Year: 2025

The Patent Thicket Just Got Thicker: Limiting Inter Partes Review for Biologic Drug Patents

While a best-selling small molecule drug could be covered by up to five patents, biologic drugs (large chemical compounds produced by living cells) are covered by hundreds of patents. A primary purpose of patents is to give a limited monopoly to inventors to incentivize innovation, but this monopoly comes at a cost to consumers. For example, Humira (a rheumatoid arthritis medication) has 134 active patents and AbbVie Inc. charges consumers $6,500 per month for treatment. Most of these patents are “secondary patents” of questionable validity, covering things like dosage, drug formulations, and methods of using the drug to treat a new condition.

To combat these exorbitant prices, companies have been using biologic drugs as templates to produce biosimilars—therapeutically equivalent molecules. Without the extensive research and development costs associated with producing a novel biologic drug, biosimilars are brought to market and sold for less—around 90% less. Returning to the previous example, the biosimilar for Humira cost as little as $650 per month—just a tenth of the $6,500 monthly payment for the brand-name biologic.

The price of biosimilars could become even more affordable due to a recent announcement from the U.S. Food and Drug Administration (FDA) that it would be simplifying the process by which companies could bring biosimilar drugs to market. Now, the FDA will allow biosimilar manufacturers to circumvent expensive clinical testing in exchange for analytical testing. The manufacturer must show that their biosimilar does not have any clinically meaningful differences from the brand-name biologic drug (which has undergone clinical testing). The FDA used to require biosimilars to conduct “switching” clinical tests where patients would be treated first with the biosimilar drug then with the biologic drug (or vice versa) to determine any difference in responses to the drugs. If no meaningful differences were found, then the biosimilar was given “interchangeable” status, allowing pharmacists to prescribe the cheaper biosimilar instead of the brand-name biologic.

However, generic drug companies face another issue: challenging the validity of patents on a brand-name biologic drug. The web of patents protecting a single biologic drug makes it difficult for generic drug companies to enter the market because they must first demonstrate all the existing patents are invalid or not infringed by their product. Litigating these patents in a district court is expensive, complicated, and time-consuming.

Inter partes review (IPR) exists as an easier way for generic drug companies to clear out the patent thicket created by brand-name biologic drug manufacturers. However, the U.S. Patent and Trademark Office (USPTO) proposed a rule shortly before the FDA’s announcement, limiting the ability of biosimilar manufacturers to challenge the numerous patents filed on brand-name biologics. Previously, biosimilar manufacturers often used IPR through the Patent Trial and Appeal Board to challenge the validity of patents on brand-name biologic drugs. Now, IPR will not be available when “a petitioner intends to pursue invalidity challenges under §§ 102 [novelty requirements] or 103 [non-obviousness requirements] in other venues, such as district court or the U.S. International Trade Commission.” The USPTO frames this amendment as a way to “promote fairness and efficiency by channeling similar patent challenges to a single forum” and ensuring that IPRs are, not used in addition to, but as a complete substitute for, at least a phase of litigation. This has the effect of eliminating IPR as an avenue for biosimilar drugs to challenge the validity of broadly-drafted patents restricting their entry to the market, and thus increasing the cost of determining whether the numerous brand-name biologic drug patents are valid.

Allowing biosimilar manufacturers to use IPR as an avenue for challenging brand-name patent validity is important for two main reasons: lower costs and accelerated market entry. First, only 5% of prescription drugs are biologic drugs, but they account for $300 billion dollars in national total spending on medications. Thus, by creating therapeutic equivalents to patented biologics—biosimilars—which can compete with brand-name biologic drugs, prices will drop closer to the marginal cost of production and become more affordable to regular Americans. Second, legal battles between biologic manufacturers and brand-name biologics manufacturers can last years, delaying the arrival of affordable alternatives to consumers. Returning again to Humira as an example, it took seven years in court before the patent issues were resolved and the biosimilar could reach the market.

Although patents are meant to incentivize innovation by providing a limited monopoly, they are also meant to increase public access to cutting edge, socially beneficial technology, such as biologic and biosimilar drugs. By making it more difficult for biosimilar manufacturers to challenge validity of biologic drug patents, inventors and their monopoly are protected, but the USPTO has forgotten the public which patent law also seeks to protect.

Does Trump’s Call For Expanding IVF Access Have Any Real Legal Teeth?

Assistance with fertility care is an urgent need for many families across the United States. According to findings from the 2024 Kaiser Family Foundation(KFF) Women’s Health Survey, one in eight reproductive-age women said that they or their partner needed fertility services to help them become pregnant or prevent a miscarriage. Fifteen states require some private insurers to cover some fertility treatment, but significant gaps in coverage remain. Only one state Medicaid program covers any fertility treatment, and no Medicaid program covers artificial insemination or in vitro fertilization.

Following the Dobbs decision, the future of assisted reproductive technology (ART) has been in question. In February 2024, the Alabama Supreme Court issued a ruling declaring frozen embryos in that state to be “unborn children” for the purposes of civil liability under Alabama’s wrongful death statute. Following national outrage from the decision, in March 2024, Alabama passed a law that provides immunity from civil and criminal charges for in vitro fertilization (IVF) patients and providers, which helped restart IVF services. However, this law did not overturn the state Supreme Court’s decision, keeping the legal status of embryos as “children” under the wrongful death statute.

In response to the uproar over the Alabama case, Senate Republicans announced support for protecting nationwide access to IVF. During the 2024 presidential campaign, Donald Trump pledged to make IVF free. On February 18, 2025, President Trump signed an executive order aimed at expanding access to in vitro fertilization (IVF). Following that executive order, on October 16, 2025, the White House revealed plans to offer discounts on certain IVF medications through a new government website, TrumpRx.gov. The White House also stated that it would work to develop more options for employers to voluntarily assist with fertility and family formation costs for their employees and dependents.

Following the White House’s announcement, the American Society for Reproductive Medicine (ASRM) issued a statement noting that, although the initiative was presented as a breakthrough for affordability, “key details about its implementation, scope, and equity remain unresolved.” Regarding legal considerations, they noted that classifying fertility coverage as an “excepted benefit” could undermine consumer protections under the Affordable Care Act (ACA) and the Employee Retirement Income Security Act (ERISA). Additionally, the announcement did not address the issue that across the country states are still navigating an evolving legal landscape that is emerging from disputes about pre-embryos making their way to court.

Many patients lack access to fertility services mainly because of high costs and limited coverage from private insurance and Medicaid. This initiative has no impact on existing state coverage mandates. As stated in the American College of Obstetrics and Gynecologists’ response to increase access to comprehensive care, employer-sponsored insurance plans should be both affordable and universally available. Coverage of IVF benefits can vary significantly and may not fully cover the entire cost of an IVF cycle, which typically ranges from $15,000 to $20,000. Many individuals facing infertility may need more than one IVF cycle. The cost of medication is just one part of the IVF process; discounts on these medications do not significantly lower the total expenses, which usually include both procedural and lab fees. As noted by KFF, laws regarding IVF insurance coverage vary, often limiting benefits to those with an infertility diagnosis and excluding single people and same-sex couples, and they do not apply to self-funded employer plans. The White House announcement leaves important gaps unaddressed. It also omits the 16 million reproductive-age individuals enrolled in Medicaid, who, even with a discount through TrumpRX, would find these treatments prohibitively expensive.

Senate Republicans have had the opportunity to support legislation that would provide comprehensive coverage of IVF and other ART treatments. However, despite their declared support, they blocked the passage of the Right to IVF twice, first in June and then in September 2024, legislation that would establish a right to IVF and ART, and help lower the costs of IVF treatments through expanded coverage. Republicans have cited increased costs to medical plans as their main concern with the bill, even though in 2024,  97% of large employers voluntarily offered fertility benefits reported no significant increase in costs to their medical plans. Despite this, the Access toFertility Treatment and Care Act, which would require most private insurance plans, as well as plans offered by Federal Employees Health Benefits Program, Medicaid, TRICARE, ERISA, and VA to provide coverage for treatment of infertility without any insurance or copays, remains a partisan bill. While the discounts are a step in the right direction, they fall short of truly enabling families to access the care they need.

Conversion Therapy on Trial: What Chiles v. Salazar Means for Medical Regulation and LGBTQ+ Protections

The Supreme Court heard arguments on October 7, 2025 to lift Colorado’s ban on “conversion therapy,” a discredited practice which targets LGBTQ+ youth to change their sexual orientation or gender identity. In Chiles v. Salazar, Kaley Chiles, a Colorado-licensed professional counselor, challenged a Colorado state regulation which prohibits providers from engaging in “conversion therapy” with anyone under 18. The practice can include anything from talk therapy to electric shock or pharmaceutical interventions. The Court heard arguments about what therapists may say to their patients—specifically, whether talk counseling is “conduct” or “speech,” and whether it is protected under the First Amendment and the Free Exercise Clause.

There is overwhelming evidence and medical consensus that the efforts to change a child’s sexual orientation or gender identity are unsafe and ineffective. In August 2025, the American Psychological Association, joined by the American Psychiatric Association and 12 other mental health and medical professional organizations, filed an amicus brief in support of the Colorado law. Research consistently demonstrates that “conversion therapy” has long-lasting consequences, including depression, anxiety, suicidality, substance misuse, damaged familial relationships, loss of connection to community, self-blame, guilt, and shame. Twenty-three states have prohibited healthcare providers from subjecting minors to “conversion therapy.” A recent UCLA study shows 698,000 LGBTQ+ adults have undergone “conversion therapy,” with half of them (350,000) receiving the treatment as adolescents.

The central question for the judges in Chiles is whether Colorado’s law interferes with free speech protected by the First Amendment, or whether it is a necessary legal regulation of professional conduct. Chiles argues that “conversion therapy” is speech, not conduct, and thus states “do not have a freer hand to regulate speech simply because the speaker is ‘licensed’ or giving ‘specialized advice.’” Conservative judges shared concerns about the law’s apparent threat to Christianity-informed free speech. Justice Alito called the statute “blatant viewpoint discrimination,” posing two hypotheticals—one in which a boy asks a therapist to help end his attraction to men, and one in which he asks for support to feel comfortable being gay—and stating that the statute requires opposite results depending on the viewpoint expressed. Justice Gorsuch and Justice Barrett also raised concerns regarding how laws justify medical regulations.

Justice Jackson, conversely, noted that states have a long history of regulating medical treatment, and doctors would clearly be liable if they used medication that the state deemed substandard care. Citing the Supreme Court 2024 decision in Skrmetti, which upheld the Tennessee law banning gender-affirming care for minors, Jackson questioned why the Colorado regulation “isn’t just the functional equivalent,” since both prohibit a medical treatment for minors that major medical associations say can lead to an increased risk of depression and suicidal thoughts. Justice Sotomayor was fundamentally concerned with whether Chiles even had standing to challenge the law, noting that “merely having a law on the books is not enough.” She pressed Chiles’ attorney to explain how she was personally harmed by the law, observing she does not face a “credible threat of prosecution.”

There is no clear consensus among circuit courts on First Amendment protections regarding professional speech. For example, the Ninth Circuit has held that there is a continuum, where on one end “public dialogue” gets robust protection, and on the other end, conduct such as individual treatment or professional counseling is not protected. Other courts insist that speech protections apply fully to counseling conversations even in professional settings, while many reaffirm that health professionals must provide treatment consistent with the government-regulated standard of care. In Chiles, the court seemed skeptical of Colorado’s claim that conversion therapy is conduct and not speech, but it remains uncertain if it will be sent back to the lower courts.

Chiles comes amidst a nationwide surge of anti-LGBTQ+ legislation and decisions, including laws that ban or punish gender-affirming care, restrict trans athletes from participating in sports, and create religious exemptions for LGBTQ+ nondiscrimination protections. In two Colorado cases, in 2017 and 2023, the Supreme Court sided with Christian business owners who opposed marriage equality and rebuked LGBTQ+ nondiscrimination laws in the process. Chiles could not only redefine the boundary between speech and conduct and set precedent for medical regulations, but also have wide-ranging consequences on legal safeguards meant to protect LGBTQ+ youth from discrimination and harm.

Phytoremediation: A Valuable Tool for Local Health Equity Initiatives in the Trump Era

The Inflation Reduction Act invested billions into green energy and environmental justice projects, including grants for phytoremediation projects, which use plants to extract, degrade, or stabilize pollutants in soil, air, and water. When the Trump administration canceled $2.8 billion in EPA grants for research and environmental justice projects, Ira Vandever’s hemp phytoremediation project in the Navajo Nation lost its funding. Another $1.6 million EPA-funded phytoremediation project spearheaded by the Mi’kmaq Nation was building upon their research demonstrating that hemp can extract PFAS (Per- and polyfluoroalkyl substances), also known as ‘forever chemicals,’ from soil, when their grant was also frozen. Projects like these are among many caught in the crossfire of culture war disputes about diversity, equity, and inclusion initiatives.

Pollutants in our soil, air, and water are modifiable risk factors for poor health outcomes. Interventions to improve our health, like phytoremediation, are urgently needed as the US lags further and further behind peer nations in life expectancy. A 2021 study found a staggering 20.4 year disparity in life expectancy between the longest and shortest living demographic clusters in the US—nearly double the gap in 2000. Geographic differences in exposure to environmental threats to health are responsible for a meaningful share of health inequality in the US. For example, one study of Medicare beneficiaries found that elevated exposure to dangerous airborne pollutants like PM2.5 particles is correlated with an increase in all-cause mortality. Another study found that for each standard deviation increase in long-term exposure to ambient PM2.5 there was a 10.8% increase in hospitalizations for non-respiratory infections. A tsunami of stories describing links between smart phones, anxiety, and our diminished attention spans spurred a spate of legislative and policy interventions to remove smartphones from the classroom. But how many Americans know about the relationship between air pollution and anxiety? Or the correlation between daily variance in air pollution and ADHD symptom burden? Or between daily variance in pollution and hospitalizations for schizophrenia? The EPA-funded phytoremediation projects now stuck in legal limbo were designed to address these very problems.

The fight to restore EPA funding is well worth it, but the protracted legal battles over the EPA’s environmental justice grants and the general erosion of the EPA’s capacity under the Trump administration should motivate state and local entities to pursue more of their own environmental justice projects. States, local governments, universities, religious institutions, hospitals, and nonprofits can act to reduce environmental health risks in their community. Small-scale phytoremediation projects are tractable, long-term investments that harness the psychological benefits of greenspace and phytoextraction capacity of particular plant species. Effective implementation requires knowledge about the local ecology, including soil types, rainfall, surrounding flora and fauna, the target pollutant(s), and potential impacts on nearby infrastructure. Well-researched plant choices include willows, cypress, and poplar trees. The right approach will be context dependent. Poplar trees are a great choice for a long-term TCE (trichloroethylene) cleanup project near a landfill or along a creek in the Southeastern US, but in Connecticut, a smaller community garden project focused on phytoextraction and phytostabilization of lead could use sunflowers. Municipalities, universities, schools, and hospital districts could invest in green barriers to reduce the PM2.5 concentration of air behind the barrier by 7-8%.

Phytoremediation is a financially competitive approach too. A study conducted by the Naval Undersea Warfare Center Division found that, by using hybrid poplar trees instead of traditional TCE cleanup and containment methods, they saved between $8.5 and $10.5 million. A 2023 study found that for agricultural land in a mining community, phytoremediation was the best soil remediation method in their cost-benefit analysis model, that best balanced cost, project duration, improved agricultural output, and health benefits measured in disability-adjusted life years.

The EPA’s environmental justice grants were unfairly targeted because culture war narratives rendered them as divisive and wasteful. But nearly all Americans agree that we must protect our air and water from harmful contaminants. The beauty of phytoremediation projects is they speak to intuitively understood universal needs, with a low cost of entry for local actors looking to build coalitions and make a difference. Whether federal agencies thrive or wither away, we can still bloom where we are planted.

From Protests to Policy Change: Applying the AIDS Activist Playbook to Future Pandemics

Early in the U.S. AIDS epidemic, government inaction allowed the crisis to escalate, leaving affected communities without support. In response,  AIDS activists organized to force national attention on the epidemic and reshape public awareness, treatment development, and federal policy.

The history of AIDS activism demonstrates how marginalized communities can turn a stigmatized public health emergencies into a playbook for overcoming institutional resistance. This analysis highlights the history of AIDS activism, the AIDS activism playbook, and strategies that can continue to serve as effective health advocacy in future pandemics.

  1. History of AIDS Activism & Its Impact On Policy

The AIDS epidemic first gained national attention in 1981, when the CDC reported five cases of a rare pneumonia in young gay men. As cases and deaths rapidly increased, the federal government remained largely silent, influenced by the political conservatism and homophobia. This denial, paired with labels like “gay cancer,” deepened public stigma and delayed research funding and education campaigns.

Anger and grief sparked the rise of activism, through groups like ACT UP, demanding treatment access and government accountability. The 1988 FDA headquarters protest— pressured agencies to adopt accelerated drug approval processes. Activists shaped clinical research by pushing for patient inclusion, alternative trial designs, and the use of surrogate markers like CD4 counts. Activism assisted in redefining AIDS, pressuring executive orders, influenced policy change, and national public education campaigns. AIDS activism transformed the nation’s response to AIDS and established a lasting playbook for public health activism.

  1. The AIDS Activist Playbook

The AIDS activist playbook shows how affected communities can drive policy change through seven key strategies.

  1. Humanize Marginalized Community

AIDS activists countered stigma by humanizing those affected. Early messages urged people to reject “othering,” while visibility events like the 1983 Candlelight March and the AIDS Memorial Quilt transformed grief into collective power and reframed people with AIDS as loved ones—not outsiders.

  1. Self-Educated Experts

Activists became self-educated experts to advocate and educate their communities and challenged institutions. ACT UP’s committees trained non-scientists to understand medical literature, FDA procedures, and trial design. They became indispensable in policy discussions and helped accelerated access to lifesaving treatments, proving knowledge can be a powerful form of activism.

  1. Offer Solutions

Instead of demanding action, AIDS activists proposed research-based solutions. ACT UP developing the “parallel track” for drug approvals, proposing this to the FDA to adopt faster drug approval processes. Solution-driven advocacy demonstrated the power of mastering science to influence policy change within agencies.

  1. Community Education and Engagement

AIDS activists engaged and educated communities to reduce risk, dispel myths, increase awareness, and provide update treatment options. Activists guided communities on harm-reduction through safe-sex education and illicitly operated clean-needle exchanges—deliberately risked arrest so they could challenge New York’s laws in court and establish a legal precedent for their constitutionality.

  1. Use Inside/Outside Strategies

ACT UP paired disruptive “outside” protestors demanding the “inside” group speak with officials to present detailed policy proposals. This dual strategy pressured agencies to speed up drug approvals, revise trial protocols, and include patients in decision-making, illustrating how confrontation with negotiation can drive policy change.

  1. Nonviolent, Media-Savvy Protests

Activists used nonviolent, media-savvy protests to raise awareness and pressure policymakers. Theatrical demonstrations—like the St. Patrick’s Cathedral protest featuring a condom balloon, a “Jesus” news anchor, and activists lying on the floor to symbolize death from inaction—captured national attention and underscored the message that safe-sex saves lives. By coordinating with journalists, issuing press releases, and covering damages, activists avoided being dismissed as extremists.

  1. Inserting Activists Into Decision-Making

Guided by the Denver Principles, activists insisted on full inclusion in research, treatment, and prevention decisions. ACT UP developed the National AIDS Treatment Research Agenda to influence every level of clinical trial design and national research priorities, proving that community expertise and inclusive decision-making are essential to effective public health responses. Their involvement helped shaped approvals of drugs like AZT, DDI, and later combination therapies.

  1. Applying the Activism Playbook to Future Pandemics

The strategies of AIDS activism provided a playbook for responding to future pandemics, particularly during political division and stigmatization that leads to government inaction. Even adopting select elements can help ensure marginalized communities shape meaningful policy change. Although not every tactic transfers directly, the core principles have already strengthened other movements, such as breast cancer awareness. Contemporary politicized health movements—including reproductive rights and gender affirming care—facing escalating restrictions at the federal and state level, make them well positioned to draw on lessons from the AIDS activism playbook. By humanizing the individual stories making it a family issue, expanding community education around medical care access, and using the inside/ outside activism strategies to assist with public pressure, these movements can better resist politicization and drive meaningful reform to healthcare access.

Ultimately, the central lesson is clear: when affected communities become empowered partners in the response, activism can catalyze scientific progress and lasting policy reform.

Criminalizing Miscarriage: How the Law Penalizes Grieving Mothers

Miscarriage—pregnancy loss prior to twenty weeks gestation—occurs in as many as one in five known pregnancies. Most of these occur in the first thirteen weeks, with chromosomal abnormalities accounting for nearly half of the miscarriages that occur in the first trimester. Treatment options include expectant management, medication, and surgical intervention, with 70-80% of mothers being able to pass a miscarriage naturally without medication or surgery. That means, with up to one million mothers experiencing miscarriage annually in the U.S. alone, over 700,000 of them are managing that loss from their own homes. Studies accounting for race have shown that black women are disproportionately affected with almost twice as much risk of miscarriage as other ethnic groups.

In the first year after the Dobbs decision, the U.S. saw criminal charges for at least 210 pregnant people related to pregnancy, pregnancy loss, and birth. This number represents a single-year high since researchers began documenting cases. For reference, only around 1,800 pregnancy-related charges were documented in the entire forty-nine years that Roe v. Wade held precedent. Since Dobbs, fetal personhood laws have expanded considerably, with seventeen states now granting fetuses the same level of legal protection as living humans. Lawmakers opposed to these measures have tried to sound the alarm about the risk of criminal charges for miscarrying mothers.

In March of this year, what began as a 911 call for a medical emergency ultimately led to the arrest of Selena Maria Chandler-Scott, a 24-year-old Georgia mother. At 19-weeks pregnant, Chandler-Scott suffered a miscarriage. First responders took her to the hospital after they discovered her unconscious and bleeding in her apartment, but a witness also reported having seen her dispose of fetal remains in the dumpster of their apartment complex. At a time when she was likely experiencing intense grief, Chandler-Scott also had to navigate criminal charges in the days following her pregnancy loss. Though they were ultimately dropped, Chandler-Scott was initially charged with concealing a death and abandonment of a dead body. She was cleared only after the autopsy report showed the miscarriage was naturally occurring.

Brittany Watts, an Ohio woman, faced charges similar to Chandler-Scott’s after miscarrying in October 2023. After hours waiting for the hospital to determine the legality of inducing labor after her water broke prematurely, Watts went home, where she ultimately miscarried naturally. When she returned for further medical treatment after miscarrying a pregnancy that the hospital had already determined was both a significant risk to Watts’s health and nonviable, the hospital reported Watts to the local police department. Unlike Chandler-Scott, however, the determination that the miscarriage was naturally occurring did not clear Watts of criminal charges for abuse of a corpse.  The county prosecutor’s office pressed forward, and Watts was cleared only after a Grand Jury declined to indict her for the fifth degree felony.

In addition to criminal charges, miscarrying mothers also face an increased risk of negative health outcomes in post-Dobbs America. Because of fetal personhood laws, doctors in many states are barred from medically intervening so long as the fetus still has a heartbeat. Under the federal Emergency Medical Treatment & Labor Act (EMTALA), doctors are legally protected for abortion care provided during emergency circumstances. The Supreme Court in 2024 held that state laws cannot preempt this legal protection for preventing “grave harms.” Doctors, however, remain fearful of legal repercussions and often wait before treating pregnant patients.  Kyleigh Thurman was discharged from a Texas hospital without treatment for her ectopic pregnancy, which ruptured days later, resulting in the loss of her fallopian tube and permanent damage to her reproductive system. Neveah Crain died after doctors failed to treat her for sepsis when she was six months pregnant.

In contradiction of the Court, the Department of Health and Human Services rescinded its letter of support for EMTALA compliance in June 2025, further complicating access to medical care for pregnant patients in fetal personhood states. To improve access to essential healthcare, we must address the underlying legal issues that threaten doctors and pregnant patients. In doing so, It is imperative that these discussions address the devastating reality of pregnancy loss experienced by hundreds of thousands of American women every year and the consequences of post-Dobbs policies on those losses.