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The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a patent, the US Court of Appeals for the Federal Circuit upheld the district court’s finding of noninfringement. Galderma Laboratories, L.P. v. Lupin Inc., Case No. 24-1664 (Fed. Cir. Dec. 6, 2024) (Moore, C.J.; Linn, Prost, JJ.)

Galderma owns and markets Oracea® (doxycycline USP) 40 mg capsules, which are used to treat papules and pustules associated with rosacea. Galderma’s patents cover a unique once-daily oral formulation of doxycycline, combining 30 mg of immediate release (IR) and 10 mg of delayed release (DR) pellets. Lupin filed an ANDA to market a bioequivalent 40 mg doxycycline product, featuring 22 mg IR and 18 mg DR pellets, and using the same enteric polymer for the DR portion as Oracea®. Galderma sued Lupin under the Hatch-Waxman Act, alleging patent infringement.

Despite Lupin’s different pellet composition, Galderma contended that Lupin’s product effectively contained 30 mg IR and 10 mg DR because of a “weak enteric coat” on the DR pellets, causing early release of some doxycycline. Lupin presented two key pieces of evidence:

  • A two-stage in vitro dissolution test at pH 1.1 and 4.5, showing some DR pellet release at pH 4.5.
  • Bioequivalence data comparing Oracea® and Lupin’s product.

The district court ultimately ruled in favor of Lupin. Galderma appealed. The issue on appeal was whether Galderma’s evidence of bioequivalence and in vitro testing was indeed insufficient to establish literal infringement or infringement under the doctrine of equivalents (DoE).

The Federal Circuit agreed with the district court: in vitro testing and bioequivalence were not enough to establish literal infringement. Crucially, Galderma’s two-stage in vitro dissolution test didn’t accurately mimic in vivo conditions. The Court highlighted that the pH 4.5 environment used in the test wasn’t physiologically relevant for a fasted stomach, which typically has a pH between 1 and 2. Moreover, the bioequivalence data failed to address the differing proportions of IR and DR pellets. Consequently, the Court found no clear error in the district court’s factual findings.

Nor did the DoE save Galderma. The Federal Circuit applied two different tests: the function-way-result test and the insubstantial differences test. Under the function-way-result test the court is charged with determining whether the accused product performs the same function, in the same way, to achieve the same result as the claimed invention. Under the insubstantial differences test – as its name suggests – the court is charged with determining whether the differences between the claimed invention and the accused product are insubstantial.

Again, Galderma relied on bioequivalence data and its in vitro testing to argue that either DoE test was satisfied. The Federal Circuit was not persuaded, finding no clear error in the district court’s reasoning. As for the function-way-result test, the in vitro testing did not show that Lupin’s ANDA product used the same function or method as the asserted [...]

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Means-Plus-Function Claims: Don’t Forget the “Way”

The US Court of Appeals for the Federal Circuit affirmed a lower court’s findings of noninfringement, in part because the plaintiff had failed to prove the “way” element of the function-way-result test for a first means-plus-function claim, and because the specification lacked disclosure of a structure for the “way” to perform a second means-plus-function claim. Traxcell Techs., LLC v. Sprint Commc’ns Co., Case Nos. 20-1852, -1854 (Fed. Cir. Oct. 12, 2021) (Prost, J.); Traxcell Techs., LLC v. Nokia Sols. & Networks Oy, Case Nos. 20-1440, -1443 (Fed. Cir. Oct. 12, 2021) (Prost, J.)

Traxcell asserted several related patents against multiple defendants in parallel litigations. One of the patents related to self-optimizing network technology for making “corrective actions” to improve communications between a wireless device and a network (SON patent). The SON patent included two means-plus-function limitations. One of the other patents related to network-based navigation in which the network, as opposed to the wireless device, determined the device’s location (navigation patent).

Traxcell asserted the SON and navigation patents against Verizon and Sprint in one action and the SON patent against Nokia in another. In both cases, the magistrate judge entered a claim construction order construing several common terms of the asserted patents and determining that the claims of the SON patent were indefinite. The lower court adopted the magistrate’s recommendations and subsequently granted summary judgment for all three defendants on each of the patents. Traxcell appealed. The issues on appeal related to infringement and indefiniteness of means-plus-function claims.

First, Traxcell disputed the lower court’s grant of summary judgment for Sprint on the SON patent, arguing that Sprint’s accused technology included a structural equivalent to the disclosed structure under the function-way-result test. The asserted claim required a “means for receiving said performance data and corresponding locations from said tower to correcting radio frequency signals of said radio tower,” the corresponding function of which was “receiving said performance data and corresponding locations from said tower and correcting radio frequency signals of said tower.” The Federal Circuit explained that the disclosed structure of this means-plus-function limitation was a “very detailed” algorithm in the patent. Citing more than two decades of precedent, the Court emphasized that infringement of means-plus-function claims requires proof of three things: That the accused structure performs the (1) identical function, (2) in substantially the same way (3) with substantially the same result, as the disclosed structure. Because Traxcell neglected to even address at least nine steps of the algorithm, i.e., the disclosed structure, with respect to Sprint’s accused system (opting instead to focus on the function and result), the Court affirmed the lower court’s finding of noninfringement.

Second, the lower court found another claim of the SON patent indefinite based on the specification’s failure to disclose the necessary structure for its means-plus-function limitation. Traxcell did not appeal the indefiniteness finding itself, but sought leave to amend the claim to cure the indefiniteness, the denial of which Traxcell raised on appeal. The Federal Circuit explained that a “means-plus-function claim is indefinite [...]

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