Prior to Madey v Duke University, universities may have felt that academic research was immunized from patent infringement by the ‘experimental use’ defence. However, the Madey case has made clear that this defence is ‘very narrow’ to the extent that universities can no longer safely rely on it. While state universities in the USA can rely on sovereign immunity under the Eleventh Amendment, that still leaves private universities (like Duke) looking for available ‘safe harbours' from patent infringement for their research. One of these is offered by the Hatch–Waxman Act if the academic research is for the purpose of securing regulatory approval from the Food and Drug Administration. Another potential ‘safe harbour’ that was tantalizing raised, but left unresolved, by the Madey case is whether federally sponsored university research is immunized from patent infringement under 35 U.S.C. §1498(a).
State Universities Push the Limits of Eleventh Amendment Sovereign Immunity at the Federal Circuit
