On May 12, 2009, a coalition of interested parties, lead by the Association for Molecular Pathology, and including researchers and breast cancer patients, filed suit in the U.S. District Court for the Southern District of New York to invalidate certain of the claims of seven patents exclusively licensed to Myriad Genetics, Inc. (A copy of the complaint can be found at the end of this blog.) The claims in question are directed to, inter alia, DNA that encodes the BRCA1 and BRCA2 polypeptides and a method for diagnosing a predisposition for breast cancer in a human by comparing his/her BRCA2 DNA sequence with the wild-type BRCA2 DNA sequence wherein an alteration (mutation) in the subject’s BRCA2 DNA sequence indicates a predisposition to said cancer. See U.S. Patent Nos. 5,747,282 and 6,033,857, respectively. (A copy of these patents can be found at the end of the blog.)
The gist of the complaint is that the “DNA claims” are invalid as claiming products of nature and that the diagnosis claims are invalid as claiming abstract ideas. More formally, plaintiffs assert that the challenged claims are invalid under the “patent clause” of the U.S. Constitution and 35 U.S.C. s. 101, since they are products of nature or abstract ideas (“or basic human knowledge and thought”) or, as such, as “unconstitutional under the First and Fourteenth Amendments to the United States Constitution.” Apart from any scholarly analysis of the second cause of action, one witty colleague commented to me at AIPLA that this lawsuit clearly involved “freedom of expression”!
It seems a safe assumption that the plaintiffs were emboldened in this attack on basic biotech patent claiming (that goes at least as far back as the 1980’s) by Justice Breyer’s dissenting opinion in Lab. Corps. of America v. Metabolite Labs., 126 S. Ct. 2511 (2006) in which he began with the statement “There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomenon.” If you are just joining us, please go back and read my post of Monday April 27, 2009, which proposes a test for deciding whether or not a process claim pre-empts a fundamental principle of nature:
Claims drawn to unpatentable natural phenomena would always be inherently or explicitly anticipated by fundamental natural phenomena.
The claims at issue in the Lab. Corps. case are drawn to “simple” diagnostic tests, wherein a bodily fluid of a subject is tested for total homocysteine and, if it is elevated above a benchmark level, the subject is diagnosed as having a deficiency in cobalamine or folate. I argued that this is not a universal or fundamental principle of nature. Nature may contain correlations but it does not sample or analyze, much less correlate, anything.
It may be a fundamental natural phenomenon that the human genome contains DNA encoding in some form of BRCA1 or BRCA2, so a hypothetical claim pre-empting this phenomenon might be “A human genome comprising DNA encoding BRAC1 containing a mutation at position x.” But this claim would not anticipate diagnostic method claim 2 of U.S. Pat. No. 6033857:
A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, where an alteration in the germline sequence of the BRAC2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
As I wrote in my April 27, 2009 post, this looks like a diagnostic assay that is a “product of human ingenuity” carried out by “the hand of man,” not like any universal or fundamental principle of nature. Here the plaintiffs argue: “What is patented here is the abstract idea that nature has made the two genes different in a manner that increases the person’s risk of breast cancer.” Period. Being a poet as well as an attorney, I encounter quite a lot of abstract ideas. How about “The love you take is equal to the love you make”? I was going to posit “A penny saved is a penny earned” but that could be characterized as a business method claim that produces a concrete and useful result. Abstract ideas are essentially not subject to confirmation using the scientific method, unlike diagnostic assays that can be objectively demonstrated to be either mostly right or mostly wrong.
Between this post and the April 27th one, I feel that I have said enough about whether or not diagnostic assays are patentable subject matter. However, the drafters of the ‘857 patent (effective filing date asserted: 1995) seem to have anticipated the recent Bilski test for process claims. Claim 4 is similar in direction to claim 2 but recites the laboratory techniques used to carry out the test, such as “observing shifts in electrophoretic mobility of single stranded DNA on non-denaturing polyacrylamide gels.” Is this enough tying to a “particular machine or apparatus” Mr. Federal Circuit Judges? Note that this is not insignificant post-solution activity; it is a step that permits detection of the BRCA2 mutation.
Ironically, this morning, the Minneapolis StarTribune carried an article: “Diagnosing A Minnesota Niche In Medical Marketplace” with the sub-heading: “Though not big in pharmaceuticals, Minnesota is emerging as a center for diagnostics technology that can help speed drugs to market. Experts say the state could be a natural incubator for firms making such technology.” Good luck!
But claims are at issue here that are more basic than the diagnostic claims in the ‘857 patent or in claims at issue in Metabolite Labs. These are the claims to isolated human DNA sequences encoding defined proteins. If these claims are still valid under the new Kubin standard, will they eventually be found to be unpatentable “products of nature”? This, as well as the policy implications of banning research tools and diagnostic assays will be the subject of future posts.
brca1-complaint US5747282 US6033857