DispatchesMarissa Zupancic is JURIST’s Washington DC Correspondent, a JURIST Senior Editor and a 3L at the University of Pittsburgh School of Law. She’s stationed in Washington during her Semester in DC.
US Senators Peter Welch (D-VT) and Amy Klobuchar (D-MN) hosted a panel discussion earlier this month highlighting new bipartisan legislation to address pharmaceutical drug patents in the US. Senator Mike Braun (R-IN) is also a co-sponsor of the legislation.
I attended “Breaking Down Big Pharma Patent Walls” at the Russell Senate Office Building on Capitol Hill as a member of the press.
The legislation focuses on what are known as “patent thickets,” or when a company asserts a myriad of different patents on the same prescription drug, often in an effort to extend the limited monopoly offered by the patent system beyond the normal 20-year life span of a patent. During the February 6 panel, Dr. S. Sean Tu explained that companies will assert “offspring” patents on the color or name of the drug to extend their original patents. Tu even stated that one prescription drug used to treat dry eye disease, Restasis, had a patent for use for dry eye disease and a separate patent for the other medical term for dry eye disease.
To combat the pervasiveness and inaccessibility caused by patent thickets, the legislation would limit the number of patents a pharmaceutical company can assert during litigation to only one, a practice commonly employed by some lower courts across the country.
Senator Welch gave a brief speech, where he explained that the US spends the most on prescription drug prices in the world. He further shared some of his own experience with the US healthcare system and stated, “They’re killing us with the prices.” He said that he knew some people in the country are struggling to pay their prescription drug prices, sometimes choosing their medication over food. Senator Welch focused on the patent thickets held by AbbVie, the maker of the prescription drug Humira, which is commonly used to treat diseases that increase swelling and pain, as well as skin disorders. Humira has 166 patents, including ones that do not directly relate to the drug itself, such as patents for the color and injector. In the US, a dose of Humira can cost a little under $4,000, but in comparable countries, the cost is $2,700. (Notably, Mark Cuban’s prescription company Cost Plus Drugs will offer a biosimilar to Humira called Yusimry for less than $600 as AbbVie’s exclusivity over Humira ended last year.) Senator Welch ended his remarks by sharing his strong belief that “health care is a right.”
A number of young adults with chronic health conditions were members of the panel. The first panelist to speak was Sneha Dave, the Executive Director of Generation Patient. Dave highlighted the unique struggles she faces with the US prescription drug system because she has ulcerative colitis, which is an inflammatory bowel disease, and how she has had to take high-cost prescription drugs for most of her life. She also emphasized the toll that the financial strain stemming from high-cost drugs takes on mental health. She attended the panel to voice her support for the legislation in order to “get timely access to generics and similar biologics.”
Jacqueline Garibay, a patient advocate with Patients for Affordable Drugs NOW, explained her experience with ankylosing spondylitis (AS), an arthritis that causes the spine to swell which leads to stiffness and pain. She shared she has had to forego her medication because the cost ranges from $5,000 to $13,000, and that as a college student, neither she nor her family can afford to pay that all the time. With that, she said this legislation would be “life changing for patients like her.”
Senator Klobuchar made a brief appearance during which she discussed the benefits that the legislation would provide to the patent system. Mainly, she said she wanted to address the “abuse of the patent system” and how patent thicketing “undermines innovation.” She stressed that she is a “firm believer in making capitalism work,” which is what she said the legislation aims to do. Senator Klobuchar pointed to a New York Times investigation from last year that looked at AbbVie, which claimed that the company “gamed” the patent system to make hundreds of billions of dollars by constantly raising its prices over the time it held a patent on the drug.
Most of the remaining panelists spoke about the impact on patients from the current makeup of the patent system for prescription drugs. Andrea Harris, the policy director for Protect Our Care, said that there is currently a lack of competition in prescription drugs due to the abuse of the patent system. Tu expanded on this, sharing that with competition and the introduction of a generic alternative, the price of a drug can drop up to 90 percent. Lauren Aronson, the executive director of Campaign for Sustainable Drug Pricing, explained that in 2019, patent thickets cost consumers billions of dollars. Further, Merith Basey, the executive director of Patients for Affordable Drugs, claimed that “almost one-third of the people in the US can’t afford their prescriptions, with a disproportionate impact in Black and brown communities.”
Early last year, the Biden administration released new information to guide federal agencies on when using march-in rights are appropriate, which allow an agency to “march in” on a drug that has been federally funded in times of great need. This means that if the federal government used this power, it would be able to sell access to the patents of high-cost drugs to other companies in an effort to introduce cheaper, generic alternatives of the prescription drugs into the market. While the government has never used these rights, the increasing cost of prescription drugs across the US has encouraged legislators and executives to consider creative new ways to aid their constituents.
Senator Welch’s office told JURIST:
With the bipartisan, pro-competition nature of the bill, our shared hope is that it will move quickly through the legislative process in both chambers. We are encouraged to see the Biden Administration’s announcement on clearing up guidelines for march-in rights, as we should utilize every tool at our disposal to bring down the cost of prescription prices for consumers and patients.
