AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021)

Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim.

The district court held a claim construction hearing to settle a dispute between the parties concerning the construction of “0.001%,” the claimed concentration of PVP. The district court construed “0.001%” according to its plain and ordinary meaning, that is, expressed with one significant digit. Mylan thereafter stipulated to infringement of certain claims of the asserted patents and the district court entered final judgment of infringement.

The district court then held a bench trial on validity of the asserted claims. The district court determined that Mylan failed to prove by clear and convincing evidence that the asserted claims would have been obvious in view of the prior art and entered a final judgment of no invalidity. The district court’s ultimate determination was based on several underlying factual findings, including a finding that one of the prior art references Mylan relied on in its obviousness combination taught away from the claimed invention.

On appeal, Mylan challenged the district court’s construction of “0.001%.”  Mylan also challenged several of the factual findings underlying the district court’s nonobviousness determination, including its finding that the prior art taught away from the claimed invention.

Regarding the district court’s construction of “0.001%,” the question before the Federal Circuit was whether the concentration of PVP being “0.001%” means 0.001% within one significant figure (encompassing a concentration of PVP in the range of 0.0005% to 0.0014%) as AstraZeneca contended and as the district court construed this term. Or, whether it has a narrower meaning in view of the specification and the prosecution history – precisely 0.001% w/w PVP with only “minor variations,” as Mylan contended.

Ultimately, the Federal Circuit concluded that Mylan’s proposed construction was correct because it most naturally aligned with the patent’s description of the invention, as further informed by the prosecution history.

The Federal Circuit found that, taken as a whole, the intrinsic record supported a narrower construction of 0.001% to reflect that term’s application to the PVP concentration in particular, and the testing evidence in the written description and prosecution history showing that very minor differences in the concentration of PVP (down to the tenthousandth of a percentage), impacted stability.

The Court found further support for its construction in the prosecution history. Over the course of the prosecution history, the inventors narrowed the claimed concentration of PVP to 0.001% w/w from a broader range without using the qualifier “about.” The inventors did this multiple times, each time emphasizing to the examiner that 0.001% w/w PVP – not concentrations slightly more or less than 0.001% w/w – were critical to stability of the claimed 2 mg/mL budesonide formulation. And the prosecution history showed that the inventors knew how to claim ranges or describe numbers with approximation, e.g., by using the term “about” to qualify the amount of PVP claimed. Yet, in the asserted claims, the inventors chose to claim exactly 0.001% w/w PVP.

Turning to the district court’s nonobviousness determination, the Federal Circuit reaffirmed same, finding that there was no clear error in the district court’s determination.

Judge Taranto dissented in part, rejecting the majority’s holding that, in claims reciting a concentration of “0.001% w/w” of a particular suspension agent in the claimed composition, the term “0.001%” should not be construed to have its conventional significant-figure meaning, but, instead, to mean “that precise number, with only minor variations.” Instead, Judge Taranto believed that “0.001%” should be construed to have its significant-figure meaning, i.e., the interval 0.0005% to 0.0014%, as the district court held.

Judge Taranto reasoned that it was undisputed that the term “0.001%” has an ordinary meaning, namely the significant-figure meaning.  And, that Mylan made no meaningful affirmative argument for the correctness of “minor variations” as an interpretation.

First, Judge Taranto reasoned that Mylan’s proposed “minor variations” construction actually added to the uncertainty of claim scope compared to the ordinary meaning. Such a construction worked against the core purpose of claim construction, which is to clarify claim scope.

Second, and relatedly, the phrase “minor variations,” without further construction to identify how much variation is too large to be “minor,” effectively reinstated the “about” language that AstraZeneca used in its original claim but removed in favor of the more precise “0.001%.” AstraZeneca’s withdrawal of its “about” language did not imply that “0.001%” was meant to have a non-interval meaning.  Instead, AstraZeneca chose to express the PVP concentration with a number having a well-defined interval (the ordinary significant-figure meaning).

Turning to the intrinsic evidence, Judge Taranto found that the intrinsic evidence did not support displacement of the ordinary meaning of “0.001%.” According to Judge Taranto, the intrinsic evidence did not show a use of “minor variations” or a comparable phrase that would displace the ordinary, significant-figure meaning so as to exclude concentrations down to 0.0005%. No such phrase was used in the specification.

Judge Taranto also disagreed with Mylan’s argument that because the significant-figure interval for “0.001%” overlapped with the significant-figure interval for “0.0005%,” the court should adopt a “minor variations” or extra-significant-digit or four-decimal-places construction.  Judge Taranto explained that overlap does not imply the absence of a distinction, as the two ranges are different even if they overlap. Moreover, even if the overlap supported some limitation on the construction, the most this overlap could possibly support would be an exclusion of the small range with the one significant-figure interval for which there was overlap.

A copy of the opinion can be found here.

By Mario E. Delegato


Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., Appeal No. 2021-1360 (Fed. Cir. Dec. 7, 2021)

In an appeal from a Patent Trial and Appeal Board (“Board”) decision, the Federal Circuit affirmed on the grounds of failure to show obviousness in relation to the asserted claims of a pharmaceutical patent.

Corcept sued Teva for infringement. Teva then sought post-grant review of the asserted claims, arguing that such claims were obvious. The Board found that Teva failed to prove obviousness. On appeal, Teva first argued that the Board failed to properly apply the reasonable expectation of success standard, instead requiring precise predictability. The Court disagreed, explaining that “the Board applied the correct standard, requiring only a reasonable expectation of success and tying its analysis to the scope of the claimed invention.” Second, Teva argued that the Board erred in declining to apply the prior art cases because it found “Teva had failed to prove the general working conditions disclosed in the prior art encompassed the claimed invention.” The Court disagreed, explaining that “[s]ubstantial evidence support[ed] the Board’s finding that the general working conditions disclosed in the prior art did not encompass the claimed invention, i.e., there was no overlap in ranges [(prior art range and claimed range)].” Accordingly, the Court affirmed the Board’s decision, finding Teva failed to prove obviousness.

The Court’s decision can be found here.

By Annie White

Check out our searchable library of all Fresh from the Bench updates.

Sign up

Ideas & Insights