Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., Appeal Nos. 2020-2073, -2142 (Fed. Cir. Nov. 24, 2021)
Our Case of the Week this week focuses on the written description requirement when the patent claims a range. The Court addressed a circumstance where the application disclosed a number of values within a range, but did not disclose the range itself. Ultimately, the Court found claims reciting the ranges did not have written description support, but found a claim to a single value to have been supported by the written description. This is a somewhat unusual case because it is a case involving written description support arising from an inter partes review—a procedure that does not provide Section 112 defenses. The issue was raised here in the context of a priority date dispute in relation to continuation patent applications.
Indivior’s patent at issue was the fifth continuation of a patent application filed in 2009. Dr. Reddy’s petitioned for inter partes review of several claims, arguing that polymer weight percentage limitations, which were added by amendment, do not have written description support in the original application as filed. Dr. Reddy’s position was that the challenged claims were anticipated by the U.S. Patent Office publication of the original application in the family. Indivior argued that the polymer weight percentage limitations were supported by the original application, and that the claims were therefore entitled to the 2009 priority date.
The independent claims at issue recited “about 40 wt % to about 60 wt % of a water soluble polymeric matrix,” “about 48.2 % to about 58.6 %,” and, in claim 8, “about 48.2 wt %.” The Board concluded that claim 8’s “about 48.2 wt %” was supported by the written description of the original specification. Specifically, the Board found that a person of ordinary skill in the art could have calculated this amount based on tables that were included in the original written description. However, the Board found that the claimed ranges were not supported by the original written description. The Board explained that the original specification did not “discuss or refer to bounded or closed ranges of polymer weight percentages.” It also found Indivior’s expert’s testimony about the issue to be not credible, and found that the specification taught away from the proposed ranges by suggesting that “the film may contain any desired level of self-supporting film forming polymer.”
The Federal Circuit affirmed. The Court reinforced that written description support is flexible, and requires merely that the disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” It is not necessary that the limitations be set forth in haec verba, or, in this case, in haec numera. But it must nonetheless “indicate with some clarity what the claim recites.” “In the case of a claimed range, a skilled artisan must be able to reasonably discern a disclosure of that range.”
With respect to the first range of about 40 to about 60%, the Federal Circuit noted that the original application did not claim that range, the values “40%” and “60%” were not stated in the specification, and that range was not in the specification. Concerning the tables in the specification, each provided only exemplary formulations. While multiple formulations were shown that had a value for the polymer that fell within the range, neither disclosed a range. The Court held that this did not provide sufficient clarity of a range. Rather, to find support from the tables, “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. That is not a written description of the claimed range.”
With respect to the range of “about 48.2” to “about 58.6,” the Court held the same. It noted that:
if one looks to Tables 1 and 5, plucks out the polymer components and creates a range from the percentage totals (while ignoring contradictory statements in paragraph 65), then one has obtained the range recited in claim 7. But that amounts to cobbling together numbers after the fact. Indivior failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %.
On the other hand, the Court affirmed that claim 8 was valid. Dr. Reddy’s argued that “48.2” is “not explicitly set forth” in the application. Nevertheless, the Board, as fact finder, found that the amount could be derived, and the Federal Circuit panel deferred to its fact finding role.
Judge Linn dissented with respect to the claimed ranges. Judge Linn believed the majority’s opinion conflicted with two prior cases concerning written description support for claimed ranges, one, a 1976 case from the CCPA, and the other a 2019 Federal Circuit opinion.
A copy of the opinion can be found here.
By Nika Aldrich
ALSO THIS WEEK
The Court issued for the first time a redacted copy of a previously-sealed opinion, originally issued on October 22, 2021.
University of South Florida Research Foundation, Inc. v. FujiFilm Medical Systems U.S.A., Inc., Appeal No. 2020-1872 (Fed. Cir. Public Opinion Issued November 23, 2021)
On an appeal from a district court order dismissing a case for lack of standing, the Federal Circuit reversed and remanded for further consideration. The case involves statutory and Constitutional standing for a licensee of a patent.
A mere licensee of a patent does not have statutory standing to sue for infringement unless it has obtained all substantial rights in the patent. Determining whether a licensee has obtained all substantial rights requires examining the totality of the license agreement, including two critical factors: (1) whether the licensee has obtained the exclusive right to make, use, and sell the licensed patent; and (2) whether the licensor has retained any right to sue for infringement of the licensed patent. Where a licensor retains an option to sue for infringement (even if that option only comes into play if the licensee first elects not to sue), or where the licensee must consider the licensor’s interests when determining whether or how to sue for infringement, these factors will likely weigh against the licensee. In this case, both license agreements under which plaintiff claimed rights were silent on whether it could sue for infringement. The licensor, the University of South Florida, also reserved the right to make, have made, develop, import, and use the subject invention for internal research, clinical, and educational purposes. The Federal Circuit held that USFRF was a mere licensee and therefore did not have statutory standing to sue for infringement on its own.
But the Federal Circuit reversed the District Court on the issue of Constitutional standing, holding that while USFRF did not obtain all substantial rights, it did gain at least one exclusive right to the patent-in-suit (the specific right was redacted from the public opinion), and that receiving at least one exclusive right satisfied constitutional standing. The Federal Circuit remanded back to the District Court to determine whether USFRF could join USF to cure USFRF’s lack of statutory standing.
A copy of the opinion can be found here.
By Tyler Hall
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