Generation Patient Applauds Passage of Affordable Prescriptions for Patients Act to lower prices for patients and promote innovation

On behalf of the young adult patient community we serve, we welcome the passage of the Affordable Prescriptions for Patients Act (S. 150), which addresses patent thickets. 

Patent thickets occur when brand-name pharmaceutical companies accumulate numerous patents, creating a dense "thicket" that makes it difficult for cheaper biosimilars and generics to enter the market. This means patients will go years, even decades, without access to affordable alternatives to the brand-name medications they need. Tackling patent thicket abuse is important not only for timely access to affordable drugs but also for promoting innovation in the pharmaceutical industry.

As young adults diagnosed with chronic conditions, patent reform is especially important to us as we face decades of financial strain due to the significant expenses associated with managing our medical conditions. The high cost of essential medications places an enormous strain on us, and those from lower socioeconomic backgrounds face an even harsher reality, as the cost of managing their conditions often perpetuates a cycle of poverty, making financial independence nearly impossible. This strain not only impacts their immediate quality of life but also their long-term financial stability, hindering their ability to invest in education, housing, and other opportunities.

While we are thrilled for the unanimous passage of this legislation, young adult patients need much greater reform to ensure access to affordable therapeutics now and throughout our lifetime. We look forward to seeing legislation address product hopping, pay-for-delay, enhanced collaboration, and transparency between the USPTO-FDA. We await continued bi-partisan efforts to promote affordability and increase competition. 

We’d also like to note that this bill does not cap the number of patents to 20; rather only caps certain types of patents to 20 related to the following: 

• The biologic product, its method of use, or a method or product used to manufacture the biological product

• That have a filing date of more than 4 years after the first approval of the branded drug

• That include a claim to a manufacturing process that is not being used by the branded drugmaker.

We urge further action from Congress and commend patent reform champions and members of the Senate Judiciary Committee for supporting efforts to ensure the affordability of our drugs. We thank the numerous patient groups, researchers, and representatives for continuing to work toward reforming the patent system.

A Reflection on My White House Visit: The Implications of Biden’s Prescription Drug Law for Women

By Peyton Miles

I find myself reflecting on the women who have shaped me into who I am today. Each woman, whether a mother, sister, or daughter, offers a unique perspective on what it means to be a woman. However, I have found that resilience and strength out of the sheer necessity to ensure the health and well-being of oneself and one’s family, are burdens that every woman must carry. 

The U.S. healthcare system encompasses many barriers for women: from a lack of research into women’s specific health needs, economic disadvantages, gender bias, and cultural and societal bias. President Biden sought to combat some of these issues through his Prescription Drug Law. On Tuesday, April 2, 2024, I had the distinct honor of attending The White House convening on ‘How Women are Benefitting from President Biden’s Historic Prescription Drug Law’ to learn about the multidisciplinary approach that Biden’s policy team has taken to ease the burden that healthcare so greatly affects women across the U.S.  

Before I get into the events of the day, let me introduce myself. My name is Peyton Miles (she/her). I am a Black 20-year-old female, living with New Daily Persistent Headache (NDPH), and co-morbidities. While my various conditions have uprooted my initial life plans, they have provided me with the opportunity to become a health policy scholar at Generation Patient. It was through this program that I found myself at the Eisenhower Executive Office Building in Washington D.C., about to embark on my first in-person event as a member of Generation Patient.   

There was an immediate air of excitement as I entered the room where the convening was to be held. Just to be here, I gained a sense of historical significance. Expansive arches, vaulted ceilings adorned with intricate sconces and hand-carved wood, and four beautiful chairs on the platform at the front of the room momentarily left me breathless. The room was full of about 30-40 people all eager to hear what strides the Biden Administration has taken in improving women’s health in the U.S. 

The session began with Domestic Policy Council Director Neera Tanden, Deputy Secretary of Health and Human Services Andrea Palm, Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure and Deputy Administrator and Director of the Center for Medicare Dr. Meena Seshamani, and Gender Policy Council Deputy Director Katie Keith, providing an overview of the multidisciplinary approach taken to create Biden’s Prescription Drug Law whose goal is to improve the lives of women on Medicaid. In each of their introductions, they highlighted the ways in which the Inflation Reduction Act will reduce barriers to healthcare. 

The Inflation Reduction Act had four key improvements for women: prescription drug cost reduction, caps on out-of-pocket expenses, extended subsidies, and improved access to preventative services. The implementation and impact of these changes were presented in the form of speakers and a panel featuring our very own Sneha Dave - Executive Director of Generation Patient, Stacie Dusetzina - Professor at the Vanderbilt University School of Medicine, Jocelyn Frye - the President of the National Partnership for Women and Families, and Leigh Purvis - the Prescription Drug Policy Principal of the AARP, and last but certainly not least, Samantha Reid - a Patient Advocate and Senior Director of Digital Engagement at the Center for American Progress.    

The implementation of these improvements was described to be in the form of a “phased rollout.” Ten prescription medications are the initial focus of the prescription drug cost reduction, with a focus on medications that specifically impact women and minorities. This includes life-saving medications such as treatments for cancer, autoimmune disorders, asthma, and insulin, which will specifically have a significantly lower cap of $35 per month for those on Medicare. The law also includes capping out-of-pocket costs for Medicare subscribers to $2000 per year by 2025. These changes will help to ease the financial burden that healthcare often brings for women as they look to care for themselves and their families. 

As someone who is constantly dealing with the “other side” of the healthcare system, it was energizing to be in a room full of people who not only acknowledged the barriers and inequities that women face, but also took action to improve access and quality of care. As we look ahead to health policies even beyond the transformative IRA, that impact access to medicines for young adults with chronic conditions, I am looking forward to engaging in our work to reform the patent system to ensure innovation and timely access to biosimilars and generics.  

Strengthening FDA Guidance: Essential Steps to Combat Online Prescription Drug Misinformation

The FDA’s updated guidance on online prescription drug misinformation, titled “Addressing Misinformation About Medical Devices and Prescription Drugs,” is a welcome first step in tackling the dangerous and under-regulated world of direct-to-consumer marketing of pharmaceutical products. However, this guidance alone is not nearly enough to address this serious problem.

To really protect patients from the harm of misinformation, the FDA’s guidance needs to better account for the unique features of social media and the agency needs to prepare actions to actually enforce its guidance. 

Generation Patient recommends five immediate steps the FDA can take to bolster its guidance: 

1. Provide greater clarity on what an "independent third party" is. For example, does "independent third party" include entities with any past or present financial relationship with the manufacturer, even if that relationship is unrelated to the ad or post in question?

2. Directly address micro-interactions between influencers and followers. There is no mention of how to handle misinformation spread through comment sections, direct messages, or other micro-interactions. Generation Patient’s community of young adults with chronic medical conditions has identified these exchanges as the most impactful and potentially misleading.

3. Directly address the advertising strategy of following TikTok trends. We’ve seen ads with misinformation rack up millions and millions of views thanks to their virality; ignoring that factor is a big missed opportunity.

4. Provide greater clarity on what kind of organizations this guidance applies to. The guidance lacks explicit mentions or examples of the kinds of organizations this applies to. Organizations and paid influencers alike should be held to the same accountability standard for sharing false/misleading information.

5. Provide data on the benefits of the FDA’s actions. While FDA has outlined some of its public actions to combat misinformation, we need data on the benefits of the FDA’s actions, especially for websites like FDA’s Rumor Control which require resources to produce. Could these resources be better spent elsewhere?

As the FDA goes further into its new oversight over this space, it is essential that they engage young adult patients and bring them in to co-create material, assess health information, and inform regulation. No one knows the danger of this content better than us.

Check Out Generation Patient's Comments on PTAB Rules

Take a look at our comments to the U.S. Patent & Trademark Office on the Patent Trial and Appeal Board (PTAB) rules! These rules impact the affordability of medications by addressing invalid pharmaceutical patents, which can drive up drug prices for patients like us!

Key Points:

• Empowerment in Healthcare: Our comments emphasize the importance of patient voices in healthcare policy, advocating for regulations that support lower drug prices by challenging invalid patents.

• Support for Proposed Regulations: We support regulations that prioritize the merits of petitions and preserve the ability for any individual to file a review, which can lead to significant reductions in drug costs.

• Impact on Public Health: We feel the proposed changes aim to balance public interest and maintain accessible PTAB proceedings, which we believe to be crucial for innovation and competition in the pharmaceutical industry.

Read more to gain insight into how these changes could enhance healthcare access and quality for young adult patients with chronic conditions!

Reflections from our time at the Disability Inclusion Fund grantee convening!

Earlier this month, our team had an amazing time attending Building Power Together, the first-ever Disability Inclusion Fund grantee convening in Chicago, Illinois!

This event was an amazing gathering of leaders from disability communities across the U.S., both in person and virtually. Over three days, we dove into workshops and discussions that really energized our work. We swapped stories, shared resources, and met so many incredible people doing fantastic work.

We connected with folks from all kinds of organizations, like those empowering individuals with developmental disabilities to advocate for themselves within their communities, civil rights education and enforcement centers, dance and theater groups, and nonprofits working to end violence in deaf communities, just to name a few.

Discussions covered everything from health and policy to community organizing, and even the breakout sessions focused on the different challenges faced by organizations working in specific regions throughout the U.S. We also attended numerous workshops that provided a wealth of information, such as:

⁃ Online Toxicity and Disinformation

⁃ Building a Radical Disability Politic and Access-Centered Cultures

⁃ Imagining a Disability Justice Filled World

⁃ Building Campaigns that Win

And much more! Each session was full of insights and strategies that we can apply to our work. It was also extremely rewarding to connect with so many amazing advocates in the disability space.

The sense of community and shared purpose at Building Power Together was incredibly empowering. We came back from Chicago feeling energized and armed with new ideas and tools to push our mission forward.

Overall, it was an unforgettable experience, and we’re excited to put everything we learned into action!!

Comment for the Record Submitted to Senate Committee Hearing

Take a look at our comment for the record submitted to the Senate committee hearing on “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market!”

Dear Chair Durbin, Ranking Member Graham, and Senate Judiciary Members:

We write to you as a generation of patients living with chronic and rare conditions such as Crohn’s disease, lupus, arthritis, and many others. For too long, young adult patients have been left out of conversations to address the high costs of medications that we rely on not only to survive but to thrive as we enter adulthood. Many of us know that a cure is not attainable in our lifetime, and we will rely on incredibly high-cost medications for our entire lives, meaning that innovation and fair prices are crucial to reaching our potential. As a young adult patient-led organization, we believe strongly that reforming the patent system to promote competition, incentivize innovation, and create more ways for the public to challenge patents is an opportune way for our community to have better futures. 

We implore you to personally consider the profound impact that reforming the patent system could have on young adult patients like us. We are finding work for the first time, navigating insurance changes, the possibility of pursuing further higher education, and financial instability, with the added stress of affording our prescription medicines. 

We see clear opportunities to address patent abuses that are keeping the price of critical prescription drugs high, including pay-for-delay tactics, patent thickets, and product hopping. We also are thrilled to see steps in the right direction, such as the collaboration between the United States Patent and Trademark Office and the Food and Drug Administration. These reforms would benefit patients and foster a more competitive and innovative pharmaceutical industry. 

Competition will lower our drug prices: Our community members are on high-cost medications such as Nurtec ODT, Stelara, and Eliquis - all of which have extremely high prices and tremendous patent abuse. Many of us are also living with highly complex conditions requiring multiple prescription medicines. And the price relief we expect from competition through biosimilars and generics being introduced into the market has been delayed for far too long. Access to prescription medications is a basic human need. According to the Georgetown University McCourt School of Public Policy, 53% of people ages 18-34 use prescription drugs. Moreover, 21% of people ages 18-49 years old say they have difficulty affording their medication. The share is likely to be even higher for younger adults, given that the subgroup 18-24 has one of the highest poverty rates. This is a moment to ensure our community is well-represented as you consider the impact of high drug prices on the current and next generation of patients.

Innovation is particularly crucial for young adult patients: As young adult patients who will rely on therapeutics throughout our lifetime, we hope for new and better inventions that can benefit our community. Many of us cycle through therapeutics frequently, meaning that what is in the pipeline could be life-saving and life-changing. For patients in our community with rare conditions without prescription medicines left for us to try, we are navigating many changes in treatment options. Promoting true innovation could give many people the tools to increase their functionality and ease the pains of living with a chronic illness. 

Increase public participation in the patent system: Patients and public interest groups should have clearer opportunities to engage in the patent system. Instead of scaling back opportunities to challenge invalid patents, we need to create more opportunities. While we spoke at the USPTO-FDA listening session in January 2023 and have engaged in other ways, we look forward to seeing more meaningful opportunities for patients to be included. 

Indeed, we are grateful for the research and development of public-private partnerships that have contributed to bringing life-saving therapeutics to market. Over 85% of young people with chronic conditions are now surviving into adulthood, many of whom live with complex, lifelong conditions. However, pharmaceutical companies exploiting loopholes in the patent system make these life-saving drugs unaffordable and inaccessible. As more young people are being diagnosed with chronic conditions, it is crucial that we urgently activate policies that can reform the patent system for now and in years to come. Thank you for your time and for including our perspectives on this critical and timely issue. 

Sincerely, 

Generation Patient 

admin@generationpatient.org

Take a look at our Patent Reform Primer!

Why should young adult patients care about patent reform? Why does it matter, and how can you learn more? Check out our Patent Reform Primer!

Many young adult patients with chronic and rare conditions require a lifetime of access to treatments and therapies, costing them thousands and thousands of dollars.

Unfortunately, the pharmaceutical industry abuses loopholes in the patent system to increase profits and, as a result, patients are often denied access to more affordable alternatives and are unable to afford the prescription medications they need to live.

To ensure affordable access to essential medication, these abuses of our current patent system must end. This primer is meant to educate young adult patients in our community by briefly introducing the different patent abuse practices employed by brand-name pharmaceutical companies.

If you have any questions or comments about our primer, please contact us at admin@generationpatient.org!

Updates From our Peer-Support Roundtable!

This blog post is part of a series about our PCORI Engagement Award - we will post updates on our discussions every few months, so you can follow along! 

Last year, we shared that Generation Patient received an Engagement Award from PCORI (Patient-Centered Outcomes Research Institute) to “engage in patient-centered outcomes research and comparative effectiveness research (PCOR/CER) to assess peer support as a crucial intervention for young adults with chronic conditions.” 

Want to learn more about what this means? Interested in the work we’re doing? Read on! :) 

What are “patient-centered outcomes research” and “comparative effectiveness research”?

Simply put, patient-centered outcomes research (PCOR) addresses issues that patients have concerns about or are interested in rather than focusing just on the interests of researchers or medical providers. In PCOR, patients are included in every step of the research process—we’re not just the “test subjects” but also help design research questions, create studies, and discuss results! 

Comparative effectiveness research (CER) looks at multiple ways of addressing a problem and compares how effective each solution is. For example, comparative effectiveness research might be helpful if we want to know if treatment A or treatment B is better for treating a specific medical issue. Or, we might want to know if a specific action (ex: watering your plants every week) leads to better outcomes (healthier plants) when compared to another action (watering every 2 weeks). 

What is an “intervention”?

In clinical research, the specific action or treatment that you’re studying (often to see if it helps improve health/well-being in some way) is referred to as the intervention. So, in the above examples, our interventions were “taking treatment A” or “watering the plants once a week.”   

What is Peer Support?

There are a variety of different definitions of peer support - for our purposes, peer support refers to supportive connections between young adults living with similar chronic conditions/medical disabilities or navigating similar life challenges. Peer support can take many different shapes, such as:

• talking one-on-one with a friend who has the same diagnosis

• joining a virtual group to talk through different topics

• or even connecting with other folks in the chronic illness community from around the globe via social media! 

While there are many benefits to other forms of support (like therapy, hospital-based groups, etc.), we think peer support is special! There’s something inherently powerful about talking with others who understand what you’re going through and have been through similar things. At GP, one of the ways we define ‘peer support groups’ is based on who leads/creates these spaces - which is why all our groups are run by members of our community (young adults living with chronic conditions). 

So what does this mean? Putting the pieces together:

We’re interested in highlighting the importance of peer support *as an intervention* for young adults with chronic conditions. Essentially, we want to show that peer support is an important way to address some of the challenges that young adults with chronic conditions face! 

Don’t we already know peer support is helpful?? Why is this research important, and what are you going to do with this research? 

While there is existing research that shows that young adults with chronic conditions could benefit from increased mental, emotional, and social support in general (Nearchou et al., 2019), there is not much out there examining how peer support can be beneficial specifically! 

Even if we already know (from personal experience) how important peer support can be, it’s also important to have research that shows the impact of peer support as an intervention. Peer support programs are generally seen by the medical field as “extra” services: they are nice to offer patients if the resources exist, but are not seen as a critical aspect of treatment. But in our experience as young adult patients, peer support is a HUGE part of addressing our mental, emotional, and social well-being. If we can point to research that shows peer support is clinically beneficial (has measurable/observable benefits) for patients, this helps show why medical systems should invest resources and funding into these types of programs. 

Right now, we’re working on showing WHY there’s a need for this research, laying out the current challenges in doing this research, and looking at opportunities to further develop this research.

Interested in following along with our roundtable discussions? Stay tuned for more updates on some of the research we’ve reviewed so far and some of our key takeaways from these meetings! 

Two Health Policy Scholar Alumni Meet with Chief Competition Officer Stacy Sanders

In mid-March, two of our Health Policy Scholar alumni, Grace Shults and Tai Chou-Kudu, had the opportunity to meet Ms. Stacy Sanders, the first Chief Competition Officer at the Health and Human Services. At Generation Patient, we believe competition in healthcare—whether within the pharmaceutical, insurance, hospital, or pharmaceutical benefit manager industries—is crucial to promoting patient options and lowering prices. We also believe that lived experience and patient voices must lead conversations about healthcare transformation in the United States. Please read this reflection from Tai below! 

“In 2023, I participated in the Health Policy Scholars program, a year-long initiative for young adults living with chronic health conditions facilitated by Generation Patient. I was born with Hemophilia, a rare condition that prevents my blood from clotting properly, necessitating me to rely on one of the most expensive drugs on the U.S. market for treatment. Following the program's conclusion, Generation Patient has continued encouraging me to stay involved with the Generation Patient community. They have connected me with this opportunity to engage with Stacy Sanders, the newly appointed Chief Competition Officer at the Department of Health and Human Services (HHS), whose role includes a focus on drug pricing policies that directly impact those with Hemophilia in the U.S., where the cost of pharmaceuticals, insurance, and medical care can be prohibitively expensive. This opportunity allowed me to articulate my experience and concerns regarding drug pricing and gain insights from my peers with different conditions.

It’s my hope that more policymakers at the macro level will be able to hear our stories firsthand and begin to see us as individuals rather than statistics or case studies. It would be great if those who directly work on the policies that impact my daily life could be deeply affected by our patients' stories as well.” 

To learn more about our health policy work, please visit https://generationpatient.org/health-policy-lab!

Attend a Peer Support Meeting

If you’ve never attended a Generation Patient peer support meeting, we’d love to have you join us! All our meetings are run by/for young adult patients with chronic conditions/disabilities, and are a great way to chat with peers who understand what you’re going through. These are generally an hour long and the monthly schedule can be found here. We currently offer six peer support meetings per month. 

Some of our meetings focus on specific topics, while others are just opportunities for “casual chats” with other members of our community. We also host activity-based groups (usually once a month), like poetry workshops, draw & talk sessions, game nights, and more! Even when we’re playing games (and not explicitly discussing the challenges of chronic illness), we believe that peer groups are still a really powerful source of support and community care. 🙂

Some of the topics we discussed last year:

• Coping with unpredictability

• Navigating outside perceptions of chronic illness

• Communication strategies and connecting with peers

• Self-Advocacy in the classroom and beyond

• Dealing with FOMO

• Navigating exam season

• Easy self-care

• Self-compassionate goal setting

If it’s your first time joining us (or if you just want a refresher!), please take a look at our Group Guidelines - this helps us ensure our meetings are as accessible as possible for our community members. 

Have any questions about our peer support meetings, or just want to learn more? Email rosa@generationpatient.org! 

Generation Patient on Prescription Drug Advertising Letter to Food and Drug Administration

Generation Patient applauds Senator Durbin (D-IL) and Senator Braun (R-IN) for their joint letter to FDA Commissioner Dr. Robert Califf to inquire about the oversight of pharmaceutical advertisements on social media. 

In January 2024, Generation Patient executive director Sneha Dave and director of operations Sydney Reed, with Dartmouth professor Dr. Steven Woloshin, published an opinion piece in STAT News. Soon after, Senator Durbin's office released this letter requesting several questions and highlighting concerns, some of which were based on areas of concern we have identified, including addressing the potential influence of comment sections when influencers advertise prescription drugs. 

Generation Patient has been pushing for the Food and Drug Administration to update its 2014 guidance and host a public workshop last held in 2009. In addition, Generation Patient has advocated increasing coordination between the Federal Trade Commission and the Food and Drug Administration to ensure oversight of these advertisements. 

Sneha Dave has also lectured at the University of Pennsylvania on increasing oversight of these advertisements on social media and spoke at a recent Duke-Margolis Center for Health Policy meeting.  

…

Generation Patient is a nonprofit advocating for young adults with chronic and rare conditions. The young adult patient-led organization leads peer support, health policy, and research programming. Generation Patient does not take any funds from the private healthcare industry. 

Introducing our 2024 Health Policy Scholars!

At Generation Patient, we aim to strengthen the advocacy skills of our fellow young adult patients while also ensuring that our perspectives are represented within health policy. We do this through our three key policy areas and the Health Policy Scholars program.

Our Health Policy Scholars Program combines peer support with educational and advocacy opportunities for young adults living with chronic and rare medical conditions. Our scholars bring a vital viewpoint to the health policy arena, united by their lived experiences and a keen interest in actively engaging with health policy matters, particularly those related to lowering healthcare costs and the prices of prescription medicines.

In 2023, we launched our first class of Health Policy Scholars. We're excited to announce the following young adult patients who will comprise our second cohort of scholars for 2024:

• Giovanna Burno

• Casey Doherty

• Adam Koch

• Peyton Miles

• Rachel Litchman

• Genna Goist

You can learn more about our scholars here!

Letter to the Senate Judiciary Committee

To Members of the Senate Judiciary Committee:

As young adults living with chronic medical conditions, we write today to inform you why we oppose S. 2140 - the Patent Eligibility Restoration Act, which your committee will hear on Tuesday, January 23. We are a patient advocacy group that has refused all funding from the private healthcare industry, ensuring our voices represent our experiences as young adult patients. Central to our belief, the patent system should incentivize innovation and competition and allow patients timely access to biosimilars and generics.

We oppose the Patent Eligibility Restoration Act, which allows predatory companies to exploit patent eligibility and harm efforts to treat health conditions. More specifically, the legislation would: 

• Eliminate all judicial exceptions to patent eligibility. 

• Enable any invention or discovery that can be claimed as a “useful process, machine, manufacture or composition of matter, or any useful improvement thereof,” is eligible for patent protection, except under specific provisions. 

• Asserts that patent eligibility should no longer be determined with consideration of Sections 102, 203, or 112 of Title 35.

In summary, if PERA gains momentum and passes, pharmaceutical companies will be allowed to get patents they cannot get today. We will see more monopolization of treatments, blocking crucial competition. The legislation would enable companies to charge higher prices for medical tests and treatments. It would impede innovation that we rely on as young adults living with lifelong conditions. 

We need innovation and affordability. In addition to the physical, emotional, and social tolls of such severe, complex conditions, too often, the lifesaving medications we need to survive are unaffordable. We look forward to sharing our perspectives further and to your continued prioritization of the current and next generation of Americans. 

Sincerely, 

The Generation Patient Team

Our Prescription Drug Affordability Board (PDAB) Primer

Check it out! We created the Prescription Drug Affordability Board (PDAB) Primer for patients and patient groups to advocate effectively for lower drug prices at the state level.

There is a lot of misinformation about PDABs, and we feel it is essential to address how critical they will be to help our community of young adult patients afford therapeutics! Do you have any other questions? Feel free to email us at admin@generationpatient.org; we will do our best to address them! 

Patent Letter to Congress

We write today as young adults living with chronic medical conditions to urge Congress to act on the need for meaningful pharmaceutical patent reform. While the Inflation Reduction Act marked a historic milestone, it predominantly benefits older patients, and it remains necessary to make significant reforms to the patent system that would make prescription drugs more affordable and accessible to patients across all age groups and demographics. We are committed to ensuring that the voices of young adult patients are included in this critical effort to reform the patent system.

Our young adult patient population is unique. We live with Crohn’s disease, lupus, arthritis, Ehlers-Danlos syndromes, frequent strokes, and numerous other health conditions. Many of these conditions are chronic, meaning we will likely live with them. The financial impact of these conditions can significantly impact the trajectory of our lives and futures. In addition, as young adults, we are experiencing times of transition, often marked by significant financial instability. We are pursuing education, developing independence, exploring our identities, and navigating complex health conditions, all while the devastating potential loss of health insurance looms over us. In addition to the physical, emotional, and social tolls of such severe, complex conditions, too often, the lifesaving medications we need to survive are unaffordable.

While reform to the patent system must ultimately include many reforms, we call on Congress to address the pharmaceutical industry’s abusive patent-thicketing tactics in January. Drug companies create patent thickets when they strategically apply for and accumulate dozens of approved patents on a single drug. This tactic essentially creates a “thicket” of patents around a product and makes it so that no generic company can challenge them all, thus delaying and preventing the entry of a lower-cost generic competitor drug from entering the market. 

Consider Amgen’s Enbrel, which treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and moderate-to-severe juvenile idiopathic arthritis. According to the Initiative for Medicines, Access and Knowledge (I-MAK), Amgen filed 57 patent applications on Enbrel, which could block generic competition for the drug for 39 years. Victoria, a young adult patient, takes Enbrel to treat her chronic condition. The medication carries a list price exceeding $1,000 per month. Between her family’s insurance plan, for which she is still eligible, and a manufacturer-provided co-pay card, Victoria is able to afford the medication. Nevertheless, as a medical student without a steady source of income and student loans, Victoria worries constantly that the manufacturer support could end at any time about the options that will be available to her when she turns 26 and is no longer able to stay on her family’s insurance, and whether she will be able to afford Enbrel in the future.

Legislation to curb the anticompetitive practice of patent thicketing should include limits on the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company that seeks to sell a biosimilar version. These limits would speed the arrival of biosimilars to the market. Furthermore, legislation should incentivize and coordinate collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to close loopholes that brand manufacturers exploit. Finally, patent legislation should also address product hopping, which is the practice of a manufacturer switching to a follow-on product with a patent that expires later than when the patents on a reference product expire. Prohibiting this practice and including an enforcement mechanism in the legislation would speed the arrival of lower-cost generics to market and bring relief to patients. 

When discussing the pharmaceutical patent system and the desperately needed reforms, it is essential to acknowledge that many patient groups remain relatively quiet on the issue. This reticence stems partly from the complexity surrounding the substantial funding that several major patient groups receive from the pharmaceutical industry, which has often hindered their active engagement. These conflicts of interest display Big Pharma's power to influence the issues many non-profit organizations choose to advocate for or against - or to stay “neutral.”As a community of young adult patients living with chronic medical disabilities, Generation Patient is one of the few patient groups free of pharmaceutical or other industry funding and influence. 

We hope that you will prioritize meaningful patent reform for patients, not the interests of companies that have for too long from the conditions we will endure for a lifetime. We look forward to working together in the year's final weeks to ensure young adult patients' voices are represented in all policy decisions.