The Intellectual Property Owners Association (IPO) and the U.S. Department of Justice (DOJ) are two of at least 15 parties that have filed briefs as friends of the court in the Association for Molecular Pathology v. U.S. Patent and Trademark Office and Myriad Genetics, Inc., Case No. 10-1406 (Fed. Cir.).

In this closely followed case, Association for Molecular Pathology (AMP) is challenging patents covering diagnostic tests for mutations in genes as not being patent-eligible subject matter under 35 U.S.C. §101. The district court ruled in favor of AMP, holding that patents for detecting inherited breast cancer related to the human genes known as Breast Cancer Susceptibility Genes 1 and 2, or BRCA1 and BRCA2, were invalid. The district court ruled that isolated human DNA is patent-ineligible. Myriad appealed.

The amicus brief filed by the IPO presented two arguments: that the plaintiffs do not have standing sufficient to establish declaratory judgment jurisdiction in the suit against patent owner Myriad, whose patent rights are being challenged, and that isolated human DNA is patent-eligible. The IPO presented arguments that there is no substantial controversy in the present case of sufficient immediacy and reality to warrant declaratory judgment jurisdiction. IPO warned, echoing Myriad’s position, that if the facts of this case are adequate to provide a foundation for declaratory judgment standing, that nearly anyone may try to challenge the validity of any patent.

The IPO also argued that claims directed to isolated DNA constitute patentable subject matter under 35 U.S.C. §101 as decided by the Supreme Court in Diamond v. Chakrabarty, and that the district court erred in ruling that isolated DNA molecules are merely “purification of a product of nature” and patentable only if they possessed “markedly different characteristics” from naturally occurring DNA. As to the latter issue, the IPO brief warns that this type of interpretation of the Patent Act could have a broader impact that would extend in principle to any patent claim encompassing a “natural product.” For example, a ban on patenting isolated human DNA has the possibility of extending to isolated DNA from all known organisms, biologics based on “naturally occurring” human proteins and any other invention produced as the result of exploitation of naturally-occurring compounds or substances (e.g., compounds isolated from petroleum, products of fermentation by microorganisms and even inorganic matter, such as ultrapure silicon used to produce computer microchips).

The very same week, the DOJ filed an unsolicited amicus brief, asking the Federal Circuit to affirm the lower court judgment that patent claims on isolated gene sequences, without material change to its naturally occurring chemical structure and function, are not patentable subject matter. The DOJ argued that human genes, in and of themselves, are not patentable, and suggested that the Patent Office policy is wrong. The DOJ stated that “the district court’s judgment in this case … 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.”

The DOJ brief addressed only the question of patent eligibility of DNA, bypassing the jurisdictional and method claim issues. The brief also faults the district court for not distinguishing claims drawn to patent-eligible “man-made compositions” and suggests that man-made inventions based on DNA, such as vaccines and genetically modified crops, are eligible for patent protection. The DOJ brief further distinguishes patent eligible methods of identifying, isolating and using DNA molecules from genomic DNA itself.