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Tag: Protection

  • Pros and Cons of the Patent Eligibility Restoration Act of 2023

    Pros and Cons of the Patent Eligibility Restoration Act of 2023

    Background Information

    Artificial intelligence (AI) is transforming the patent landscape, creating an influx of patent applications that mirrors a rise in modern-day innovation. However, the discussion of patentable inventions under U.S. law lags behind. The Patent Eligibility Restoration Act of 2023 (PERA) aims to address this by reversing court rulings that have narrowed the scope of patent eligibility in emerging fields like AI. Ultimately, PERA stands at the intersection of technology, law, and political ideology, shaping the role of government in maintaining intellectual property (IP).

    Supreme Court decisions in Mayo v. Prometheus and Alice v. CLS are widely recognized as turning points in patent law. The cases, which restricted patent eligibility for abstract ideas and natural laws, marked the first narrowing of patent eligibility since the 1950s. PERA would “eliminate all judicial exceptions” to patent law in an attempt to remedy the confusion caused by the Mayo and Alice rulings. The bill was introduced in the Senate by Senators Thom Tillis (R-NC) and Chris Coons (D-DE) in 2023. Its House companion was introduced by Representatives Scott Peters (D-CA) Kevin Kiley (R-CA) in 2024. While it received bipartisan support and a hearing in the Senate Intellectual Property Subcommittee, PERA ultimately died in committee at the end of the 118th Congress. 

    PERA presents three key advantages: 

    1. Economic and Innovation Benefits: Boosts innovation and economic growth.
    2. International Competitiveness:  Secures U.S. innovation against global competitors.
    3. Expansion of AI and other emerging technologies:  Clarifies AI patent eligibility to strengthen U.S. leadership on the global stage.

    In terms of economic and innovative benefits, the United States Patent and Trademark Office advocates for PERA as a catalyst for innovation. It specifically states that small to medium-sized firms “need clear intellectual property laws that incentivize innovation…[as it’s] critical for job creation, economic prosperity,” in addition to several extended impacts. Furthermore, the American Intellectual Property Law Association (AIPLA), argues that PERA enacts clearer policies that will generate efficient product development and innovation, improving both industry standards and marginal utility for the consumer. Wilson Sonsini, a nonpartisan outlet that conducts the legal analysis, finds that the bill would in fact reverse the stagnation of innovation. In a written testimony submitted to the Senate Subcommittee on Intellectual Property, law professor Adam Mossoff argued that PERA is essential for restoring American dominance in global innovation and patent sectors.

    PERA not only aims to improve U.S. innovation and investment, but also clarifies AI patentability to bolster America’s edge on the global stage. According to Republican Representative Kevin Kiley, the U.S. must expand patentability to compete with China, emphasizing PERA as a key to gaining a competitive edge through clearer patent laws. In an interview with Representative Kiley, the Center for Strategic and International Studies (CSIS) found that China’s approach to intellectual property poses a significant threat to American innovation and prosperity, strengthening the case for PERA. Senator Coons, a PERA co-sponsor, believes that the bill is necessary to help the U.S. catch up to Europe and China in the realm of AI patent law. 

    Other supporters argue that PERA’s expansion of patentability will open the door to advancement in domestic AI technology. A multinational law firm argues that expanding patent eligibility to AI models and business methods is crucial for the development of the U.S. technology industry. By broadening patentability, PERA can reduce the backlog of unsuccessful patents, sparing inventors from having to revalidate their claims. To reinforce this, the global law firm McDermott Will & Emery contends that PERA reduces ambiguity in patent eligibility by defining AI-related patents and human involvement in AI inventions.

    However, while PERA offers significant benefits for innovation, global competitiveness, and emerging technologies, it also raises concerns about potential drawbacks, including the risk of overly broad patents and unintended legal complexities. 

    PERA presents three key disadvantages:

    1. Overbroad Patentability: Risks limiting access to life-saving technologies.
    2. Hurting Small Inventors: Creates an ambiguous legal landscape that only large corporations can afford to navigate.
    3. Ethical and Global Concerns: Conflicts with global patent norms, risking international relations. 

    The NYU Journal of Intellectual Property and Entertainment Law highlights concerns that broadening patent eligibility could negatively impact the life sciences sector by creating barriers between consumers and newly-patented technologies. It argues that PERA undermines the balance between rewards gained from innovation and public accessibility to products they depend on. Another critique from the Center for Innovation Promotion finds that PERA disrupts established legal standards, creating uncertainty in the patent system. Its broad eligibility could stifle innovation by exacerbating patent disruptions instead of encouraging progress and innovation. 

    Other critics worry that PERA could negatively impact small businesses. U.S. Inventor, an inventor’s rights advocacy group, critiques the bill for creating a complex legal landscape that only large corporations can afford to navigate. It argues that PERA lacks definitions for most of its crucial terms will only create more confusion, stating, “Investment into anything that risks falling into PERA’s undefined ineligibility exclusions will be hobbled.”

    PERA also raises ethical concerns, particularly in its treatment of genetic material, which may conflict with international patent standards. According to the NYU Journal of Intellectual Property and Entertainment Law, these discrepancies could lead to tensions between U.S. patent law and global practices, disrupting international collaborations and agreements. The BIOSECURE Report emphasizes PERA’s potential for significant harm to global patent standardization, as countries may struggle to reconcile U.S. policies with their own systems. These challenges could strain international relations, as nations may view PERA’s approach as a threat to their sovereignty and global patent harmony.

    The Status Quo and Future of PERA

    PERA was proposed in a time of heightened awareness and discussion of IP policy. With regard to national security concerns, the Foreign Affairs House Report finds Chinese IP theft against U.S. companies, emphasizing China’s competitive threat in innovation. Similarly, Reuters reports on Tesla’s IP theft case, showcasing ongoing challenges in protecting American technology. These challenges in protecting American innovation set the stage for potential policy shifts under a Trump presidency. According to IP Watchdog, changes in IP law could influence public trust and perceptions of America’s stance on innovation and patent protection. However, as Wolf Greenfield Think Tank notes, broader geopolitical implications, especially regarding competition with China in biotech and AI patents, may not fully align with Trump’s campaign vision. Additionally, Senate Judiciary reports highlight how bipartisan concerns over innovation could shape the future prospects of bills like PERA, with legislative gridlock potentially influencing amendments throughout the current presidential term and beyond. This gridlock could ultimately lead to a slower passing of patent-related legislation.

    Conclusion

    While PERA aims to expand patent eligibility and boost economic growth, critics are wary of overbroad patents, harm to small inventors and businesses, and geopolitical conflicts. Striking a balance between innovation, equity, and competition remains essential to ensuring a patent system that fosters progress without preventing accessibility.

  • Maternal Mortality Review Committees and the PMDR Reauthorization of 2023: Key Perspectives

    Maternal Mortality Review Committees and the PMDR Reauthorization of 2023: Key Perspectives

    Introduction

    The United States faces a maternal mortality crisis, with maternal death rates significantly higher than other high-income nations. According to the CDC, maternal mortality disproportionately affects Black, Indigenous, and rural communities, with Black women experiencing maternal deaths at 2.6 times the rate of White women. The factors contributing to these disparities are complex and include unequal access to quality healthcare, socioeconomic barriers, and more. Despite advancements in healthcare, 80% of maternal deaths are preventable through timely medical intervention and comprehensive data collection. 

    What are MMRCs?

    State-based Maternal Mortality Review Committees (MMRCs) have been shown to play a pivotal role in analyzing maternal deaths to recommend evidence-based interventions. MMRCs are multidisciplinary teams that examine maternal deaths occurring during pregnancy or within one year postpartum. They utilize comprehensive data sources, including medical records, autopsy reports, and social service information. MMRCs assess preventability and contributing factors, allowing them to identify patterns and propose targeted policy solutions. Their review process centers on critical questions related to medical factors, social determinants, delays in care, and provider bias. By systematically addressing these factors, MMRCs generate insights that inform strategies to reduce preventable maternal deaths, which comprise 20% to 50% of all maternal deaths in the U.S.

    However, MMRCs face inconsistent funding and regulatory barriers, limiting their ability to track and analyze maternal deaths across states. Disparities in data collection methods and access to comprehensive patient records further hinder efforts to address maternal health inequities. Some states lack the authority to access certain medical records, while others experience delays in data sharing, reducing the timeliness and effectiveness of recommendations. Without consistent federal funding, many MMRCs struggle to maintain operations, particularly in rural and underserved areas, where maternal health disparities are often most pronounced. 

    Introduction to the Preventing Maternal Deaths Reauthorization Act

    The Preventing Maternal Deaths Reauthorization Act of 2023 (PMDR) was introduced to the House Committee on Energy and Commerce by Congresswoman Robin Kelly (D-IL) on May 18, 2023. The bill passed out of the Senate Health, Education, Labor, and Pensions (HELP) Committee in Fall 2023 and passed the House with bipartisan support in March 2024. However, the bill failed to pass the Senate before the end of the legislative calendar, rendering the bill “dead”. The reauthorization built upon the original Preventing Maternal Deaths Act of 2018, which helped establish and fund state-based Maternal Mortality Review Committees (MMRCs) to investigate maternal deaths and identify preventable causes. It sought to extend funding for MMRCs, enhance data collection, and address racial disparities in maternal health outcomes through the following provisions:

    1. Extending funding for state-level MMRCs to continue investigating maternal deaths
    2. Authorizing $58 million annually for the CDC to support state-level efforts
    3. Enhancing data collection on factors related to maternal health outcomes, particularly for minority populations
    4. Strengthening community-based interventions to reduce racial and ethnic disparities 
    5. Enhancing coordination among agencies to implement evidence-based solutions
    6. Expanding research on social determinants of maternal health 

    Arguments in Support

    Proponents of the PMDR Act of 2023 argue that the bill provides critical support for tried and true interventions to prevent maternal deaths. They emphasize that scientific literature identifies state-based MMRCs as the “gold standard” for preventing maternal deaths due to their multidisciplinary analysis. However, inconsistent funding threatens the effectiveness of MMRCs, particularly in states with high maternal mortality rates. In a letter to Congress, 125 public health and social services associations urged legislators to treat the PMDR as a top-priority bill, stressing the nation’s consistently high maternal mortality rate. Several national associations, including the American Medical Association, argue that continued federal funding is crucial to preventing maternal deaths. They highlight that past funding gaps resulted in reduced MMRC operations, hospital closures, and increased barriers to care. Supporters contend that the only way to ensure MMRCs can continue their vital work without funding disruptions is to pass the PMDR.

    Proponents of the PMDR Act also highlight its potential to promote health equity. Beyond identifying risk factors, MMRCs are critical in addressing racial, socioeconomic, and geographic disparities in maternal health by filling critical knowledge gaps on the drivers of maternal mortality in underserved populations. The PMDR Act directly supports these efforts by requiring MMRCs to report on disparities in maternal care and propose solutions. Federal support through this bill enables MMRCs to strengthen provider training, expand access to prenatal care, and address structural barriers contributing to maternal deaths. Without reauthorization, proponents argue, efforts to close maternal health gaps would be fragmented, leaving vulnerable populations without necessary protections.

    Arguments in Opposition

    The most prominent critique of the PMDR Act is that it focuses too heavily on MMRCs. Critics voiced concerns about MMRCs’ inconsistency, lack of accountability, and failure to acknowledge all social determinants of health. 

    Opponents highlight that legal and logistical challenges, such as data collection issues and lack of legal protections for participants, can create disparities in MMRC operations. Rural populations, who face higher maternal mortality rates and limited access to care, are often overlooked in MMRCs, further exacerbating disparities. Additionally, bureaucratic barriers and state laws limiting community involvement in MMRCs reduce their effectiveness in addressing maternal health challenges. 

    Others argue that MMRCs lack accountability, particularly regarding inclusivity and equitable decision-making. Advocates contend that MMRCs often exclude community representatives or organizations that challenge the status quo, prioritizing clinical expertise over individuals with lived experience. This exclusion can foster distrust, as community members may feel their knowledge and perspective are undervalued. The lack of compensation for community members to attend all-day MMRC meetings – unlike salaried clinicians – adds another barrier, further entrenching inequalities. Laws that impose burdensome requirements on MMRCs further complicate the process and reduce diversity in ideas. Opponents of the PMDR contend that these factors contribute to a lack of accountability from MMRCs, preventing them from fully creating lasting and inclusive solutions. 

    Finally, critics assert that MMRCs often fail to adequately address the underlying social determinants of health that contribute to maternal mortality. While MMRCs focus on clinical factors, such as healthcare quality and implicit bias, they can lack the frameworks to assess other social determinants like housing instability, food insecurity, or socioeconomic status. Often, these factors are deeply rooted in the broader healthcare system and community environments. Critics argue that the absence of these social factors in MMRC reviews limits the committees’ ability to develop holistic prevention solutions. Reports suggest MMRCs could benefit from incorporating a health equity framework and utilizing socio-spatial measures to address the full spectrum of challenges mothers face. Without this consideration, critics argue that MMRCs fall short of offering effective solutions to reduce maternal deaths and disparities. 

    Due to these critiques of MMRCs, critics of the PMDR argue that the bill should allocate more funding toward alternate interventions 

    Conclusion 

    The Preventing Maternal Deaths Reauthorization Act of 2023 represented an effort to extend investment in evidence-based maternal health interventions. While it received strong bipartisan support in the House, it died before a vote in the Senate, leaving MMRC funding uncertain in the years to come. While the bill was applauded for its potential to expand access to maternal care and fill critical knowledge gaps on maternal mortality factors, critics argued it placed too much emphasis on an intervention that lacked consistency and accountability to marginalized communities. 

    Future Outlook

    The Trump administration has implemented significant changes to the National Institutes of Health (NIH), including halting medical research funding and restructuring the agency, which has led to delays and uncertainties in grant approvals. These actions have raised concerns about the future of critical medical research, including studies on maternal health. Given these developments, the future of the PMDR may depend on an evolving public health funding environment. Advocacy groups and policymakers will need to collaborate to ensure that maternal health research and interventions receive the necessary support, despite the current challenges in the federal funding landscape.

  • Protecting Our Democracy Act: Weighing the Pros and Cons

    Protecting Our Democracy Act: Weighing the Pros and Cons

    Background

    The Protecting Our Democracy Act (PODA) is a bill under consideration in Congress that aims to protect the integrity of the democratic process. The bill was originally passed in the House in 2021. It was received in the Senate in late 2021, where it failed to pass due to the use of a filibuster. It was reintroduced to the House in 2023, where it remains.

    PODA’s provisions center around three main goals:

    • Shifting power from the executive to the legislative branch: PODA would limit presidential powers, reassert Congress’s constitutional authority over federal spending decisions, and require congressional approval of presidential emergency declarations. PODA would also codify Congress’s subpoena and investigatory power, giving the legislative branch greater oversight of the executive branch.
    • Preventing corruption: PODA would require greater presidential transparency, enact new protections for both inspectors general and whistleblowers, and codify the Constitution’s Emoluments Clauses, which prevent government officials from receiving profits from foreign officials or states. It would also reinforce the Hatch Act of 1939, which limits the political activities of federal employees and other government officials involved with federally-funded programs.
    • Strengthening election integrity laws: PODA also prohibits foreign election assistance in the form of donations and would require greater transparency in digital political advertisements.

    Arguments in Favor of the Protecting Our Democracy Act

    One of the main arguments in support of PODA is that gradual institutional decay has undermined congressional authority. PODA’s proponents point to resistance to congressional oversight by former Presidents Donald Trump and Barack Obama as evidence of this phenomenon. They argue that the recent growth of the executive branch at the expense of the legislative branch can be mitigated through PODA’s provisions, which give Congress clear authority to enforce subpoenas, reassert congressional power over federal spending, and restrict a president’s use of emergency declarations. Proponents believe that this would effectively reform the balance of power between the two branches and restore the democratic process to the federal government.

    PODA’s supporters also emphasize a need for greater defenses against corruption and abuses of power. They point to the Trump administration’s refusal to disclose tax returns, dismissals of inspectors general, and issuance of pardons for corruption charges against close associates as evidence of the need for greater oversight of the executive branch. They believe that reinforcing the Hatch Act would keep federal programs fair and non-partisan, reduce corruption, and prevent political patronage. Supporters also believe that government whistleblowers need greater protections. A poll conducted by Marist in 2020 found that 86% of American voters agree that there should be more legal protections for federal employees who report fraud. Whistleblower protections are also popular across party lines. Supporters of PODA believe that the bill would provide these popular protections by granting whistleblowers increased anonymity and a private right of action if outed by other government officials.

    Finally, proponents of PODA argue that the bill will prevent foreign interference in elections. The federal ban against foreign interference in national elections has not been updated since the Supreme Court’s 2010 Citizens United v. FEC decision, which allowed corporations and other organizations to spend unlimited amounts of money on campaigns and elections. PODA’s supporters believe that this outdated policy has allowed foreign interests to fund campaigns, pay for digital advertising, and conduct social media campaigns freely, potentially spending almost $1 billion total on U.S. elections in the past decade. If passed, the bill intends to decrease foreign influence by explicitly banning foreign assistance in elections and requiring political groups to report all attempts by foreign actors to influence campaigns or elections.

    Arguments Against the Protecting Our Democracy Act

    The main argument against PODA is that the bill interferes with the separation of power between the three branches of government. Opponents of PODA argue that its provisions diminish the executive branch by requiring congressional oversight of the presidential pardon, a constitutionally-granted presidential power. Critics also believe that PODA would diminish the judicial branch by attaching new definitions to constitutional language that courts have already ruled upon, overriding court decisions and further upsetting the balance of power. Specifically, they point to PODA’s new definition of emoluments, which expands the definition to include payments arising from commercial transactions at fair market value. In light of this, opponents believe that PODA’s passage would upset the American political system of checks and balances by tipping the scales too far in the direction of the legislative branch.

    Opponents of PODA also point to the bill’s protections for whistleblowers and inspectors general as a key reason to oppose the proposal. They believe that the increased protections and anonymity for whistleblowers make it difficult for the federal government to vet claims, shielding poorly-performing employees from scrutiny. They also believe that requiring congressional oversight for firing Inspectors General decreases government efficiency and intrudes on internal operations.

    Critics also believe that PODA is politically-motivated. They argue that the bill specifically targets former President Trump and his administration’s actions. As such, they believe that PODA’s proponents only support it with the intent of politically damaging Trump and that the bill’s provisions are unnecessary.

    Conclusion

    In summary, PODA supporters argue that the bill would restore congressional authority, defend against government corruption and abuses of power, and prevent foreign interference in elections. Critics argue that PODA is a politically-motivated bill that would interfere with the constitutional separation of powers, make it difficult to vet whistleblower claims, and decrease the efficiency of the federal government. 
    After its introduction to the Senate in December 2021, PODA entered committee, where it has remained for the last three years. Even with its recent reintroduction to the House, it is unlikely to pass the Senate in its entirety unless the filibuster is abolished.