The many patent cliffs seem to have emboldened generic drugmakers: Pharma patent litigation is on the rise, particularly when it comes to newer IP – 2014 was a record year for ANDA suits, according to a new report from Menlo Park legal analytics firm Lex Machina. This graphic says it all: The Hatch-Waxman/ANDA Litigation Report analyzes 1,671 cases filed […]
It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984. So much in...
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By Kurt R. Karst – The number of citizen petitions pending at FDA concerning Hatch-Waxman exclusivity continues to pile up. As we previously reported (here and here), FDA has already been asked on three separate occasions in 2013 to recognize...