The Intellectual Property Owners Association (IPO) an amicus curiae brief in the AMP v. USPTO and Myriad Genetics case, a lawsuit challenging patents covering diagnostic tests for mutations in genes.  In the district court, the University of Utah and Myriad Genetics lost in a U.S. court ruling over patents for detecting inherited breast cancer related to the human genes known as Breast Cancer Susceptibility Genes 1 and 2, or “BRCA1” and “BRCA2.”  (Myriad Decision)

In its brief, IPO argued:

  1. 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
  2. isolated human DNA is patent-eligible.  IPO’s brief said the consequences of the district court decision are not limited to isolated human DNA or biologic drugs produced from such DNA, but extend to any “natural product.”

In summary:

IPO believes that the declaratory judgment plaintiffs lack standing to challenge the validity of the patents in suit because: (1) Myriad has not directed any action toward the plaintiffs that would create an actual controversy of sufficient immediacy and reality to warrant declaratory judgment jurisdiction; (2) Myriad’s actions from over ten years ago are not of sufficient immediacy to create a justiciable controversy between the parties in this case; and (3) the plaintiffs’ mere formations of intent to potentially engage in undefined conduct that may or may not infringe any particular claim of the patents at some unspecified time in the future do not amount to “meaningful preparation” to conduct infringing activity. As a result, there is no substantial controversy in the present case of sufficient immediacy and reality to warrant declaratory judgment jurisdiction. Indeed, if the facts of this case provide adequate foundation for standing, then nearly anyone might seek to file a declaratory judgment action to challenge the validity of any patent — a result that would place a heavy burden on patent owners and on the already overburdened judicial system.

IPO also believes that claims directed to isolated DNA constitute patentable subject matter under 35 U.S.C. § 101. The standard for patent eligibility was enunciated by the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (1980), to include “anything under the sun made by man.” The Supreme Court has never overruled this standard and has never promulgated a categorical exclusion from patent eligibility for products derived from nature. Under this controlling Supreme Court precedent, claims to isolated DNA are patentable under Section 101.

If the standard for patentable subject matter applied by the District Court were adopted, it could render broad categories of important inventions patent-ineligible, including most biologic drugs, antibodies, antibiotics, hormones, metabolites, proteins, and genetically-modified organisms and food. This in turn would have a devastating effect on the viability of large portions of the biotechnology, pharmaceutical and other industries, industries that are built upon the availability of valid and enforceable patent protection for the fruits of their costly and risky research efforts.

Although isolated DNA molecules clearly are “composition[s] of matter,” the district court ruled them unpatentable because it believed them to be the “purification of a product of nature” and patentable only if they possessed “markedly different characteristics” from naturally-occurring DNA.

IPO argues that the district court’s decision that isolated human DNA is patent-ineligible is based on an interpretation of the Patent Act having a broader impact than merely the patents-in-suit or similar patents claiming isolated human DNA, but would extend in principle to any patent claim encompassing a “natural product.”

A Ban on Patenting Isolated Human DNA Would Encompass More Than Human Genes

While isolated human DNA is the only DNA at issue in this case, a ban on isolated human DNA does not rely wholly on its status as being from a human being. The district court’s decision that isolated human DNA is the “physical embodiment of [genetic] information” applies with equal force to isolated DNA from other organisms. Banning patenting of isolated DNA from all known organisms would mean such a ban would apply to almost a thousand U.S. patents that claim isolated plant DNA, almost 25,000 U.S. patents on isolated animal DNA, almost 3,000 U.S. patents on isolated bacterial DNA, over 3,000 U.S. patents on isolated viral DNA, and 50 U.S. patents claiming vaccines based on isolated DNA.

The Vast Majority of Human Therapeutics Are Also “Natural Products”

Patents on isolated human DNA also support the development of biologics, i.e., drugs based on “naturally-occurring” human proteins. If the district court’s decision that patents on isolated human DNA are directed to patent-ineligible “natural products,” then biologics perforce would be patent-ineligible as well. Indeed, proteins like human Blood Clotting Factors VIII and IX, insulin, human growth hormone, erythropoietin, tissue plasminogen activator, and all monoclonal antibodies are “isolated” in substantially homogeneous form, are structurally unchanged from their sources in blood and other bodily fluids, and are less altered than the isolated human DNAs that are the subject of the claims to isolated human DNA that were invalidated as “natural products” by the district court.

District Court’s Decision Extends to Any “Natural Product”

Despite the district court’s attempt to limit the scope of the ban on isolated human DNA as a “natural product,” the rationale used by the court could logically be extended to any other invention produced as the result of exploitation of naturally-occurring compounds or substances. These include any naturally-occurring chemical compound, including compounds isolated from petroleum and other sources of organic matter, the products of fermentation by microorganisms, and chemical compounds produced by microorganisms, plants or non-human animals that can be adapted for human use.

Taken to its logical conclusion, the district court’s “natural products” ban on patent eligibility would extend even to inorganic matter, such as ultrapure silicon used to produce computer microchips, isolated metal products prepared from ore and other natural sources, minerals and glasses produced from silicon and other natural sources, and any other compound produced from any naturally-occurring source. Such a determination would categorically exclude such inventions from patent-eligibility regardless of how novel, useful and non-obvious such inventions may be.

IPO believes such a broad ban is not justified, since there is no other source for these materials but nature. Whether materials are “natural” should not determine whether such inventions are patent-eligible, but rather whether the hand of man has been used to invent them.

The IPO brief was approved by the Board of Directors and drafted by IPO members Paul Berghoff, Kevin Noonan, and Jeffrey Armstrong of McDonnell Boehnen Hulbert & Berghoff.

See the entire IPO Brief here:  IPO Myriad Brief

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