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Patent Docs: Does the Myriad decision presage a golden age of patent-free personalized medicine?
September 2013
SHARING OPTIONS:
The U.S. Supreme Court's Myriad decision has been almost universally hailed as being
a great victory for patients, doctors,
personalized medicine and research.
Indeed, several genetic analysis companies announced plans to offer BRCA gene
testing. The natural question to ask
is: Are all of these "experts" correct?
During oral arguments before the Federal Circuit Court the
first time the case came before the
appellate court, Gregory Castanias,
representing Myriad Genetics,
argued that the plaintiffs would not be able to
perform genetic diagnostics on the BRCA genes because Myriad's patents
contained additional method
claims of different scope (other than the claims
targeted by plaintiffs in their lawsuit) that Myriad could assert. For example,
Claim 1 of U.S. Patent
No. 6,033,857 is illustrative of the invalidated claims:
A method for identifying a mutant BRCA2 nucleotide
sequence in a suspected mutant BRCA2 allele, which involves comparing the
nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type
BRCA2 nucleotide sequence, wherein a difference between the suspected mutant
and the wild-type sequences identifies a mutant BRCA2 nucleotide
sequence.
Whether Castanias is correct depends on how the court's Mayo
v.
Prometheus and Myriad decisions affect the patent-eligibility of these
remaining claims. This question should be answered in one of two
lawsuits
Myriad filed against two of its competitors (Ambry
Genetics and Gene by Gene),
who announced they were
offering BCRA gene testing. Myriad asserted
substantially the same claims against both defendants, and these claims are
directed both to genetic
diagnostic methods and composition of matter claims
for oligonucleotide primers and probes.
The
specific claims Myriad alleges Ambry and Gene by Gene
infringed include claim 6 of U.S. Patent 5,707,999:
A method for detecting a germline alteration in a BRCA1
gene, said alteration selected from the group consisting
of the alterations set
forth in Tables 12A, 14, 18 or 19 in a human, which comprises analyzing a
sequence of a BRCA1 gene or BRCA1 RNA from a human
sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said human sample with the provision
that said germline alteration is not a deletion
of four nucleotides
corresponding to base numbers 4184-4187 of SEQ ID NO:1, wherein a germline
alteration is detected by amplifying all or part of a
BRCA1 gene in said sample
using a set of primers specific for a wild-type BRCA1 gene to produce amplified
BRCA1 nucleic acids and sequencing the
amplified BRCA1 nucleic acids.
The companies also include claim 16 of U.S. Patent No.
5,747,282:
A pair of single-stranded DNA primers for determination
of a nucleotide sequence of
a BRCA1 gene by a polymerase chain reaction, the
sequence of said primers being derived from human chromosome 17q, wherein the
use of said primers in a
polymerase chain reaction results in the synthesis of
DNA having all or part of the sequence of the BRCA1 gene.
Finally, the companies' allegations also include claims from
Myriad patent Nos. 5,654,155; 5,750,400; 5,753,441; 5,837,492;
6,033,857;
6,051,379; 6,951,721; and 7,250,497.
As Myriad states in its complaint, the company
"has 24
patents and 520 claims, of which only five were invalidated by the Supreme
Court," and it clearly intends to assert these claims.
The method claims asserted by Myriad against Ambry and Gene
by Gene differ from the claims invalidated
by the U.S. District Court (and
affirmed by the Federal Circuit) in the Myriad case, which recited as limitations merely "comparing" an
individual's
BRCA gene sequence with the "normal" one. Myriad is less likely to be estopped
from asserting these claims against defendants. Other
claims, particularly
those directed to oligonucleotides, are less likely to be successfully
asserted; this is because these claims have other
patentability issues, e.g., on novelty grounds, and because the Supreme Court's Myriad decision could be interpreted to make the identity
of these sequences with naturally occurring sequences, rather than their
synthetic nature, the touchstone for patent eligibility.
Whether or not Myriad is successful, it is significant that
Myriad has decided to assert these patents, and its
continued ability to do so
illustrates one of the generally unappreciated aspects of the Myriad case. The plaintiffs in that case, the American Civil
Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT), and their
supporters chose the claims
against which to assert their challenge to the
validity of Myriad's patents, and those claims did not include the claims
Myriad now asserts. The
court's Myriad decision not only does not preclude patent-eligibility for these
claims, it affirmatively suggests that claims to such
applications
(particularly when directed to using cDNA) are the type of claims the court
believes do not suffer from the deficiencies the court found
attached to claims
to "merely" isolated genomic DNA.
In view of these considerations, it should
be clear that any
"victory" claimed by the ACLU or PUBPAT is of the Pyrrhic variety, and the
female patient plaintiffs are in no better a position
than they were before the
court's decision.
Kevin Noonan
is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and
represents biotechnology and
pharmaceutical companies on a myriad of issues. A
former molecular biologist, he is also the founding author of the Patent Docs
weblog, http://patentdocs.typepad.com/. Back |
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