Intendis GMBH v. Glenmark Pharmaceuticals Inc., USA, Glenmark Pharms., Inc. (Fed. Cir. May 16, 2016) (Before Taranto, Moore, and Prost, C J.) (Opinion for the court, Moore, J.) Click Here for a copy of the opinion.
Bayer Healthcare Pharmaceuticals holds a New Drug Application (NDA) for Finacea® Gel, which is “a topical medication for various skin disorders.” The FDA’s Orange Book lists the ‘070 patent as covering this gel. Glenmark submitted its Abbreviated New Drug Application (ANDA) to the FDA seeking to market a generic version of the gel as well as a paragraph IV certification asserting that the ‘070 patent was invalid and not infringed. The generic gel substituted isopropyl myristate for the claimed triglyceride and lecithin.
The district court held a Markman hearing and a bench trial on infringement and validity. Using the function-way-result test, the district court had determined that the ‘070 patent had been infringed under the doctrine of equivalents (DOE), and that the patent was not invalid. Specifically, the court concentrated on the fact that Glenmark’s generic product met the claim elements of the ingredients used by Bayer, under the doctrine of equivalents. The court rejected Glenmark’s claims that such infringement would encompass the prior art, and that it was barred by prosecution history estoppel. The district court also rejected Glenmark’s argument of obviousness. The court directed the FDA not to approve Glenmark’s ANDA until after the ‘070 patent expired. Glenmark appealed.
The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine of equivalents to apply. It looked to what the claim element’s function in the claimed composition is to one of skill in the art, which it held may be determined by looking at extrinsic evidence. The Court found no error in the district court’s finding of infringement under the doctrine of equivalents. In applying the two part test (constructing a hypothetical claim that covers the accused device and comparing that claim to the prior art), the district court correctly determined that the hypothetical claim properly included the disputed excipients, i.e. Glenmark’s excipient. The district court properly rejected Glenmark’s argument that the hypothetical claim must encompass all penetration enhancers, i.e. prior art enhancers.
The Court also affirmed the district court’s analysis in determining that prosecution history estoppel did not bar a DOE finding. Glenmark argued that the ‘070 patent applicants surrendered a lecithin-free composition, which is the proposed generic product, as an equivalent during prosecution because two dependent claims which recited lecithin concentrations of up to 1% and 3% could include zero lecithin. Applicants argued that those ranges did not include zero because they are depend from claims which clearly required lecithin. The Court disagreed, because a dependent claim can never be broader than its independent claim.
The Court also affirmed the district court’s determination of non-obviousness, finding that a skilled artisan would not have been motivated to combine the prior art, and there was no reasonable expectation of success based on the evidence of record. For all the reasons above, the Court affirmed the district court.
Parker Hancock and Puja Dave contributed to this summary.