Trabectedin – USA

Trabectedin – USA

Janssen Products, LP v. Evenus Pharmaceutical Labs. et. al

Case : 20-9369

Judge: Zahid Quraishi

Court: District of Delaware

Date: Apr. 07, 2022 – Claim construction (US 8,895,557 expiring on Jul. 07, 2028)

 

This is a Hatch-Waxman case involving product, Yondelis® (trabectedin) 1 mg/vial product. Defendants (Natco & Sun Pharma) sought construction of following term.

1. A lyophilized anti-tumor composition comprising a single active anti-tumor compound and a disaccharide selected from sucrose, lactose, and a combination thereof, wherein the antitumor compound is ET-743 and wherein the disaccharide is present in a sufficient amount to inhibit conversion of the ET-743 into ET-701, such that the ET-743 composition comprises less than 2% ET-701 after storage of the ET-743 composition at 5°C for 3 months.

 

CONSTRUCTION OF DISPUTED TERM:

1. “a single active anti-tumor compound”

Plaintiff’s construction: Plain and ordinary meaning (no construction needed) or “a single compound providing
the anti-tumor activity of the composition”

Defendants’ construction: “single compound possessing anti-tumor properties”

Court’s construction: Plain and ordinary meaning

 

Court said that the term “comprising” in claim is a transitional phrase which represents open claim language that would not exclude additional unrecited elements. The claim later specifies, however, that the antitumor compound “is ET-743,” effectively limiting the universe of claimed anti-tumor compounds to ET-743. The fact that the claim excludes ET-701 as an active is clear because ET-701 is instead specified in the claim as a compound whose formation is to be kept to no more than 2% upon storage at the stated condition. Moreover, in specification ET-701 is absent from the list of exemplary ecteinascidin compounds identified in the Background of Invention section. Instead, consistent with the claims, the specification calls ET-701 out as the main impurity that is produced when ET-743 is lyophilized and stored. Court thus concluded that while the specification may broadly contemplate other ET compounds as an active ingredient for the formulations of the invention, the specification more specifically supports the plain and ordinary meaning of the claim, under which ET-743 is the sole active anti-tumor compound.

 

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