Canada: Confirmation Of The Patentability Of DNA/Gene Sequences In The United States

Canadian courts showed promising support for DNA/gene patents by ruling in favour of Monsanto in its often-cited patent infringement case.¹ Recent jurisprudence from the United States reaffirmed the patentability of some DNA/gene patents after a hotly debated District Court decision and its much anticipated Court of Appeal counterpart involving Myriad Genetics (Myriad).²

The Myriad cases show the importance of understanding complicated science when applying patent law. At issue was the validity of patents awarded to Myriad that covered (1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence, (2) screening potential cancer therapeutics via changes in cell growth rates and (3) methods for comparing or analyzing their gene sequences in order to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.

US DISTRICT COURT DECISION

The plaintiffs sought to obtain a declaration of invalidity on a patent issued by the US Patent and Trademark Office (USPTO) to Myriad. After years of research, investment and genetic engineering, Myriad had developed a chemical compound having a sequence of nucleotides which never before existed in nature. Specifically, Myriad isolated two breast cancer susceptibility genes, BRCA1 and BRCA2, and made a synthetic DNA probe that could be used in a detection assay to determine a patient's susceptibility to breast cancer due to mutations in these genes.

The District Court held that Myriad's claims were not patentable subject matter, as the claimed isolated DNA is not "markedly different" from native DNA "in light of DNA's unique qualities as a physical embodiment of information".³ Furthermore, the method claims were held not to be patentable as they were mental processes.

However, on appeal, the Court of Appeals for the Federal Circuit (CAFC) held that the District Court, in effect, created a rule categorically excluding isolated genes from patent eligibility. When the CAFC considered the applicable law, it held that such categorical exclusions were not warranted unless the legislature expressly stated such a limitation, which was not the case with respect to this subject matter.⁴ Thus, the CAFC reversed the District Court's ruling on Myriad's "composition" claims and in part on the "method" claims.

CAFC: SCIENTIFIC AND LEGAL ANALYSIS

In Myriad, a proper understanding of the science was essential to a just application of patent law. The decision of the CAFC lays out a summary of the science behind isolated DNA and why it is patentable subject matter. Importantly, the CAFC recognized that isolated DNA is patent eligible as it has a "distinctive chemical identity and nature – from molecules that exist in nature".⁵ It was also recognized that unlike native DNA, which exists as part of a much larger structural complex, isolated DNA is free-standing and has been cleaved or synthesized resulting in a product that is a mere fraction of its native form.⁶ Specifically, the CAFC was persuaded that isolated BRCA1 and BRCA2, which lack introns, are not the same molecules that exist in the body.⁷

The CAFC used this scientific understanding when applying the United States Supreme Court's test for deciding whether a composition is patent eligible. In Funk Brothers, the United States Supreme Court (USSC) held that "works of nature" are not patent eligible subject matter.⁸ This decision was further elaborated in Chakrabarty, where the USSC held that in order for claimed subject matter to be patent eligible it should have "markedly different" characteristics than those found in nature.⁹

The CAFC in Myriad applied the Chakrabarty test to the composition claims covering isolated DNA. While the Court recognized the information coding capabilities of DNA, it acknowledged it as but one similarity between native DNA and its isolated form. Importantly, the Court held that this one similarity does not negate the many differences between native and isolated DNA. The Court recognized much fault in the part of the Plaintiff's argument that focused on the retention of the information coding capabilities in isolated DNA and ultimately concluded that isolated DNA was "markedly different" from its native constituent and, as a result, was eligible for patent protection. The CAFC also recognized that the longstanding practice of the USPTO to patent isolated DNA molecules should not be disturbed by the courts.¹⁰ In keeping with jurisprudence from the USSC, the CAFC recognized that if there was to be a change it should come from Congress itself.¹¹

Regarding the method claims, the CAFC found all but one type valid. Specifically, Myriad claimed methods of "comparing" or "analyzing" BRCA sequences in order to identify whether a person is genetically susceptible to cancer. The Court relied on Benson,¹² which held that basic tools of scientific work such as mental processes are not patent eligible as they are basic components of work in science and technology. The Court found that comparing and analyzing a sequence from a tumor sample is nothing more than a mental process and that comparing the two sequences requires nothing more than inspection, thus claims are patent ineligible.¹³

In terms of Myriad's claim to methods of screening potential cancer therapeutics, the Court recognized the inclusion of an important difference – transformative steps. The Court considered the ruling of the USSC in Bilski that stands for the presence of "transformative" steps being an "important clue" indicating patentability.¹⁴ The claim by Myriad involves "growing" host cells that contain an altered BRCA1 gene in an environment containing a potential cancer therapeutic, as well as determining their growth rate and comparing them to normal cells.¹⁵ The Court found that "growing" such transformed cells and "determining" growth rates is a method of transformation, requiring much more than just mental steps of comparison. Thus, it held that these claims were patent eligible.

CONCLUSION

The District Court's decision in Myriad represented a change in the longstanding practice of the USPTO in granting patents covering isolated DNA molecules. Had it been upheld by the CAFC, the results could have been disastrous for more than just the biotechnology sector, as they likely would have led to a decrease in investment, resulting in a further decrease in innovation.

Thousands of DNA/gene patents exist and help to promote innovation and investment through promoting healthcare and agriculture advancements. Without gene patents, companies all over the world could face multi-million dollar losses from loss of sales of products which were easily being copied by others. The CAFC's decision in Myriad makes a thorough and careful examination of the science and considers years of patent law. It is important that the courts in Canada make note of the CAFC's attention to scientific reasoning and of the longstanding practice of the Canadian Intellectual Property Office if issues such as the ones considered by the Court in Myriad come before them.

Footnotes

^{1 Monsanto Canada Inc v Schmeiser, 2004 SCC 34, 31 CPR (4th) 161 (SCC).}

^{2 Association for Molecular Pathology et al v The United States Patent and Trademark Office et al, 702 F Supp (2d) 181 (SDNY 2010) [Myriad TD ]; rev'd Fed Cir, No 2010-1406 (29 July 2011) [Myriad CAFC ].}

^{3 Myriad TD, ibid at 229.}

^{4 Myriad CAFC, supra at 45.}

^{5 Ibid at para 41.}

^{6 Ibid at para 42.}

^{7 Ibid at para 42.}

^{8 Funk Brothers Seed Co v Kalo Inoculant Co, 333 US 127 (1948) at 130.}

^{9 Diamond v Chakrabarty, 447 US 303 (1980) at 310.}

^{10 Myriad CAFC, supra at para 47.}

^{11 Ibid.}

^{12 Gottschalk v Benson, 409 US 63 (1972) at 67.}

^{13 Myriad CAFC, supra at para 50.}

^{14 Bilski v Kappos, 130 S Ct 3218.}

^{15 Myriad CAFC, supra at para 53.}

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