Earlier, the American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole gaggle of others filed a lawsuit challenging patents covering diagnostic tests for mutations in genes.   Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.

On March 29, 2010, the University of Utah and Myriad Genetics lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the human genes known as Breast Cancer Susceptibility Genes 1 and 2, or “BRCA1” and “BRCA2.”  The 152-page decision (Myriad Decision) addresses questions about whether human genes should be subject to patent protection.

Sandra Wells, VP and Chief IP Counsel of Affymetrix, gave her view that a purified product must possess “markedly different characteristics” from a product of nature in order to be patentable.  Wells believes that gene patents potentially inhibit development and commercialization of products and technologies that look at many genes simultaneously, à la Affymetrix.

Now, the briefs are rolling in to the CAFC, including Myriad’s own brief (Myriad’s Brief of Appellant) arguing that Judge Sweet’s ruling is an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” for the continued development of biotechnology.

In an amicus brief filed by the Department of Justice (DOJ), on behalf of the United States, the Government has gone against the longstanding policy of the US Patent and Trademark Office (PTO) in arguing 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.

In 2001, PTO published revised examination guidelines for the “utility” requirement of section 101. See Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001). The PTO stated that, if the specification of a patent discloses a particular use for a gene — e.g., that the specified gene expresses a useful protein — then “an inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it.”  The PTO stated that a DNA molecule that has been “isolated” in this way is not a product of nature “because that DNA molecule does not occur in that isolated form in nature.”

The Government argues that no court has previously addressed whether an isolated but otherwise unaltered genomic DNA itself — that is, genomic material excised from an organism’s genome and isolated from the cellular environment in which it normally occurs, but without material change to its naturally occurring chemical structure and function — is patentable subject matter under 35 U.S.C. § 101.

QUESTIONS PRESENTED

Whether human-engineered DNA molecules, such as cDNAs, are patent-eligible subject matter under 35 U.S.C. § 101.

Whether isolated but otherwise unmodified genomic DNA is patent-eligible subject matter under section 101.

The Government’s brief argues that:

The boundary between eligible and non-eligible subject matter is defined, in significant part, by the settled principle that the patent laws do not embrace laws of nature, physical phenomena, or abstract ideas. See Bilski, 130 S.Ct. at 3225.

In attempting to apply that principle here, the district court erroneously cast doubt on the patent-eligibility of a broad range of man­made compositions of matter whose value derives from the information-encoding capacity of DNA. Such compositions — e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules — are in every meaningful sense the fruits of human ingenuity and thus qualify as “‘human-made inventions’” eligible for patent protection under section 101. J.E.M. Ag  Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 130 (2001) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 313 (1980)). The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the ‘282 patent, that are directed solely to cDNAs.

The district court correctly held, however, that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

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. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

The Patent and Trademark Office has issued thousands of patents on genes of various organisms, including on an estimated 20 percent of human genes.  The fact that the Government is jumping into the fray now probably has a lot to do with the bad publicity Myriad has attracted on its patents covering BRCA1 and BRCA2 genes — along with the over $3,000 that Myriad charges to perform the test on the genes to see if women carry mutations that predispose them to breast and ovarian cancers.

The brief does not mention that biotechnology companies spent an average of eight years and $1.2 billion to get a new treatment to the market, about 24 percent more than it cost makers of traditional drugs to develop a medicine. Source: Tufts University.

Government programs directly cover 27.8% of the population (83 million), including the elderly, disabled, children, veterans, and some of the poor, and federal law mandates public access to emergency services regardless of ability to pay. Public spending accounts for between 45% and 56.1% of U.S. health care spending.  You can see why the federal government would be so interested in biotech patents:

Ernst & Young estimate global biotech industry revenues for publicly-held companies at $79.1 billion for 2009, an 11.8% decrease from the previous year.  The firm also estimates that revenues of publicly-held biotech companies in the U.S. declined 13% to $56.6 billion.

Genetically-engineered drugs, or “biotech” drugs, represent about 9% of the total global prescription drugs market, and about 19% of the U.S. prescription market.  The U.S. Centers for Medicare & Medicaid Services (CMS) forecast called for prescription drug purchases in the U.S. to total about $260.1 billion during 2010, representing about $800 per capita.  That projected total is up from $246.3 billion in 2009 and a mere $40 billion in 1990.

The Government stated flat out that this was a reversal of decades long practice at the PTO, writing:  “We acknowledge that this conclusion is 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.”

The Government’s new policy seems to be a result of discussions among agencies within the Obama administration, including the National Institutes of Health and the Patent and Trademark Office.  For now, the patent office said that it would not immediately put the policy into effect and will “maintain the status quo while this matter is pending resolution by the Federal Circuit Court of Appeals.

See the Governments brief here:  US Amicus Brief in AMP

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