At the BIO IP Counsels Committee Conference (IPCC) in Boston last week, Sandra Wells, VP and Chief IP Counsel of Affymetrix, gave a talk about the evolving patent-eligibility standards for genes.
Earlier, the American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole gaggle of others have filed a lawsuit challenging patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers. Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. (09 Civ. 4515). A copy of the decision is here: Myriad Decision (pdf).
On March 29, 2010, the University of Utah and Myriad Genetics lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the genes BRCA1 and BRCA2. The 152-page decision addresses questions about whether human genes should be subject to patent protection.
Wells reviewed the policy arguments against gene patents:
- Are not necessary to incentivize gene discovery
- Are not necessary to incentivize commercialization of gene tests
- Lead to fewer genetic test providers
- Cause inflated prices for genetic tests
- Restrict patient access to genetic tests
- Lead to lower quality of genetic tests and other genetic technology
- Stifle basic or applied research into new or improved genetic technologies
- Create infringement liability for women who donate cancer samples for research
- Prevent patients from getting a second opinion
2. The claims preempt all uses of the information the genes contain, regardless of variation or of method used for analysis, i.e., there is no way to design around.
3. The scope of patentable subject matter should balance reward for research and ensuring opportunity for future innovation, i.e., Myriad is being overcompensated for its contribution.
Are isolated human genes and the comparison of their sequences patentable?
Are the sequences products of nature? That is: “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Chakrabarty, 447 U.S. at 309. But Chakrabarty in contrast found patentable “a new bacterium with markedly different characteristics from any found in nature.” Is sequencing a gene more like finding a plant in the wild than a newly engineered bacterium?
For composition of matter claims, the purified product must possess “markedly different characteristics” from a product of nature. Wells noted that the isolated and purified products do not have any functions that they did not have already so the required change is absent.
Question: Is “Isolated DNA” claimed by Myriad “markedly different” from native DNA as it exists in nature?
Judge Sweet’s Opinion: “Isolated DNA” not Patentable.
“In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences … between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents … render the claimed DNA ‘markedly different.’”
“The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.”
Typically, when the question of patent-eligibility has come up, the Supreme Court has identified human intervention as the touchstone. Diamond v. Chakrabarty; (“the invention is not nature’s handiwork, but his own”), accord J.E.M. Ag-Supply; Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.N.Y. 1911). (Purified adrenaline so superior to previous adrenal gland extracts so as to be different not just in degree, but in kind). The invention must have been transformed through human intervention from the natural thing into something that is qualitatively different, new, and man-made.
Wells then proceeded to give an overview of the history of product of nature case law:
- American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. 566 (1874) (pure cellulose pulp preparation prepared by novel chemical process held not novel over prior art cellulose pulp preparations made by old process);
- Cochrane v. BASF, 111 U.S. 293 (1884)(claimed “artificial alizarine” prepared by new chemical process not novel over prior art impure alizarine extracts from madder root);
- American Fruit Growers v. Brogdex Co., 283 U.S. 1 (1931)(Borax-treated citrus fruit is insufficiently changed from natural fruit, and not a manufacture within the meaning of the Patent Act);
- Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)(claimed inoculate of mutually non-inhibitive root-nodule bacteria held not inventive over preexisting state of the art);
- Lab. Corp. v. Metabolite, 548 U.S. 124 (2006)( Breyer., J. dissenting from dismissal as improvidently granted) A diagnostic method correlation claim is an unpatenable discovery of a law of nature.
Wells also noted that some some claims might be invalid under other provisions, for example claim 5 of the ‘282:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
Claim 5 is directed at any 15 nucleotide sequence coding for any part of BRCA1 protein. This includes ~1.6 million sequences or about 1 in 600 of all possible 15-mers with 340,000 “infringing” 15-mers on human chromosome 1.
Wells believes that gene patents potentially inhibit development and commercialization of products and technologies that look at many genes simultaneously.
While it has to be noted that Affymetrix has a personal interest in having gene sequences free from patents — Affymetrix sells integrated GeneChip microarrays (chips) consisting of nucleic acid sequences with total revenues of $327.1 million for 2009 — it was eye-opening to know that the cost of sequencing the entire human genome is projected to be $1,000 in near future. If you add just $100 per gene for royalties for each of the 25,000 genes, the cost would be $2,501,000! That, of course, is if you can get all of the patentees to agree.