Association for Accessible Medicines Statement on Senate Judiciary Committee Hearing, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
WASHINGTON, DC (May 7, 2019) — AAM has worked extensively with the Senate Judiciary Committee to ensure that the patent system strikes an appropriate balance. We are especially grateful for this Committee’s work on addressing anticompetitive gaming of the regulatory system and in advancing the bipartisan Creating and Restoring Equal Access to Equivalent Samples CREATES Act (S. 340) out of committee last year. Under the leadership of Senators Leahy, Grassley, Lee, and Klobuchar, the CREATES Act is now supported by more than 90 organizations and would reduce federal spending on prescription drugs—including for seniors with Medicare coverage—by $3.9 billion, according to the Congressional Budget Office.
Importantly, AAM and our member companies support a patent system that rewards true innovation and serves the public interest by allowing true inventions to be patented for a single, limited time. After that time expires, the door should be opened to free competition—competition that naturally leads to lower prescription drug prices.
AAM is pleased that the Committee is holding today’s hearing. The current patent system has fallen out of balance, and the cost is ultimately being borne by patients, taxpayers, health plans, and everyone who pays for medicine. Take the biologic medicine Humira®, for example. It has become a more lucrative franchise than the entire National Football League.1 The high price of this much-in-demand medicine is a direct function of the U.S. patent system, which has allowed AbbVie to obtain approximately 136 patents and more than 30 years of market exclusivity on Humira®—far more than the exclusivity period contemplated by Congress.2 As AbbVie has itself admitted, its 136-patent estate on Humira® is “designed to make it more difficult for . . . biosimilar[s].”3 The intent is to accumulate patents—not because they are innovative—but rather to increase the litigation and development costs for potential would-be generic and biosimilar competitors.
Something must change. In this submission, we propose five areas for reform:
- strengthening inter partes review to weed out bad patents faster and more efficiently;
- improving the process of patent examination so that fewer bad patents are issued;
- maintaining high standards for patent eligibility;
- preserving procompetitive patent settlements; and
- improving the rules governing biologic medicines to provide a date certain for biosimilar entry.
- Anna Rose Welch, AbbVie’s Humira Can Tackle the NFL – But Can It Handle Biosimilars?
- Humira Patent Fortress at Center Stage During Pharma Execs’ D.C. Showdown.
- Statement of William Chase, AbbVie 6.11.2014 Goldman Sachs Healthcare Conference Transcript.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.