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Novo filed 14 new lawsuits against telehealth providers,

weight-loss clinics

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Hims defends personalized medicine as healthcare's future

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Legal experts say Novo's strategy may pressure Hims to

negotiate

By Maggie Fick and Diana Novak Jones

LONDON, Aug 11 (Reuters) - In Novo Nordisk's

legal fight against dozens of U.S. pharmacies and companies

selling cheaper copies of its weight-loss drug Wegovy, one name

remains conspicuously absent: Hims & Hers.

The high-profile telehealth company continues to sell

compounded versions of Wegovy at lower prices, testing the

limits of federal restrictions on such copies and contributing

to weaker sales growth for Novo.

In June, Novo accused Hims of violating its intellectual

property and endangering patients, scrapping a brief arrangement

enabling them to sell Wegovy directly to consumers and raising

expectations of litigation.

A Novo spokesperson said the Danish drugmaker was not ruling

out further legal action after announcing new lawsuits against

14 small pharmacies, telehealth providers and weight-loss

clinics this week, but declined to comment on Hims. The

drugmaker has filed more than 130 cases in 40 U.S. states.

A spokesperson for Hims defended personalization of

medicines as the future of healthcare, saying patients and

providers use their platform to make clinical decisions.

"Investors are happy to see Novo getting more aggressive on

the litigation front, but remain puzzled as to why they haven't

confirmed that they are filing or have filed litigation against

Hims yet," said Barclays analyst Emily Field.

Legal experts say Novo's expanding litigation against

smaller telehealth players could add pressure on a company like

Hims to negotiate a settlement or help the drugmaker test out

strategies.

At the same time, the fact that Novo and Hims had a prior

collaboration may complicate legal action.

"Business happens in the shadow of the law," said Robin

Feldman, a professor at UC Law San Francisco who has written

books on the pharmaceutical industry and its intellectual

property battles. "Sometimes companies file against smaller

players as a shot across the bow, a way to rattle the larger

players."

The U.S. Food and Drug Administration set a May 22 deadline

for compounding pharmacies to cease mass-producing copies of

Wegovy, a practice allowed only when a drug is in shortage.

Hims says it still offers personalized versions of Wegovy,

in doses not manufactured by Novo, that better suit individual

patient needs. The telehealth provider argues that

individualized dosing remains legal under compounding rules.

Compounding laws "are just vague enough to allow for

different interpretations, and the interpretation that matters -

that of the courts - has not been provided to our knowledge,"

said TD Cowen analyst Michael Nedelcovych.

Novo's cases against smaller compounders could shape how

courts interpret those boundaries, said Gaston Kroub, a partner

at patent litigation firm Kroub, Silbersher & Kolmykov.

"This is an untested set of affairs," said Kroub. "If you

want to train for a heavyweight championship fight, you start

sparring with lighter opponents."

In addition to trademark infringement, Novo has accused

pharmacies of steering people toward compounded Wegovy by

interfering with the relationship between clinicians and

patients.

Josh Gerben, an intellectual property attorney, said the

fact that Hims and Novo had a prior business relationship will

complicate any claim Novo could bring.