1
GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., No. 18-1976 (Fed. Cir. Oct. 2, 2020) (“Slip Op.”),
available at
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1976.OPINION.10-2-2020_1663180.pdf see also --- F.3d ---, 2020 WL 5856868
2Under 21 U.S.C. § 355(j)(2)(A), an abbreviated application for a new drug (commonly referred to as an “ANDA”) “shall contain (i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a [listed drug, i.e., the branded product],” and section viii (§ 355(j)(2)(A)(viii)) allows the ANDA-filer to include a statement that it is not seeking approval for a method of use that is claimed in a patent that is listed in the Orange Book for the branded product.
3Slip Op., Dissent at 7.
4Slip Op. at 7.
5
Id. at 8 (emphasis in original).
6
Id. at 3.
7Slip Op., Dissent at 4.
8Teva argued that the district court’s jury instruction concerning lost profits damages was incorrect because it “require[d] the jury to ignore the reality of the marketplace,” which consisted of multiple generic manufacturers of carvedilol “who had not been sued for infringement.” Slip Op. at 19. Teva had sought a jury instruction requiring that GSK prove that “for every infringing sale made by Teva, the direct infringer would have purchased the prescribed carvedilol as GSK’s Coreg® branded product, and not from another generic producer.” Slip Op. at 18. The majority concluded, however, that the “district court correctly instructed the jury that the availability of carvedilol from other generic producers is not a ‘non-infringing substitute.’” Slip Op. at 20. The dissent did not address this.
9
See Coreg® Product Label and Full Prescribing Information, Revised Dec 2008,
available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf
10Slip Op. at 3-4.
11
Id. at 4.
12
Id. at 5.
13Slip Op., Dissent at 8-9.
14
Id.
15Slip Op., Dissent at 8-9.
16
Id. at 9.
17
Id. at 23.
18Slip Op. at 5.
19Slip Op., Dissent at 9.
20
Id.
21Slip Op. at 13, Dissent at 9.
22Slip Op., Dissent at 10.
23Slip Op. at 6 (modification in original incorporated).
24Slip Op., Dissent at 10 (emphasis in original).
25Slip Op. at 6.
26
Id. at 7.
27
Id. at 8.
28
Id.
29
Id. at 10 (quoting 35 U.S.C. § 271(b)).
30Slip Op. at 11 (citing
Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 770-71 (2011)).
31
Id. (quoting
MGM Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936 (2005)).
32Slip Op. at 11 (quoting
Power Integrations, Inc. v. Fairchild Semiconductor, Int’l, Inc., 843 F.3d 1315, 1335 (Fed. Cir. 2016)).
33Slip Op. at 11-12 (citing
Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1369 (Fed. Cir. 2017);
Sanofi v. Watson Labs. Inc., 875 F.3d 636, 645 (Fed. Cir. 2017);
AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010);
Mentor H/S, Inc. v. Med. Device All., Inc., 244 F.3d 1365, 1379 (Fed. Cir. 2001)).
34Slip Op. at 10.
35
Id. at 12 (quoting Teva’s June 9, 2004 press release).
36Slip Op. at 13-14 (quoting trial transcript).
37
Id. (modification in original, quoting trial transcript).
38
Id. at 14 (quoting trial transcript).
39
Id. at 14-15 (quoting trial transcript).
40
Id. at 15 (quoting trial transcript).
41Slip Op. at 14.
42
Id. (quoting trial transcript).
43
Id. at 15.
44
Id.
45
Id. at 16.
46
Id.
47Slip Op. at 16.
48
Id. at 15 (quoting jury instructions).
49Slip Op., Dissent at 1.
50
Id. at 1-2.
51
Id. at 2-3.
52
Id. at 2-3 (emphasis in original).
53
Id. at 3.
54Slip Op., Dissent at 4 (citing
Caraco Pharm. Labs., Ltd. v. Novo Nordisk, 566 U.S. 399, 405 (2012)).
55
Id. at 7.
56
Id. at 17-18 (citing
Vanda Pharm., Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1129 (Fed. Cir. 2018) and
Sanofi v. Watson Labs. Inc., 875 F.3d 636, 646 (Fed. Cir. 2017)).
57
Id. at 18 (emphasis in original).
58
Id. at 19.
59
Id. at 19 (citing
Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364-65 (Fed. Cir. 2003)).
60Slip Op., Dissent at 19-20 (citing
Takeda Pharm. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 631-32 (Fed. Cir. 2015)).
61
Id. at 20.
62
Id.
63Slip Op., Dissent at 20 (citing
Warner-Lambert, 316 F.3d at 1364;
Takeda Pharm., 785 F.3d at 631).
64
Id. at 28.
65Slip Op. at 17.
66Slip Op., Dissent at 17.