The Association for Accessible Medicines applauded the Senate Judiciary Committee for holding a hearing today on “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
Addressing committee chairman Lindsey Graham, R-S.C, Ranking Member Diane Feinstein, D-Calif., and members of the Committee: the AAM said, “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."
"AAM and its 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," the AAM said.
The AAM said 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.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. As AbbVie has itself admitted, its 136-patent estate on Humira is “designed to make it more difficult for . . . biosimilar[s].” 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," the statement said.
Finally, in its submission, AAM said it proposes 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.