Source: https://www.orangebookblog.com/2011/11/index.html
Timestamp: 2019-04-20 06:48:18+00:00

Document:
LEO Pharma A/S sued Tolmar, Inc. in the District of Delaware for patent infringement under 35 U.S.C. § 271(e)(2) after Tolmar submitted an ANDA for a generic version of DOVONEX, certifying that a certain LEO Pharma patent is invalid or would not be infringed by Tolmar’s ANDA products. Subsequently, LEO Pharma sought to amend its complaint to, among other things, add Teva Pharmaceutical Industries Ltd. as a defendant.
"pursuant to 35 U.S.C. § 271(b), because Teva has 'engag[ed] in a cooperative venture with Tolmar to submit the ANDA and [has] incorporate[d] by reference Teva's DMF thereto to the FDA to obtain approval to engage in the commercial manufacture, use, sale and/or importation’ of Tolmar's ANDA products. . . ."
Although "[p]arties 'actively involved' in preparing an ANDA are deemed to have 'submit[ted]' the ANDA," Cephalon, Inc. v. Watson Pharmaceuticals, Inc., 629 F. Supp. 2d 338, 349 (D. Del. 2009), I decline to extend liability under § 271(e)(2) to third parties for work protected under § 271(e)(1). In this regard, I conclude that the allegation that Teva "participated in the work related to the submission" is distinguishable from actually preparing the ANDA.
In doing so, the court recognized a fine line between "engaging in protected work under § 271(e)(1), which 'enables generic manufacturers to test and seek approval to market' ANDA products, Warner-Lambert, 316 F.3d at 1358, and being 'actively involved in preparing the ANDA,' e.g., by 'contributing employees to the various teams responsible for preparing the ANDA,' and having employees of each prepare and execute ANDA-related documents, Cephalon, 629 F. Supp. 2d at 349. . . ."

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