Federal Circuit Review | April 2024

April 2024 Federal Circuit Newsletter (Japanese)

April 2024 Federal Circuit Newsletter (Chinese)

Obviousness Analysis Does Not Consider Unclaimed Limitations

In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals Usa, Inc., Appeal No. 22-1258, the Federal Circuit held that district court erred by adding unclaimed limitations to the claims in analyzing obviousness.

Janssen sued Teva for infringement of a patent claiming a dosing regimen for administering paliperidone to treat schizophrenia.  Specifically, the patent claimed a long-acting dosing regimen, comprising a series of three intramuscular injections.  Teva stipulated to infringement but challenged validity.  After a bench trial, the district court found, among other things, that Teva had not proven that the claims were invalid as obvious.

On appeal, the Federal Circuit vacated the district court’s determination that the claims were not obvious.  First, Teva argued that the district court improperly considered unclaimed limitations in analyzing obviousness.  The district court found that Teva’s prior art did not demonstrate general-population-wide safety and efficacy and thus did not teach a generalized dosing regimen.  However, the Federal Circuit noted that the asserted claims recite a dosing regimen for “a psychiatric patient in need of treatment for schizophrenia” and that “[n]othing in the claims requires that the regimen be used for . . . the patient population generally or a certain percentage of the patient population.”  The Federal Circuit remanded because this misunderstanding about the claims permeated the district court’s obviousness analysis.

Second, Teva argued, and the Federal Circuit agreed, that the district court’s obviousness analysis was “erroneously rigid” and did not comport with KSR.  The district court concluded there was no reason to combine Teva’s prior art references because of differences in doses and injection sites.  The Federal Circuit explained that the district court’s “siloed and inflexible approach” left insufficient room for a POSITA’s ordinary creativity, “thereby inflating the significance of minor variations between the prior art and the claims.”  This error also required remand.

Going Down with the Ship: Non-Infringing Indications in ANDA Applications Are Barred by Infringing Indications Under Section 271(e)(4)(A)

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals., Inc., Appeal No. 22-2153, the Federal Circuit ruled that an ANDA listing an infringing indication cannot be approved during the pendency of the infringed patent even if the ANDA also lists a non-infringing indication. 

Norwich filed an abbreviated new drug application (ANDA), seeking approval of a generic version of rifaximin to treat hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea.  Salix sued Norwich in the District of Delaware for infringement of various patents, including patents directed to methods of treating HE with rifaximin.  After a bench trial, the district court found the HE patents valid and infringed.  The district court therefore instructed the FDA that Norwich’s ANDA should not be approved before the expiration of the HE patents in accordance with 35 U.S.C. § 271(e)(4)(A). Norwich subsequently amended its ANDA application to remove the infringing indication for treatment of HE with rifaximin.  Norwich then moved to amend the final judgment to allow its ANDA application to be approved immediately for the noninfringing restrictions.  The district court denied the motion to modify the judgment.

On appeal, Norwich argued that the district court misinterpreted Section 271(e)(4)(A) in ordering the FDA to withhold approval of its ANDA until the HE patents expired.  Norwich argued that, in requiring the FDA to restrict “infringement,” the statute required the restriction of only the infringing indications in the ANDA. Norwich also argued that the district court abused its discretion in denying Norwich’s motion to amend the judgment in view of the amendments to the ANDA application.

The Federal Circuit affirmed.  The court held that, for purposes of Section 271(e)(4)(A)’s requirement that the FDA restrict infringement, the relevant infringement “is the submission of the ANDA that included an infringing use.”  “That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission.”  Thus, the district court correctly barred approval of the entire ANDA application under Section 271(e)(4)(A).

The Federal Circuit also held that the district court did not abuse its discretion when it denied Norwich’s motion to amend the judgment based on the amended ANDA application. The Federal Circuit stressed that Norwich had presented no evidence that the amended ANDA would not infringe the HE patents, and that making that determination “would essentially be a second litigation.”

Unclean Hands and Inequitable Conduct: Dishonesty Is Not the Best Policy

In Luv N’ Care, Ltd. v. Laurain, Appeal No. 22-1905,  the Federal Circuit held that the district court correctly found unclean hands, but erred by finding no inequitable conduct without addressing the collective weight of the evidence of prosecution misconduct. 

Luv N’ Care (“LNC”) sued Laurain and Eazy-PZ, LLC (collectively “EZPZ”) seeking a declaratory judgment that LNC did not infringe EZPZ’s patent for self-sealing dining mats for toddlers.  EZPZ counterclaimed for patent and trade dress infringement.  After a bench trial, the district court found that LNC failed to prove EZPZ’s patent was unenforceable for inequitable conduct.  The district court determined EZPZ’s misrepresentations to the USPTO about the self-sealing functionalities of certain prior art only showed EZPZ’s gross negligence, not deceptive intent.  However, the district court found that unclean hands barred EZPZ’s infringement counterclaims.

The Federal Circuit affirmed the finding of unclean hands.  The Federal Circuit agreed that EZPZ attempted to gain an unfair advantage in the litigation through deceit and reprehensible conduct, including by failing to disclose related patent applications relevant to claim construction until after the close of discovery and motion practice, lying about the existence of responsive documents and prior art searches, and “repeatedly provid[ing] false testimony” during depositions and at trial.

The Federal Circuit vacated and remanded the district court’s determination of no inequitable conduct.  On appeal, LNC argued that the district court erred by failing to consider EZPZ’s overall conduct and finding that EZPZ’s misrepresentations about the self-sealing functionality of a prior art mat did demonstrate a specific intent to deceive the PTO.  The Federal Circuit agreed.  The Federal Circuit found that the district court erred by considering EZPZ’s acts of prosecution misconduct “in isolation,” and that it “failed to address the collective weight of the evidence regarding each person’s misconduct as a whole.”  The Federal Circuit also explained that EZPZ’s selective disclosure and “purposeful omission” of material information may “be indicative of a specific intent to deceive the PTO.”  Thus, the Federal Circuit held that, on remand, the district court should consider whether EZPZ’s prosecution misconduct, collectively with its other acts of misconduct, show that either person involved in the misconduct intended to deceive the PTO.