WASHINGTON, DC (May 18, 2018) –AAM filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit calling on the court to reject gamesmanship of the patent system which keeps prescription drug prices high for patients. In this case, Allergan Inc. has transferred its patents to the St. Regis Mohawk Native American Tribe with the intent to use the tribe’s sovereign immunity to evade review of the drug company’s patents. AAM is joining with a diverse range of groups, including America’s Health Insurance Plans, in opposing this abuse of the patent system.
AAM commends the Supreme Court for upholding the constitutionality of the Inter Partes Review (IPR) process. This is a win for patients who depend on continued access to safe, effective and affordable generic and biosimilar medicines. IPR helps enhance patient access to generic and biosimilar medicines by providing a more efficient mechanism for determining whether the patents of brand-name drug manufacturers are valid.
The Average Annual Price of Specialty Drugs Has Tripled Over the Last Ten Years.
Prescription drugs treat conditions and improve patient health. But when drug prices are too high, access to medicines becomes out of reach for far too many patients.
Share the infographic below to help educate lawmakers on how generic and biosimilar medicines are the remedy to high drug costs.
Banning Patent Litigation Settlements Will Keep Biosimilars and Generic Drugs Off the Market No Patient Benefit - Only Helps Big Pharma Companies Abusing the Patent System
“With everyone from patients to the president demanding action on drug pricing, AAM welcomes the introduction of the Preserving Access to Cost Effective Drugs (“PACED”) Act of 2018. This legislation will put a stop to the recent anticompetitive ploy made infamous by Allergan when it rented sovereign immunity from a Native American tribe to avoid legitimate review of disputed patents by the U.S. Patent and Trademark Office (PTO).
Our position paper addresses the HHS FY19 Budget as released on Feb 19, 2018. AAM holds:
In September 2017, Allergan, the maker of Restasis, adopted an unprecedented strategy: it paid the St. Regis Mohawk Tribe millions of dollars to rent its tribal sovereign immunity in a blatant effort to shield the patents on Restasis from review. The maneuver has deservedly attracted attention in the media (see The New Yorker and Fortune) and, now, the House Judiciary Committee.
In September 2017, Allergan adopted an unprecedented strategy: it paid millions of dollars to rent the sovereign immunity of a Native American Tribe, and now claims that its patents are beyond the reach of the U.S. Patent and Trademark Office (PTO). In effect, Allergan's patents are seeking asylum on tribal lands.
For more than four decades, U.S. Patent and Trademark Office (PTO) review of issued patents has been considered a vital component of a healthy patent system, and Congress has worked to improve that review system to systematically eliminate invalid, competition-killing patents. The rental of Native American sovereign immunity by brand name drug companies is a transparent attempt to thwart this process.
“The objective is to win: fairly, squarely, decently, win by the rules, but still win.” – Vince Lombardi
When it comes to prescription medicines, patients win when companies innovate new cures and treatments. Patients also win when more affordable generic versions of those medicines enter the market. Unfortunately, some brand manufacturers aren’t playing by the rules.