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Association for Molecular Pathology v. Myriad Genetics No. 11-725 was a case challenging the eligibility of gene patents in the United States, specifically challenging patents on cancer genes held by Myriad Genetics. Prior to this case, the US Patent Office accepted patents on isolated DNA sequences as a composition of matter. This case was originally heard in the United States District Court for the Southern District of New York, which ruled that these claims were not patent eligible as genes are products of nature. Myriad Genetics then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit court overturned the previous decision, ruling that isolated DNA which does not exist alone in nature can be patented. Proponents of the validity of these patents argue that they incentivize investment in biotechnology and promote innovation in genetic research by not keeping technology shrouded in secrecy. Opponents argued that these patents stifle innovation by preventing others from conducting cancer research, limit options for cancer patients in seeking genetic testing, and are not valid because they claim to patent genetic information that is intrinsic to all humans.

Patent dispute
Myriad Genetics is a genetics company that manufactures diagnostic tools to predict patients' risk of developing certain cancers due to hereditary predisposition. Namely, their BRACAnalysis product detects certain mutations in the BRCA1 and BRCA2 genes, which put women at high risk for breast cancer and ovarian cancer. Screening for BRCA mutations are critical for doctors and patients to make decisions on the best course of cancer treatment, and also to determine if prophylactic surgery would be useful. The patents involved in this BRCA diagnostic product, which covered not only the isolated BRCA gene sequences but also the diagnostics methods to detect these mutations were filed in the 1990's jointly with co-defendant University of Utah Research Foundation. Due to these patents, Myriad remains the only US commercial provider of BRCA diagnostics today.

In 1998, plaintiffs from the University of Pennsylvania's Genetic Diagnostic Laboratory received cease and desist letters on the basis of patent infringement from Myriad, who requested researchers to stop testing patient samples for BRCA without licensing Myriad's technology.

Litigants
Aside from the University of Pennsylvania, other plaintiffs in the suit include several non-profit societies (including Association for Molecular Pathology) which advocate for medical researchers; researchers at Columbia, NYU, Emory, and Yale; several patient advocacy groups; and several individual patients. They filed suit against Myriad and co-patent owners at the University of Utah because, from a research perspective, these patents restrict research for clinicians and limit scientific progress. From a patient's perspective, the patents not only make it impossible to obtain a second opinion on a patient's genetic predisposition to breast and ovarian cancer, but also keeps the cost of BRCA1/2 testing high by preventing competition.

The ACLU and Public Patent Foundation represented the plaintiffs, and Jones Day represented Myriad.

Arguments
Association of Molecular Pathology et al. argued that the patents were invalid on the basis of violation of §101 of Title 35 of the United States Code, these claims were not patentable. This law describes what is patent-eligible: "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof". If the invention falls under one of several categories, however, including a naturally occurring article, then it is not patent eligible. Association of Molecular Pathology posed that genes cannot be patented because they occur in nature.

Myriad defended their patents to be valid because the US Patent Office issues patents for genes as "isolated sequences" in the same way it issues patents for any other chemical compound, since the isolation of the DNA sequence renders it different in character from that present in the human body.

District Court Decision: Association for Molecular Pathology v. U.S. Patent and Trademark Office
On March 29, 2010, the District Court for the Southern District of New York declared the patents invalid.

Judge Robert W. Sweet's decision stated: "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. §101." The decision also found that comparisons of DNA sequences involved in these patents are abstract mental processes, therefore also not patent eligible.

Myriad appealed this decision.

Federal Circuit Appellate Decision
Myriad's appeal was granted, and the case was heard in United States Court of Appeals for the Federal Circuit. On July 29, 2011, the Federal Circuit overturned the district court's decision in part, (reversing that an isolated strand of DNA is patent-ineligible, and the district court's decision that methods for screening cancer therapeutics is patent-ineligible) and affirmed its ruling in part (agreeing that the district court's decision that Myriad's claims for comparing DNA sequences are patent-ineligible). Judge Alan Lourie, who wrote the majority ruling, reasoned that isolated DNA is chemically very different from the natural state of a gene in the body. An isolated gene is just short segment of DNA, devoid of extraneous introns, while genetic information in the body naturally exists in the large and complex form of chromosomes.

Judge Lourie cited the Supreme Court case Diamond v. Chakrabarty, which used the test of whether a genetically modified organism was "markedly different" from those found in nature to rule that genetically modified organisms are patent eligible. Thus, he concluded that since Myriad's patents describe DNA sequences that do not alone exist in nature, they are patent eligible.

Supreme Court Ruling
After the unfavorable Federal Circuit ruling, the Association for Molecular Pathology petitioned for a writ of certiorari to the Supreme Court, asking it to review this case. The Supreme Court granted the writ, vacated the Federal Circuit decision, and remanded the case back to the Federal Circuit. In other words, the Supreme court revoked the original ruling of the Federal Circuit, and asked the lower court to re-hear the entire case again. These Supreme Court actions were made in light of its recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., where the Court ruled that certain kinds of claims in medical diagnostics patents, including natural phenomena, were not patentable. The Supreme Court expected the Federal Circuit to take this precedent into account in its new ruling. Dr. James Watson famously submitted a brief supporting Association of Molecular Pathology to the Supreme Court.

Federal Circuit Decision: second hearing
The Federal Circuit held its ground, ruling again in favor of Myriad Genetics. The new court opinion was nearly identical to the original. It also stated that the Mayo precedent was not particularly relevant to this case, because it did not deal with the patent eligibility of gene patents. Judge Lourie stated: "The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature."

Reactions
This was a landmark case on the practice of gene patenting. The District Court's decision was received as an unexpected ruling, because it contradicted the generally accepted practice of gene patents.

The Federal Circuit's decision was a return back to the status quo, in which the US Patent Office issues patents for isolated gene sequences. However, it still ignited much controversy and interest from the public. Many proponents of gene patents argue that §101 of Title 35 of the United States Code clearly allows for it, and that if DNA should be excluded from patent eligibility on the basis that it conveys special genetic information, then that should be done through an act of Congress, not under courts' powers to interpret that law.