[author: Kevin E. Noonan]

The Biotechnology Industry Organization (BIO), joined by the Association of University Technology Managers (AUTM) and the Coalition for 21st Century Medicine filed an amicus brief in support of Myriad (unlike many other amici on both sides of the issue, who wrote ostensibly "in support of neither party").  Authored by a group including Seth Waxman, former U.S. Solicitor General, and Hans Sauer of BIO, the brief argues that the patent-eligibility of isolated DNA claims is unchanged by the Supreme Court's decision in Mayo v. Prometheus.  First, the brief argues that the Mayo decision simply does not apply to composition of matter claims.  Second, that the procedural posture of the case, where the Court granted certiorari, vacated the former panel opinion, and remanded does not in any way imply that the Supreme Court thinks that its Mayo decision applies to composition of matter claims.  Finally, the brief argues that it would be error having "far-reaching negative consequences" for the Federal Circuit to apply Mayo to defeat the patent-eligibility of Myriad's composition of matter claims.  The brief also contains a short section regarding the continued patent eligibility of claim 20 of U.S. Patent No. 5,747,282 (the screening method claim that was the subject of an alternative view in an amicus brief filed by Eli Lilly & Co.; see "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad").

The first argument set forth in the brief is that the Court's Mayo decision is limited to "policing" the line between laws of nature and their applications in methods of applying such laws.  This decision did not "alter the proper framework for analyzing manufacture or composition of matter claims," according to the brief, and that precedent is governed by Diamond v. Chakrabarty.  The brief then assesses the Court's Mayo decision (which was on its own terms limited to "an examination of the particular claims before [it]").  The Court's decision was ultimately based on its conclusion that the claims at issue in Mayo "simply tell a doctor about the relevant natural laws" and do not "require any change in treatment or other action" on a doctor's part.  The claims in Mayo were not patent-eligible, according to the brief, because "this bare recitation of an idea combined with what the Court deemed to be insignificant steps placed the claim squarely within the contours of prior decisions prohibiting the preemption of abstract ideas or principles."  This "framework" for performing the Court's analysis in Mayo was not new, according to amici, being "already in place when [the Federal Circuit] issued its [now-vacated] panel decision" and this precedent "did not affect [the Federal Circuit's] analysis of the Myriad composition claims" ("and rightly so" says the brief).  This is because "it makes no sense" to apply the Court's analytic methods for assessing the patent-eligibility of a method claim to a manufacture or composition of matter claim.  The very language of the Court's Mayo decision, requiring an assessment of whether a claim "merely 'append[s] conventional steps' to a law of nature" does not apply because "[c]omposition of matter claims do not have 'steps.'"  This is not mere semantics, because as the brief points out compositions of matter have "physical form and can be claimed without regard to the manner in which they are made or used."  (This latter point is an important one, because it illustrates why a broad, undifferentiated "product of nature" ban would also preclude patenting of a synthetic form of a natural product that did not differ in physical structure from the product as it is found in nature.)  The brief cites Chakrabarty as well as Funk Bros. Seed Co. v. Kalo Inoculant Co. for the proposition that the Supreme Court has already set forth the proper measure for the patent-eligibility of a manufacture or composition of matter, i.e. "whether the claimed invention has different characteristics and uses from the naturally occurring analogue."  This standard, of course, was applied by the panel majority in deciding that Myriad's isolated DNA claims were patent-eligible when the case was last before the Federal Circuit, as amici remind the remand panel.

The brief further argues that it could not have been the Supreme Court's intention to require the rubrics enunciated in Mayo to apply to manufacture and composition of matter claims, because if it did the Court would have included Chakrabarty and Funk Bros. in its "consideration of the controlling precedents."  On the contrary, the brief reminds the Federal Circuit that those precedents were completely omitted from the Supreme Court's opinion, which "strongly implies that the Court did not consider" these cases, and thus Mayo does not control the Court's assessment of patent-eligibility for Myriad's DNA claims.  Calling the Court's delineation of patent-eligibility of manufacture and composition of matter claims in Chakrabarty a "careful textual analysis" of Section 101, the brief argues that the Court did not discard it "in favor of a free-floating 'products of nature' exception," reminding the Federal Circuit that "the Supreme Court specifically 'cautioned that courts 'should not read into the patent laws limitations and conditions which the legislature has not expressed.''"  Applied to "products of  nature," the brief asserts that its patent-eligibility might be compromised only if there was "a complete absence of human involvement," a standard consistent with the earlier panel decision and not changed, amici argue, by the Court's Mayo decision.

Turning to the procedural posture of the case, the brief notes that "grant [certiorari], vacate and remand" decisions are "a regular consequence of an intervening Supreme Court decision" and does not imply that a Court of Appeals' earlier decision was incorrect, citing Hughes Aircraft Co. v. U.S., 140 F.3d 1470, 1473 (Fed. Cir.1998).  The brief then revisits a pair of cases directly on point, Chakrabarty and it companion case, In re Bergy.  In those cases (which were heard by the Federal Circuit's predecessor court, the Court of Customs and Patent Appeals), on remand the Court, and specifically Judge G.S. Rich, decided that the intervening Supreme Court decision there, Parker v Flook, was "'inapplicable' because 'Flook was concerned only with the question of what is a "process" under 101,'" in contrast to the issue in Chakrabarty and Bergy, which "involve[d] only the construction of the terms 'manufacture, or composition of matter.'"  Ultimately, in Chakrabarty, the Supreme Court agreed (and, the brief notes that the Court in Chakrabarty did not "dissect the claimed microorganism into its individual components" but rather considered the claims "as a whole").  The CCPA avoided error in determining that Flook was not relevant to its assessment of the manufacture and composition of matter claims before it, and the brief argues that coming to the opposite conclusion here, by changing the Federal Circuit's opinion in the face of Mayo, would be error.

Finally, the brief turns on the negative consequences of a patent-eligibility ban on Myriad's DNA claims (as it must, because this is ultimately more a policy question than a legal one).  Here amici argue that the policy balance "overwhelmingly favors [the Federal Circuit's] earlier determination that isolated genomic DNA and cDNA are patentable subject matter," based on "[n]umerous studies [that] have refuted the claim that patents on isolated genomic DNA or cDNA molecules 'inhibit future innovation' or 'impede the flow of information.'"  In addition to several cited studies supporting this argument, the brief also notes that the question of whether the scope of Myriad's DNA claims "are unduly 'preemptive' cannot be substantiated or resolved without examining what activities actually infringe such claims, something that is strikingly absent from plaintiffs' case" (as is any attempt to construe the claims by either the parties or the courts).  The brief notes that "it is highly questionable" whether the isolated DNA claims would be infringed by sequencing the BRCA genes, either using existing technologies or as part of "whole genome sequencing," "because such techniques do not require isolation of the gene being sequenced."  The brief also uses rapamycin and modified analogues thereof to illustrate the unnecessary complications and uncertainties that would arise should Mayo's analytical framework for assessing the patent-eligibility of method claim be unwisely extended to manufacture and composition of matter claims.  And the brief includes several examples of how "[r]eliable patent protection is critical to the discovery, disclosure and commercialization of new and useful compositions of matter that are isolated or derived from natural sources," including erythropoietin, rapamycin, muromonab-CD3 (a mouse monoclonal antibody used to prevent transplant rejection), phytase (an enzyme used as a cattle feed component to reduce environmental phosphate pollution), and isolated enzymes used in the biofuels industry.  The brief also is careful to remind the Court that in all these instance and others, patenting "can speed the pace of innovation by encouraging the inventor to disclose the invention and make it available to other researchers," and that the fact that patents expire must be contrasted with the eternal availability of the patent disclosure.

The final section of the brief, comprising a single paragraph, relates to claim 20 of Myriad's '282 patent:

20.  A method for screening potential cancer therapeutics which comprises:  growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

The patent-eligibility analysis for this claim "need not detain [the Court] long," according to the brief, because the claim includes the step of "growing a transformed eukaryotic cell containing an altered BRCA 1 gene."  The transformed cell itself being novel, the brief argues that its use "cannot be the type of 'well-understood, routine, conventional activity already engaged in by the scientific community' required by the Mayo decision to render a claim patent-ineligible."

For additional information regarding this topic, please see:

• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012