Indivior v. Dr. Reddy’s Laboratory – Homeless on the Range
In Indivior v. Dr. Reddy’s Laboratory (“DRL”), Appeal nos. 2020-2073, -2142 (Fed. Cir., November 24, 2021) a split panel (Lourie [writing] and Dyk, with Linn concurring in part and dissenting in part) affirmed a Board decision that claims 1-5 and 7-14 were invalid. Indivior had issued these claims in U. S. Pt. No. 9,687,454 out of one of a long chain of continuations. However, it had added two ranges to the claims directed to an “oral, self-supporting, mucoadhesive film”. One “new claim” (1) added the element that the film comprised “about 40 wt % to about 60 wt % of a water soluble polymeric matrix.” The other claims in suit added the element that the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix.
Dr. Reddy argued that all—we’ll get back to that—of the disputed claims failed to meet the written description requirement, and so were only entitled to a filing date that would render them anticipated by Indivior’s earlier filings in the chain, such as 12/537,571. Indivior argued that all of the applications contained two tables showing the composition of a number of films falling within—or at the recited values—of the claimed ranges that are sufficient to meet the WDR. In fact, all of the Judges agreed that claim 8, that just recited the 48.2 wt % limitation, did meet the WDR.
When I was a beginner, one of the first things my mentor told me is that Examiners would allow us to “bridge ranges”. In other words, if 10-20 and 15-19 were disclosed as useful ranges in a specification, the range of 15-20 was also supported by the disclosure. We could also bridge from a single value in an example to an endpoint in a range. As discussed by Judge Linn, In re Wertheim, 541 F2d 257 (CCPA 1976) disclosed a solid’s range of 25-60 and contained embodiments of 36 and 50. The Fed. Cir. found that the specification adequately disclosed the range of “between 36 and 50.” Judge Linn also opined that a disclosure of individual embodiments, such as 5, 6, 7, 8, 9 and 10 would support a range of 5-10.
I also looked at the parent application. It contains a disclosure of 40-60% of members of the polyethylene oxide class of polymers that are used to make the films. See page 4, Col. 1 of US 2011/0033541. The range for a second polymer is disclosed, e.g., the range of HPMC, but it can be absent. No Judge differentiated claim 1 (40-60 wt %) which is clearly a range disclosed by the ‘541 application, from the 48.2-58.6 wt % range that is derived by bridging specific examples. I do not see how claim 1 requires any bridging of examples.
If this is to be a teaching moment, I think we prep/pros folks have to look for language (like that in the old “savings clauses”) that will protect our clients from this anti-patent application of the WDR—that will make it clear that pairs of examples describe ranges of operable embodiments that fall within the ranges created by bridging the pairs.
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