[Ip-health] Carol Mimura: Gutting IP rights will upend university research, innovation

James Love james.love at keionline.org
Fri Oct 22 16:42:37 PDT 2021

Carol Mimura is the UC Berkeley Assistant Vice Chancellor for Intellectual
Property & Industry Research Alliances.  She is often described as "one of
the more reasonable" University technology transfer officials. But here she
pens intellectually lightweight propaganda defending drug companies and
opposing the TRIPS waiver.

An example of the misleading arguments is where she claims that drug
companies spend an average of $3 billion to bring a drug to market,
compared to an average University grant of $3 million, or "one-tenth of the
upfront cost invested by the private sector."

Among the misleading elements in the op ed (and Carol is certainly smart
enough to know this) is that the $3 billion number for industry outlays
includes roughly $1.3 billion for pre-clinical research (which sometimes is
licensed from a University), and extensive imputed costs associated with
risks of failure and capital costs, none of which she associates with
public sector funding.

If a University gets $3 million in an NIH grant, it's not as if every NIH
grant leads to a successful product. So by not adjusting the NIH
contributions for a risk of failure (or for capital costs for that matter),
but allowing the industry to do so, even when the NIH funded the
pre-clinical research, she is misleading the public, and deliberately.

This strategy, comparing nominal out-of-pocket grant dollars against super
adjusted industry outlays (adjusted for inflation, risk of failure, cost of
capital and ignoring ALL R&D subsidies), is a classic ATUM talking point.

And of course, when mentioning the mRNA vaccines, she leaves out the
massive subsidies from the US government to Moderna and the subsidies and
de-risking from the EU, Germany and the US to Pfizer/BioNtech.

This is Carol, your taxpayer funded lobbyist for big pharma, at Berkeley,
lobbying against the WTO TRIPS waiver.


Opinion: Gutting IP rights will upend university research, innovation
Protections provide needed incentives to develop breakthrough drugs


PUBLISHED: September 9, 2021
The Biden administration recently announced support for a push by the World
Trade Organization to strip intellectual property protections from COVID-19

That endorsement, though well-intentioned, should send shivers down the
spines of university and corporate R&D lab workers across America.
Especially since it follows on the heels of some policymakers’ attempts to
seize American firms’ intellectual property, using a strained
interpretation of a four-decade-old law.

Gutting IP protections would eliminate the incentives for private sector
investors to take initial discoveries — often made in university labs — and
turn them into tangible medicines and medical devices that actually benefit
patients. It’d be a disaster not just for health care workers striving to
save people’s lives. It’d also prevent the commercialization of
ground-breaking discoveries arising in universities — including those that
could spawn entirely new industries.

Advocates for stripping IP protections often point to successful drugs that
initially benefitted from research at a university that was federally
funded and thus should be “controlled” by the government. These IP rights,
however, are currently protected by the University and Small Business
Patent Procedures Act. This bipartisan legislation, enacted in 1980 and
better known as the Bayh-Dole Act, allows universities to own and to
license inventions that arose from federally-funded research.

Universities license IP rights to private sector companies that
commercialize research discoveries and make products available to the
public. Before this law, the federal government (not universities) held the
rights to such patents. Some 30,000 of those patents languished, gathered
dust in federal filing cabinets, with fewer than 1 in 20 ever reaching the
clinic or the open market.

For Sens. Birch Bayh, D-Ind., and Bob Dole R-Kan., the purpose of the act
was to “spur the interaction between public and private research so that
patients would receive the benefits of innovative science sooner.” In the
ensuing 40 years, their legislation has enabled universities and industry
licensees to develop and bring to market more than 200 life-saving new
medicines. Many such advances have arisen from research at the University
of California, including UC Berkeley.

I had a front-row seat to the ground-breaking T-cell research performed at
UC Berkeley by James Allison that led — thanks in large part to the
Bayh-Dole Act — to the monoclonal antibody ipilimumab and the birth of
immunotherapy to attack a patient’s cancer cells. Today, Allison’s approach
is used to treat 15 types of cancers, including Hodgkin lymphoma, colon
cancer and breast cancer.

All have witnessed the most recent fruit of the Bayh-Dole Act — mRNA
technology from the University of Pennsylvania was licensed to Pfizer and
Moderna, who used it to develop COVID-19 vaccines.

Similarly, and thanks to the public-private sector bridge built by
Bayh-Dole, research from UC Berkeley’s Robotics and Human Engineering
Laboratory, licensed by SuitX, has created robotic exoskeletons that allow
people living with paralysis or neurological disorders to walk.

I fear that Biden’s IP waiver on Covid-19 vaccines, coupled with ongoing
attempts to twist the Bayh-Dole Act to allow government officials to modify
the terms of IP licenses that companies receive from universities, will
disincentivize the private sector from investing in early-stage university
inventions that are years away from becoming viable commercial products.

An existing clause in the Bayh-Dole Act allows the government to “march in”
and take away patents from licensees — but only in rare cases, such as when
licensees are not commercializing an invention deemed potentially valuable.
Many lawmakers want the government to use march-in rights to seize
brand-name drug patents and relicense them to generic manufacturers.

They have good intentions.  Everyone wants to make prescriptions more
affordable for patients.

But if companies fear that the government will intervene after years of
expensive R&D, they will not invest in the first place.

Industry spends, on average, nearly $3 billion to bring a single drug to
market; by contrast, the average federal grant to a university researcher
whose work may lead to patentable material is in the range of $3 million —
one-tenth of 1% of the upfront costs invested by the private sector. Hence,
the level of investment by the federal government is exceptionally
effective “seed money” for fostering innovation. Upsetting this
relationship and partnership would be exceedingly deleterious.

IP protections exist for a reason — because they work. We must not allow
the admirable quest for health equity to kill the research goose that lays
innovation’s golden egg.

Carol Mimura is the former executive director of the Office of Technology
Licensing at the University of California, Berkeley, and current UC
Berkeley Assistant Vice Chancellor for Intellectual Property & Industry
Research Alliances.

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