Bill to Map the United States Pharmaceutical Supply Chain

A fair amount of concern has been raised concerning the security of supply chains, including the pharmaceutical supply chain.  U.S. Senator Gary Peters (Michigan) has introduced legislation to make a step in the direction of protecting the pharmaceutical supply chain.  The Press Release states:

U.S. Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, introduced bipartisan legislation that would help the federal government better prepare for future public health threats by creating a database to map vulnerabilities in the pharmaceutical supply chain. The database would include the country of origin, quantity and other key information about critical drug products to identify supply chain weaknesses that could lead to shortages or other challenges in a future public health emergency.

The legislation builds on recommendations from two reports released by Peters in 2019 and 2023 that identified national security concerns related to our nation’s overdependence on foreign sources for critical drug products and insufficient visibility into U.S. pharmaceutical supply chains. Peters’ 2023 report found that both industry and the federal government lack visibility into the entire pharmaceutical supply chain – from the key ingredients needed to make drugs to the distribution of those products, presenting both health and national security risks. The COVID-19 pandemic exacerbated many of these longstanding challenges, and a 2022 Peters report examining the federal pandemic response found that federal agencies struggled to obtain needed supply chain data in critical early months that could have informed federal actions to mitigate shortages.  

“As we saw firsthand during the COVID-19 pandemic, federal agencies did not have enough visibility into our reliance on foreign manufacturers and other chokepoints in the supply chain, limiting their ability to anticipate and respond to drug shortages and related challenges,” said Senator Peters. “This bipartisan legislation will provide the federal government with a more comprehensive understanding of the weaknesses in our pharmaceutical supply chains so we can take steps to address them and prevent future shortages.”

The Mapping America’s Pharmaceutical Supply (MAPS) Act would require the Secretary of the Department of Health and Human Services (HHS) to establish a federal database to map the origin of each drug, the location of the facilities used to manufacture them, and associated inspections and risks, such as recalls and import alerts. HHS will use this information to make data-driven decisions on supply chain threats and how to increase resiliency through strategic investments in domestic manufacturing. The bill also requires HHS to report to Congress on how they are using the database to predict and prevent vulnerabilities for critical drug supply chains and what gaps in data remain.

This legislation follows Peters’ efforts to mitigate national security risks within the pharmaceutical industry. This Congress, he introduced a bipartisan bill to address the U.S. dependency on foreign drug manufactures. Earlier this year, as Chairman of HSAGC, Peters released a report and convened a hearing on the national security risks presented by continued drug shortages.

Bipartisan Letter from U.S. Senators on Drug Patent Thickets

In June, U.S. Senators Leahy (Democrat) and Cornyn (Republican) (and others) sent a letter to the United States Patent and Trademark Office requesting that the USPTO review practices concerning granting “an excessive” amount of patents on pharmaceuticals, such as biologics, that may be driving up drug pricing costs. 

The press release concerning the letter states:

Senators Patrick Leahy (D-VT) and John Cornyn (R-TX) led a bipartisan letter Wednesday asking the U.S. Patent and Trademark Office to address an issue that is a significant cause of soaring drug prices.  Senators Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Mike Braun (R-IN) also joined the letter.

The senators explained that drug companies and other large companies sometimes artificially extend the period in which they can charge high prices by filing many patents on nearly the same invention, creating a so-called patent thicket of dozens of patents on a single drug.  Those thickets make any challenge to the patents, or to the drug companies’ pricing of the covered drug, nearly impossible.  Because of the exorbitant cost of taking on each of the patents in these patent thickets, generic manufacturers are impeded from entering the market, hurting competition and raising prices for American consumers.  The secondary patents, which are similar to the originals, often receive less scrutiny from the Patent Office but have an outsized effect on everyday Americans who struggle to afford expensive medication.

Leahy believes the Patent Office has the ability to address this abusive practice, and he is asking the agency to take action to rein in this misuse of the patent system.  The letter requests that the Patent Office look into specific ideas for curbing the abuse and “take regulatory steps to improve patent quality and eliminate large collections of patents on a single invention.”  The Patent Act clearly states an inventor may obtain a single patent for a single invention, not dozens.  The senators believe the Patent Office can and should stop these large companies from undermining the patent system, obstructing appropriate competition, stifling innovation, and hurting Americans, who end up paying for all of this at the pharmacy.

The letter contains several ideas for the USPTO and the public to consider concerning future potential rule-making:

1. Terminal disclaimers, allowed under 37 C.F.R. 1.321(d), allow applicants to receive patents that are obvious variations of each other as long as the expiration dates match. How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variations of each other, affect patent prosecution strategies and patent quality overall?

2. Currently, patents tied together with a terminal disclaimer after an obviousness-type double patent rejection must be separately challenged on validity grounds. However, if these patents are obvious variations of each other, should the filing of a terminal disclaimer be an admission of obviousness? And if so, would these patents, when their validity is challenged after issuance, stand and fall together?

3. Should the USPTO require a second look, by a team of patent quality specialists, before issuing a continuation patent on a first office action, with special emphasis on whether the claims satisfy the written description, enablement, and definiteness requirements of 35 U.S.C. § 112, and whether the claims do not cover the same invention as a related application?

4. Should there be heightened examination requirements for continuation patents, 2 to ensure that minor modifications do not receive second or subsequent patents?

5. The Patent Act requires the USPTO Director to set a “time during the pendency of the [original] application” in which continuation status may be filed. Currently there is no time limit relative to the original application. Can the USPTO implement a rule change that requires any continuation application to be filed within a set time frame of the ultimate parent application? What is the appropriate timeframe after the applicant files an application before the applicant should know what types of inventions the patent will actually cover? Would a benchmark (e.g., within six months of the first office action on the earliest application in a family) be preferable to a specific deadline (e.g., one year after the earliest application in a family)?

6. The USPTO has fee-setting authority and has set fees for filing, search, and examination of applications below the actual costs of carrying out these activities, while maintenance fees for issued patents are above the actual cost. If the up-front fees reflected the actual cost of obtaining a patent, would this increase patent quality by discouraging filing of patents unlikely to succeed? Similarly, if fees for continuation applications were increased above the initial filing fees, would examination be more thorough and would applicants be less likely to use continuations to cover, for example, inventions that are obvious variations of each other?

Senator Tillis' New Proposed Patent Eligible Subject Matter Legislation

Senator Thom Tillis has been busy.  He has proposed a new act to clarify patent eligibility doctrine in the United States.  This is definitely a relatively broad vision of patent eligibility.  Some work on the pricing side of pharmaceuticals/biologics would be helpful if this gets passed.  I am wondering if this may get tacked on to another piece of legislation—the timing is interesting.  The Press Release states:

U.S. Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022, legislation that will restore patent eligibility to important inventions across many fields, while also resolving legitimate concerns over the patenting of mere ideas, the mere discovery of what already exists in nature, and social and cultural content that everyone agrees is beyond the scope of the patent system. This bill affirms the basic principle that the patent system is central to promoting technology-based innovation. 

“I have long said that clear, strong, and predictable patent rights are imperative to enable investments in the broad array of innovative technologies that are critical to the economic and global competitiveness of the United States, and to its national security,” said Senator Tillis. “Unfortunately, our current Supreme Court’s patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations. This legislation, which is the product of almost four years of consensus driven stakeholder conversations from all interested parties, maintains the existing statutory categories of eligible subject matter, which have worked well for over two centuries, and addresses concerns regarding inappropriate eligibility constraints by enumerating a specific but extensive list of excluded subject matter. I look forward to continuing to work with all interested stakeholders on this important matter. Passing patent eligibility reform remains one of my top legislative priorities during my second term.”

Background:

Unfortunately, due to a series of Supreme Court decisions, patent eligibility law in the United States has become confused, constricted, and unclear in recent years. This has led to inconsistent case decisions, uncertainty in innovation and investment communities, and unpredictable business outcomes. This has resulted in a wide range of well-documented negative impacts.

As of 2021, all 12 judges of the United States Court of Appeals for the Federal Circuit have lamented the state of the law. Witnesses and stakeholders from a wide array of industries, fields, interest groups, and academia have testified and submitted comments confirming the uncertainty and detailing the detrimental effects of patent eligibility confusion in the United States. And there is now widespread bipartisan agreement in Congress and across all recent Administrations that reforms are necessary to restore the United States to a position of global strength and leadership in key areas of technology and innovation, such as medical diagnostics, biotechnology, personalized medicine, artificial intelligence, 5G, and blockchain.

The proposed legislation states, in part:

SEC. 2. PATENT ELIGIBILITY. (a) IN GENERAL.—Chapter 10 of title 35, United 8 States Code, is amended— (1) in section 100— (A) in subsection (b), by striking ‘‘includes a new use of a known process’’ and inserting ‘‘includes a use, application, or method of manufacture of a known or naturally-occurring process’’; and (B) by adding at the end the following: ‘‘(k) The term ‘useful’ means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.’’;

and (2) by amending section 101 to read as follows: ‘‘§ 101. Patent eligibility ‘‘(a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in sub section (b) and to the further conditions and requirements of this title.

‘‘(b) ELIGIBILITY EXCLUSIONS.— ‘‘(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such: ‘‘(A) A mathematical formula, apart from a useful invention or discovery. ‘‘(B) A process that— ‘‘(i) is a non-technological economic, financial, business, social, cultural, or artistic process; ‘‘(ii) is a mental process performed solely in the human mind; or ‘‘(iii) occurs in nature wholly independent of, and prior to, any human activity. ‘‘(C) An unmodified human gene, as that gene exists in the human body. ‘‘(D) An unmodified natural material, as that material exists in nature.  ‘‘(2) CONDITIONS.— ‘‘(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform. ‘‘(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified.  

‘‘(c) ELIGIBILITY.—  ‘‘(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—  ‘‘(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and ‘‘(B) without regard to— ‘‘(i) the manner in which the claimed invention was made; ‘‘(ii) whether a claim element is known, conventional, routine, or naturally occurring;  ‘‘(iii) the state of the applicable art, as of the date on which the claimed invention is invented; or ‘‘(iv) any other consideration in section 102, 103, or 112.  

‘‘(2) INFRINGEMENT ACTION.— ‘‘(A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact. ‘‘(B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.’’.

It is simplistic and short-sighted to undermine Covid-19 patent rights

President Biden’s administration is making a major mistake by its top trade advisor, Katherine Tai, advocating a waiver of patent rights for Covid-19 vaccines.

While all who are involved, or would like to be, should move heaven and earth to increase Covid-19 vaccine supply until everybody worldwide who wants to be vaccinated has been vaccinated, undermining patent rights will not help but only hinder achieving that objective.

Patents are not recipes and do not provide the knowledge and expertise needed for production

All evidence is that the limiting factor is in vaccine supply—not in patent-licensing costs. The pressing need is to remove constraints—such as export bans that block ingredient supply chains— and to increase manufacturing capacity. Production supervision and training from those with the expert knowledge in operating such facilities who can ensure high-quality output reliably and on a massive scale are also required.

Instead of stripping Covid-19 patent owners of their core assets and rights, incentives to license patents and owners’ wider range of intellectual property—also including vital trade secrets such as how to make the vaccines with manufacturing process know-how—should be retained.

Vaccine demand remains immense. Many highly populated nations still have very low vaccination rates in the single digit percentages, for example, in India where the pandemic is currently raging with hospital facilities being overwhelmed. Satisfying demand will benefit us all when most of the world’s entire population is vaccinated because none of us will be safe from the virus and the threat of new variants until then. This is also a major incentive to vaccine patent owners—for example, BioNTech whose business model is in technology transfer, licensing and collaboration with downstream partners—to scale up that further. Fair reward for such efforts will enable licensors to justify up-front commitments and investments required in providing that support.

Patents encourage R&D investment and licensing-based horizontal business models

While the debate about whether patents stimulate or impede R&D investment and innovation continues among those with strong vested interests on either side, research including empirical data over many decades indicates that strong patent rights are particularly important to small, non-vertically integrated firms like BioNTech. A recently recorded LeadershIP seminar publicly available online illustrates this by featuring academic Jonathan Barnett’s new book on the subject entitled Innovators, Firms and Markets: The Organizational Logic of Intellectual Property. The session also includes remarks from others including entrepreneur and venture capitalist Greg Raleigh on the importance of patents to small companies such as BioNTech in biotechnology being able to raise investment capital to fund R&D.

The first-to-market and highly efficacious BioNTech/Pfizer vaccine is a stellar example of how the patent system works. In absence of strong patent protection companies like BioNTech would not exist. Not only did patents incentivise venture capitalists to make large and risky investments ahead of BioNTech’s technology commercialisation prospects, patents also enabled the firm to partner Pfizer, with its wide gamut of complementary resources required to collaboratively complete R&D and bring the vaccine through clinical trials to production and distribution. The partnership’s rapid delivery of Covid-19 vaccine is a huge technical, commercial and humanitarian success story.

Vaccine costs including patent fees are small versus economic costs of pandemics

The Covid-19 epidemic has cost several trillion dollars in the $88 trillion global economy—given a projected economic decline of 5.2 percent in 2020 versus growth of 2.3 percent in 2019. Patent licensing fees pale in comparison to this given that the entire cost of doses has averaged approximately $20 each. In comparison, I recently spent more than $100 on a Covid-19 PCR test and anticipate having to do that several more times in coming months. With competition among many different clinically approved vaccine technologies and suppliers including the highly effective, safe and easy to distribute Oxford/AstraZeneca vaccine priced at around $5 per dose already, existing free market commercial pressures on licensing charges—including patent royalties and for transfers of other intellectual property—are substantial.  With around 1.3 billion total doses of Covid-19 vaccines administered worldwide so far, at that price, vaccinating the rest of the world’s entire 7.8 million population with two doses would cost around $70 billion.

Other people’s money and redistribution of wealth

While, as Tai said recently, "This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures", this is not the first and it will not be the last global health crisis. President Biden plans to spend $3 trillion in government borrowings and tax receipts with various programmes including construction in response to the economic harm from the pandemic. An opportunistic raid on patent owners would also redistribute wealth to intermediaries such as manufacturers, but the world needs ongoing technical developments from large and small, young and old companies in the biotechnology and pharmaceutical industry to deal with new variants of Covid-19 and other new pathogens that will surely emerge. There is abundant economic justification not to undermine the valuable long-term gains the patenting and licensing system is providing. As well as rewarding existing patent holders, availability of such potential returns in “a global health crisis” will reassure and attract others to invest in additional R&D. While this pandemic is terrible with around 3.3 million deaths worldwide already, the next one could be even worse given that the 1918 Spanish flu epidemic killed 50 million people. We need to be as well prepared as we possibly can for whatever might ensue.

Trump to Push Pharma on Drug Pricing

President Trump is continuing his push to fulfill campaign promises.  Apparently, he is meeting with pharmaceutical companies this week to negotiate lower drug prices.  This seems to be in response to his supposed Executive Order to link the drug prices that Medicare is charged to prices paid by foreign nations.  This was not an exciting development to pharmaceutical companies and they canceled a scheduled meeting with the President to discuss it.  It will be interesting to see if pharmaceutical companies will be willing to "play ball" with President Trump given the election.  For sure, part of the calculation is whether Presidential Candidate Joe Biden's administration would be better for pharmaceutical companies.  My guess is no.  However, I think the Obama Administration did not do as much as it could have on drug pricing directly--except that President Obama signed the Leahy-Smith America Invents Act into law which included rules concerning Inter-Partes Review Proceedings.  Also, pharmaceutical companies may be worried about additional Democratic appointees to the U.S. Court of Appeals for the Federal Circuit, where the battle over the scope of patent eligible subject matter is being waged (See American Axle en banc denial), and appointees to the U.S. Supreme Court.  FTC and DOJ antitrust enforcement is another issue as well as trade agreements.  Bayh-Dole Act march in rights could be an issue.  Moreover, under President Trump, pharmaceutical companies may be seeing some light at the USPTO concerning patent eligible subject matter.  Let's see if pharmaceutical companies are going to give President Trump a big win with Seniors (aka people who reliably vote). A compromise setting Medicare pricing near the most developed European countries would be interesting and an improvement.  

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.

 To learn more about more BIO’s work to fight antimicrobial resistance, visit WorkingToFightAMR.org.

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.

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. 

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. 

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.

Legislation Introduced to Raise Manufacturing of Active Pharmaceutical Ingredients in the United States

On March 11, 2020, Senators Blackburn and Menendez introduced a bill, Securing America’s Medicine Cabinet, designed to raise the manufacturing of active pharmaceutical ingredients in the United States to stem reliance on China.  The Press Release notes that part of the reason for doing this is concerns with the safety and quality of active pharmaceutical ingredients from China.  The Press Release states: 

Blackburn, Menendez Lead Bipartisan Bill to Increase US Prescription Drug Manufacturing 

WASHINGTON, D.C. – Senators Marsha Blackburn (R-Tenn.) and Bob Menendez (D-N.J.) have introduced the Securing America’s Medicine Cabinet (SAM-C) Act to increase American manufacturing of active pharmaceutical ingredients (APIs), the building blocks of prescription drugs. Currently, only 28% of API-producing facilities are in the United States and the number of Chinese facilities has more than doubled since 2010. “When confronted with a serious challenge such as the corona virus, it is important to take stock, look at lessons learned and build upon them in order to respond better the next time,” said Senator Blackburn. “Currently, we are too reliant on foreign manufacturing of critical APIs. The SAM-C Act is one step on the right path to strengthen our drug supply chain.” “The COVID-19 is a real health emergency and we have to do everything in our power to increase our preparedness and response,” said Senator Menendez. “This bipartisan proposal will do that by encouraging drug manufacturers to partner with our best minds in higher education on new advancements, creating good jobs and increasing the national production of vaccines and drugs that can save lives. With New Jersey’s concentration of pharmaceutical companies and institutes of learning, we can lead the way and make a difference.” The corona virus outbreak has heightened concerns about dependence upon China and India for prescription medications. On February 27, 2020, the FDA announced the shortage of one drug used to treat patients with coronavirus. They attributed the shortage to difficulties obtaining the API from a site in China affected by coronavirus. Additionally, in its 2019 report to Congress, the U.S.-China Economic and Security Review Commission revealed “serious deficiencies in health and safety standards in China’s pharmaceutical sector.” Dependence upon China and others for prescription drugs combined with safety concerns needs to be addressed. This urgent health event provides an impetus to improve our pharmaceutical supply chain. The SAM-C Act will encourage pharmaceutical drug manufacturers to spur innovations similar to those in other industries such as automotive, aerospace and semiconductors and bring drug manufacturing back to the United States, where ingredients and processes can be more easily verified.  The legislation would expand upon the Emerging Technology Program within the Food and Drug Administration to prioritize issues related to national security and critical drug shortages, as well as bring pharmaceutical manufacturing jobs to the United States. In addition, the SAM-C Act authorizes $100 million to develop centers of excellence in advanced pharmaceutical manufacturing in order to develop these innovations as well as train the workforce needed in this industry. These centers will be partnerships between institutes of learning and the private sector.  RELATED Last month, Senator Blackburn wrote about how the coronavirus outbreak exposes the U.S.’s pharma supply chain vulnerability: “Without intervention, the FDA expects the pharmaceutical industry will continue to rely on Chinese companies to make active pharmaceutical ingredients… The status quo has made us vulnerable. The fix, however, is sitting right in front of us.”

State of California and Others to Manufacture Generic Drugs

In a bid to lower drug prices in California, Governor Gavin Newsom has proposed that the state of California create its own generic drug label and enter into partnerships to have generic drugs manufactured on behalf of the state.  The details are located in the new proposed budget: http://www.ebudget.ca.gov/2020-21/pdf/BudgetSummary/HealthandHumanServices.pdf.
  

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

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

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

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

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

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

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

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

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

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

More information is available, here. 

Heavily Taxing Billionaires to Promote Innovation

An important issue confronting the world concerns the high concentration of wealth and redistribution of that wealth through the tax system. Part of the problem is what to do with the wealth gained from additional taxation of billionaires (and what is a politically defensible use of that additional revenue). Democratic presidential candidates are starting to create a "dream list" of things to do with billionaires' money.  Well, why not use that money to invest in research and development which may lead to more jobs, innovation (even life saving innovation), and additional tax revenue.  

Professor Michael Simkovic from University of Southern California Gould School of Law takes on general claims that taxing billionaires may lead to less innovation in a short five page article titled, “Taxes, Spending and Innovation.”  Professor Simkovic points to studies concerning patents and Nobel Prize winners.  Professor Simkovic states:

Public policy can be used to promote innovation by raising taxes and extensively funding high quality science, math, and engineering education, or by encouraging immigration of people with those skills.

There has been a general decline in the amount of federal funding in terms of real dollars for some time for the National Institutes of Health.  Well, billionaires give to universities and other charities, right?  We don't need to heavily tax them as they choose to give their wealth to charitable organizations that innovate.  Professor Simkovic notes that voluntary gifts to charity, including to universities, is relatively small at “2% of GDP”—for gifts from all donors.  He concludes we should look to peer-reviewed empirical work to test claims and that, “Claims that we can drive more innovation and growth through a higher concentration of resources in the hands of a small number of billionaires—while providing fewer resources to middle and upper middle--‐class knowledge workers—are not empirically supported.”  [Hat Tip to Professor Paul Caron’s Tax Prof Blog]. 

U.S. State Wants to Adopt "Netflix" Model for Paying for Pharmaceuticals

The state of Louisiana is attempting to adopt the Netflix model of paying for pharmaceuticals as a way to tackle the high cost of pharmaceuticals and public health issues.  The Netflix model was proposed in a recent article.  Basically, the state pays a set price for an unlimited number of drugs for its citizens.  This has the benefit of providing certainty as to price as well as opens up access to the drugs to more people than previously treated.  The Washington Post discusses Louisiana and the Netflix model, here.  The abstract of the article titled, Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model”, authored by Mark R. Trusheim, MS; William M. Cassidy, MD; Peter B. Bach, MD is in the November issue of the Journal of the American Medical Association states:

Drug prices in the United States remain the highest in the world. New payment approaches are needed, a point illustrated by the new treatments for hepatitis C virus (HCV) infection that are highly effective but also very expensive, at least from the view of many payers, physicians, and patients. Five years after the introduction of these drugs, and due in many cases to budgetary constraints of state Medicaid programs and prisons, only 15% of the estimated population of more than 3 million individuals with HCV infection in the United States have been treated. Yet the optimal way to treat HCV is at the population level, that is, by treating every patient possible, with as much speed as is possible. Doing so would reduce the health consequences for those infected, generate the most future savings from improved health, and help decrease future transmission of HCV from person to person.

Bloomberg Tracking Pharmaceutical Prices

One way the Trump Administration appears to attempt to control drug prices is through use of the “bully pulpit.”  Wikipedia states that the “bully pulpit”: “is a conspicuous position that provides an opportunity to speak out and be listened to. This term was coined by United States President Theodore Roosevelt, who referred to his office as a "bully pulpit", by which he meant a terrific platform from which to advocate an agenda.”  

President Trump has used strong language to apparently shame pharmaceutical companies from raising drug prices.  Indeed, two pharmaceutical companies announced they would not raise prices for their drugs.  Those two examples make great headlines for President Trump, but are drug prices as a whole getting lower in the United States.  Bloomberg seeks to answer that question and is tracking the pricing of "widely used" and "well known" drugs across several different disease categories and updating that information as time passes.  Notably, prices (excluding Pfizer's drugs, who announced it would not raise prices) appear to be moving up.  Interestingly, the price increases are mostly hovering around 9% to 10%.  Also, the prices tracked by Bloomberg do not include the rebates that are provided by pharmaceutical companies, but are the list prices.  

The Trump Administration is moving on other fronts to try to control drug prices, but many experts state that some of those attempts will not impact the cost of drugs in the United States by much.  It will be interesting to see if actions taken by the Food and Drug Administration discussed here will make a significant difference.  

New Trump Administration U.S. FDA Working Group on Importation of Pharmaceuticals

The U.S. Secretary of the Department of Health and Human Services, Alex Azar, has recently directed the Food and Drug Administration (FDA) Commissioner Scott Gottlieb to establish a working group to explore importing “safe” pharmaceuticals from other countries in the case of a dramatic price hike by a pharmaceutical company.  The Press Release is careful to note that this would not include pharmaceuticals covered by “patents or other exclusivities.”  However, there is the recent U.S. Supreme Court case in Impression Products v. Lexmark International concerning an international exhaustion rule for U.S. patents.  The Press Release states:

As part of the Trump administration’s efforts to lower drug prices and put American patients first, Health and Human Services Secretary Alex Azar requested today that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.

“We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients,” said Secretary Azar. “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent.

“Safe, select avenues for importation could be one of the answers to these challenges. When HHS released the President’s Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.

“Importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue, and appreciate the voluminous work FDA has done to increase competition in America’s drug markets.”

Disincentivizing the Use of IPRs and PGRs Against Pharmaceutical and Biologic Patents

Senator Orrin Hatch has introduced legislation designed to curb the use of IPRs and PGRs against pharmaceutical and biologic patents by essentially denying the benefits to generic/biosimilar companies of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.  Allowing the usage of IPRs against pharmaceutical and biologic patents was a serious oversight in enacting the America Invents Act.  Senator Hatch’s Office has released the following information concerning the new Hatch-Waxman Integrity Act of 2018 (which includes a section by section analysis):

In 2012, Congress enacted the America Invents Act to fix a problem unrelated to drug/biologic innovation and drug/biologic affordability; it created the inter partes review (“IPR”) and post-grant review (“PGR”) processes to combat the growing problem of patent trolls.

Even though Congress did not intend to upset its drug/biologic-specific Hatch-Waxman and BPCIA procedures with the enactment of the IPR and PGR processes, generic drug and biosimilars manufacturers have increasingly used the IPR process to circumvent the Hatch-Waxman Act and BPCIA patent challenge processes while nonetheless taking advantage of their abbreviated processes for drug entry.1  Moreover, hedge funds with no interest in manufacturing or marketing drugs have filed IPR challenges against drug patents with the goal of profiting from stock market declines triggered by the IPR filings—a type of market manipulation.

The Hatch-Waxman Integrity Act of 2018 would close the loophole unintentionally created by the America Invents Act. To restore the careful balance of the Hatch-Waxman Act and the BPCIA, and to prevent the IPR or PGR processes from undercutting them, the FD&C Act and the PHS Act would be amended to prevent using IPR (or PGR) challenges to circumvent the specific patent challenge processes for drugs and biologics painstakingly created by Congress. In addition, the federal securities rules would be clarified to indicate that filing IPR patent challenges and profiting from resulting stock price changes is a form of prohibited market manipulation.

The Press Release is available, here.  The text of the proposed legislation is available, here.  [Hat Tip to Professor Dennis Crouch’s Patently Obvious Blog]

The Importance of an Accurate Assessment of Patent Valuation and Potential Market

A recent article in the Saint Louis Post Dispatch by Christopher Yasiejeko describes a patent-related dispute between two academic institutions.  Two major research universities, University of Wisconsin (through its technology licensing arm, Wisconsin Alumni Research Foundation (WARF)) and University of Washington, Saint Louis (WUSTL) are engaged in litigation concerning royalty payments over a jointly invented patented invention that was licensed to Abbott Laboratories.  The inventors included a researcher from Wisconsin and one from WUSTL. 

One of the issues with university developed technology is who will cover the patent prosecution costs.  Here, WARF apparently agreed to cover the costs for a higher royalty rate.  The dispute concerns apparent representations made by WARF concerning the value of the patent—allegedly representations were made that the value was not very high by WARF.  WUSTL appears to assert that WARF made representations to others that the patent was actually quite valuable and eventually important to the pharmaceutical, Zemplar, which according to the article “generated $409 million in sales in 2011.”  This appears to be a case where fraud in the inducement in entering the contract is relevant.  However, it seems strange that WUSTL was unable to arrive at their own valuation or understand the potential market for the invention—perhaps they did not have the resources at the time invested in technology transfer.  WARF was likely well financed at that time and certainly experienced.

[Hat Tip to Technology Transfer Central]

Professor Margaret Kyle on Whether Pharmaceutical Innovations are Rewarded

Our friends at Oxfirst are hosting another interesting webinar on March 14, 2018 at 15.00 BST and 16.00 CET.  The webinar is titled, “Are Important Innovations Rewarded?  Evidence from Pharmaceutical Markets.”  The presenter is Professor Margaret Kyle. 

Here is a description of the presentation:

This research focuses on the relationship between therapeutic value and different measures of market rewards (the number of patents, price, market share, and total revenues) of a new treatment. Using an assessment of therapeutic value provided by the French Haute Authorité de Santé (HAS), I find a weak relationship between most measures of rewards and this assessment of therapeutic value, suggesting that the returns to developing a “me-too” product are not very different from developing treatments with greater therapeutic effects. One interpretation is that the HAS score is a poor assessment of therapeutic value, in which case the use of similar health technology assessments by governments and other payers should be re-examined. Alternatively, if the HAS score is informative, the results suggest countries are spending too much on less innovative products, and that a re-balancing of innovation incentives may be worth considering if therapeutic value is highly related to social welfare.

Here is Professor Kyle’s biography:

Prof. Margaret Kyle (MINES ParisTech and CEPR) currently holds the Chair in Intellectual Property and Markets for Technology at MINES ParisTech. Her research concerns innovation, productivity and competition. She has a number of papers examining R&D productivity in the pharmaceutical industry, specifically the role of geographic and academic spillovers; the firm-specific and policy determinants of the diffusion of new products; generic competition; and the use of markets for technology. Recent work examines the effect of trade and IP policies on the level, location and direction of R&D investment and competition. She also works on issues of innovation and access to therapies in developing countries. Her papers have been published in various journals of economics, strategy, and health policy, including the RAND Journal of Economics, Journal of Public Economics, Review of Economics and Statistics, Journal of Public Economics, Journal of Law and Economics, Antitrust Law Journal, Management Science, and Health Affairs. Margaret holds a PhD in economics from the Massachusetts Institute of Technology and is an associate editor of the International Journal of Industrial Organization. She previously held positions at Carnegie Mellon University, Duke University, London Business School, and the Toulouse School of Economics, and is a visiting professor at the Kellogg School of Management, Northwestern University. She has also been a visiting scholar at the Center for the Study of Innovation and Productivity at the Federal Reserve Bank of San Francisco and at the University of Hong Kong.

Registration is available, here.  Space is limited and you must register with a professional email address.