IP Law Daily Glenmark’s ANDA infringed Intraserv’s skin medication patent
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Monday, May 16, 2016

Glenmark’s ANDA infringed Intraserv’s skin medication patent

By Mark Engstrom, J.D.

A federal district court did not err in finding that Glenmark Pharmaceuticals infringed an Intraserv patent titled “Composition with Azelaic Acid” by submitting an Abbreviated New Drug Application for a generic version of Finacea Gel, a skin medication that contained azelaic acid as a therapeutically active ingredient, the U.S. Court of Appeals for the Federal Circuit has ruled (Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, May 16, 2016, Moore, K.). The judgment of the district court was therefore affirmed.

Intendis Gmbh, Intraserv Gmbh, and Bayer Healthcare Pharmaceuticals sued Glenmark Pharmaceuticals Inc., USA, and Glenmark Pharmaceuticals Ltd. for the infringement of U.S. Patent No. 6,534,070, which was assigned to Intraserv and was exclusively licensed to Intendis.

The patent covered Finacea Gel, which contained azelaic acid as the therapeutically active ingredient, and triglycerides and lecithin as inactive ingredients, or “excipients.” Unlike Finacea Gel, the proposed generic product substituted isopropyl myristate for the claimed triglyceride and lecithin.

The district court concluded that 12 claims of the patent in suit were not invalid and were infringed under the doctrine of equivalents. It entered a final judgment in favor of Intendis, Intraserv, and Bayer, and it directed the FDA to withhold approval of Glenmark’s Abbreviated New Drug Appplication (ANDA) until the November 18, 2018 expiration of the patent in suit. Glenmark appealed.

Glenmark argued that: (1) the district court had erred in its application of the function prong of the function-way-result test for infringement under the doctrine of equivalents; (2) infringement under the doctrine of equivalents would encompass the prior art; (3) the appellees had expressly disavowed and disclaimed a formulation without lecithin; and (4) the district court erred in its obviousness analysis. All four arguments were unavailing.

Glenmark challenged the district court’s determination that Glenmark’s isopropyl myristate performed substantially the same function as the claimed triglyceride and lecithin. The circuit court had to decide whether the district court had clearly erred when it found that triglyceride and lecithin functioned as penetration enhancers in the claimed compounds.

The circuit court found no clear error in the district court’s finding of infringement under the doctrine of equivalents. First, it did not agree that the lack of disclosure of the claimed excipients as penetration enhancers in the patent in suit was fatal to a claim of infringement. The Federal Circuit had never held that a patent had to spell out a claim element’s function, way, and result in order for the doctrine of equivalents to apply as to that element. To the contrary, the court had held that, when the claims and specification of a patent were silent regarding the result of a claim limitation, the court should consider the ordinary skilled artisan.

Glenmark argued that the district court had erred in finding that the claimed excipients functioned as penetration enhancers in light of the evidence of record. Fatal to Glenmark’s argument, however, was its own ANDA submission to the FDA, which repeatedly referred to the claimed excipients (triglyceride and lecithin) as “penetration enhancers.”

The circuit court saw no reason why a district court acting as a fact finder should ignore a party’s representation to a federal regulatory body that was directly on point. Ultimately, the district court’s finding regarding the function of the claimed excipients was not clearly erroneous. Because Glenmark’s arguments did not persuade the circuit court that the district court had clearly erred in finding that the isopropyl myristate in Glenmark’s generic product performed substantially the same function as the claimed triglyceride and lecithin, the circuit court concluded that the district court did not clearly err in its doctrine of equivalents findings.

Glemark’s argument regarding obviousness, prosecution history estoppel, and the scope of equivalency capturing the prior art were similarly unavailing. Because the court found no reversible error in the district court’s finding that: (1) Glenmark’s generic product infringed the asserted claims and (2) the asserted claims were not invalid, the judgment of the district court was affirmed.

The case is No. 2015-1902.

Attorneys: Bradford J. Badke and Sona De (Sidley Austin LLP) for Intendis GmbH, Intraserv GmbH & Co. KG, and Bayer Healthcare Pharmaceuticals Inc. William M. Jay, Brian Timothy Burgess, Elizabeth Holland, Linnea P. Cipriano, Huiya Wu, and David Zimmer (Goodwin Procter LLP) for Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd.

Companies: Intendis GmbH; Intraserv GmbH & Co. KG; Bayer Healthcare Pharmaceuticals Inc.; Glenmark Pharmaceuticals Inc.; Glenmark Pharmaceuticals Ltd.

MainStory: TopStory Patent FedCirNews

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