Attorneys for Branded Companies Should Carefully Review ANDAs for Admissions Regarding Generic Infringement


Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals.[1] In so doing, the label would closely reflect limitations in the asserted patent claims to best insure that actions for infringement, particularly inducement of infringement of method-of-treatment patents are successful, and situations like those in Bayer Schering Pharma AG v. Lupin, Ltd.[2] could be avoided. There, Bayer's inducement action was dismissed where the claimed method simultaneously treated three separate medical conditions but the approved label only mentioned one. The lack of conformity between the label and the patent claims proved fatal. Here, it is recommended that regulatory attorneys and patent attorneys carefully review ANDAs to uncover admissions by generic filers that would assist patentees in proving infringement, especially under the doctrine of equivalents.

As one example, a generic company could specify the "function" of a component in a purposed formulation and that would assist the patentee attorney satisfying the function prong of the tripart test for infringement doctrine of equivalents.  See, e.g., Par Pharmaceutical, Inc. v. Hospira, Inc.[3]; Shire Development, LLC v. Mylan Pharmaceuticals, Inc.[4] Similarly, any statements by the generic that its purposed product was designed to "mimic" certain claimed properties of the branded version would similarly assist the patentee. See generally Wyeth v. Sandoz, Inc.[5]

An ANDA, of course, must characterize the proposed generic product, its formulation or use, where applicable. However, little need for an infringement inquiry is required where an ANDA "define[s] the compound in a manner that directly addresses the question of infringement." Abbott Laboratories v. Torpharm, Inc.[6]  The critical effect of statements by a generic in its ANDA is best illustrated in the Federal Circuit's decision in Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc.,[7] where the court stated:

[I]f an ANDA specification defines a compound such that it meets the limitations of an asserted claim, then there is almost never a genuine issue of material fact that the claim is infringed.[8]

There, statements in Teva's ANDA indicating that it could market a product within the scope of the patent claims trumped its promise not to do so. In other words, "[s]imply saying 'But I won't do it' is not enough to avoid infringement."[9]

A damaging characterization by generic was clearly exemplified in Intendis GMBH v. Glenmark Pharmaceuticals Inc., USA,[10] where the issue was whether Glenmark's isopropyl myristate excipients performed substantially the same function as the claimed triglyceride and lecithin excipients, i.e., as penetration enhancers. In affirming the district court's holding of infringement under the doctrine of equivalents, the Federal Circuit stated:

[The District Court also reasoned that] Glenmark's ANDA included repeated statements that both Glenmark's excipient and the claimed excipients function as penetration enhancers. It noted that Glenmark "should not be permitted to liken their product to the claimed composition to support their bid for FDA approval, yet avoid the consequences of such a comparison for purposes of infringement."[11]

In rejecting Glenmark's arguments, the court stated: "Fatal to Glenmark's argument is its own ANDA submission to the FDA repeatedly referring to the claimed excipients (triglyceride and lecithin) as penetration enhancers."[12] Accordingly, careful attention should be paid to a generic's characterization of the properties of its proposed product.

Similarly, in Recro Gainesville LLC v. Actavis Laboratories FL, Inc.,[13] the court found infringement under doctrine of equivalents based, in part, on statements in Actavis' ANDA. The key dispute was whether Actavis' ethylcellulose-based coating was equivalent to the claimed polyacrylic coatings. The court found that statements in the ANDA supported Recro's argument that both coatings function "in substantially the same way."[14] Thus, the court held that Actavis' "ethylcellulose-based coating performs the same function as the claimed polyacrylic coatings."[15]

However, statements in an ANDA can often assist a generic. For one example, in Bayer AG v. Elan Pharmaceutical Research Corporation,[16] the asserted claims required that the product's surface area was less than a given numerical value. Because the ANDA explicitly stated that the surface area of the final product would exceed the claimed value, summary judgment of non-infringement was granted.[17] It would appear that the ANDA was drafted with the patent claims in mind. Attorneys for branded companies should be aware of these purported "helpful" statements by the generic and be prepared to counter them.


Authors: Brian Coggio and Katie Ning

[1] Coggio, "Drug Labels Can Provide Specific Intent' for Inducement," Law360 (Oct. 3, 2014).

[2] 676 F.3d 1316, 1321-22 (Fed. Cir. 2012).

[3] 420 F. Supp. 3d 256, 263-65 (D. Del. 2019).

[4] 235 F. Supp. 3d 1298, 1317 (M.D. Fla. 2017).

[5] 703 F. Supp. 2d 508 (E.D.N.C. 2010).

[6] 300 F.3d 1367, 1374 (Fed. Cir. 2002).

[7] 731 F.3d 1271 (Fed. Cir. 2013); see also In re Wellbutrin XL Antitrust Litig., 868 F.3d 132, 149-50 (3d Cir. 2017).

[8] Sunovion, 731 F.3d at 1280.

[9] Id.

[10] 822 F.3d 1355 (Fed. Cir. 2016).

[11] Id. at 1361 (quoting Intendis GMBH v. Glenmark Pharm. Ltd., 117 F. Supp. 3d 549 (D. Del. 2015)).

[12] Id.

[13] 2017 WL 1064883 (D. Del. 2017).

[14] Id. at *6.

[15] Id. at *5.

[16] 212 F.3d 1241 (Fed. Cir. 2000).

[17] Id. at 1248-50; see also Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1567 (Fed. Cir. 1997).