After years of debate over allegations of anticompetitive conduct by the pharmaceutical industry, both Congress and the Food and Drug Administration (FDA) are poised to take final action to change key features of the generic drug approval process and substantially reform the 1984 Hatch-Waxman amendments.
Hatch-Waxman
Under the law, a brand manufacturer lists its patents with the FDA as part of a new drug application (NDA). The FDA publishes these patents in its Orange Book, and any generic competitor filing an abbreviated new drug application (ANDA) must certify to the status of these patents.
If the competitor files a Paragraph IV certification asserting a patent is invalid or won’t be infringed by the generic drug, notice must be given to the patent holder that the patent is being contested, giving them 45 days to bring an infringement suit.
If suit is timely filed, the FDA must refrain from approving the ANDA for the shorter of 30 months from the time of the notice or a court decision in the infringement suit. Under current law, more than one “30-month stay” may delay approval of the ANDA if multiple Paragraph IV certifications are filed and infringement suits are brought against the generic competitor.
Finally, as an incentive to encourage competition, the law also grants 180 days of market exclusivity to the first generic manufacturer who files a “paragraph IV” certification as part of its ANDA. The exclusivity is triggered by commercial marketing of the generic or a court decision against the brand-name patent holder in a patent infringement suit.
Schumer-McCainThe U.S. Senate responded to allegations that brand name manufacturers were seeking to delay generic competition by listing inappropriate patents in the Orange Book and invoking multiple 30- month stays, and that brand name manufacturers were colluding with their first potential generic competitors to use the 180-day generic exclusivity as a means of defeating competition.
In July 2002, the Senate passed legislation sponsored by Sens. Charles Schumer, D-N.Y., and John McCain, R-Ariz., that would limit 30-month stays to one per generic competitor and create forfeiture conditions under which the 180 days of generic market exclusivity would not be available.