Association for Molecular Pathology, et al., v. United States Patent and Trademark Office, et al, No. 09 Civ. 4515. (Southern District of New York March 29, 2010)
In a decision with far reaching implications, the United States District Court for the Southern District of New York held that isolated human gene sequences and the comparison of their sequences are not patentable subject matter under section 101 of the United States Patent Act (35 USC § 101).
The plaintiffs, the American Civil Liberties Union and the Public Patent Foundation (on behalf of scientific organisations, breast cancer and women’s health groups, as well as individuals) commenced proceedings against the United States Patent and Trademark Office (USPTO), Myriad Genetics Inc (Myriad Genetics) and the University of Utah Research Foundation. The plaintiffs sought a declaration that 15 claims contained within seven Breast Cancer Susceptibility Gene (BRCA) patents owned or licensed to Myriad Genetics and granted by the USPTO were invalid or unenforceable on statutory and constitutional grounds. The BRCA patent claims were directed to various isolated DNA sequences encoding the Breast Cancer Susceptibility Gene 1 (BRCA1) and the Breast Cancer Susceptibility Gene 2 (BRCA2), together with methods of analysing, comparing and using this DNA (including the diagnosis of breast cancer and the development of cancer treatments).
The question before Judge Robert Sweet was whether isolated human genes and the comparison of their sequence constituted patentable subject matter under the United States Patent Act (35 USC § 101). The plaintiffs argued that the DNA sequences, even as isolated, were a product of nature and were not patentable. Myriad Genetics countered that the purification of the isolated nucleotide sequences from other cellular components found in naturally occurring DNA rendered these sequences patentable subject matter.
The Court held that Myriad Genetics’ isolated DNA was not “markedly different” from native DNA and was not patentable subject matter. In reaching its decision, the Court reaffirmed that the mere purification of a product of nature does not render the isolated compound patentable subject matter. Rather the purified product must possess “markedly different characteristics” to satisfy the requirements of Section 101. The structural and functional differences between native and isolated BRCA1 and BRCA2 did not, in the opinion of the Court, alter its essential characteristic – the embodiment of biological information – nor the information it encodes.
Similarly, the Court held that the claims for analysing and comparing DNA sequences were “abstract mental processes” and were not patentable subject matter. As a result, the Court invalidated the patent claims and declined to consider the constitutional challenge.
Myriad Genetics has appealed the ruling to the Federal Circuit Court of Appeals, a process which may take several years. In light of this appeal the effect of this decision on the patentability of genetic material in the US and abroad remains to be seen.
Despite this there are some suggestions that this decision may signal the beginning of the end for gene patents. On 8 June 2010, Cancer Voices Australia and Yvonne D’Arcy initiated proceedings in the Federal Court of Australia against Myriad Genetics Inc and Genetic Technologies Limited, seeking to invalidate the Australian BRCA patents. Against this background, the Australian Senate will in September 2010 release its findings from an enquiry into whether the Australian Patents Act 1990 should be amended to expressly prohibit the granting of patents for human and microbial genes, proteins and their derivatives.
| What this means for you |
- The US District Court for the Southern District of New York has held that isolated human gene sequences and the comparison of their sequences are not patentable subject matter under section 101 of the United States Patent Act (35 USC § 101). Although persuasive, this ruling is not binding on Courts outside the Southern District of New York.
- This case is currently on appeal to the Federal Circuit Court of Appeals. Applicants for US patents should not alter their patenting strategies in the US prior to a ruling from the Federal Circuit, or indeed the US Supreme Court if the case is appealed further.
- The validity of gene patents in Australia will depend on the outcome of the Myriad Genetics proceedings in Australia and any recommendations arising from the soon to be released Australian Senate Enquiry into the validity of gene patenting.
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Gabrielle Hirsch
Solicitor
Phone: 61 3 9602 9430
Gabrielle_Hirsch@tresscox.com.au
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