Putting a Patent on Human Genes
While patent practitioners are well familiar and accepting of the phrase that patentable subject matter may include “anything under the sun that is made by man”, recently the U.S. District Court for the Southern District of New York heard arguments that may call the rationale behind that famous quote or rather infamous quote into question. This quote was part of verbal submissions heard before a House subcommittee in 1951 regarding the Patent Act of 1952 which largely appears in affect as it was originally passed.
Background-The Complaint
In a lawsuit filed on May 12, 2009 Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. before the U.S. District Court for the Southern District of New York on behalf of breast cancer and women’s health groups, individual women and scientific groups representing a total of 150,000 professionals. The suit was filed as against the United States Patent and Trademark Office (USPTO), as well as Myriad Genetics and the University of Utah Research Foundation the assignees of the patents on a series of patents relating to the BRCA1, and BRCA2 genes.
The Complaint as filed by the Plaintiffs asserts inter alia that:
Specifically, the Plaintiffs challenged the validity and constitutionality of the claims associated with seven (7) patents as issued by the USPTO with titles incorporating the common thread “Linked Breast and Ovarian Cancer Susceptibility Gene”.
Moreover, the Plaintiffs challenged the aforementioned claims based up four (4) categories:
1) Against natural human genes;
2) Against natural human genes with natural mutations;
3) Against claims over any method, including non-patented methods for looking for mutations in natural human genes; and
4) Against claims over the thought that two genes are different of have different effects, including but not limited to the thought that the differences correlate with an increase risk of breast and/or ovarian cancer.
Patentable Subject Matter
At the crux of this litigation is what constitutes patentable subject matter. As defined by Section 101 of Title 35 U.S.C. patentable subject matter is defined in the following manner:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
While one may not readily reconcile this statement so far as to infer “anything under the sun that is made by man” especially in the view of the biological sciences, the USPTO has been willing to accept genetically modified microorganisms as patentable subject matter, in addition to patents on other genetic material in addition to genetically modified mouse (see Harvard mouse or OncoMouse US Patent No. 4,736,866).
Moreover, while the language of the statute appears at first blush to define a broad range of potentially patentable subject matter, a number of limits have been prescribed by the judiciary that include limits against patenting laws of nature, physical phenomena and abstract ideas.
It should be noted that one of the main arguments being brought forth by the Plaintiffs is that the BRCA1/BRCA2 genes were not “manmade” and were in fact natural physical phenomena, as such, they should not be considered to be patentable subject matter.
Redefining Patentable Subject Matter—Has Happened Before
In view of considerable pressure from the American Medical Association (AMA), a resolution condemning the patentability of medical procedures and surgical methods was adopted and came into effect by the President in 1996 under Public Law 104-208 thereby rendering said procedures and methods no longer patentable subject matter.
Conclusion
While a final decision has yet to be reached in this case, the court of public opinion has already handed down their verdict in which Myriad Genetics has been referred to as “probably the most hated diagnostics company” for its refusal to license its products to any other company.
Moreover, it would appear that should an unfavorable ruling be obtained by the Plaintiffs in the present case, if significant pressure is exerted in Washington, the law with respect to patentable subject matter could very well be amended as evidenced by the AMA’s successful lobbying in 1996.
1. Testimony of P. J. Federico in hearings on H.R. 3760 before Subcommittee No. 3 of the House Committee on the Judiciary, 82d Cong., 1st Sess., 37 (1951).
2. Online: The Complaint, http://www.aclu.org/files/images/asset_upload_file939_39568.pdf.
3. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
6. Bailey, R., “The Tragedy of the Anticommons”, Reason Magazine, Oct 2, 2007.
Heydary, Javad
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