Linagliptin / Linagliptin & Metformin – USA

Linagliptin / Linagliptin & Metformin – USA

On Oct 15, 2018, New Jersey district court found two patents of Boehringer Ingelheim related to antidiabetic drug(s) invalid.
According to news, Court found in favor of Defendants (Mylan & Aurobindo) which were seeking to market generic versions of Tradjenta® (linagliptin) and Jentadueto® (linagliptin/metformin), for treatments of controlling blood sugar levels in patients with type 2 diabetes. In 2015, Boehringer Ingelheim Corporation brought a Hatch–Waxman suit & trial was held in Aug 2018. Court ruled that the two patents-in-suit (US 8,673,927 & US 9,173,859 expiring in May 2027) were invalid on grounds of both non-statutory double patenting and obviousness. Specifically order states that the Claims 7, 9, 15, 17, 19, 25, 26 of ‘927 Patent and Claims 1, 14, 15, 20, and 21 of ‘859 Patent are invalid on the grounds of non-statutory double patenting; The Claims 7, 9, 15, 17, 19, 25, 26 of ‘927 Patent and Claims 1, 14, 15, 20, and 21 of ‘859 Patent are invalid due as obvious in view of the prior art under 35 U.S.C § 103.

The case is Boehringer Ingelheim Pharms., Inc. v. HEC Pharm Co., No. 3:15-cv-05982. The Memorandum is sealed for a period of sixty days within which the parties shall confer and redact the Memorandum.

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