Methylphenidate – USA

Methylphenidate – USA

On Aug. 16, 2022, New Jersey court gave mixed ruling in QuilliChew ER® Hatch-Waxman litigation.

 

Tris pharma (Plaintiff) sued Teva (Defendant) for infringement of five patents: US 9,545,399; US 9,844,544; US 9,844,545; US 11,103,494 and US 11,103,495. Teva filed ANDA seeking to produce and sell a generic version of QuilliChew ER®.  Tris alleges that Teva’s proposed generic product would infringe claims 22 and 24 of the ’399 patent; claim 37 of the ’544 patent; claims 17, 23, 24, and 28 of the ’545 patent; claim 28 of the ’494 patent; and
claim 23 of the ’495 patent (“asserted claims”). In counter, Teva argued that patents are invalid for obviousness or indefiniteness. The Court conducted a bench trial on these issues beginning on May 23, 2022 and concluding on May 26, 2022. Here is the final conclusion:

 

Teva has established by clear and convincing evidence that that the following claims are invalid for obviousness:

1) Claim 24 of the ’545 patent and

2) the AUC0-∞ and Cmax elements of the claims 22 and 24 of the ’399 patent, claim 37 of the ’544 patent, claims 17, 23, 24, and 28 of the ’545 patent, and claim 28 of the ’494 patent.

Claim 23 of the ’495 patent is fully valid. When shorn of the invalid limitations related to AUC0-∞ and Cmax, claims
22 and 24 of the ’399 patent, claim 37 of the ’544 patent, claims 17, 23, and 28 of the ’545 patent, and claim 28 of the ’494 patent are valid.

Tris has shown by a preponderance of the evidence that all valid asserted claims (i.e., all asserted claims except for claim 24 of the ’545 patent) were infringed by Teva’s ANDA product.

 

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