On the front page...
To say that NIH intramural researchers had a banner
year in 2005 is an understatement, at least according to one business
standard. Last year, the NIH Office of Technology Transfer collected
close to $100 million in royalties from products or processes invented
by scientists working here. That's nearly double the $56 million-plus
NIH inventions earned for 2004. Even better for medical research
are the millions more people these new concepts will help by going
|One of NIH’s top inventions — a
stent coated with a chemotherapy drug — spares some people
heart bypass surgery.
Take, for example, one of the top NIH inventions in recent years — the
Taxol-coated stent. Both the drug Taxol (paclitaxel) and the stent
were already on the market separately, being used to treat cancer
and heart disease, respectively. Who would have thought of combining
the two — coating the stent with Taxol — for even further
benefit? Two NIA scientists did. Dr. Steven Sollott and Dr. James
Kinsella found that implanting stents coated with the chemotherapy
drug significantly reduces re-clogging of arteries. The invention,
which went on the U.S. market in 2004, has been a medical marvel
for the more than half a million Americans each year who now can
avoid heart bypass surgery by having the stent placed instead.
It was also the top commercially successful intramural invention
for fiscal year 2005, based on royalty income.
OTT has dozens of similar success stories about brainstorms-turned-breakthroughs
by NIH inventors — ideas that may never have reached nearly
as many people without going through the patenting/licensing process
that OTT oversees.
"There are more than 200 products on the market that include NIH
technologies," says OTT deputy director Dr. Bonny Harbinger. "Employees
should be extremely proud of what's coming out of here."
Medical Research — Spreading the Results
In addition to garnering millions of dollars in royalties — which
are split between inventors and the institute or center where the
invention was made active — there's also another economic
reason for NIH to shout its commercial success from the rooftops:
NIH inventions boost the nation's return on its investment in medical
research. In an era of flat budgets, that's news everyone wants
to share. NIH director Dr. Elias Zerhouni made that case Apr. 6
to Congress at the House appropriations hearing. Showing the stent
and a few other successful NIH inventions, he pointed out the broad
health dividends the American public receives compared to the relatively
small amount it spends per capita on medical research. Innovations
that started with NIH ideas are a crucial part of the bottom line.
"NIH's intramural inventions generated about $100 million in royalties
last year, which is much larger than other science-oriented federal
agencies such as NASA," notes OTT director Dr. Mark Rohrbaugh.
In fact, NIH's OTT accounts for more than half of all royalties
for all federal laboratories, due in part to the nature of the
research conducted here. The world's hunger for more effective,
easier and faster therapies, medical procedures and methods to
diagnose ailments only grows stronger every year. Also, much of NIH's
royalty income is generated by biological material licenses that
are aimed more at research than clinical/medical use in patients,
points out Laurie Arrants of the NINDS Office of Technology Transfer.
|These products are just a sampling
of the dozens of OTT success stories about brainstorms-turned-breakthroughs
by NIH inventors.
With an 80-person staff, including contractors, OTT currently
manages more than 1,500 active licenses for NIH and the Food and
Drug Administration. By law, inventions that emerge from NIH labs
belong to the federal government. Successful commercial products
that license and incorporate NIH discoveries bring in royalty income
that the originating IC can pump back into its research program
to pay tech transfer costs and continue work on other projects.
The inventor as well can earn up to $150,000 per year in royalty
So if patenting a concept is that beneficial to public health,
the public's balance sheet, the NIH research enterprise as well
as its scientists, why are some researchers reluctant to enter the
|Top Commercially Successful NIH Inventions
Over the years, NIH scientists have invented hundreds
of vaccines and therapeutics, diagnostics, instruments and
devices as well as research materials that have been successfully
delivered to the public via commercial development. Below
are the top 10 for 2005, based on royalty income.
1. Paclitaxel-Eluting Coronary Stent System (NIA)
2. Monoclonal Antibody for Treatment of RSV (NIAID)
3. Serological Detection of Antibodies to HIV-1 (NCI)
4. AIDS Drug ddI (NCI)
5. Paclitaxel as a Cancer Treatment (NCI)
6. Synthetic Thyrotropin as Adjuvant in Thyroid Cancer (NIDDK)
7. Hepatitis A Vaccine (Strain HM-175) (NIAID)
8. Nutritional Supplement to Treat Macular Degeneration
9. Radioimmunotherapy for Non-Hodgkin's Lymphoma (NCI)
10. Proteosome Inhibitor for Treatment of Multiple Myeloma
"Probably one of the strongest factors influencing the investigators
is both in volume and length of time it can take to go through
the initial paperwork and the review process of filing for a patent," Arrants
explains. "Whereas an investigator may be able to prepare several
publications in a 2- to 3-year period, a single patent can take
2-3 years just to get to first review. Clinical investigators have
the additional process of regulatory review by the FDA. Meanwhile,
the scientist wants to publish — and publishing certainly
gains attention for licensing — but early-on disclosure of
the invention must be avoided if commercialization is being considered,
which sometimes results in rushed patent filings or delayed publications.
"So an investigator's reluctance is easy to understand in light
of getting the moons and stars of scientific research, patenting
and the regulatory process to align into a smooth, integrated pattern,
and not getting as much recognition in their review from commercialization
as is given for publication," says Arrants. "It is also why technology
transfer in a federal lab is very much an art and dependent on
tedious attention to detail and luck."
After Your 'Eureka' Moment
The first step to commercializing an invention is sharing your
idea with your IC tech transfer component, Rohrbaugh said. Each
IC has a tech transfer staff that initiates the process by working
with the investigators to claim and report inventions. Technology
development coordinators (TDCs) for each IC are listed online at
the OTT web site. The IC's tech development staff does an initial
review of the idea before an employee invention report is passed
along to OTT staff, who determine patentability and work with the
inventor and the TDC to file for a patent. In essence, OTT and
TDCs work together to help investigators protect the invention
and otherwise navigate the paperwork. "It takes this teamwork of
inventors, ICs and OTT to successfully begin commercialization
with a strong patent strategy," Arrants says.
"Asking an inventor to participate in the patent and licensing
process is very labor intensive," agrees NHLBI Technology Transfer
and Development Director Lili Portilla, who has been involved in
tech transfer since 1989. She remembers when most TDCs did tech
development only part-time, in addition to their regular jobs. "Now
the process and the profession have become very sophisticated," she
Still, old perceptions about the difficulty of the process may
also cause would-be inventors moments of pause. OTT began handling
technology in 1989 and the learning curve seemed steep.
"Navigating the realm of technology transfer takes time and effort
away from science," acknowledges Donald Bortner, NIA administrative
officer and TDC. "It requires persistence in overcoming barriers
to commercialization and tolerance working under a complex set
of laws and rules. The early years of technology transfer presented
challenges associated with less experience. Some scientists remain
apprehensive about devoting too much time to commercializing discoveries
at the expense of missed scientific opportunities and fewer publications.
NIH's experienced cadre of technology licensing transfer attorneys
and specialists, coupled with better contract support with law
firms, enhances the likelihood of success by providing more support
However, the process is not for every scientist, nor should it be,
says Dr. Robert Balaban, chief of NHLBI's Laboratory of Cardiac Energetics.
His research group invented an imaging technique that is among the
top 20 royalty generators for 2005. Success didn't happen overnight,
he says, and not without a lot of hard work.
||NIH director Dr. Elias Zerhouni
took a handful of homegrown inventions — including the
stent (top, l) and the HIV-AIDS test kit (top, r) — with
him to Capitol Hill to demonstrate the public’s return
on its investment in NIH.
"I believe the NIH process has improved greatly from when we did
our original filing many years ago," he recalls. "Frankly, our
original experience was quite painful. Over the last several years
the applications we have filed have been much easier and more streamlined.
We have enjoyed working with some very skilled contract lawyers
and advisors in putting together sensible packages. Some of this
is likely due to our own experiences in this process."
The NIH mission to get the benefits of medical research delivered
to the public it serves is paramount, Balaban stresses, and a scientist
should do a lot of soul-searching before beginning tech transfer
"The patent experience has really not changed my research agenda,
nor do I believe it should," he explains. "We completed what I
thought we could contribute to the field more than 8 years ago
and rather than 'milk' more applications for this technology, my
lab has moved on to many other topics using the unique NIH resource.
Though I believe the patent process is critical for the translation
and commercialization of technology, as well as recouping some
of the research costs, I do not believe that NIH research should
be guided by the pursuit of intellectual property alone. When an
opportunity arises where protecting an invention can enhance the
public investment, this should be done and it is a very important
aspect of the translation of basic research to clinical or practical
OTT chief Rohrbaugh agrees completely. "We're always working to
find the right balance," he concludes. "We try to find ways to
stimulate tech transfer without inhibiting further research and