A recent blog published in IPWatchdog expresses outrage at accurate observations made by James Love, director of Knowledge Ecology International (KEI), that former Senators Birch Bayh and Bob Dole acquired financial ties to the pharmaceutical industry between the enactment of the Bayh-Dole Act in 1980 and a 2002 letter to the editor in the Washington Post authored by the former senators. The letter argued that the Bayh-Dole Act was never intended to regulate drug prices, an argument that stands in conflict with the statute’s plain language.
According to the blog, it is “mean spirited” and “galling” for someone to raise questions about the reliability of Bayh and Dole’s statements in the letter.
Love’s statements were made during a public hearing organized by the National Institute of Standards and Technology (NIST), the agency that is charged with promulgating regulations implementing the Bayh-Dole Act and is proposing modifications that would weaken the statute’s public interest safeguards, including but not limited to the government’s ability to march-in and issue a compulsory license on a federally-owned invention when the contractor charges an unreasonable price for the resultant product.
The blog was written by Joseph Allen, a former staffer to former Senator Bayh, and for many years, an ardent crusader against the public interest safeguards under the Bayh-Dole Act. Allen likes to be referred to as one of the “founding fathers” of the Bayh-Dole Act.
Allen argues that because Bayh and Dole sponsored the bill, the public should defer to their statements on the statute’s intent. Anyone who questions the reliability of their statements, according to Allen, should be chastised for personally attacking the former Senators.
This would be of minor importance, but the notion that Bayh and Dole’s statements about march-in rights and reasonable pricing obligations in the Bayh-Dole Act are authoritative as regards legislative intent are at the heart of NIST’s proposals to gut the reasonable pricing obligation. This post-enactment legislative history, moreover, has been echoed by dozens of march-in critics in supporting the proposal.
The issue is thus whether statements made by the sponsors of a bill, decades after it was enacted, are reliable and entitled to deference on the meaning of a statute, including, in this case, when both sponsors have been or currently are employed as lobbyists and influencers for rights holders and drug companies.
According to accepted standards of statutory interpretation applied by the United States Supreme Court and dozens of other court cases, the answer is resoundingly: no.
In Graham County Soil and Water Conservation District v. United States ex rel. Wilson, the U.S. Supreme Court held that a statement by the sponsors of a statute, made 13 years after the law was enacted, “d[id] not qualify as legislative ‘history,’” and “[wa]s consequently of scant or no value” in construing the statute. Graham Cty. Soil & Water Conservation Dist. v. U.S. ex rel. Wilson, 559 U.S. 280, 298 (2010). Similarly, in Bruesewitz v. Wyeth, the Supreme Court observed that “[p]ost-enactment legislative history (a contradiction in terms) is not a legitimate tool of statutory interpretation[,]” because “by definition” it “could have had no effect on the congressional vote[.]” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 242 (2011)(quotation omitted). There are at least sixty-two cases that quote Bruesewitz v. Wyeth for this proposition. Even the contemporaneous statements of a bill’s sponsors are not legitimate, relevant, or controlling in interpreting the legislation. See 73 Am. Jur. 2d Statutes § 82 (stating that when interpreting statutes, “[t]he opinions of individual legislators, or the testimony of a member of the legislature as to the intention of the legislature in enacting a statute, may not be given consideration”); 73 Am. Jur. 2d Statutes § 88 (observing that the “views of a single legislator, even a bill’s sponsor, are not controlling on the meaning of legislation” and that “[t]he motive or purpose of the drafters of a statute is not relevant to its construction”).
As further evidence that the former Senators’ views on the intent of the Bayh-Dole Act are not controlling, the Supreme Court resolved a dispute regarding the meaning of another provision of the Bayh-Dole Act contrary to the interpretation advanced by Bayh in an amicus brief. Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, 563 U.S. 776 (2011).The opinion did not cite Bayh’s brief. Id.