Politico: False Claims Suits Pose New Patent Challenge Pathway

Politico has this coverage of Herrera Purdy’s Apriso qui tam suit:


An argument heard in San Francisco Federal District Court earlier this month — and teed up in a similar case in October — could open a new door for generic drugmakers to challenge brand-name manufacturers’ patents. First, patent lawyers have filed a false claims suit over Apriso, an ulcerative colitis medicine that Valeant (now Bausch) launched in the early 1990s but has no generic rivals. They’re also targeting Allergan’s Namenda XR, a dementia medicine it reformulated as an extended release drug several years ago to stave off competition (and had a similar case over Johnson & Johnson’s prostate cancer medicine Zytiga earlier this year.)

To win, the challengers, representing the U.S. government, 27 states and the District of Columbia, need to show that a key patent extending the drugs’ exclusivity isn’t for anything actually innovative. With Apriso, they’re pretty sure they have a solid case: Valeant tried six times to win a new patent on the medicine but only secured one in 2008 when it added two words: [that patients could take it] “without food.” The patent lawyers have argued that the company knew it didn’t have a real innovation years before that but continued to push its case.

Read the rest of the article here.