For those of you that are not familiar with the story, Myriad Genetics has patent rights for BRCA1 and BRCA2 screening. A consortium led by the ACLU and AMA spent several years in court trying to get some of the Myriad patent claims invalidated as being directed towards non-patentable subject matter. Ambry is a "generic"
competitor offering similar screening following the outcome of the earlier lawsuit.
The current complaint is in response to an announcement by Ambry that it would begin to offer BRCA testing .
One interesting thing is that Ambry
offers three different types of BRCA tests, priced at $3300; $2200 and $500. Ambry
also indicates that it will provide BRCA1 and BRCA2 gene sequencing and
deletion/duplication results at no extra charge as part of its existing “BREAST
NEXT” ($4,120); “OVANEXT” ($5,310) and “CANCERNEXT” ($5,830) NGS panels. Those of you that have been following the
Myriad saga from the district court in New York, to the Court of Appeals of the
Federal Circuit (CAFC) and then to the Supreme Court (SCOTUS) are aware that
the plaintiffs (including the ACLU and the AMA) were vociferous in their
opinion that the patents held by Myriad were keeping the cost of BRCA1/2
testing high, to the detriment of women that wanted to know what their risk of
developing breast cancer/ovarian cancer is.
To the best of my knowledge,
neither the ACLU nor the AMA has criticized Ambry’s price schedule.
Myriad genetics offers a financial assistance program for uninsured patients, and
a 25 month payment plan for insured patients. Ambry genetics also offers a
financial assistance program. Comparison of the relative merits of the two
financial assistance programs is beyond the scope of this blog.
Looking at the list prices, it is
not at all clear if testing by Ambry is significantly cheaper than testing by
Myriad. Even with a Ph.D. in molecular biology I’m not sure what are the differences between the $3300; $2200 and $500
tests offered by Ambry. It seems likely that the typical patient concerned
about her future risk of breast/ovarian cancer has less than a Ph.D. in
molecular biology. While we would all like to believe that her primary care
physician can provide meaningful guidance on the differences between the $3300;
$2200 and $500 tests, that is not always the case.
Hypothetically, a woman that
received “bad news” from the $500 Ambry test could easily consider ponying up
another $3300 or $2200 before undergoing
the double mastectomy/ovarectomy she was presumably contemplating if she took
the test. This would bring the total cost into the same price range as the
Myriad test or higher.
Conversely, a woman that received “good
news” from the $500 Ambry test might still be uncertain as to the reliability of
the “cheap test” and lay out another $3300 or $2200 to be certain she doesn’t need
a double mastectomy/ovarectomy. After
all, the ACLU and AMA also stressed the importance of a woman’s right to a
second opinion. Again, this would bring the total cost into the same price range as
the Myriad test or higher.
So, what did the much touted legal
battle concerning the BRCA portfolio belonging to Myriad genetics actually
accomplish?
Well, some patent claims were
invalidated by the CAFC. Additional patent claims were invalidated by SCOTUS.
Was
this a victory for the ACLU, the AMA and the various patients and doctors that
joined the suit?
Perhaps not.
The Supreme court decision clearly
indicates :
“[a]s the first party with
knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position
to claim applications of that knowledge. Many of its unchallenged claims are limited
to such applications.”
SCOTUS did what it routinely does.
It issued a decision, accompanied by a clear statement of what that decision does
not do.
One of the things the SCOTUS
decision does not do is prevent Myriad from enforcing its rights based upon any
claims not invalidated by the CAFC or SCOTUS. While there is a theoretical
possibility that the District of Utah, Central Division will find that Myriad
is estopped by the previous lawsuit, that seems unlikely. One reason is that Myriad is physically
located in Utah and therefore enjoys a “home court” advantage. Another reason is that Ambry was not a party
to the previous lawsuit; presumably because they were not offering testing
services which could be perceived by Myriad as infringing their patent claims until
after the previous suit had run its (incredibly long) course. Another reason is
that the claims at issue in the case against Ambry were not at issue in the
previous case because there was no allegation of infringement in that case.
The previous lawsuit seems to have
helped Myriad retain exclusive control of the market for several years. The
current complaint against Ambry seems likely to help them retain that exclusive
control for several more years.
Kudos to those that conceived and
executed the Myriad BRCA patent portfolio. One of my mentors said “A good
portfolio is one that takes so much time and money to analyze that nobody will
do the analysis.” That seems to be the
case here. The analysis will occur during litigation and/or licensing
negotiations.
Since the initial suit against Ambry is to be heard
in a friendly jurisdiction, by a jury, and since the issue of section 101
patent eligibility has already been addressed by the courts, I predict that
Ambry will need to do what all accused infringers hate to do: focus on whether
infringement is actually occurring at trial.
Whether Myriad will visit the CAFC and/or
SCOTUS again is anybody’s guess.
