Federal Circuit Restricts Ranges for lack of Written Description
| January 19, 2022
Indivior UK LTD., v. Dr. Reddy’s Labs S.A., Dr. Reddy’s Labs, Inc.
Decided on November 24, 2021
Lourie, Linn and Dyk. Opinion by Lourie. Dissent by Linn.
Summary
The Federal Circuit Court affirmed a Patent Office ruling for an IPR finding that there is lack of written description support in an application for ranges in claims of a continuation patent thereby resulting in the claims being anticipated by prior art. The Court found that the Tables in the application, relied on for support, lacked sufficient clarity as the values therein did not constitute ranges but only specific, particular examples.
Details
Indivior owns USP 9,687,454 (the ’454 patent), directed to orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of an application filed on August 7, 2009 to which Indivior claimed the filing date.
Dr. Reddy’s Labs (DRL) petitioned for inter partes review of claims 1–5 and 7–14 at the PTAB alleging that the polymer weight percentage limitations, added to the claims by amendment, do not have written description support in the application as filed and thus are not entitled to the benefit of its filing date. Specifically, the limitation in question of claim 1 reads:
…. about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;…
Also in question was claim 8’s polymer weight percentage limitation of “about 48.2 wt %,” which the Board found that Tables 1 and 5 in the application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art.
Regarding claims 1, 7 and 12 recitations of polymer weight percentage limitations as ranges: “about 40 wt % to about 60 wt %” (claim 1) and “about 48.2 wt % to about 58.6 wt %” (claims 7 and 12), the Board found that the application does not “discuss or refer to bounded or closed ranges of polymer weight percentages.” The Board also found that a person of ordinary skill would have been led away from a particular bounded range by the application’s teaching that “[t]he film may contain any desired level of self-supporting film forming polymer.” Based thereon, the Board determined that claims 1–5, 7, and 9–14 do not have written description support in the application.
Indivior appealed the Board’s decision as to claims 1, 7 and 12 while DRL cross-appealed as to the Board’s decision as to claim 8.
Discussion
Indivior’s Appeal – Claims 1, 7 and 12
Indivior argued that the Board erred in finding that the polymer range limitations in claims 1, 7, and 12 lack written description support in the application. Indivior specifically argued that Tables 1 and 5 disclose formulations with 48.2 wt % and 58.6 wt % polymer and that the application also discloses that “the film composition contains a film forming polymer in an amount of at least 25% by weight of the composition.” Indivior argued that the combination of these disclosures encompasses the claimed ranges. DRL, countered that the application does not disclose any bounded range, only a lower endpoint and some exemplary formulations from which a skilled artisan would not have discerned any upper range endpoint.
Regarding claim 1, the Court agreed with the Board that there is no written description support in the application for the range of “about 40 wt % to about 60 wt %.” The Court noted that the range was not expressly claimed in the application; nor are the values of “40 wt %” and
“60 wt %” and a range of 40 wt % to 60 wt %.
The CAFC went on to further note that not only was there no express description of these values, various other indications of the polymeric content of the film are present in the application, rendering it even less clear that an invention of “about 40 wt % to about 60 wt %” was contemplated as an aspect of the invention. Most specifically, the Court reiterated the PTAB’s reliance on the application’s paragraph 65 statement that “[t]he film may contain any desired level of . . . polymer.” The Court asserted that this statement is contrary to Indivior’s assertion that the level of polymer should be closed and between “about 40 wt % to about 60 wt %.” of claim 1.
Regarding the disclosures in Tables 1 and 5 of the application, the Court noted that in Table 1 there are four polymer components of the described formulations, polyethylene oxide, NF (MW 200,000); polyethylene oxide, NF (MW 100,000); polyethylene oxide, NF (MW 900,000); and HPMC, and when they are added up, each total is within the “about 40 wt % to about 60 wt %” range. However, the CAFC found that these values do not constitute ranges but only specific, particular examples.
Thus, the Court concluded that this was insufficient written description support for the claimed ranges, stating:
Here, 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 ’571 application to create an otherwise unstated range.
As such the CAFC affirmed that the Board properly determined that claims 1, 7, and 12 do not have written description support in the application and are therefore anticipated by the prior art asserted during the IPR.
DLR’s Cross-Appeal – Claim 8
Regarding claim 8, which the Board had found sufficient written description for, the Court affirmed that determination, even though, as DRL argued, the number “48.2 wt %” is not explicitly set forth in the application. The Court noted that “even though one might see some inconsistency” between this result and their ruling as to claims 1, 7 and 12 since claim 8 does not recite a range, but only a specific amount, this can be derived by selection and addition of the amounts detailed in Tables 1 and 5 of the application.
Dissent
Judge Linn dissented from the majority as to affirming the Board’s decision on Indivior’s appeal, specifically taking exception to the majority’s interpretations of the often-cited written description cases In re Wertheim and Nalpropion.
Linn particularly noted that the majority too narrowly interpreted the disclosures of the application. Specifically, Linn referred to the noted paragraph 65 of the application as a truncated text “[t]he film may contain any desired level of … polymer” to wrongly suggest that the statements about film polymer levels of “at least 25%” or “at least 50%” fail to provide clear support for the claimed “about 40 wt % to about 60 wt %” range. He asserts that the quoted passage is taken out of context and ignores the remaining part of the sentence, which expressly links the aggregate polymer percentage to the key claimed characteristics of mucoadhesion and rate of film dissolution shared by films having the stated polymer levels. He quotes the full text from paragraph 65 noting that it states that “any film forming polymers that impart the desired mucoadhesion and rate of film dissolution may be used as desired.” Linn asserts that this statement does not suggest that any polymer percentage is acceptable but oppositely explicitly identifies the essential desired characteristics possessed by the films of the claimed invention and identifies the polymer levels needed to impart the characteristics.
As to the majority’s treatment of In re Werthiem, Linn notes that the majority cites no authority that written description support for a “closed range” requires a disclosure of a closed range rather than discrete values, and there is no logical reason why such a disclosure should be required as a strict rule to show possession. He remarks that in Wertheim, the CAFC had found “[b]roadly articulated rules are particularly inappropriate in this area.” Wertheim, 541 F.2d at 263-65 (Rich, J.) and an obvious example would be a disclosure with express embodiments of 5%, 6%, 7%, 8%, 9% and 10% of a particular substance, and a continuation application that claims a range of 5-10%. Relating this back to the discussion as to the disclosures of paragraph 65 of the application, he asserts that the paragraph does disclose a closed range of “at least 25%” and “at least 50%” and in light of In re Werthiem, those ranges are no different than if restated as “25%-100%” and “50%-100%,” respectively.
Hence, Linn concludes that he would reverse the Board’s holding that claims 1, 7 and 12 do not have written description support in the application and are thus anticipated by the prior art. Linn did concur-in-part as to the majority finding that Indivior was in possession of a film with 48.2 wt % polymeric matrix as claimed in claim 8.
Takeaway
- Care needs to be taken when patent prosecutors incorporate range limitations into the claims based on disclosures within Examples and Tables. The application should clearly contain evidence that the individual Examples may be formulated into the range claimed.
