3 July 2013
The U.S. Supreme Court recently reached a unanimous decision declaring certain claims of Myriad Genetic’s breast cancer gene patents invalid. In a highly anticipated decision, the Court ruled that naturally isolated DNA is not patentable. But, it’s not all bad news for Myriad. Synthetically created strands of complementary DNA were declared by the Court to be patent eligible subject matter.
On June 13, 2013 the United States Supreme Court reached a unanimous decision in Association for Molecular Pathology v Myriad Genetics, Inc (“Myriad”) finding that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. The Supreme Court further distinguished naturally occurring DNA from synthetic DNA created in the laboratory from mRNA, known as complementary or ‘cDNA,’ stating that cDNA did not present the same obstacles to patentability as naturally occurring, isolated DNA segments. While cDNA contains the same protein-coding information as that found in a segment of natural DNA, it has been modified to omit portions of the DNA segment called introns that do not code for proteins and, accordingly, cDNA was ruled to be patent eligible.
After discovering the precise location and sequence, Myriad Genetics, Inc. obtained patents on the BRCA1 and BRCA2 genes, mutations of which increase a person’s risk of developing breast and ovarian cancer. Myriad was, in turn, able to develop and patent medical tests useful for detecting mutations in these genes in order to assess a patient’s cancer risk. Myriad was not, however, the only entity to offer BRCA testing, and after learning of others’ endeavours, Myriad sent letters asserting patent infringement. Effectively, Myriad was able to stifle the competition. In 2009, the Association for Molecular Pathology, the University of Pennsylvania, and other plaintiffs including researchers, patient advocacy groups, and individual patients filed a lawsuit against Myriad seeking a declaration that Myriad’s patents were invalid.
Nine composition claims from three of the Myriad patents (US5,747,282; US5,693,473; and US5,837,492) were at issue. If valid, Myriad’s patents would in effect give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA.
The District Court granted summary judgment and concluded that Myriad’s claims were invalid because they covered products of nature. The United States Court of Appeals for the Federal Circuit ultimately reversed the District Court’s ruling, finding both isolated DNA and cDNA to be patent eligible. The case was appealed to the Supreme Court.
The issue before the Supreme Court was whether Myriad’s patents claimed a new and useful composition of matter under 35 U.S.C. §101, or a naturally occurring phenomena. §101 defines subject matter that is eligible for patent protection in the U.S and reads, “Whoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.” However, §101 contains an implicit exception from patentability for “laws of nature, natural phenomena, and abstract ideas.” Applying this standard, the Court stated that the fact that isolating DNA from the human genome severs chemical bonds thereby creating a non-naturally-occurring molecule could not save Myriad’s claims. Myriad’s claims were not expressed in terms of a chemical composition and did not rely on the chemical changes that result from the isolation of a particular section of DNA. Rather, the claims broadly focused on the genetic information encoded in the BRCA1 and BRCA2 genes, not the specific chemical composition of a particular molecule.
Since it was uncontested that Myriad did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA, the Court stated that “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” While Myriad found the location of the BRCA1 and BRCA2 genes, the Court held that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”
With regards to synthetic cDNA, the Court went on to say that “the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible under §101”.
Some commentators project that this decision will likely impact the cost of genetic testing for some health risks. The price of the Myriad test is often more than $3,000; however, as competitors begin offering their own tests, the price is predicted to come down.
The Myriad decision follows the U.S. Supreme Court’s unanimous holding in the spring of 2012. In Mayo Collaborative Services v Prometheus Laboratories Inc, No 10-1150 (2012), two patents held by Prometheus Laboratories covering a method for determining proper drug dosage were invalidated on the grounds that the particular claims at issue effectively claimed underlying laws of nature.
At this stage, the scope of the Myriad decision in the U.S. is unknown. The Court’s naturally-occurring vs. synthetically created distinction may have broad effects that could threaten the patentability of bacterial and other non-human genes and the validity of issued gene patents. The United States Patent and Trademark Office (“USPTO”) issued a Memorandum later the same day as the U.S. Supreme Court issued its ruling. Therein, the USPTO urged its patent examiners to reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter. The USPTO did not limit its Memorandum to human genes. The Supreme Court did explicitly note that the Myriad decision did not involve method claims, patents on new applications of knowledge about the BRCA1 or BRCA2 genes, or the patentability of DNA in which the nucleotide sequence had been altered.
The patentability of human genes has been considered in other jurisdictions, such as in Australia where the Federal Court in Cancer Voices Australia v Myriad Genetics Inc  FCA 65 held that a claim covering the composition of isolated nucleic acid from a naturally occurring sequence may be protected by a valid patent. An appeal was lodged against this decision on March 4, 2013. The patentability of isolated human genes has not yet been considered by Canadian courts and, in light of the U.S. Supreme Court decision in Myriad, the question may soon find itself before our Supreme Court.
In Canada, section 2 of the Patent Act defines an “invention” as any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement thereof. The definition of “invention” has been interpreted to exclude certain subject matter. For example, in Harvard College v Canada (Commissioner of Patents)  4 SCR 45, the Supreme Court of Canada denied patent protection to a “higher life form”, namely a mouse genetically modified to carry a cancer-causing gene, finding that higher life forms do not fit within the defined categories of “invention”.
The only explicit statutory exclusion of subject matter is found in section 27(8) of the Patent Act which states that a “mere scientific principle or abstract theorem” is non-patentable. There is no prohibition in Canada relating to “laws of nature” or “natural phenomena,” as there is in the U.S., which was crucial to the U.S. Supreme Court’s ruling in the Myriad decision. Therefore, in Canada, if the subject matter in question is not a mere scientific principle or abstract theorem, and it falls within at least one of the categories set forth for an “invention,” then it is patentable as long as it satisfies the other requirements of novelty, inventiveness, and utility.
Isolated genes do not fall under the statutory exclusion as a mere scientific principle or abstract theorem. Further, isolated genes are arguably a composition of matter and therefore would fall within the definition of invention under the Patent Act. Indeed, the Canadian Intellectual Property Office currently regards (human and non-human) genes as patentable given the number of issued patents claiming isolated DNA. For example, Myriad is the holder of 13 Canadian patents directly claiming isolated nucleic acids
However, patentability exclusions are a hot patent law topic in Canada following the Federal Court of Appeal’s reconsideration of the validity of business method patents last year in Canada (Attorney General) v Amazon.com, Inc, 2011 FCA 328. Arguably, human and non-human naturally-occurring genes could become subject to challenge by parties emboldened by the Myriad decision or by a change in patent office policy in wake of this decision.
While we may see developments in this area of patentable subject matter in Canada, in the interim, Canadian patent applicants may still be able to obtain patent claims directed to isolated human and non-human genes.
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