As a lethal coronavirus triggers a humanitarian crisis in the world’s
most populous nation, who owns the rights to a potential cure?
Bay Area’s pharmaceutical powerhouse Gilead Sciences is first in line
for a Chinese patent for its drug called Remdesivir, which shows promise
against the broad family of coronaviruses.
But now a team of
Chinese scientists say they’ve improved and targeted its use — and, in a
startling move, have also filed for a patent.
As the world
braces for a pandemic, the contest for rights to the potential treatment
is a test of global competition and cooperation during a trade war
between two top economies. On Thursday, the World Health Organization
announced 59,804 cases and more than 1,300 deaths. Almost all of the
infected are in China; 15 are in the U.S.
“Each side wants to be
the entity that came up with the treatment for coronavirus,” said Jacob
Sherkow, professor of law at the Innovation Center for Law and
Technology at New York Law School. “This is not a knockoff of a Louis
What’s at stake? Potentially massive revenues
and reputational luster for Gilead, the $93.4 billion Foster City-based
company with 3,200 Bay Area employees.
Five years ago, it sorted
through 1,000 chemical compounds to find the new antiviral agent. In
2016, it filed a patent in China for Remdesivir for use against all
coronaviruses, which has not yet been issued. Patent protection — and
market exclusivity — is the lifeblood of drug companies such as Gilead,
creating the incentive to find, test and market a medicine.
the stakes also are high for the government-run Wuhan Institute of
Virology in China, at the epicenter of the outbreak, which asserts it
has found a better way to use the drug to save lives.
Gilead is donating the drug in a clinical trial with Chinese doctors to
test its safety and effectiveness in nearly 800 infected patients with
If both patents are granted and the drug is approved
for use, the profits will be split, predict experts. And the two nations
will be linked like twins to future use of the drug, with both teams
But in surprising twist to the story, on
Wednesday a Chinese drug company announced it has copied the Gilead drug
and is successfully mass producing its own generic version. BrightGene
Bio-Medical Technology did not disclose what efforts, if any, it made to
license its imitation version from Gilead.
The race to claim the cure is playing out on a fraught economic landscape.
global leadership in pharmaceuticals is being challenged by China,
which has targeted the industry for development through its “Made in
China 2025” plan, according to the nonpartisan Information Technology
and Innovation Foundation.
Like so many other industries in which
China has gained global market share, its core strategy appears to
involve copying, according to the foundation. The nation has a history
of weak intellectual property protection, biased drug approvals, severe
price controls, subsidies, import restrictions and substandard exports.
But China also is making rapid progress in biomedical knowledge creation, greatly expanding research and development efforts.
it is becoming more friendly to foreign companies and is strengthening
its patent system to reward innovation, according to Stanford Law School
professor Lisa Larrimore Ouellette, who studies the economic effect of
both U.S. and international patent laws.
There is currently no
treatment for the illness, called COVID-19, which has spread to two
dozen countries, and the death toll in China continues to rise.
Remdesivir offers hope. In animals, it has combated the pathogens MERS
and SARS, which are structurally similar to the new virus. The drug is
thought to work by confusing a key enzyme that a virus needs to
Gilead, which specializes in antiviral drugs,
found it by “screening” the company’s vast library of chemical
compounds, an approach that is revolutionizing drug discovery. Companies
spend a lot of money building these libraries, then test promising
compounds on different cells or molecules to see if they are a “hit” for
a certain disease target. Most hits go nowhere.
The company hoped it would work during the West African Ebola outbreak of 2013 to 2016. But as an Ebola drug, it was a flop.
the drug has been repositioned as a treatment for coronaviruses. And it
seemed to help the first U.S. case of the virus, a man in Snohomish
County, Washington. While no broad conclusions can be made from a single
treatment, the patient’s condition improved dramatically the next day.
Now Gilead is ramping up manufacturing — “working night and day,” said
CEO Daniel O’Day — to prepare for demand.
researchers are desperately trying to find a treatment, as well. In
January, after testing at least 30 drug candidates against the new
pathogen, they stated that Remdesivir, when used with two other drugs,
had “fairly good inhibitory effects” on infected cells in culture.
week, the elite Wuhan Institute of Virology and China’s Military
Medicine Institute announced it had applied for a patent. This step was
necessary, it said, “to protect national interests.”
institute’s application is not public, China says it is seeking a “use
patent” — unlike Gilead’s approach, the drug is to be used in
combination with chloroquine, a common medication used to treat malaria,
and not alone. Such “use patents” are common in China, because of the
nation’s history of using varying formulations of traditional Chinese
herbs as medicine.
And the Chinese say their approach is
different because they’re specifically targeting the new virus, not the
general family of viruses.
“My impression is that the patent
situation in China is driven by two concerns: scientific prestige and
priority,” said Sherkow. “For China’s state sovereignty, it does not
want a U.S. company holding the keys to treating what is mostly an
endemic illness at this point.”
Gilead is not conducting
interviews about the dispute. But company spokesman Ryan McKeel told the
Associated Press that Gilead has no influence over whether a patent
office issues a patent to the Chinese researchers.
approach could have merit, said Mark Cohen, who heads the Asia
Intellectual Property Project at the Berkeley Center for Law and
Technology at UC Berkeley Law School.
“It could be more
efficacious,” he said. “It could be that putting ‘this’ and ‘that’
together has a synergism that makes it more effective.There Is nothing
inherently wrong with a research organization filing for a patent on an
existing pharmaceutical compound for a new use.”
Even if China’s
contribution is minor, it might help patients, he said. “There are
things we work with every day that are better because of incremental
But he’s suspicious why Gilead’s application sat
for three years — then, “in a matter of weeks, China asserts the
discovery of a novel application.”
“And the track record for
Western pharmaceutical companies in China isn’t good,” he added, “due to
long regulatory delays, China’s challenges to patent validity, and the
fast introduction of generic drugs.”
How will it end?
Remdesivir works as hoped, experts agreed, the drug will cement Gilead’s
role as a savior in an emerging public health crisis.
China’s patent application is granted, it will not cause Gilead to lose
rights in China; anyone who wants to use Remdesivir would still need to
license it from the U.S. company, said Stanford’s Ouellette. But if both
patents stand, Gilead and China must get licenses from each other. If
Gilead resists licensing the drug, China also has the right under World
Trade Organization rules to declare an emergency — and compel Gilead to
This would shrink Gilead’s profits, because it would no longer have a monopoly.
“It won’t be at the price point they want,” said UC Berkeley’s Cohen.
Associated Press contributed to this article.