[author: Donald Zuhn]

With oral argument in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") less than two weeks away, Patent Docs continues its examination of some of the twenty-three amicus briefs that have been filed in this case.  Today, we look at the amicus brief filed by the Intellectual Property Owners Association (IPO).  (For the sake of full disclosure, the IPO brief was co-authored by Patent Docs author Kevin Noonan.)

The IPO brief makes three arguments.  First, the brief argues that claims to isolated DNA molecules constitute patent eligible subject matter under 35 U.S.C. § 101; second, the brief contends that method claim 20 is patent eligible under § 101; and third, the brief asserts that a ban on the patenting of isolated DNA molecules and gene-based diagnostic screening methods would negatively impact innovation.

With respect to the first argument, the brief begins by pointing out that Supreme Court precedent supports the patent eligibility of isolated DNA, noting that:

The Supreme Court in [Diamond v.] Chakrabarty found no constitutional, philosophical, or jurisprudential infirmities in the choice by Congress to define patent eligible subject matter broadly.  Indeed, the Court cited Thomas Jefferson for the proposition that the patent laws should be broadly construed with regard to what is patent eligible, referencing the first Patent Act of 1793 and Jefferson’s exhortation that "ingenuity should receive a liberal encouragement."  Id. (quoting 5 Writings of Thomas Jefferson 75-76 (Washington ed. 1871)) (citing Act of Feb. 21, 1793, § 1, 1 Stat. 319).

While acknowledging that "[t]he Court recognized that the scope of patent-eligible subject matter was not infinite," the brief notes that "the Court was parsimonious in setting forth what was not patent eligible: 'laws of nature, physical phenomena, and abstract ideas.'"  According to the brief:

The Court fashioned a straightforward test of whether a manufacture or composition of matter was patent eligible:  it must demonstrate the "hand of man," something that is "a product of human ingenuity 'having a distinctive name, character [and] use.'"  Id. at 309–10 (quoting Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)).

Asserting that "any manufacture or composition of matter evincing the 'hand of man' should be patent eligible," the brief argues that isolated human DNA is patent eligible because it evinces the hand of man.  In particular, the brief explains that:

Isolated human cDNA is a manufacture under the Patent Act because it is made by enzymatically-generating copies of cellular messenger RNA (mRNA).  In manufacturing isolated DNA, an inventor must identify a cell that expresses a gene, isolate the mRNA and enzymatically convert the mRNA into DNA.  The enzymatic conversion is performed by a viral enzyme called reverse transcriptase that is absent from cells that have not been intentionally infected by a virus that produces the enzyme.  Significantly, cDNA copies of mRNAs encoding isolated human DNA do not exist without human intervention.

The brief also argues that "[a]s a consequence of the intervention of the 'hand of man' in isolating the claimed DNA, the manufactured DNA has uses not shared with naturally occurring DNA (for example, as genetic probes and for producing useful quantities of proteins encoded by the DNA)," and therefore contends that the "claimed DNA . . . becomes 'a product of human ingenuity 'having a distinctive name, character [and] use.'"

The IPO brief also points out that the Supreme Court did not overrule Chakrabarty in Mayo Collaborative Services v. Prometheus Laboratories, Inc., but rather cited that case with approval.  In addition, the brief notes that among the concerns cited by the Mayo Court was that certain claims might inhibit future innovation.  The brief counters that:

These concerns do not apply to Myriad's DNA claims because the information content of DNA is not patented.  Myriad's claims are limited to chemical compounds, the isolated DNA molecules themselves.  The genetic information contained within naturally occurring DNA -- the sequence of the A, T, C, and G nucleotides -- does not fall within the scope of these claims.

Moreover, the IPO brief argues that "Myriad's DNA claims have not had any negative effects on technological development, another concern of the Supreme Court in Mayo," noting that "a cursory scan of the medical and scientific literature reveals more than eight thousand articles and reports regarding human BRCA 1 and BRCA 2 genes since the patents-in-suit were granted."

With respect to Myriad's method claim 20, the IPO brief argues that this claim is "directly analogous" to the method claim that was upheld by the Supreme Court in Diamond v. Diehr.  In particular, the brief contends that "[w]hen considered as a whole, claim 20 should be patent eligible because it is directed to a specific drug screening process that employs an altered form of the BRCA1 gene and does not preempt other uses of the naturally occurring BRCA1 gene."

The IPO brief concludes by asserting that a ban on the patenting of isolated DNA molecules and gene-based diagnostic screening methods would negatively impact innovation.  The brief argues that "[i]f the possibility of patent protection is removed, innovation in genetic-based diagnostics would be harmed," suggesting that "[t]here would be no incentive (indeed, there would be strong disincentives) to disclose the genetic basis of complex diagnostic assays."  The brief also predicts that:

[T]he impact of affirming the district court's decision is not limited to isolated human DNA or medical and pharmaceutical applications thereof.  Many other fields, including industrial biotechnologies involving alternative fuels, industrial biochemicals, and genetically modified foods, would be harmed because these industries have depended for decades on patent protection for isolated DNA inventions from non-human organisms.

Patent Docs will examine other amicus briefs as the date of oral argument in Myriad approaches.  In addition, we will be updating our list of briefs filed in the case later this week.

For additional information regarding this topic, please see:

• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012