By Donald Zuhn —

In a paper published in
March in the journal Genome Medicine,
Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New
Jersey and Dr. Christopher Mason of Cornell University contended that due to
the non-specificity of sequence uniqueness across the genome and the broad
scope of claims to nucleotide sequences, the Supreme Court and Congress should
limit the patenting of existing nucleotide sequences ("Pervasive sequence patents cover the entire human genome,"
Genome Medicine 5:27 (2013)). 
Their paper was discussed in this space shortly after publication (see "Genome Medicine Article Calls for Limits on Patenting of Existing
Nucleotide Sequences" and "Revisiting Genome Medicine Article on 'Pervasive Sequence Patents' That
'Cover the Entire Human Genome'"),
and was followed by a response from Dr. Mason (see "Dr. Chris Mason Responds to Blog Posts on Genome Medicine
Article"),
and then our discussion of the paper and Dr. Mason's response to our coverage concluded
with two further posts (see "A
Primer on Claim Construction — Comments on Dr. Mason's Response" and
"A Response to Dr. Mason's "Rebuttal" to Criticisms of His
Genomics Medicine Article").  Last week, the co-authors of the paper
announced that they had started a company, Genome Liberty, Inc., to determine the
medications a person should take and the medications a person should avoid
based upon that person's DNA.

In
an e-mail distributed last week, Dr. Rosenfeld noted that the co-authors "are
extremely proud that there are no longer patents on human genes and that researchers
can sequence any gene without the risk of litigation."  With respect to the type of analyses that
their company will perform, Dr. Rosenfeld provided two examples:  first, assaying for individuals who convert
codeine to morphine in their livers too quickly, leading to an overdose of
morphine (citing Kelly et al., 2012,
"More Codeine Fatalities After Tonsillectomy in North American Children"
Pediatrics 129(5): e1343-47),
and second, testing for a condition known as Factor V Leiden where people who
are given estrogen, either as birth control or as hormone replacement, can have
severe blood clots.  In a follow-up
e-mail distributed earlier today, Dr. Rosenfeld indicated that "[f]or a large percentage
of medications, there are DNA markers indicating whether [such medications]
should be used or avoided, but doctors do not routinely perform these tests."

In
a statement released by the co-authors, they note that their company
"will democratize the human genome and give people direct access to their own
genetic information — which can have an immediate impact on their health and
well being," adding that the Supreme Court's decision in AMP v. Myriad Genetics "opened an
era of genomic liberty, allowing people to look at the DNA for all of their
genes — which had been hidden behind patent walls for companies that had a
monopoly on such testing."  The
release states that the company will "begin offering immediate,
personalized genetic testing to the public that can be directly ordered by
patients," while suggesting that "the results should used in concert with
your doctor."  The company's
founders explain that:

Genome Liberty, with the Supreme Court's
blessing, ushers in a new paradigm of personalized medicine, which complements
the traditional health care model.  Previously,
individuals had to rely on their doctors to understand their health and to make
proper medical decisions for them.  Recently,
people are becoming more involved in their own health care, in a phenomenon
called "participatory medicine." 
Various organizations, including patientslikeme.com and the Society for
Participatory Medicine, have been leading the charge in this field to overcome
inherent weaknesses in our medical system. 
Many people have found that drugs do not work for them, and they have
formed patient groups to attempt to help each other.  And, as scientists and doctors have found the
molecular basis for disease and drug response, it has become increasingly clear
that a "one-size-fits-all" framework for medicine is not in the best
interest of each patient.

According
to the release, Genome Liberty will be examining genetic markers associated
with drug response for "hundreds of frequently prescribed drugs,"
including codeine, Plavix, Nexium, Prilosec, Zocor, Dilantin, Coumadin,
Haloperidol, Abilify, and Celexa, and that the test will cost $99.

In
an effort to secure funding for their new company, the co-authors have
initiated a crowd-funding campaign on
the website RocketHub.  As of August 12,
40 funders had committed $8,285 towards a goal of $100,000 to be raised by September
5.  The company's RocketHub page includes
the following video discussing the AMP v.
Myriad Genetics decision and the company's plans: