• Nov 24 2021
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  • Category: CAFC Updates

Dr. Reddy’s petitioned for inter partes review of Indivior’s U.S. Patent 9,687,454 relating to orally dissolvable films containing therapeutic agents. The Board held certain claims unpatentable, but that Dr. Reddy’s failed to demonstrate that claim 8 is unpatentable. Both parties appealed. Indivior argues that the Board erred in finding that the polymer range limitations in the claims lack written description support. The CAFC notes that it is not necessary that the limitations of a claim be set forth in haec verba, (or in the case of numbers, in haec numera), but in the case of a claimed range, a skilled artisan must be able to reasonably discern a disclosure of that range.  In this case to get to the claimed range, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the application to create an otherwise unstated range. The CAFC finds that this not a written description of the claimed range and concludes that the Board properly determined that the claims do not have written description support in the application. With respect to Dr. Reddy’s cross-appeal, although the number “48.2 wt %” is not explicitly set forth in the application (but is a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components), the CAFC upholds the Board’s decision out of deference to the Board’s factfinding, even though one might see some inconsistency between this result and the above-noted holding concerning the principal appeal. Accordingly, the CAFC affirms. Judge Linn, concurs-in-part and dissents-in-part because in his view the majority dismisses long-standing guidance on written description support for claimed ranges, and incorrectly concludes that the claims do not have written description support.

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