WASHINGTON, DC (October 17, 2018)–Yesterday the Association for Accessible Medicines (AAM) filed an amicus brief in the Supreme Court case Helsinn v. Teva calling on the court to reject one form of patent system manipulation attempted by a brand-name drug company. The case will be heard on December 4.
For nearly two hundred years, the “on-sale bar” has funneled inventors into the patent system by preventing inventors from commercializing their inventions indefinitely before filing a patent application. Congress incorporated a prohibition on patenting “on sale” inventions into the Patent Act in 1836, and this prohibition remains unchanged. Yet Helsinn, a brand-name drug company has argued that a drug is not “on sale” if at least one “term” of the sale is not disclosed to the public.
AAM’s brief emphasizes the extent to which Helsinn’s interpretation of the on-sale bar would invite manipulation and foster confusion in the pharmaceutical market, with deleterious consequences for patients, taxpayers, and others who seek more affordable medicines.
Jeff Francer, AAM’s Senior Vice President and General Counsel stated, “Helsinn’s position reflects a variation on patent evergreening. It seeks to obtain monopoly profits for a period exceeding the statutorily prescribed monopoly period. Helsinn’s position is inconsistent with the national policy of fostering generic and biosimilar competition after that period has expired to ensure affordable patient access to prescription drugs.”
View AAM’s brief in the case, Helsinn v Teva.
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.