Action Fund, visit www.AMRActionFund.com.

Thursday, 9 July 2020

Third QMIPRI Webinar on IP Responses to Covid-19: Co-ordinating Access

Third QMIPRI Webinar on IP Responses to Covid-19: Co-ordinating Access



Webinar Details 

Date: Tuesday 14 July 2020
Time: 12:00 - 13:15 BST

The panel will examine mechanisms for co-ordinating access via international IP agreements, how international investment protection might interfere with national access measures, why it is important to adequately manage the public interest in technology transfer agreements, and how 3D printing can help fight the pandemic.

Moderator:
Duncan Matthews, Professor of Intellectual Property Law and Director of the Queen Mary Intellectual Property Research Institute
Speakers:
Roya Ghafele, Director of OxFirst
Rochelle C. Dreyfuss, Pauline Newman Professor of Law, New York University School of Law and Arthur Goodhart Visiting Professorship in Legal Science (2019-20), University of Cambridge
Henning Grosse Ruse-Khan, Reader in International and European Intellectual Property Law and Co-Director of Centre for Intellectual Property and Information Law, University of Cambridge
Dinusha Mendis, Professor of Intellectual Property and Innovation Law and Co-Director of the Centre for Intellectual Property Policy and Management, Bournemouth University
Book Here for Free:

US FTC and DOJ, Antitrust Division, Release Vertical Merger Guidelines

The U.S. Federal Trade Commission and the Department of Justice, Antitrust Division, have released updated vertical merger guidelines.  The Press Release concerning the guidelines states, in relevant part: 


Vertical mergers combine two or more companies that operate at different levels in the same supply chain. A primary goal of the new Vertical Merger Guidelines is to help the agencies identify and challenge competitively harmful mergers while avoiding unnecessary interference with mergers that either are competitively beneficial or likely will have no competitive impact on the marketplace. To accomplish this, the guidelines detail the techniques and main types of evidence the agencies typically use to predict whether vertical mergers may substantially lessen competition. The Guidelines will help businesses, antitrust practitioners and other interested persons by increasing transparency into the agencies’ principal analytical techniques, practices, and enforcement policies for evaluating vertical transactions.

The new Vertical Merger Guidelines reflect the agencies’ analysis of vertical mergers. The revised guidelines:

  • Explain that mergers often present both horizontal and vertical elements, and the agencies may apply both the Horizontal Merger Guidelines and the Vertical Merger Guidelines in their evaluation of a transaction, as part of a fact-specific process that involves a variety of tools to determine whether a merger may substantially lessen competition.
  • Clarify that its analytical techniques, practices, and enforcement policies apply to a range of non-horizontal transactions, including strictly vertical mergers, “diagonal” mergers, and vertical issues that can arise in mergers of complement.
  • Clarify that when the agencies identify a potential competitive concern in a relevant market, they will also specify one or more related products. A related product is a product or service that is supplied or controlled by the merged firm and is positioned vertically or is complementary to the products and services in the relevant market.
  • Provide detailed discussions, including multiple diverse examples, of the “raising rivals’ costs” and “foreclosure” theories of harm. In recent decades, these theories of harm have been the principle theories investigated in merger reviews.
  • Identify conditions under which a vertical merger would not require an extensive investigation, because the merger does not create or enhance the merged firm’s incentive or ability to harm rivals.
  • Emphasize that analyzing efficiencies is an important part of reviewing vertical mergers.
  • Explain in detail the analysis of the elimination of double marginalization (“EDM”), which economists emphasize is a frequent procompetitive result of vertical transactions.

The guidelines address the usage of confidential information in vertical mergers: 


b. Access to Competitively Sensitive Information

In a vertical merger, the transaction may give the combined firm access to and control of sensitive business information about its upstream or downstream rivals that was unavailable to it before the merger. For example, a downstream rival to the merged firm may have been a premerger customer of the upstream firm. Post-merger, the downstream component of the merged firm could now have access to its rival’s sensitive business information. In some circumstances, the merged firm can use access to a rival’s competitively sensitive information to moderate its competitive response to its rival’s competitive actions. For example, it may preempt or react quickly to a rival’s procompetitive business actions. Under such conditions, rivals may see less competitive value in taking procompetitive actions. Relatedly, rivals may refrain from doing business with the merged firm rather than risk that the merged firm would use their competitively sensitive business information as described above. They may become less effective competitors if they must rely on less preferred trading partners, or if they pay higher prices because they have fewer competing options.

The guidelines are available, here

Tuesday, 7 July 2020

Nonimmigrant F-1 and M-1 Students Must Leave United States if Enrolled in Fully Online Course Program


The US Department of Homeland Security will release rules stating that nonimmigrant students must leave the country if enrolled in a fully online course program.  The Press Release below outlines the rules.  Notably, Harvard University and USC will be online or mostly online.  Several law schools have announced a move to online for the Fall of 2020, including UC Hastings and UC Berkeley.  It will be interesting to see if this rule announcement results in changes to a hybrid mode for some classes directed to foreign students at those universities. 


Temporary exemptions for the fall 2020 semester include:

  1. Nonimmigrant F-1 and M-1 students attending schools operating entirely online may not take a full online course load and remain in the United States. The U.S. Department of State will not issue visas to students enrolled in schools and/or programs that are fully online for the fall semester nor will U.S. Customs and Border Protection permit these students to enter the United States. Active students currently in the United States enrolled in such programs must depart the country or take other measures, such as transferring to a school with in-person instruction to remain in lawful status. If not, they may face immigration consequences including, but not limited to, the initiation of removal proceedings.
  2. Nonimmigrant F-1 students attending schools operating under normal in-person classes are bound by existing federal regulations. Eligible F students may take a maximum of one class or three credit hours online.
  3. Nonimmigrant F-1 students attending schools adopting a hybrid model—that is, a mixture of online and in person classes—will be allowed to take more than one class or three credit hours online. These schools must certify to SEVP, through the Form I-20, “Certificate of Eligibility for Nonimmigrant Student Status,” certifying that the program is not entirely online, that the student is not taking an entirely online course load this semester, and that the student is taking the minimum number of online classes required to make normal progress in their degree program. The above exemptions do not apply to F-1 students in English language training programs or M-1 students pursing vocational degrees, who are not permitted to enroll in any online courses.

Schools should update their information in the Student and Exchange Visitor Information System (SEVIS) within 10 days of the change if they begin the fall semester with in-person classes but are later required to switch to only online classes, or a nonimmigrant student changes their course selections, and as a result, ends up taking an entirely online course load. Nonimmigrant students within the United States are not permitted to take a full course of study through online classes. If students find themselves in this situation, they must leave the country or take alternative steps to maintain their nonimmigrant status such as a reduced course load or appropriate medical leave.

Due to COVID-19, SEVP instituted a temporary exemption regarding online courses for the spring and summer semesters. This policy permitted nonimmigrant students to take more online courses than normally permitted by federal regulation to maintain their nonimmigrant status during the COVID-19 emergency.

Monday, 6 July 2020

Where will the Great Brand Odwalla Land?


In a past post, I wrote about how great brands and products never die.  I provided two examples: the first, was Sesame Street; and the second, was Hostess products.  There’s another example of a great brand and product that is on the chopping block: Odwalla smoothies and juices.  Coca-Cola has announced that it is terminating the Odwalla brand.  According to CNN, this is a reaction, in part, to changing consumer demand and simplifying their supply chain.  Those smoothies do have a lot of sugar!  

Notably, Coca-Cola has over 500 brands.  Unlike Hostess, which was in bankruptcy, it will be interesting to see whether Coca-Cola will sell the brand.  If Coca-Cola truly wants to exit the smoothie business, then perhaps they won’t be concerned about a future competitor in that business line.  Coca-Cola does have other juice products.  However, even if demand for smoothies is falling off, I do wonder whether the demand will pick up again.  Interestingly, last year, Coca-Cola offered a zero calorie smoothie—perhaps they didn’t invest enough in marketing the new product.  For sure, it does take a while for trademark abandonment to kick in.  We’ll have to wait and see what happens.  Oh, and by the way, Odwalla was purchased for US $181 million almost two decades ago.  (And, if you are curious about my children's politics--now 15, 12 and 11--they think "cancel culture" is very troubling (everybody makes mistakes, redemption and what happened to free speech). They would vote for Biden if they could, but are relatively lost about what he stands for except that he's the alternative to President Trump--I think some debates will help.  They are concerned about Biden's comments about how if African Americans don't vote for him then they're not black and are somewhat mollified by his back-tracking.)

Saturday, 4 July 2020

More Trademark Bullies, Please -- At Least in the Charitable Space


Over the years I’ve come to the conclusion that trademark law and policy in the United States is likely the least appreciated area of intellectual property law, but also likely the most important.  Trademarks importantly allow the benefits of goodwill to be realized.  Consumer perception guides the development of U.S. trademark law for better or worse, as demonstrated by the U.S. Supreme Court’s recent Booking.com case.  This makes the boundaries of the legal protection provided by trademark law somewhat difficult to cabin-in and may facilitate over-reaching and over-enforcement with the danger of squelching free speech, competition and innovation.  


A benefit of intellectual property is its ability to allow owners to give it away.  The recent Open COVID Pledge is a good example of IP philanthropy.  So, how do trademarks aid in philanthropy?  One way trademarks facilitate philanthropy is by allowing people and entities to donate money to what they believe are worthy causes.  In the United States, we’ve had issues with people choosing trademarks similar to the trademarks of well-regarded charities and profiting from confusion from those marks.  I’ve written about that, here.  It seems that related problems have arisen from the Black Lives Matter movement—particularly given its non-hierarchical structure.  MarketWatch has a helpful article discussing the issues, here.  Charitable causes seem to be an area where greater trademark enforcement would be needed and welcome. 

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.