Tag: FDA

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.

Lawsuits Continue to Spike for Ozempic: Express Warranty Claims for the Drug Manufacturer

Ozempic and other GLP-1 medications have taken center stage in popular culture, reshaping how Americans think about weight loss, but they are not encountering growing legal challenges. Ozempic and related GLP-1 medications have been dominating popular culture and reframing how the entire country approaches weight loss but are now facing increasing legal challenges. Ozempic and GLP-1s are a tool for weight loss, but if it sounds too good to be true, that might just be because it is. With the rapid consumption of these medications, consumers are mounting lawsuits against the drug manufacturers for extended warranty claims, failure to warn of potential side effects, and risk association.

Originally intended for Type 2 Diabetes, Ozempic’s notoriety lies with the off-label weight loss side effect. According to the CDC, 42% of Americans suffer from obesity. GLP-1 agonists are glucose-like peptide-1,  a class of medications that lowers your blood sugar (glucose) levels to help manage and treat diabetes, but also treats obesity. Approved by the Federal Drug Administration (FDA) as a medication for diabetes, its popularity on social media and advertising has been aligned with the off-label use for weight loss. These medications reduce hunger levels and trigger insulin responses in your body by inducing naturally occurring hormones. These “Ozempic Drugs” have different names and ingredients, but all the big-name brands of this class of medications are “Ozempic” and “Wegovy,” which share the same ingredient, alongside others such as “Zepbound” and “Mounjaro”. While originally intended for the demographic of diabetes impacted individuals and those with a high BMI, the drug has become readily accessible to celebrities and individuals looking for a weight-loss supplement due to its rapid weight loss effects without the traditional output effects like intense dieting or extensive exercise.

Despite the success of the drug in treatments beyond diabetes, the lawsuits demonstrate concern about the potential, and sometimes permanent, side effects of taking these weight-loss drugs. Ozempic is manufactured by Novo Nordisk and has already amassed over 1800 lawsuits consolidated into federal multidistrict litigation, with experts estimating over $2 billion in total liability, and growing. Affected patients are claiming to have developed symptoms like gastroparesis (stomach paralysis), intestinal blockages, gallbladder and kidney injuries, alongside vision loss. The suit’s main claim is the drug manufacturer’s failure to warn patients of the potential side effects.  Litigation is in its early stages for manufacturers, but it sheds important light on the safety concerns, informed consent, and what risks should be disclosed when participating in such a popular class of medications. These recent legal disputes imply that drug manufacturers have not been explicit with warnings and potential harm associated with a semiglutide compound, and consumers should take time to consider if this is the right choice for them before starting.

With Ozempic and other GLP-1s impacting the way society views weight loss, experts see a future where many more of us are taking them. The public should recognize that pharmaceutical medications should be a tool in approaching obesity regulation, not the only approach. Having a balanced approach to weight management strategies will reduce the reliance on these medications and offset the amount of adverse consequences patients are facing from taking these medications. The fast-growing market for these medications will have lasting effects on society, and the legal implications should caution people taking or planning on taking these medications to know the risks associated with them. Drug companies should implement more comprehensive policies that will adequately warn people of the adverse side effects of these medications. The legal landscape in the future will be influenced by the increasing complexity of mainstream medications and how these large drug companies structure their warning labels.

M&A Momentum in the Medical Device Industry

From EpiPen smartphone cases to portable kidney dialysis, the MedTech industry revolutionizes access to life saving care for patients. Robust market innovation has improved personalized treatments, reduced time in hospitals, and lowered healthcare costs. In the past year, high value investments and acquisitions have gained significant traction as businesses seek to leverage their portfolios to generate new solutions for healthcare providers. Over 305 acquisitions were announced in 2024, exceeding $63 billion, according to JPMorgan figures. In light of regulatory challenges and complex mega-deals, M&A legal teams have taken a leading role in facilitating these high stakes transactions, counseling clients across borders and fostering vital alliances. The strategic consolidation of smaller innovators with well-established MedTech companies catalyzes a swifter deployment and integration of new devices into health systems around the world. This article investigates driving forces behind the industry’s M&A surge and future implications across the health law landscape.

External innovation has long played a crucial role in market capitalization for leading MedTech companies, such as Johnson & Johnson, Medtronic, Stryker, Abbott Laboratories, and Boston Scientific. Although multi-billion dollar deals draw more public attention, smaller strategic opportunities have become an attractive avenue for garnering strong returns by harnessing the novel creativity of breakthrough start-ups. Specialized technologies that impact essential clinical areas, such as cardiovascular health, stroke prevention, and advanced screening and diagnostics, have grown through recent advancements in AI. In an industry hungry for innovation, competitive designs specifically related to preventative medicine and remote monitoring have become high-demand targets of M&A activity. These deals tend to offer a more cost effective method for portfolio growth and maintaining a competitive advantage, rather than developing products in-house. Law firms across the globe diligently guide corporations in navigating intricate regulatory, commercial, and ethical challenges to help bring cutting-edge products to the market.

Along with recent scientific progress, economic and political factors contribute to the rise in MedTech transactions and venture investments, such as declining interest rates and industry deregulation. From advising on intellectual property protections to litigating industry-wide resolutions, M&A lawyers assume a significant role in the oversight of successful MedTech deals. In response to modern technology, legislators continuously adjust regulations on both national and state-specific levels, requiring practitioners to adapt to ongoing changes across the industry. For example, many digital products in medicine present future challenges for safeguarding patient privacy and ensuring consumer transparency, placing a greater emphasis on compliance for market expansion in the field. In order to make products accessible in the global market, corporations must secure various approvals, often requiring the regulatory expertise and risk-averse strategies of legal counsel. Specialized knowledge about data privacy, structured finance, and market dynamics are a key backdrop of MedTech dealmaking, with the goal of delivering and implementing life changing health care devices.

With a variety of unique ideas and actors populating across the medical device industry, new and exciting products are on the horizon. Many have already accumulated data and evidence reflecting success but await FDA approval for public distribution. Because of extensive relations between physicians and medical device companies, incremental modifications are made in the research and development process to maximize potential. The emergence of “wearable” health technologies, such as electrocardiograms, glucose monitors, and AI-powered robotic prostheses, offer numerous benefits to patients by adapting to the body using real-time data and trends. Smartwatches that detect irregular heart rhythms offer a vital form of self-monitoring, as heart disease remains the leading cause of death worldwide. Certain types of paralysis and blindness, previously incurable diagnoses, are now targeted with neural implants, altering the future of regenerative medicine and stimulating cell growth. By facilitating deals between promising tech firms and far-reaching device companies, M&A has expedited patient access to remarkable tools and encouraged a competitive edge in pushing innovative boundaries.

DTC Advertising Under Fire: A Turning Point for Drug Promotion?

The Trump Administration has taken assertive steps to rectify the overmedicalization of American citizens by increasing oversight of Direct-to-Consumer (“DTC”) prescription drug advertising. Specifically, President Trump delegated authority to the Food and Drug Administration (“FDA”) to implement stringent regulations to ensure patients receive balanced information. The Administration has emphasized that DTC advertisements have become increasingly misleading by omitting critical risk information, glamorizing the use of prescription medication, and deterring patients from cheaper or healthier alternatives.

On September 9, 2025, President Trump released an Executive Memorandum that underscored the prominence of deceptive DTC advertisements and the necessity for stricter regulation. The memorandum authorized the FDA and the Department of Health and Human Services to “regulate prescription drug advertising” by ensuring compliance with the principles of transparency and accuracy. President Trump additionally commanded the Commissioner of Food and Drugs to enforce the Federal Food, Drugs, and Cosmetics Act (“FDCA”) in connection with DTC advertising in the pharmaceutical space.

The Administration has pursued three key strategies to regulate DTC advertisements. Their approach includes (1) issuing warning letters to pharmaceutical companies, (2) reforming the adequate provision rule, and (3) restricting social media advertisements. Experts anticipate an increase in agency activity in the coming months.

Following President Trump’s memorandum, the FDA has released over 100 warning or untitled letters to various pharmaceutical companies, telehealth providers, and online pharmacies to target deceptive advertising practices. On September 16, 2025, the agency issued over 60 warning letters citing alleged violations of the FDCA. The violations primarily involved minimizing risks or side effects and publishing misleading content about medications. In light of this action, Alnylam Pharmaceuticals Inc. removed a DTC advertisement for its new heart medication, Amvuttra. The FDA alleged that the advertisement, which broadcast patients being active, was misleading because it indicated that patients with heart disease “can be carefree.” While President Trump’s initiative may reduce faulty advertisements, it may also limit patients’ access to information on transformative medications. However, these are merely pre-enforcement measures, and actual enforcement will possibly require the Department of Justice to intervene on behalf of the FDA.

The FDA is additionally establishing a regulatory framework to “close the ‘adequate provision’ loophole created in 1997,” which allows pharmaceutical companies to “conceal critical safety risks” in their DTC advertisements. Before the adoption of the adequate provision rule, DTC advertisements were obligated to include full boxed warnings and clearly state all risks. Further, in the 1990s, over 130 enforcement letters were issued annually to ensure compliance. After 1997, pharmaceutical companies circumvented these rigorous requirements due to the ease of restrictions, which permitted them to only include the most prevalent risks. This led to a profound increase in DTC advertisements, and in 2024, pharmaceutical companies spent $10.8 billion on advertising. From 1997 to 2016, there was a 460% increase in DTC advertisement spending.

Pharmaceutical companies have used the rise of social media to expand DTC advertising. However, according to the FDA, 88% of top-selling drug advertisements on social media allegedly failed to comply with the agency’s requirements of balanced information. Phase three of the Administration’s reform targets influencer partnerships, sponsored advertisements, and AI-generated content.

While the Trump Administration has illuminated the negative effects of DTC advertising, it is vital also to consider positive factors. The increase in patient exposure to drug advertisements provides crucial information about possible treatments or relief, and allows patients to make inquiries with their doctors. Additionally, DTC advertisements permit individuals to stay informed about pioneering developments in the pharmaceutical industry. With heightened awareness, the word-of-mouth spread of positive experiences can help inform others about possible treatment avenues.

President Trump’s DTC advertisement restriction is likely to be met with legal ramifications. Legal action to challenge the paradigm shift would plausibly be focused on First Amendment and commercial free speech rights. A 1980 Supreme Court case, Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, established a four-part test to evaluate the constitutionality of regulation. Essentially, Trump’s administration would have to affirm that their regulations would strictly benefit public health—yet pharmaceutical companies could adequately counter-argue using the aforementioned positive factors. To efficiently navigate this evolving climate, pharmaceutical companies and the government should collaborate on policies going forward.

The Future of Abortion Pill Mifepristone Now Uncertain as it Faces a New Missouri District Judge

The US District Court for the Eastern District of Missouri is the new battleground for the legal fight over access to the abortion pill Mifepristone. This development comes after the Supreme Court remanded Judge Matthew Kacsmaryk’s injunction against the FDA’s current regulations on the drug last summer, ruling the case had no legal standing in Texas. Given the options to dismiss the case or transfer it to another venue, Judge Kacsmaryk announced his decision to transfer the case to the Eastern District of Missouri.

The Attorney Generals for Missouri, Idaho, and Kansas joined the plaintiff, the Alliance for Hippocratic Medicine, last October to challenge the FDA’s restrictions on Mifepristone.

Their arguments challenging the FDA’s 2000 approval of Mifepristone center around claims that the drug is unsafe, citing statistics that 3-5% of women who take Mifepristone end up hospitalized due to complications from the medication. The plaintiffs are advocating for the reinstatement of previous regulations surrounding the drug, including rolling back the Mifepristone REMS program, which allows the medication to be dispensed by mail. Additionally, they’re requesting that the FDA implement new regulations requiring three in-person doctor visits before access to Mifepristone is granted. Given that medical abortions made up 63% of all abortions in 2023, restricting access to this abortion medication would have a significant impact nationwide.

This latest development leads to new apprehensions for reproductive health advocates. One such concern is how the new Missouri venue may grant the plaintiff, specifically the Attorney General of Missouri, an advantage in the forthcoming litigation.  The pool of judges is also a worry in reproductive rights groups. Among Missouri district judges who could hear this case are Zachary Blueston and Christian Stevens, who were both nominated to the court by the Trump Administration. Other potential judges include Joshua Divine and Maria Lanahan, two more Trump nominations who both represented Missouri in prior Mifepristone litigation earlier this year. The Trump Administration has been public about its pro-life views and has already taken steps to cut access to abortion. More recently, the Administration expressed skepticism about Mifepristone. These findings suggest that the judges who may potentially preside over the Mifepristone case already have anti-abortion biases that reproductive health advocates are worried will reflect in the court’s ultimate decision.

The Eastern District of Missouri has not publicly announced whether it will accept the case, nor given any statement about who the presiding judge might be. Now that this case has gone up and back down from the Supreme Court, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration is up for a second round of litigation. It is to be seen if the battle will reach its climax in Eastern Missouri’s District Court.

The Trump Administration Issues Inconsistent Guidance Regarding Acetaminophen and Autism

The current presidential administration has placed significant focus on addressing a cited increase in the rate of autism diagnoses. Late last month, President Trump, alongside the Health Secretary, Robert F. Kennedy Jr., issued new health guidance and announced in a press conference that there is evidence of a link between the use of acetaminophen during pregnancy and neurological effects, specifically autism and attention-deficit/hyperactivity disorder (ADHD), in children post-birth. The announcement was coupled with a notice from the U.S. Food and Drug Administration (FDA) that it plans to initiate a process for a label change on acetaminophen products to inform consumers of the link, as well as a letter issued by the FDA to physicians about the potential link. The FDA’s letter specifies that “a causal relationship has not been established” between use of the medication and autism, while also asserting that clinicians may want to suggest pregnant people reduce their use of the medication. The issuance of sweeping advice from the Trump Administration in light of these inconsistencies is unsettling from a public health perspective because acetaminophen remains the recommended drug for fever reduction in pregnant people. The guidance to minimize acetaminophen use could be harmful for pregnant people because it may lead them to endure unnecessary pain and fever, which are dangerous for the pregnant person and the fetus.

In addition, mixed messages have created confusion in the legal context because of the announcement’s reliance on a study that was previously found inadmissible by a judge. In 2022, a group of families sued the maker of Tylenol, an acetaminophen product, for failure to warn consumers of the risk that prenatal exposure to the medication may create a heightened risk of autism. One of the experts used to support the families’ proposition was Andrea Baccarelli, MD, PhD, who was also cited in the Trump Administration’s recent announcement. The judge rejected this expert, as well as all of the families’ other experts, in an order in 2023, stating that the experts had “cherry-picked” data in their analyses. The case was subsequently dismissed in 2024, and the dismissal is currently on appeal.

In light of the executive branch’s reliance on one of the same experts as the families, the plaintiffs’ attorney has filed a letter with the court in support of their appeal, noting that the expert had been relied upon in the conclusions of a recent White House briefing. The lawyer notes the separation of power concerns that would arise if the ruling that this expert’s opinions are inadmissible in court is affirmed, while the opinions are simultaneously cited as valid by the executive branch. On the other hand, the attorney for Tylenol in the same lawsuit has also filed his own letter referencing the advice put out by the Trump administration as support of the defendant’s position that they have not failed to include any warning of a link to autism on their products. The defendant’s lawyer cites the language in the FDA’s letter to doctors stating that there is no causal relationship between the drug and autism. In light of each of letters, the judge has pushed back oral argument on this appeal that was set to occur on October 6, 2025 to November 17, 2025.

The use of the Trump administration’s guidance in this litigation to both support and disprove a link between Tylenol and autism emphasizes the confusion the new health guidance has created. What does this mean going forward? In the immediate future, the guidance may create fear among pregnant people about treating their pain and fever during pregnancy. If moving forward, the guidance does successfully ignite litigation aimed at a requirement to label acetaminophen products as not recommended during pregnancy, it could lead to an increase in pregnant people leaving pain and fever untreated during pregnancy, potentially putting them in danger of other complications.