By Kevin E. Noonan —

Sadly (you'd expect they would know better), the
editorial board of Nature Biotechnology has decided to get on-board the
anti-gene patenting bandwagon.  The
editors are entitled to their opinion, of course, but it shouldn't be too much
to ask that they be more informed about the issues.

This development appears as an editorial in the May
edition of the journal.  Entitled "Sitting up and taking notice," the editorial
announces Judge Sweet's March 29th decision in favor of the
plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office.  That announcement marks the last time
the editorial makes completely factual statements, tending instead to promote
the idea that gene patenting is a problem by inference direct and indirect.

For example, the editorial characterizes the
procedural aspects of Judge Sweet's decision, on summary judgment, as
indicating that "the judge felt Myriad had no case to argue."  This is incorrect:  summary judgment is used when there are
no disputed issues of material fact, and the court finds that it can decide the
matter as a matter of law.  The
prudence of this judgment can be questioned, not merely on the basis that the
judge actually chose to make law on patentable subject matter by deciding that
DNA is sui generis as "the physical embodiment of genetic information."  The editorial also is mistaken in
stating that "[t]he plaintiffs won on virtually every count," in view
of the fact that the District Court avoided the Constitutional issues that were the basis
for the Court to deny defendants' motions to dismiss.  This is not a trivial matter, since as a consequence the PTO
was dismissed from the case, and without these issues the breast cancer
patients had no standing to bring the suit in the first place (not to mention
that these are the issues that created the political frisson for the ACLU and
PubPat).

The editorial also continues to mistake the effects
on research of the BRCA patents with the use of these patents to prevent
infringing, for-profit commercial activity.  The editorial states that "Myriad's influence has been
particularly pernicious.  Its lawyers have issued cease-and-desist letters to
genetics laboratories in universities, hospitals and clinics that offered
diagnostic services based on the BRCA1 and BRCA2 genes."  These uses of the patented tests
constitute infringement — the fact that the infringer is a university,
hospital, or clinic doesn't absolve them from for-profit, commercial,
infringing activities.  The
difference between this type of activity, which is not "research"
(although the results can be used for research purposes) is in stark contrast
to the several thousand basic research papers in scientific journals that have
been published since the BRCA gene patents were granted.  That is where the research to support
innovation is occurring, not in university, hospital, or clinic labs doing
fee-based, diagnostic assays for patients, and there is no evidence that Myriad
or any other gene patent holder has inhibited basic biological research by
threatening patent infringement litigation.

The piece also attempts to achieve "truth by
association" in noting the several groups that have "concerns"
about gene patents, including the International Center for Technology
Assessment, Greenpeace, the Indigenous Peoples' Council on Biocolonialism, and
the Council for Responsible Genetics, all of whom filed amicus briefs in the
case.  Their contribution to the
debate would be more welcome if it did not include patently incorrect
statements regarding the consequences of gene patenting, including "the
privatization of genetic heritage, the creation of private rights of unknown
scope and consequences and the violation of patients' rights."  The editorial was correct in noting
that "[t]he alignment of physicians' and patients' groups with what are,
in effect, antibiotech lobbyists is a worrying development," albeit ignoring
the fact that not only the biotech sector but the public should be worried if
these groups should get their way.

The editorial did supply a data point for the
debate, in noting that Myriad reported "$326 million in revenue from
diagnostic testing against $43 million in costs."  Assuming these numbers to be correct,
and to reflect only BRCA testing, an indication of the profitability of BRCA
testing results (perhaps unintentionally providing a motivation for the "universities,
hospitals, and clinics" to be so keen on getting into the business,
infringing or no).  However, the
figures are completely out of context; there is no indication if these profits are out of the ordinary for
diagnostics companies, traditional or genetic, or whether the "costs"
include ancillary costs like genetic counseling or physician education (both
critical in genetic diagnostics due to the consequences for a patient of
receiving a genetic diagnosis).  Surely, if Myriad's profits were actually significantly higher that other
companies, that fact would be relevant and the absence of any comparisons
suggests that the absolute numbers were used because they better supported the
editorial's views.

Then there is the portion of the editorial that
seems divorced from reality:

It often seems unfair that the patent
system rewards only the last inventive step — the small breakthrough that enables
a concept to be realized.  The research
enterprise, which continually renews itself, especially in rapidly moving areas
like genetics, is increasingly at odds with the commercial conservatism of
patent monopolies based on gene findings that are obsolescent compared with
current art.  Despite both cultural and economic incentives for innovation, the
difficulty in dislodging incumbent approaches is reinforced by a patent system
that insists that any use, however small, of a protected method is
infringement.  Is it so outrageous to expect that a properly functioning IP
system could provide an unobstructed path to the market both for the initial
innovators and for subsequent improvers?  Surely, a different balance of rights
is possible that better serves the society with whom the patent bargain has been
struck.

The patent system rewards inventors who disclose
how to make and use an invention that is new, useful, and non-obvious.  Whether the improvement is
groundbreaking or incremental, satisfaction of the statutory requirements
governs patentability.  Thus, if
technology becomes "obsolescent," new technology takes its place — if
only because patents expire, as indeed Myriad's patents will start to expire in
2014.  The passage indicates just
how little the writers understand the "balance of rights" that the
patent bargain actually strikes.

Finally,
the editorial does touch on the coming issue of patent protection for methods
of detecting specific genetic polymorphisms and techniques such as whole genome
sequencing that could infringe such patent claims.  These are not "gene patents" per se, since they involve assays on genes (actually, fragments of
genes) rather than the genes themselves.  The editorial thinks little of "patent pools" as a means for
overcoming the potential issues, stating that such mechanisms "are not
going to emerge in biotech of their own accord" and ignoring how the
(unregulated) computer and telecommunications industries have developed just
these types of patent pools.  Instead, the editorial posits that it will probably take some form of government
or legal coercion to get things moving for gene tests, disagreeing with the
recommendations for such tools from the U.S. Health and Human Services SACGHS
report.

The
editorial ends by exhibiting a consistent lack of understanding of innovation as
well as the patent process.  It
suggests assigning rights to specific genes in multigene tests based on "the
importance of any specific gene sequence to the utility of the test,"
something the marketplace can be counted on to do without the government's
help.  Saying that the "early
gene mutant discoveries . . . now look trivial" (!), such a approach is
suggested to provide incentive for "those who continue to develop tests of
high medical value with commensurate financial remuneration."  Those "trivial . . . early gene
mutant discoveries" are certainly not trivial to the patients benefiting
from diagnostic assays or therapies based on them; moreover, if by "trivial"
the writers meant "amenable to early discovery" that is just a
reflection on the strength of the phenotype resulting from the mutation.  And while the last sentence of the
piece was clearly meant to be exhortative:

That this ideal is implausible within
the current petrified patent system and commercial infrastructure doesn't have
to stop the dream, and certainly shouldn't stop the discussion.

It is merely incoherent:  the dream of better diagnostics and therapies is and has
been realized by thirty years of biotechnology and protection thereof by an
invigorated patent system in the U.S.  Changing that now, particularly if based on the wooly-headed arguments
(really, sentiments) in the Nature Biotechnology editorial, is the fastest and
surest way that those hopes and dreams will be dashed.