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Tuesday, May 04, 2021 2:59:07 PM
As for the narrowed scope see the excerpt:
Recent developments, however, suggest that the dispute in GSK v. Teva may be shifting away from the larger statutory and policy questions regarding “section viii” and “AB-rated” generics – and towards a narrower, factual dispute regarding the contents of Teva’s 2008-2011 generic labeling. In its January 29, 2021 response to Teva’s Petition (“GSK’s Petition Response”), GSK argued that Teva did not actually “carve out” the patented “congestive heart failure” indication – but rather “left in” language sufficient for the jury to find “run-of-the-mill” induced infringement based on express “encourage[ment]” by Teva’s label itself.[ix] GSK further contended “that finding is implicit in, and necessary to, [the panel majority’s] decision,” which “noted [Teva’s] label provided evidence from which a jury could conclude Teva encouraged the patented use.”[x] Accordingly, GSK dismissed Teva’s concerns of “section viii nullification” as an unrealistic “doomsday scenario,” contending that the majority opinion “reiterate[d] that generics who wish to [enter the market with partial labels] must comply with section viii by completely carving out the patented use.”[xi] According to GSK: “As long as generics fully carve out the patented use, they can continue to enjoy the carve-out statute’s protection.”[xii]
And on February 9, rather than granting en banc review, the Federal Circuit granted a panel rehearing for February 23, 2021, on the “limited” issue of “whether there is substantial evidence to support the jury’s verdict of induced infringement” for the “partial label” period between 2008 and 2011.[xiii] While the outcome remains to be seen, it is possible that the panel majority may use the rehearing to refine its original opinion on the evidentiary issues raised by GSK – i.e., whether Teva’s label was insufficiently “carved-out” to avoid inducement – rather than focus on the broader legal questions regarding induced infringement of completely “carved-out” uses that Teva and its amici urged for en banc review.
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