ARTICLE · 19 MARCH 2018

Apotex Released From Infringement Finding After Claim Construction Appeal

McDermott Will & Emery

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Second, the Federal Circuit's construction specifies that the extended release coating be a continuous film.

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Krista Vink Venegas

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The US Court of Appeals for the Federal Circuit found that the US District Court for the District of Delaware erred in its claim construction and consequently vacated the ruling that Apotex's proposed abbreviated new drug application (ANDA) product infringed Aptalis/Ivax's asserted patent claiming an extended release form of the muscle relaxant cyclobenzaprine hydrochloride. Aptalis Pharmatech, Inc. v. Apotex Inc., et al., Case No. 2017-1344 (Fed. Cir., Jan. 4, 2018) (Stoll, J).

Aptalis and Ivax own US Patent Nos. 7,790,199 and 7,829,121, which are Orange Book-listed for AMRIX^®, approved for treating muscle spasms. Apotex filed an ANDA seeking to market a generic version of the product prior to patent expiry.

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