Patzke+Background

BACKGROUND MEMO

A triangulation of different events

__1. Justice Breyer’s dissent in__ //__ Lab.Corp. v. Metabolite __//__ (2006): __ Justice Breyer’s dissent establishes an “anti-patent” (for lack of a more nuanced phrase) tone to both USPTO established practices as well as “frivolous” patent cases. At the Supreme Court Level, Chief Justice Roberts dismissed the petition to hear the case because of a legal technicality, what Justice Breyer referred to as a "technical procedural objection."[1] Initially (in the lower courts) //Lab.Corp. v. Metabolite// was a dispute of licensing agreements. However, as the case was petitioned to the Supreme Court, the plaintiff, Lab.Corp. attempted to discard issues of licensing disputes and instead focused on patent validity and whether or not the patent-in-suit claimed a law of nature. Chief Justice Roberts dismissed the case as improvidently granted, citing the lack of foresight on the part of the plaintiff. As cases are petitioned to the Supreme Court, the plaintiffs must maintain the same issues as stake and LabCorp’s inability to maintain consistency was in violation of Supreme Court Rules. However, Justice Breyer, with whom Justice Stevens and Justice Souter joined, wrote a dissent to Robert's dismissal. In the //dicta// of the dissent (those components of the written opinion not directly addressing the Robert’s dismissal) Justice Breyer presented a hypothetical ruling on the case. He took issue with the "technical procedural objection"[2] as insubstantial, claiming that the legal briefs submitted to the court accounted for adequate information to allow for the Supreme Court Justices to decide the case. Furthermore, Justice Breyer stated, "the important considerations of the public interest -- including that of clarifying the law in this area sooner rather than later -- argue strongly for our deciding the question presented now."[3] In this way Justice Breyer confirmed the Supreme Court as a general (and not specialized) court, able to adjudicate the "ongoing debate…as to whether the patent system, as currently administered and enforced, adequately reflects the"[4] the intent of federal laws as established in Title 35, the Patent Code. With this dissenting document, Justice Breyer sets the tone of the Supreme Court for ensuing patent disputes brought to the US judiciary. The District Court recognized this intent and implemented Breyer's reasoning as "persuasive and relevant" to the 2001 case //Prometheus v. Mayo[5]//. While Breyer's dissent was not official legal precedent, it offered a sort of "stand-in" precedent not only for the District Court, but also for the Supreme Court ruling on //Lab.Corp. v. Metabolite.// The issues raised in the dissent (namely the patentability of correlations) were the same issues the Justices questioned representatives for the plaintiffs and the defendants during the Supreme Court hearing of //Mayo// in December of 2011. Furthermore, Justice Breyer identified two controlling precedents in the //Lab.Corp. v. Metabolite// decision. //Flook// and //Diehr// represented the boundaries in which the patents-in-suit arise. In the unanimous decision for //Prometheus v. Mayo//, the opinion states, "[t]he claim before us presents a case for patentability that is weaker than //Diehr//'s (patent-eligible) claim and no stronger than //Flook//'s //(//unpatentable) one."[6] These two precedents are the same as those iterated in Breyer's dissent for //Lab.Corp. v. Metabolite.// Justice Breyer's dissent represents a unique dissenting precedent for which the District Court drew upon. Unfortunately, Federal Circuit Court purposefully "decline[d] to discuss a dissent" because "it is not controlling law"[7] when that reviewed //Mayo//. However, in doing so, they failed to recognize the fluidity of precedent as a legal technology. Specifically, the Federal Circuit Court did not acknowledge the //context// of the dissent as precedent, namely that the dissenting document stood in lieu of any concurring opinion as the case was dismissed.

__ 2. Myriad’s problematic business practices in the US __ The scholarly work of Shobita Parthasarathy has focused on comparisons of genetic healthcare testing between the United States and Great Britain. In her work, she claims that national context shapes the development of genetic healthcare testing. Issues of privacy, patenting and how healthy citizens are constituted are configured differ according to national frames of reference. Parthasarathy has focused on the commercial and legal practices of the co-defendant, Myriad Genetics in both the US and Great Britain. In the US the company has denied access to patented gene sequences to laboratories that show interest in researching the BRCA 1 and 2 gene sequences. The economic viability of the test relies on Myriad’s monopolization of the patent licenses of these sequences. Parthasarathy emphasizes the biotech company’s privileging of commercial profits in selling testing regimes over accessibility and accuracy (cite Parthasarathy declaration in the district court case). As she compares the dual legal and commercial structures in US and Britain, Myriad’s business practices, conform to the respective national legal and commercial structures in place. In her analysis of the comparative politics of healthcare, the established legal practices matter in //what// research a nation is able to conduct and //who// has access to the results of such work.

3. Biotech Patents

[1] Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U. S. 124 (2006), at *9 [2] ibid, at *5 [3] ibid, at *10 [4] ibid, at *15 [5] Prometheus Labs. v. Mayo Collaborative Servs. 2011 U.S. Trans. Lexis 76. at *16 [6] Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150, Supreme Court of the United States, 2012 U.S. LEXIS 2316; p13 [7] Prometheus Labs., Inc. v. Mayo Collaborative Servs. & Mayo Clinic Rochester, 2010 U.S. App. LEXIS 25956; at Footnote 2