Several associations and organizations of intellectual property lawyers submitted amicus briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case). While many make the same arguments, there are some points that may stand out enough to get the court’s attention.
The Amicus Briefs
The following legal industry organizations (listed in alphabetical order) submitted amicus briefs:
- American Intellectual Property Law Association (AIPLA)
- The Biotechnology Industry Organization (BIO)
(jointly with the Association of University Technology Managers and The Coalition for 21st Century Medicine)
- Federal Circuit Bar Association
- Intellectual Property Owners Association (IPO)
- New York Intellectual Property Law Association (NYIPLA)
The Common Themes
Many of these briefs make the same fundamental points:
- Myriad’s isolated DNA claims raise different patent eligibility issues than the Prometheus method claims.
- The Supreme Court has developed separate lines of precedent for analyzing the patent eligibility of compositions of matter (which must not claim “products of nature”) and methods (which must not preempt “laws of nature”).
- The Supreme Court’s decision in Mayo v. Prometheus does not impact or undermine the panel decision that upheld the patent eligibility of Myriad’s isolated DNA claims, which is governed instead by Chakrabarty.
- Even if Mayo somehow is relevant to the issues before the court in Myriad, the isolated DNA claims are patent eligible because isolated DNA is “markedly different” from naturally occurring DNA and so the claims relate to “significantly more” than anything found in nature.
- A holding that isolated DNA claims are not patent eligible would upset investment-backed expectations and negatively impact research and innovation.
- Myriad’s method claim 20 recites a specific transformative process using man-made materials and does not preempt any law of nature.
Some of the more unique points raised in the briefs are outlined below.
The AIPLA Brief
The AIPLA brief urges the court not to read Mayo as conflating the § 101 inquiry with the requirements of § 102 and § 103. The AIPLA points out that the Supreme Court relied on its 1981 decision in Diehr, and that Diehr itself states that novelty is “of no relevance in determining whether the subject matter of a claim” satisfies § 101.
The AIPLA brief asserts that
[I]t is not germane to ask whether the skill, hard work, and ingenuity Myriad scientists used in the transformative process of making the claimed isolated DNA molecules can somehow be deemed “routine,” “conventional,” or “well-understood.”
The BIO Brief
The BIO brief highlights the “far-reaching negative consequences” that could result from an “overbroad reading” of Mayo. In particular, BIO points out that the court’s decision could impact “innumerable other patents claiming medically and industrially useful compounds that are isolated or derived from natural sources.”
The BIO brief raises the possibility that a patent eligibility assessment based on “whether the techniques used to make [the claimed subject matter] are ‘routine,’ ‘conventional,’ or ‘well-understood’ could render even new synthetic chemicals non-patentable.
The brief highlights specific examples of patented compositions that were “isolated or derived from natural sources,” including:
- Isolated DNA encoding erythropoietin, which underlies Amgen’s Epogen® product.
- Sirolimus, a macrocyclic compound produced by a specific strain of bacteria that has antifungal and antibiotic activity, and that led to the development of RAPAMUNE® which is used to prevent organ rejection in kidney transplant patients.
- Muromonab-CD3, a monoclonal antibody derived from mice that is used to prevent transplant rejection and that has been commercialized as Orthoclone OKT3®.
- A phtyase enzyme produced by E. coli that is used to enhance the ability of livestock to digest phytate present in grain.
- A glucoamylase enzyme produced by the fungus Trichoderma reseii that is useful in the field of biofuels.
According to BIO:
[These examples] illustrate that the stakes of this case extend far beyond the diagnostic use of human DNA or the practices of a single company, and that any discussion of policy must consider the impact on new and emerging research regarding non-human DNA, therapeutic proteisn, agriculture, food safety, and industrial and environmental biotechnology.
BIO also argues that the sirolimus example demonstrates that the patent system can “speed the pace of innovation” because the disclosure of the original patent made the invention available to other researchers who developed the commercial product.
The Federal Circuit Bar Association Brief
The Federal Circuit Bar Association brief emphasizes that isolated DNA molecules “are synthetic human creations that are eligible for patenting.” The brief distinguishes “observing a natural relationship” (Mayo) from “creating a chemically distinct new DNA molecule (Myriad). The brief analogizes the isolated DNA to the organisms at issue in Chakrabarty and distinguishes them from the compositions at issue in Funk Brothers. The brief argues that the deciding factor is that isolated DNA molecules “are novel creations that are chemically distinct from naturally occurring DNA.”
The IPO Brief
The IPO brief argues that isolated DNA is patentable as a “manufacture” because it “evinces the hand of man.” The brief outlines several of the steps involved in obtaining isolated DNA:
In manufacturing isolated DNA, an inventor must identify a cell that expresses a gene, isolate the mRNA and enzymatically convert the mRNA into DNA . . . [using an enzyme] that is absent from cells that have not been intentionally infected by a virus that produces the enzyme.
(I wonder if Prof. Holman agrees with this description.)
The IPO brief emphasizes that “[c]laims to isolated human DNA do not encompass the naturally occurring genes that are present in cells,” so “a patent claim on isolated human DNA does not implicate an individual’s right to her own genes.” The brief also explains that the claims are “limited to chemical compounds” and do not cover the “genetic information” itself.
The IPO brief asserts that “Myriad’s DNA claims have not had any negative effects on technological development.” In particular, the brief states 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.” Thus, according to IPO, there is “no policy basis” for excluding isolated DNA claims from patent eligibility.
The NYIPLA Brief
The NYIPLA brief reads Supreme Court precedent as indicating that “human intervention is the key to this analysis.” The brief cites the discussion of the 1930 Plant Patent Act in the USPTO’s Manual of Patent Examining Procedure as distinguishing “a new plant found in the wild” from “the work of the plant breeder,” and analogizes isolated DNA to the latter.
The NYIPLA notes that the Supreme court has “continually rejected new categorical exclusions from patent-eligible subject matter as well as rigid rules of patent-eligibility.”
Putting It All Together
The Federal Circuit has just under a month to review all of the briefs that have been filed in the Myriad remand, and prepare for the oral hearing scheduled for July 20. It will be interesting to see if the questions from the bench at this hearing are different from those the judges asked previously and whether prognosticators will be willing to predict the outcome now that there is a better understanding of just how much could be at stake.