In a move that surprised many in the U.S. patent community, the Department of Justice filed a brief in the Federal Circuit appeal of Association for Molecular Pathology v. USPTO, arguing against the patentability of isolated genomic DNA sequences. This brief may raise the stakes in the appeal, and certainly shines a brighter spotlight on a case that already has garnered far more general media attention than any other patent case.

The District Court Decision

The district court determined that Myriad’s “isolated DNA” claims are not patent-eligible under 35 USC § 101 because they encompass products of nature. Claim 1 of U.S. Patent 5,747,282 is representative of this category of claims:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

The court read Supreme Court precedent, including American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1 (1931); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948); and Diamond v. Chakrabarty, 447 U.S. 303 (1980), as setting forth the following test for patent-eligibility:

[T]he purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess ‘markedly different characteristics’ in order to satisfy the requirements of § 101.

The DOJ Brief

The DOJ brief makes the following arguments:

  • Section 101 Embraces Only “Human-Made Inventions”
  • Engineered DNA Molecules, Including cDNAs, Are Human-Made Inventions Eligible For Patent Protection

“[T]he 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.”

On this point, DOJ disagrees with the district court, which invalidated some Myriad claims directed to cDNAs.

DOJ also disagrees in principle with the district court’s premise that because the value of isolated DNA molecules rests in their encoded biological information they are non patent-eligible as products of nature.

  • Isolated But Otherwise Unmodified Genomic DNA Is Not A Human-Made Invention
    • Unmodified Genomic DNA Is A Product Of NatureDOJ tries to set the record straight on one point:“No one doubts that the native BRCA genes in situ are products of nature.”

      If the general public, including the 60 Minutes editors, would understand this, we would no longer have to endure hysterical claims that Myriad could go after BRCAI breast cancer patients because they carry the patented genes.

    • “Isolation” Does Not Transform A Product Of Nature Into A Man-Made Invention”Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it. The very term “isolated” suggests only that extraneous matter has been separated from the natural product of interest, not that the product itself has been transformed or altered into something man-made.”
    • Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is A Literal Composition Of Matter
    • Isolated Genomic DNA Is Not Rendered Patentable On The Theory That It Is “Pure””[T]hese cases do not hold that natural products may be patented whenever they are extracted from impure environments. Rather, they provide that patent eligibility may arise when a natural compound has been so refined and purified through human intervention as to become a substance different in kind from the natural product.
    • Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify

The DOJ admits that its position on the non-patent-eligibility of isolated DNA claims is contrary to longstanding USPTO and NIH positions:

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 district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

Indeed, the DOJ position in this brief is contrary to the position taken by the USPTO in the district court proceeding.

Raising the Stakes

Now that the DOJ has taken a position contrary to the USPTO, the Federal Circuit is expected to take an even closer look at the issues raised in this appeal. While I always assumed that whichever party loses at the Federal Circuit will petition the Supreme Court for review, that likelihood may have increased now that the DOJ has come down on what many biotech patent practitioners have viewed as the losing side.

On the first day of my Constitutional Law class, I was called on to discuss Marbury v. Madison, the 1803 Supreme Court case that proclaimed the Court’s power to review and interpret acts of Congress. I always will remember the pronouncement:

It is emphatically the province and duty of the judicial department to say what the law is.

This case affords the judiciary another opportunity to exercise its unique power to independently decide whether isolated DNA claims are eligible for patenting under 35 U.S.C. § 101.

Amicus Briefs Filed By Foley & Lardner LLP

Attorneys at Foley & Lardner LLP have filed two separate amicus briefs in this appeal, both supporting reversal of the district court decision: one on behalf of Alnylam and one on behalf of Rosetta Genomics and George Mason University.