Ah, the glorious patent — such a simple concept, and yet so
utterly essential to a properly functioning society. In basements
and R&D departments across the country, innovators are hatching
newfangled gadgets, widgets, and services — products that will
fuel economic growth and improve lives — because they are
reasonably confident that a patent will prevent competitors and
criminals from stealing their inventions.
The folks at pharmaceutical companies are no different. Yes,
that’s right, drug companies, like most innovators, are in business
to make money. They invest huge sums in research that leads to
life-saving medical advances, and they hope to be rewarded for
their efforts. Without strong patents protecting new drugs and
processes, much of the research simply cannot continue.
How distressing, then, that the U.S. Senate has taken up a bill
that would pretty much decimate patents as we know them. The Patent
Reform Act of 2007, a version of which has already passed the
House, would require every patent application to be published on
the Internet only 18 months after filing.
Considering the years of research underlying most medical
innovations, it is madness to require pharmaceutical companies to
reveal their secrets so early. It seems even more unfair when you
consider that it often takes in excess of 36 months after filing a
patent to actually have it approved. This means that competitors
and criminals will have a window of at least 18 months to replicate
new drugs and medical research.
Proponents of the bill claim that medical patents are being
applied to inventions that are so small that they routinely
overlap. They add that since many patented chemicals and processes
are discovered through incremental advances, competing claims on
them have stifled progress in the medical field.
But as any medical scientist will tell you, there are few
“Eureka!” moments in health research. Progress comes step-by-step,
one incremental innovation at a time. Companies more often profit
by improving existing chemicals and making processes more efficient
than by revolutionizing the whole field with new products. And even
the smallest innovations are made only after large amounts of very
expensive research.
What’s more, those clamoring for congressional action are
seriously exaggerating the problems of the present system. They
often cite, for example, the case of Myriad Genetics, a company
that in 1998 patented a test for a genetic variation that,
according to the company’s website, increases a woman’s risk of
breast cancer.
Instead of licensing its expertise, Myriad has decided to charge
clinicians $3,000 a pop to perform the test. And since it will not
open the test to outside scrutiny, other researchers have been
unable to verify the procedure’s effectiveness. Critics say the
public has been ill-served.
It is true that $3,000 seems expensive for a test, but one
should not underestimate the cost of developing this procedure. And
in any case, as Claire Driscoll, Director of the National Human
Genome Research Institute, recently told Reason magazine,
situations like Myriad’s are the exception. “In my 10 or 15 years
of doing this,” she said, “I hear the same five or six examples
[including Myriad Genetics] repeated over and over.”
The vast majority of patents are on medicines and procedures
that have undergone extensive outside scrutiny. According to the
Center for the Study of Drug Development at Tufts University, of
every 5,000 compounds tested, only 250 enter pre-clinical testing,
only five make it to clinical testing, and only one eventually
receives FDA approval. There is no reason why a medicine so
thoroughly vetted should not enjoy the protection of a patent that
prevents outsiders from snooping into the specifics of how it
works.
Even as the U.S. Congress considers weakening America’s patent
law, officials in other countries are recognizing the importance of
protecting intellectual property. Singapore, for example, has made
a point of luring biotech and drug companies with promises to
protect their inventions. “No pharmaceutical company is going to
have its precious patents disclosed,” former Singaporean Prime
Minister Lee Kwan Yew told Der Spiegel magazine in
2005.
Indeed, America’s strong patent law is a major reason why many
pharmaceutical companies are still based here, instead of, say,
Canada, where laws are weaker. If the Senate passes the Patent
Reform Act of 2007, some companies might pack up and leave. Or,
more worryingly, they might simply halt research on what could be
tomorrow’s life-saving cures.
