Patent Case Summaries December 15, 2021

Patent Case Summaries | Week Ending December 10, 2021

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.


Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., No. 2021-1360 (Fed. Cir. (PTAB) Dec. 7, 2021). Opinion by Moore, joined by Newman and Reyna.

Corcept owns a patent directed to a method of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor. Corcept asserted the patent against Teva, and Teva sought post-grant review arguing that the claims would have been obvious in light of certain prior art. The Patent Trial and Appeal Board issued a final written decision concluding that Teva had failed to prove obviousness. Teva appealed, arguing that the Board committed two legal errors.

First, Teva argued that the Board required precise predictability, rather than a reasonable expectation of success, in achieving the claimed invention. Teva stated that the Board improperly required it “to show an expectation that the specific dose recited in the claims would have been safe.” The Federal Circuit held that the Board did not err. The claims require safe administration of a specific amount of mifepristone (600 mg), and “the Board was required to frame its reasonable-expectation-of-success analysis around that specific dosage of mifepristone.” The court explained that “this does not mean Teva was required to prove a skilled artisan would have precisely predicted safe co-administration of 600 mg of mifepristone.” “But Teva was required to prove a reasonable expectation of success in achieving the specific invention claimed, a 600 mg dosage.”

Second, Teva faulted the Board for not applying the Federal Circuit’s prior-art-range precedents—cases in which a claimed range of values overlap the ranges disclosed in the prior art. The Board had declined to apply those cases because it found that Teva “had failed to prove the general working conditions disclosed in the prior art encompass the claimed invention.” The Federal Circuit ruled that substantial evidence supported the Board’s finding. The prior art capped the range of co-administration dosages at 300 mg per day, supporting the Board’s finding “that the prior art ranges do not overlap with the claimed range.”

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AstraZeneca AB, et al. v. Mylan Pharmaceuticals, Inc., et al., No. 2021-1729 (Fed. Cir. (N.D. W.Va.) Dec. 8, 2021). Opinion by Stoll, joined by Hughes. Opinion dissenting in part by Taranto.

AstraZeneca sued Mylan for infringement of three patents relating to an inhaler asthma treatment. The claims are directed to pharmaceutical compositions that include certain active compounds as well as a number of inactive ingredients at specific concentrations. One of the claimed inactive ingredients is “PVP K25” that “is present at a concentration of 0.001% w/w.”

The district court construed the claim term “0.001%” according to its plain and ordinary meaning “expressed with one significant digit.” Mylan stipulated to infringement under that construction. The district court then held a bench trial on validity of the asserted claims and made several findings supporting validity, including that one of the prior art references taught away from the claimed invention. Mylan appealed.

Mylan argued that the district court erred in its claim construction because the requirement of “0.001% within one significant figure” encompasses a concentration of PVP in the range of 0.0005% to 0.0014%. Mylan argued that the term has a narrower meaning in view of the specification and prosecution history—namely, “precisely 0.001% w/w PVP with only minor variations.”

The Federal Circuit agreed with Mylan, noting that the issue “is a close call.” The court stated that “0.001%,” being expressed with only one significant digit, would ordinarily encompass a range from 0.0005% to 0.0014%. But here, “taken as a whole, the intrinsic record supports a narrower construction.” The Federal Circuit explained that “both the written description and prosecution history place considerable emphasis on the stability of the claimed formulations, i.e., formulations with 0.001% w/w PVP, compared to formulations with slightly higher or slightly lower concentrations of PVP, including for example 0.0005% w/w.” “Thus, while an acontextual read of the term 0.001% might encompass amounts of an excipient or active ingredient between 0.0005% and 0.0014%,” here the intrinsic record indicated that “the claimed formulations with 0.001% w/w PVP were intended to be more exact.”

The Federal Circuit therefore vacated the stipulated judgment of noninfringement and remanded for further proceedings under the proper construction. The Federal Circuit also concluded that the district court did not clearly err in finding that the prior art taught away from the claimed invention, and thus the Federal Circuit affirmed the judgment of no invalidity.

Judge Taranto dissented with respect to the construction of “0.001% w/w.” In his view, 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” (but “with only one possible interval-shrinking change” that Judge Taranto noted “cannot matter in this case”). He explained that the majority’s construction should be rejected “for the simplest of claim-construction reasons”: “Adopting this construction requires rewriting the claim term. And that rewriting is counter to the specification and prosecution history,” where AstraZeneca had “uniformly used just one significant figure when referring to PVP concentrations in its compositions.”

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