By Kevin E. Noonan —

The Internet over the past decade has given rise to
a wide variety of "alternative media" outlets, including for example Slate, The Drudge Report, The
Huffington Post, and arguably blogs like this one.  Even conventional news outlets like The
New York Times, The Washington Post, and The Wall Street Journal have exclusively
on-line content.  Despite the
differences between these disparate sources, including writing by some
non-traditional "journalists," news outlets of all stripes have many
things in common.  Unfortunately
one of these is an uninformed antipathy to biotechnology, particularly with
regard to gene patenting.

This similarity is evidenced most recently in The Huffington Post, in a piece entitled
"Gene Patenting Produces Profits, Not Cures."  The author, Harriet A.
Washington (who also authored Deadly
Monopolies; more on that
later) writes that Myriad Genetics "predictably" appealed Judge
Robert Sweet's decision invalidating fifteen claims in seven patents challenged
by several breast cancer patients, medical associations, and researchers (and
supported by the ACLU and the Public Patent Foundation).  The piece is replete with misstatements
concerning the scope of rights conferred by gene patents, such as that Biogen controls
"your kidney's essential KIM gene" as well as a list of other genes
patented by the University of California and other patent holders.  Ms. Washington boldly asserts that the "coalition"
challenging gene patents in the Myriad
case may have too narrow an agenda, and proposes (conveniently, since her
argument provides a précis of her "forthcoming book") that all "life
patents" should be banned.  These include "the more than 500,000 genes that control the most
basic processes of human life," a stunning statement in view of the
reality that there are only about 30,000-40,000 genes in the human genome.  Setting her sights even higher than
genes, she believes that patents on "bacteria,
viruses, biologicals such as 'artificial blood', cell lines, tissues,
pharmaceuticals, and even on medically important plants and animals such as
Harvard's patented cancer-prone 'oncomouse'" should be banned.  Why?  Because "[t]he $60 billion pharmaceutical industry
became the most profitable industry on the planet by exploiting its plethora of
patents."

She sets forth a
generally correct history of the development of the biotechnology industry.  She mentions the Diamond v. Chakrabarty decision, and passage of the Bayh-Dole Act that encouraged
universities to protect their inventions (instead of letting them fall into the
public domain where they could be exploited by corporations, including foreign
corporations, with no compensation to the university or its researchers).  She also discusses the rise in
university patenting, from about 260 patents/year prior to Bayh-Dole to more
than 3,000 patents/year today.  She
also notes that "by 1991 [universities] had gleaned $218 million in
royalties" (an amount certainly much higher today).

Where she begins to
show her naïveté about how technology its transferred between academia and
pharmaceutical companies is when she says that "corporations receive valuable, ready-made
patents on medications, biologicals, genes, devices, plants and animal hybrids,"
which suggests that the technology transferred is ready to be commercially
exploited solely as the result of federal grant support and "university
brainpower."  While necessary,
these factors are woefully insufficient, at least because the FDA requires
extensive safety and efficacy studies before any pharmaceutical comes on the
market (protection it is unlikely Ms. Washington opposes).

Her argument seems to
be that with all the patents and all the research, the public has received less
than they were promised.  She cites
in support of this proposition that "[b]y 2003, North American university
researchers had started 374 companies and academic institutions had completed
4,516 licensing arrangements earning them more than $1.3 billion" and that
"[b]y 2006, university technology transfer offices had generated at least
$45 billion, largely from licensing fees."  The result, she maintains, is that universities have become
research "satellites" rather than independent entities.  This charge is, ironically, belied by
the statistics on licensing, which illustrate how universities, due to their
patent rights, are in the position
to grant licenses to those companies committed to commercializing their
inventions.  Indeed, most such
licenses have commercialization milestones and other provisions that, for
example, change an exclusive license to a non-exclusive one (that can be
licensed to another company) should the performance milestones not be met.

She repeats some
oft-told tales, such as the purported pernicious effects of Chiron's hepatitis
C virus test, and the company's failure to produce better treatment despite
patents on isolated viral genes.  She uses Chiron's lawsuit against a commercial infringer to
allege that there was a "chilling effect on researchers who wish to work
on better HCV treatments," but provides no evidence that Chiron has sued
any basic (non-commercial) researcher working on HCV biology.  This is similar to allegations in the Myriad suit that the company was
inhibiting basic research, despite the >8,000 basic research papers easily
found in PubMed and other databases.

Ms. Washington raises
some real limitations to the Western medical research model, including that
diseases prevalent in the undeveloped world (such as trypanosmiasis) have not
been adequately addressed, and the inefficiencies in business models that
require "blockbuster" drug status to support the incredible costs
($800 million – $1.2 billion) of bringing a drug to market.  And she mentions John Moore's hairy
cell leukemia, Henrietta Lack's vulval adenocarcinoma (HeLa) cells, and Canavan's
disease patient samples as examples of corporate exploitation.  On the contrary, all of these incidents
occurred in a university setting, and the HeLa example occurred in the same
time period that saw Jonas Salk perform experiments on his polio vaccine with
retarded children from a nearby sanitorium, with precious little informed (or
parental) consent.

What Ms. Washington
refuses to acknowledge (because it doesn't support her argument) is the real
benefits (or "cures") that biotechnology has provided over the past
30 years.  Nowhere in her piece is
there anything about the thousands (millions?) of heart attack patients whose
lives have been saved by recombinant tPA (Genentech), or the thousands
(millions?) of kidney disease patients leading relatively normal lives due to
recombinant EPO (Amgen), or the thousands (millions?) of breast cancer patients
treated with Herceptin® (Genentech), or colon cancer patients treated with
Avastin® (Genentech) or macular degeneration patients whose eyesight has
improved using Lucentis® (Genentech), not to mention the hundreds of other
biotechnological drugs on the market or in development.  No, these triumphs don't exist in
the world Ms. Washington describes, which must make it easier for her to say:

Some argue that gene patents are
necessary to generate the profits essential to funding the medical cures.  But
as the cases of breast cancer, hepatitis C and hemochromatosis illustrate,
genes are more commonly used for faster, easier routes to profit, such as
marketing tests, selling licenses and suing those patent-infringers who step on
the corporation's biomedical toes.

The biotechnology industry
is not without its inefficiencies, but failing to acknowledge the benefits
along with the deficiencies makes it easier to set forth the portrayal
contained in Ms. Washington's article.  But doing so fails to describe "the rest of the story," and
does a disservice to anyone wanting to understand the role of both universities
and patenting in the biotechnology industry.