Clear Disavowal in Specification Can't be Remedied by Non-Material Change in Claims
Friday, August 30, 2019

Addressing an appeal from four related actions concerning Orange Book patents covering Suboxone® sublingual film, the US Court of Appeals for the Federal Circuit affirmed the district court’s judgments that certain generic manufacturers did not infringe a patent because the specification limited the scope of the claims by disparaging a particular embodiment. Indivior Inc. et al. v. Dr. Reddy’s Laboratories, S.A. et al., Case Nos. 17-2587, 18-1010, -1058, -1062, -1114,  -1115, -1176, -1177 (Fed. Cir. July 12, 2019) (Lourie, J) (Mayer, J, dissenting).

Indivior markets and holds the new drug application for Suboxone film, an opioid addiction treatment that combines the opioid buprenorphine and the opioid antagonist naloxone. Suboxone film is applied below a patient’s tongue, where it rapidly dissolves to release the active ingredients. Indivior owns patents that generally relate to methods of producing films that have drug content uniformity using controlled drying techniques that avoid the rippling problems produced by conventional drying methods. The specification distinguished Indivior’s invention from conventional drying methods, which apply hot air to the top of the film, thus producing non-uniform films.

Several generic drug companies filed abbreviated new drug applications (ANDAs) to market generic versions of Suboxone film. Indivior then brought several actions for patent infringement against the generic drug manufacturers, including Dr. Reddy’s Laboratories (DRL), Watson and Alvogen, accusing them of infringing Indivior’s patents. After conducting four bench trials, the district court found that two patents were not invalid, that DRL did not infringe those two patents and that Alvogen did not infringe one of those patents. In finding noninfringement, the district court relied on the patentee’s disclaimer and construed the drying limitation to mean “dried without solely employing conventional convection air drying from the top,” finding that this limitation, as construed, was not met by the accused films. The generic drug manufacturers appealed the validity finding, and Indivior cross-appealed the noninfringement findings against DRL and Alvogen.

On appeal, the Federal Circuit found that the district court correctly construed the drying limitation because the patent specification disclaims conventional top air drying. In doing so, the Court cited the patent specification’s express statements regarding what the applicant regarded the invention to be, its repeated disparagement of conventional top drying methods, and the patent applicant’s characterization of the invention during prosecution. The Court further noted that it had previously concluded that the same language in the specification in a related patent limited the scope of the claims, even though the patentee had specifically amended the claims to remove the words “dried” and “drying.”

Affirming that the patent specification unmistakably disclaimed conventional top air-drying, the Federal Circuit concluded that DRL’s and Alvogen’s ANDA products did not infringe.

The majority also concluded that the generic companies had failed to prove that any of the asserted patents were invalid by clear and convincing evidence, finding that the claims were neither indefinite nor obvious.

In his dissent, Judge Mayer argued that a person of skill in the art “would have readily recognized that switching the location of the heat source from the top to the bottom would likely ameliorate the problem of films that were overly dry on the top and overly wet on the bottom. Indeed, any person having basic familiarity with a kitchen oven would certainly appreciate that, since hot air rises, heating an item from the bottom rather than the top facilitates uniform baking.” Quoting KSR, Mayer stated that “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress,” and that “‘[r]igid preventative rules that deny factfinders recourse to common sense’ have no place in the obviousness analysis.”

Practice Note: A specification can limit the scope of a claim (regardless of the specific claim language used) where it repeatedly disparages a particular embodiment. Here, the specification disparaged conventional top air drying, explaining that it did not produce uniform films, which were the central object of the claimed invention. Such statements, especially when coupled with examples of disparaging comparisons, may preclude a patentee from claiming the full scope of the invention if a court finds that the disclaimer is unequivocal and clear. Moreover, such disparagement may also affect related applications in the same family.

 

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