Amgen-Sanofi patent case divides makers of antibody drugs
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[March 28, 2023]
By Patrick Wingrove
(Reuters) - Amgen Inc's battle with Sanofi and Regeneron at the U.S.
Supreme Court over its cholesterol drug Repatha on Monday has some
drugmakers hoping a ruling will reshape U.S. patent law and competition
among companies that make antibody medicines.
In the dispute with Sanofi and partner Regeneron, whose
cholesterol-lowering monoclonal antibody drug Praluent works in a
similar way as Repatha, Amgen wants the court to rule on how much
information it and others need to disclose when describing inventions in
patents.
The court has been asked to weigh in on the validity of two patents for
Repatha, which garnered sales of $1.5 billion in 2022 for Amgen, to
determine whether Praluent infringes them.
The Supreme Court could maintain the legal status quo with its decision
– expected by the end of June – which would keep the antibodies market
open to numerous players. It could also decide to make it easier for
drug companies to muscle competitors out of some market areas with broad
patents that cover more ground.
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Market research consultant Global Market Insights said the monoclonal
antibodies market, which includes big-selling treatments for cancer,
high cholesterol, COVID-19 and many other conditions, was worth $181
billion in 2021.
Under U.S. patent law, drug companies can get 20 years of market
exclusivity for publishing their inventions, but must describe them
clearly enough so skilled people can copy and use them without too much
trial and error. Companies that describe inventions too broadly run the
risk of having their patents canceled.
Amgen, supported at the Supreme Court by AbbVie, Bristol Myers Squibb
and GSK, wants the high court to rule that it can use “genus claims,”
which describe a set of characteristics or features common to a group,
to describe what Repatha does in broad language.
If successful, Amgen would claim ownership of all antibodies that
inhibit the PCSK9 protein, the mechanism of action for both Repatha and
Praluent. Other companies could then do the same with their own antibody
treatments in other disease areas.
Sanofi and Regeneron, backed by Johnson & Johnson, Pfizer, Eli Lilly <
LLY.N> and at least six other companies, have argued that broad patent
protection like Amgen is seeking is not allowed by U.S. patent law.
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![](../images/032823PIX/health11.jpg)
An Amgen sign is seen at the company's
office in South San Francisco, California October 21, 2013.
REUTERS/Robert Galbraith/File Photo
![](http://archives.lincolndailynews.com/2023/Mar/28/images/ads/current/beescub_lda_SFARM_2023.png) Patent lawyer Irena Royzman of
Kramer Levin said the companies taking Sanofi and Regeneron’s side
are doing so because a win would allow them to keep bringing
competitive drugs to market more easily.
“The J&Js, Eli Lillys and Pfizers recognize that if a particular
company controls an entire therapeutic target, we’re all the poorer
for it,” Royzman said.
The case might also affect newer technologies used in medicine, such
as CRISPR gene editing and messenger RNA, she said.
Amgen's side says if forced to only claim the structural components
of their drugs in patents, competitors could easily design around
them, disincentivizing investment in monoclonal antibodies.
Baird analyst Brian Skorney said the immediate financial impact of
the decision is limited to the companies involved, although it could
give some an advantage in future litigation.
Regeneron made $130 million from Praluent in the U.S. last year, and
Sanofi collected $400 million in the rest of the world.
U.S. courts have so far sided with Sanofi. A Washington, D.C.-based
federal appeals court that covers U.S. patent cases invalidated
Amgen's patent claiming ownership of all PCSK9 inhibitors as a whole
in 2021.
Amgen sued Sanofi and Regeneron in 2014. Both drugs use lab-made
antibodies to block PCSK9 proteins that inhibit removal of bad LDL
cholesterol from the blood, but they achieve that result through
different chemical combinations.
(Reporting by Patrick Wingrove; Editing by Caroline Humer and Bill
Berkrot)
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