Jones Day
Senator Tillis, one of the bill’s sponsors, said that the bill will help “maintain the United States’ position as the global leader in technology and innovation” and emphasized that “we must work with inventors to improve and streamline our patent system.” Senator Tillis, who is one of the bill’s authors, stated that the bill would help “maintain America’s position as a global leader in innovation and technology” and that “we must work together with inventors to streamline and improve our patent system.” The PREVAIL Act was previously discussed in a blog post. The PREVAIL Act aims to reform the post grant review process by narrowing its scope in a number of ways. The PREVAIL Act first requires that parties to Inter Partes Reviews (IPRs) before the Patent Trial and Appeal Board (PTAB) satisfy the standing requirements to bring a declaration in federal district courts. The PREVAIL Act would also raise the burden of evidence required to invalidate patents to “clear and compelling evidence”. Third, the PREVAIL Act would create an estoppel provision that would require parties to a PTAB hearing to drop any invalidity defences they have in pending district courts litigation if those defenses could have been raised during an IPR. These changes will make it harder to win patent invalidity challenges. The amendment also contemplates cases related to generic manufacturers, allowing anyone who “is currently engaging in, or has a bona fide intent to engage in, conduct within the United States that reasonably could be accused by infringing one or more claims of challenged patent” to petition. The amendment also contemplates cases related to generic manufacturers, allowing anyone who “is currently engaging in, or has a bona fide intent to engage in, conduct within the United States that reasonably could be accused of infringing 1 or more claims of the challenged patent” to petition.
Takeaway:
As the PREVAIL Act moves to the Senate for a full vote, the recent amendment highlights a key point of contention: balancing access to PTAB proceedings for generic drug manufacturers and advocacy groups against the Act’s broader goal of limiting patent invalidity challenges. The debate over this amendment will likely have a major impact on the final version.