![handle is hein.journals/ipthey2 and id is 1 raw text is: Will Gene Patents Impede Whole Genomne Sequencing?:
Deconstructing the Myth that 20% of the
Human Genome Is Patented
Christopher M. Holman*
During oral arguments before the Court of Appeals of the Federal Circuit in Association
fbr Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. PTO), a high-profile
lawsuit challenging the validity of so-called gene patents, Judge Bryson asked the attor-
ney representing Myriad Genetics (owner of the specific patents under attack) whether the
company's patents would be infringed by the sequencing of an individual's genome.' The at-
torney did not seem to have previously considered the question, but ventured that in his view
whole genome sequencing (WGS) would not constitute infringement because Myriad's pat-
ent claims are directed towards isolated genes, not the entire chromosome. Later during the
proceedings, the ACLU attorney representing the plaintiffs begged to differ, offering up his
opinion that Myriad's gene patents, particularly claims directed to isolated DNA that codes
for the BRCA polypeptide, would in fact be infringed by WGS.?
The question of whether Myriad's patents would be infringed by WGS is entirely hypo-
thetical-no one has ever been sued for infringing a human gene patent based on the sequenc-
ing of an individual gene, let alone an entire genome. But Judge Bryson is understandably
concerned with the policy implications of AMP v. PTO, and his question reflects a widely held
perception that gene patents threaten to substantially impede the implementation not only of
WGS, but of other genetic diagnostic technologies that simultaneously test for variations in
multiple human genes.
*Associate Professor of Lawv, University of Missouri - Kansas City
1. Oral Argument at 11:02, Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office,
No. 2010-1406 (Fed. Cir. July 29, 2010), available at http://www.cafc.uscourts.gov/oral-argument-
recordings/search/audio.html.
2. Id.
3. Id. at 34:40.
4. See generally Christopher M. Holman, Trends in Human Gene Patent Litigation, 322 Sci. 198
(2008) [hereinafter Holman, Trends in Human Gene Patent Litigation]; Christopher M. Holman, The
Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litiga-
tion, 76 UMKC L. REv. 295 (2007) [hereinafter Holman, The Impact of Human Gene Patents].](ViewImageLocal?handle=hein.journals/ipthey2&div=1&collection=&method=preview&ext=.png&size=3)
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