Case 1:13-cv-01215-TSC Document 239-1 Filed 03/31/22 Page 137 of 187
“attempt to freely distribute standards incorporated by reference into law qualifie[s] as a use that further[s] the purposes of the fair use defense.” ASTM, 896 F.3d at 449. See also id. at 451 (“Faithfully reproducing the relevant text of a technical standard incorporated by reference for purposes of informing the public about the law obviously has great value.”) (emphasis added). However, the court finds that the incorporated standard does not provide information essential for a private entity to comprehend its legal duties, but rather is incorporated as a reference procedure. Accordingly, “while knowing the content of this incorporated standard might help inform one’s understanding of the law,” it “is not essential to complying with any legal duty,” and thus, Defendant’s use is less transformative and “its wholesale copying, in turn, less justified.” ASTM, 896 F.3d at 450.
- Second Factor: The “express text of the law falls plainly outside the realm of copyright protection.” ASTM, 896 F.3d at 451. Here, the text published by Defendant is identical to text that was incorporated into law without limitation, such that “the consequence of the incorporation by reference is virtually indistinguishable from a situation in which the standard had been expressly copied into law.” Id. at 452. Accordingly, “this factor weighs heavily in favor of fair use.” Id.
- Third Factor: The incorporating regulation does not specify that only certain provisions of the text in ASTM D3236-88 are incorporated by reference into law, nor does it indicate which specific provisions of the standard are relevant for regulatory compliance, suggesting that “a greater amount of the standard’s text might be fairly reproduced.” Id.
- Fourth Factor: Defendant’s reproductions have not had a “substantially adverse impact on the potential market for the originals,” nor have Plaintiffs shown by a preponderance of the evidence that there is a meaningful likelihood of future harm.” Memo Op. at 30–36 (internal quotation and citation marks omitted).
- Conclusion: Defendant may fairly reproduce the text of ASTM D3236-88 (1999) in its entirety.
- ASTM D3697 1992 (1996):
- Defendant identifies 21 C.F.R. § 165.110 (2015) as the incorporating by reference regulation, see Becker Decl. ¶ 57, Ex. 90 at 18, which incorporates ASTM D3697-92. While the regulation incorporates ASTM D3697-92, not the 1996 version that Defendant published, the text of the two standards is identical. See Pls. 2d SMF ¶ 35; Def. Statement of Disputed Facts at ¶ 35 (no objection); Def. Mot. at 10 (citing Def. 2d SMF ¶ 84).
Section 165.110 requires that “Analyses to determine compliance with the requirements of paragraph (b)(4)(iii)(A) of this section shall be conducted in accordance with an applicable method and applicable revisions to the methods listed in paragraphs (b)(4)(iii)(E)(1),” which includes the requirement that “Antimony shall be measured using,” in part, ASTM D3697-92. 21 C.F.R. § 165.110(b)(4)(iii)(E)–(E)(1)(iv). The regulation does not specify that only certain provisions of ASTM D3697-92 are incorporated by reference into law, nor does it indicate which specific provisions of ASTM D3697-92 are relevant for compliance with the regulation.
- Defendant identifies 21 C.F.R. § 165.110 (2015) as the incorporating by reference regulation, see Becker Decl. ¶ 57, Ex. 90 at 18, which incorporates ASTM D3697-92. While the regulation incorporates ASTM D3697-92, not the 1996 version that Defendant published, the text of the two standards is identical. See Pls. 2d SMF ¶ 35; Def. Statement of Disputed Facts at ¶ 35 (no objection); Def. Mot. at 10 (citing Def. 2d SMF ¶ 84).
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