How does the Hatch-Waxman Act affect patent infringement related to regulatory approval?
The Hatch-Waxman Act, codified in part as 35 U.S.C. 271(e), provides a safe harbor for certain activities that would otherwise be considered patent infringement. According to the MPEP:
“Congress legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and provided that it shall not be an act of infringement, for example, to make and test a patented drug solely for the purpose of developing and submitting information for an Abbreviated New Drug Application (ANDA).”
This provision allows generic drug manufacturers to conduct necessary testing and development activities for FDA approval before the expiration of the patent, without being liable for patent infringement.
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