Reading Myriad Genetics While Waiting For Bilski.

Why is this molecule different from all other molecules?

By Gerry J. Elman1

As I write on April 29, 2010, the U.S. Supreme Court hasn’t yet issued its anxiously-awaited decision in the Bilski2 case. This case is to determine the whether a particular business-related method is outside the scope of subject matter that is potentially capable of protection by the claims of a U.S. patent. The wider implications of the case are expected to be enormous.

The Framers of the Constitution understood the importance of innovation to the economy of their fledgling nation in the New World. They provided that Congress would have the power: “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”3 Congress has implemented this provision by enacting copyright and patent laws.

The patent law provides in section 101 that:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.4 [Emphasis added.]

This section of the statute implies a threshold test that must be satisfied before proceeding to inquiries raised in other sections of the law. We typically refer to it for short as the requirement for statutory subject matter, that is, that the claimed subject matter defining the invention or discovery fit into one of the four categories listed in the statute: process, machine, manufacture, or composition of matter.

On March 29th, a month ago, federal district court judge Robert W. Sweet issued a summary judgment decision in a highly publicized5 case brought by a coalition of plaintiffs, primarily groups of medical specialists and their patients.6 It sought to establish the essential unpatentability of claims practised by Myriad Genetics relating to tests for various genetic abnormalities associated with an enhanced likelihood of developing breast cancer. Following extensive briefing by the parties and numerous amici curiae, Judge Sweet held that claims to certain isolated and purified genes and to certain test methods seeking to detect those genes in a human patient are not statutory subject matter under U.S. patent law.

With particular regard to inventions in the field of biotechnology, the Supreme Court was presented in 1980 with the question of whether a novel and nonobvious microorganism was statutory subject matter for a patent. In the case of Chakrabarty,7 Mr. Justice Burger wrote for a majority of the Court that “We have … cautioned that courts ‘should not read into the patent laws limitations and conditions which the legislature has not expressed.’”

Regarding the statute itself, he wrote:

In choosing such expansive terms as “manufacture” and “composition of matter,” modified by the comprehensive “any,” Congress plainly contemplated that the patent laws would be given wide scope.

Concluding that Congress had intended patentable subject matter to “include anything under the sun that is made by man,” the Court held that:

Judged in this light, [Chakrabarty]’s micro-organism plainly qualifies as patentable subject matter. His claim is … to a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity.

Such a decision begged the question of whether the organism was a “manufacture” or a “composition of matter,” and implied that even if it was something that overlaps the two expressions, the novel organism was still patentable subject matter.

Based on that holding, it should be a slam dunk to characterize a polynucleotide – clearly within the statutory recitation as a composition of matter – as meeting the statutory test for patentable subject matter, as long as that substance hadn’t previously existed in the form recited in the patent claim under consideration.

Yet Judge Sweet had been persuaded by plaintiffs to hold otherwise. How come? The decision includes a scholarly review of the case law, including a skeptical consideration of the 1911 district court decision in Parke-Davis Co. v. H.K. Mulford Co..8 He then wrote:

In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess “markedly different characteristics” in order to satisfy the requirements of § 101.

Judge Sweet’s decision proceeds to consider whether a purified polynucleotide could meet this requirement, as follows:

The central premise of Myriad’s argument that the claimed DNA is “markedly different” from DNA found in nature is the assertion that “[i]solated DNA molecules should be treated no differently than other chemical compounds for patent eligibility,” and that the alleged “difference in the structural and functional properties of isolated DNA” render the claimed DNA patentable subject matter [citations omitted].

Myriad’s focus on the chemical nature of DNA, however, fails to acknowledge the unique characteristics of DNA that differentiate it from other chemical compounds. . . .

DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature [emphasis added]. It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.

The decision latches onto a characteristic of DNA, seeking to distinguish it from other biologically active molecules, stating:

This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as “no different” than other chemicals previously the subject of patents [emphasis added].

Myriad and many of the amici suggest that the invalidation of the patents-in-suit will result in the decimation of the biotechnology industry. See, e.g., Myriad Br. … (suggesting that a finding that DNA is unpatentable subject matter will invalidate patents to important chemical compounds such as the anticancer drug Taxol (paclitaxel) and leave “little to nothing” of the United States biotechnology industry). The conclusions reached in this opinion concerning the subject matter patentability of isolated DNA, however, are based on the unique properties of DNA that distinguish it from all other chemicals and biological molecules found in nature. [This is ftn. 51, emphasis added].

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.” This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. [emphasis added].

Judge Sweet’s decision happened to precede by just a few hours my participation in a ceremonial meal at which Jews down through the ages have recounted the Exodus. Curiously, it seems to me that these confluent events have something else in common. That’s because the Passover Seder creates a night that is different from all other nights of the year. It is traditional for a youngster to recite in Hebrew the Four Questions, starting with the words Mah nishtanah, ha-laylah ha-zeh, mi-kol ha-leylot, traditionally translated freely as: “Why is this night different from all other nights?”9

Judge Sweet’s decision holds that a polynucleotide which represents a human gene is not patentable subject matter. Never mind that the U.S. Patent Office agrees that it’s novel and useful and nonobvious. Judge Sweet holds that DNA is different from all other biologically active molecules such as adrenaline or Taxol, because DNA uniquely is a carrier of information.

But then, after the four cups of wine mandated by the Seder, I started to wonder: doesn’t the presence of biological information uniquely in DNA imply the existence of some Intelligence who’s intending to send the information or at least putting it into the DNA to be received or otherwise utilized?10 So wouldn’t that imply that the distinction that Judge Sweet draws between the claimed molecules, polynucleotides, and other biologically active molecules is due to a Source of information?

In contemplating this distinction between a molecule bearing biological information and all other molecules with a physiological function in the cell, it seemed to me that Judge Sweet’s opinion tacitly implies as an aspect of science the concept of Intelligent Design.11

Yet as a resident of Pennsylvania and former public servant of the Commonwealth, I was familiar with the federal case in Harrisburg that had settled, seemingly once and for all after a lengthy trial with eminent fact witnesses, that “Intelligent Design is not science.”12 But I did a double-take as I recalled who it was that had energetically spearheaded this successful challenge to the teaching of Intelligent Design as an alternative explanation of biological origins. Because it was none other than the folks who brought us this assault on the validity of gene patents …. the venerable ACLU, the American Civil Liberties Union.



[1] Editor-in-Chief of Biotechnology Law Report and president of Elman Technology Law, P.C. (M.S. in Chemistry, Stanford) The opinions expressed herein should not be attributed to any client or other individual or entity. This article is scheduled to be published in Biotechnology Law Report, vol. 29, no. 2.

[2] Bilski v. Kappos, — U.S. —, reviewing the en banc decision of In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). The Supreme Court argument was held November 9, 2009. see Wikipedia: In_re_Bilski

[3] U.S. Constitution, Article 1, section 8, clause 8.

[4] 35 U.S.C. § 101.

[5] See, e.g., PBS Newshour (April 2, 2010) and CBS 60 Minutes (April 4, 2010).

[6] Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., 1:2009cv04515, S.D.N.Y., filed May 12, 2009, decision on summary judgment March 29, 2010, as amended April 5, 2010 — F.Supp.2d —-, 2010 WL 1233416. The plaintiffs are: Association For Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, Breast Cancer Action, Boston Women’s Health Book Collective and certain gene researchers and individuals potentially affected by breast cancer. The lawyers for plaintiffs are with the American Civil Liberties Union (ACLU) and the Public Patent Foundation. The named defendants are: United States Patent and Trademark Office (“USPTO”), Myriad Genetics, and the directors of the University of Utah Research Foundation. The case involves U.S. Patents 5,747,282; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 5,837,492; and 6,033,857, owned by Myriad Genetics or licensed to Myriad by the University of Utah Research Foundation or other universities. For further background see the articles I co-authored, Biotechnology Law Report, vol. 29, no. 1. at 23-27 and 29-31.

[7] Diamond v. Chakrabarty, 447 U.S. 303 (1980).

[8] Parke-Davis Co. v. H.K. Mulford Co., 189 F.2d 95 (S.D.N.Y. 1911). After an extensive dissertation on the subject, Judge Sweet took the opportunity to candidly state in ftn. 46: “Although Judge Hand once turned his back on the author of this opinion arguing before him on behalf of the Government, his opinion in Parke-Davis deserves careful review but brings to mind that oft repeated adage ‘Quote Learned, but follow Gus [Hand].’ This author, confronted by genomics and molecular biology, also emphatically empathizes with Judge Hand’s complaint in Parke-Davis about his lack of knowledge of the rudiments of chemistry.” [citations omitted]

[9] Wikipedia: Ma_Nishtana

[10] Tiger, tiger, burning bright. In the forests of the night, What immortal hand or eye. Could frame thy fearful symmetry? William Blake, The Tiger (1794).

[11] Compare the science fiction novel by Robert J. Sawyer, Calculating God (Tor 2000) with Richard Dawkins, The God Delusion (Houghton Mifflin Harcourt 2006) esp. ch. 4.

[12] Tammy Kitzmiller, et al. v. Dover Area School District, et al., 400 F. Supp. 2d 707 (Docket no. 4cv2688)(M.D. Pa. 2005). Wikipedia: Kitzmiller_v._Dover_Area_School_District