[author: Donald Zuhn]

Seven organizations of health care professionals argue in an amici brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") that Myriad's isolated DNA and cDNA claims, as well as claim 20 of U.S. Patent No. 5,747,282, are all invalid under 35 U.S.C. § 101.  The organizations, which include the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, American College of Embryology, and Medical Society of the State of New York, open their brief by expressing their "concern[] about the effect of gene sequence patents on the practice of medicine," stating that "[s]uch patents interfere with diagnosis, treatment, and research and contravene the United States Supreme Court's long-standing precedents about the scope of patentable subject matter, which was reiterated in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)."

In arguing against the patent eiligibility of isolated DNA and cDNA, the amici brief, which was authored by Professor Lori Andrews of Chicago-Kent College of Law and Professor Joshua Sarnoff of DePaul University, states that:

Nature's handiwork is excluded from patentability.  Prometheus, 132 S.Ct. at 1293; Bilski v. Kappos, 130 S.Ct. 3218, 3225 (2010).  Just as a patent involving a law of nature must have an "inventive concept" that does "significantly more than simply describe these natural relations" (Prometheus, 132 S.Ct. at 1294, 1297), a patent involving a product of nature must have an inventive concept that involves significantly more than describing the product of nature.  Indeed, the claimed invention must be "markedly differently" from what occurs in nature.  Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The brief notes that:

For over 150 years, the U.S. Supreme Court has held that products of nature are not patentable (Chakrabarty, 447 U.S. at 309), nor are isolated or purified products of nature (American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. (23 Wall.) 566, 594 (1874)), nor are synthetic products that are not markedly different from what is found in nature (Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884)).  The Supreme Court has repeatedly held that compositions of matter involving products of nature or isolated products of nature must be "markedly different" from what occurs in nature to be patentable.  See, e.g., Chakrabarty, 447 U.S. at 309-10; Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948); American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11-12 (1931); Cochrane, 111 U.S. at 311; American Wood-Paper Co., 90 U.S. (23 Wall.) at 594.

The brief contends that because claims covering isolated DNA and cDNA constitute claims "on products of nature without an inventive concept" that are "not markedly different from what occurs in nature," these claims are invalid under § 101.

With respect to isolated DNA, the brief contends that "Myriad's composition of matter claims involving gene sequences are not unconventional or novel creations and do not involve an 'inventive concept,"" adding that "[t]he term 'isolated' adds nothing of significance to the claims."  In responding to the panel's earlier decision regarding these claims, the brief argues that:

[T]he breaking of covalent bonds [does not] make isolated DNA patentable.  The breaking of covalent bonds (itself a natural process that occurs in the body) is not an "inventive concept" and does not make the gene sequence "markedly different" and therefore patentable subject matter.  The change in chemical bonds is insignificant because the isolated gene sequence is the same string of nucleotides that exists in the cell.  Additionally, because the claims are written in terms of the genetic sequence, patentability should be determined by an analysis of the genetic sequence, not by the chemical structure.

Going further than other amici, the brief contends that cDNA is also patent ineligible under § 101.  Noting that "cDNA is useful in the laboratory because it has the same nucleotide sequence and contains the same information as found in the exons of naturally occurring DNA and can perform the same functions as a full nucleotide sequence or DNA molecule," the brief argues that "Myriad's use of routine chemical tools to synthesize cDNA lacks the inventive concept for patentable subject matter," and further, that "cDNA is not 'markedly different' from the sequence as it occurs within the chromosome."  According to the brief, "[o]nce the gene's naturally occurring DNA sequence -- an unpatentable product of nature -- is known, synthesis of cDNA is a routine mainstay of the art of biologists and chemists," and therefore, "[a]llowing a patent on cDNA would be a disproportionate reward in relation to what the alleged inventor contributed."

As for Myriad's method claim 20 of the '282 patent, the brief contends that the claim is analogous to the claim at issue in Mayo, arguing that claim 20 contains an "administering" step that "serves to identify who would be interested in the law of nature -- physicians or researchers using or studying cancer therapeutics," a "determining" that "tells the physician or researcher to measure the growth of the cells -- a routine activity for physicians and scientists in the field," and a "wherein" step that "tells the physician or researcher about the relevant natural law."

The brief also chastises the U.S. Patent and Trademark Office for granting gene sequence patents, stating that the Office "ignored the U.S. Supreme Court's precedents and applied invalid reasoning to grant patents on genetic sequences and, consequently, its decision should not be accorded deference."  The brief indicates that in granting such patents, "[t]he USPTO relied on the 1873 grant of a patent to Louis Pasteur for a purified yeast and on a lower court decision upholding a patent for isolated and purified adrenaline," but suggests that "Pasteur never enforced his patent, so there was no judicial assessment of whether the patent was valid."

The brief further contends that upholding Myriad's claims would be a detriment to further innovation, stating that:

Th[e] inhibition on future innovation is particularly true with patents on isolated DNA and cDNA.  There is no way to "invent around" gene patents.  Because an isolated gene sequence is identical to the sequence of the gene in the body, a patent holder can prevent scientists and clinicians from undertaking any genetic research related to a disease arising from a mutation in that gene.

In support of the detrimental effect of gene patents on innovation, the brief cites a study of laboratory directors (Mildred K. Cho et al., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services, 5 Journal of Molecular Diagnostics 3 (2003)), a study of American Society of Human Genetics members (Issac Rabino, How Human Geneticists in U.S. View Commercialization of the Human Genome Project, 29 Nature Genetics 15 (2001)), and the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.

Lastly, the brief argues that Myriad's contributions do not justify the threat to innovation presented by Myriad's claims.  Citing Mayo, the brief states that "[i]n a Section 101 analysis, courts need to weigh 'how much future innovation is foreclosed relative to the contribution of the inventor.'"  With respect to Myriad's claims, the brief argues that:

Myriad's contribution to the sequencing and identification of the BRCA1 and BRCA2 genes was minor in comparison to what their patents foreclose.  Myriad used common techniques to isolate, sequence, and clone the BRCA1 and BRCA2 genes.  Further, Myriad did not identify the sequence on its own.  Myriad had significant scientific aid and financial support, including from the U.S. government.  Controversy surrounds the question of whether Myriad even sequenced the BRCA2 gene first.

The brief therefore concludes that isolated DNA, cDNA, and method claim 20 are patent ineligible under § 101, arguing that "[i]t is crucial to patient care and to medical research that the products of nature and the basic laws of nature that Myriad has sought to propertize be freely shared, used, and analyzed."

For additional information regarding this topic, please see:

• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "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