This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.
The Government “Reevaluates” Gene Patents. The government’s brief begins by highlighting the distinction between “isolated but otherwise unmodified genomic DNA” and other “human-engineered DNA molecules, such as cDNAs” (p. 1). For at least two decades the PTO has granted patents on both types of DNA molecules and on Friday, for the first time, the United States weighed in on the propriety of that policy.
The question, according to the government, is whether isolated genes constitute patentable subject matter under § 101. It is a question that, despite a decades-long PTO policy of issuing patents on isolated genes, had never been directly addressed by a court prior to Myriad, and one which the United States had not “previously expressed its view…in litigation” (p. 6).
According to the government’s brief, Judge Sweet’s March opinion “prompted the United States to reevaluate the relationship between [isolated genomic DNA] patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature” (p. 18). On Friday, the government made the conclusion of that reevaluation quite clear: “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible” (p. 10, emphasis added).
The Brief’s Argument, In Brief. In support of this conclusion, the government employs several complementary lines of argument. The primary distinction, not surprisingly, is the familiar “human-made inventions” vs. “products of nature,” with the government taking the position that the latter – within which it includes isolated genes – belongs to “the storehouse of knowledge of all men…free to all men and reserved exclusively to none” (p. 9).
Despite supporting several critical pieces of Judge Sweet’s district court ruling, the government is not prepared to go all the way in siding with Sweet. Its brief takes pains to point out where it believes Sweet erred, including two important categories it still considers patent-eligible under § 101: (i) “man-made transformation or manipulation of the raw materials of the genome” (p. 11), including cDNA, even when the resulting molecules are valuable, like natural DNA, due to their information-carrying capacity and (ii) the processes of “identifying, isolating, and using” (p. 17) products of nature (including genes), which may be patentable even if the products of such processes are not.
From the government’s perspective, the “fundamental question” of patentability under § 101 is “whether the inventor has created something through the application of human ingenuity or merely exposed something previously unappreciated in nature.” The government’s position is that isolated genes, including the BRCA-1 and BRCA-2 genes subject to Myriad’s patents, fall into the latter category.
Welcoming the White House to the Myriad Party? There are several key takeaway points from the government’s amicus brief, but the most significant may be the fact that there is a brief to review at all. That the U.S. government would express its views on the Myriad litigation, particularly at this stage of the proceedings, was hardly a foregone conclusion.
This is due at least in part to the significance of the issue and the competing priorities and constituencies different elements of the government bring to the table, particularly when it comes to gene patents. The brief acknowledges as much, noting that the issue “implicates the expertise and responsibilities of a wide array of federal agencies,” including the PTO, NIH, DOJ and many others.
Even more telling is that the position staked out in the brief is expressly acknowledged as “contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA” (p. 18). In the eyes of the government, isolated genomic DNA no longer satisfies the § 101 test for subject matter patentability.
It is not every day that one governmental entity (the DOJ) presumes to tell another (the PTO) that, despite everything it may think it may know within its area of expertise (patents), it has been going about things all wrong. But that, more or less, is what appears to have happened here. The New York Times’ Andrew Pollack notes that an absence of PTO lawyers signing on to the brief may indicate that the PTO “opposed the new position but was overruled by other agencies.”
It is extremely unlikely that the DOJ reached this conclusion completely on its own initiative. Which leaves us to speculate that the decision to reverse federal course on gene patents originated higher up the federal food chain. We have as yet seen no public indication that the White House is paying particular attention to the Myriad litigation. However, given the former-junior-Senator-from-Illinois’ interest in genomics and personalized medicine, and the obvious importance of gene patents to the future of personalized medicine, it would not come as a surprise to find that the White House has taken an active interest in the outcome of the Myriad litigation.
Implications for the Biotechnology Industry. The initial reaction to the government’s amicus brief from many within the biotechnology industry is likely to be concern. There is, after all, an oft-told tale of biotechnology’s dependence upon patents, including gene patents, to ensure continued investment and innovation.
The Biotechnology Industry Organization (BIO) and The Association of University Technology Managers (AUTM) set out this familiar position in an amicus brief of their own (pdf):
Unless reversed, the decision below promises to cause serious harm to U.S. biotechnological innovation. The biotechnology industry depends heavily on patent protection to encourage the investment of time and capital necessary to develop inventions—including those discovered industrially or in-licensed from world-class universities in support of further academic research—into real-life products (p. 25).
The government’s brief, on the other hand, goes to great pains to reassure anxious biotechnology companies, investors and commentators that it is not advocating the abolishment of all biotechnology patents. It is not even suggesting that all gene patents fail the § 101 test. Quite to the contrary:
New and useful methods of identifying, isolating, extracting, or using genes and genetic information may be patented (subject to the prohibition against patenting abstract ideas), as may nearly any man-made transformation or manipulation of the raw materials of the genome, such as cDNAs. Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology (p. 11).
Nearly every biotechnological or pharmaceutical application of genomic DNA will involve a welter of potentially patentable products and methods: engineered DNA molecules, including cDNAs; processes of extraction and purification; optimized pharmaceutical compounds (pills, vaccines); methods of preparing and administering the same; and so on (pp. 35-36).
However, the government is equally explicit that a biotechnology invention is not patentable simply because it is “useful or requires investment to identify” (p. 34). Article I, Section 8 of the Constitution authorizes Congress to award patents to “promote the Progress of Science and useful Arts,” not to reward investors.
Creating an economic incentive for companies to develop scientific discoveries into commercial products is a byproduct of our patent system, but it is not an end in and of itself. If it were, we would award patents for difficult discoveries as well as novel and useful inventions. Instead, according to the government’s brief, patentability under § 101 hinges upon whether the claimed invention involves “something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be” (p. 11).
As for what all of this means for the biotechnology industry, the short and simple answer is “nothing,” largely for reasons described below. The slightly longer answer is that even if the government’s position was adopted verbatim – which is not particularly likely – plenty of biotechnology patents, including various gene-based patents, would survive.
Awaiting the Court’s Decision. After Judge Sweet’s district court ruling, newspaper headlines raced to declare the death of gene patenting. It is inevitable that some will similarly overstate the significance of this latest development. (Investors, for example, reacted to the development by sending Myriad’s stock down nearly 5% at the open on Monday.) Remember: this is an amicus curiae brief and not the decision of the court.
As the gene patent drama continues to unfold, there will be several opportunities for a binding legal result capable of lending significant clarity to the patentability of genes and related gene-based products and processes. Direct treatment and guidance in an opinion from the CAFC or the Supreme Court are the most likely possibilities. An act of Congress, while much less likely, would also fit the bill. The opinion of the Department of Justice, for all its significance, does not.
It is possible that the government’s brief signals a formal change in the PTO’s policy with respect to the patentability of genes, although our guess is that the PTO will wait for the CAFC’s ruling before making any significant changes. [Update 11/1: Pharmacogenomics Reporter's lengthy summary of the government's brief includes this statement from a PTO spokesperson: “The USPTO will maintain the status quo while this matter is pending resolution by the Federal Circuit.”] Even if that change does occur, its practical significance will likely be minimal given that the PTO is not believed to be issuing many new gene patents at this point in time, with obviousness likely a significant factor. (A shift in the PTO’s gene patent policy could, however, have implications for other areas of biotechnology if it results in a broader, lasting change in the way the PTO applies the product of nature doctrine for purposes of subject matter eligibility.)
The more significant aspect of the government’s brief is the undeniable weight it will be given by both the CAFC and even the Supreme Court, should the Myriad litigation wind up there. Neither court is bound by the government’s conclusions or reasoning, but the government’s obvious interest in the issue makes a direct treatment of the fundamental issue – whether an isolated gene is patentable, and why – more likely than ever before. Such a decision, which would effect not only new gene patent applications but previously issued gene patents as well, would be truly significant for the biotechnology industry.