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 These drugmakers are now increasingly straddling both sides of the
courtroom, too, protecting their high-price products from
biosimilars - biopharmaceutical drugs with the treatment properties
of medicines they seek to mimic - while simultaneously challenging
rivals' patent claims.
Biologics, manufactured in living cells, then extracted and
purified, are more complex than traditional medicines and cannot be
copied with precision, and so their knock-off versions are called
biosimilars instead of generics.
The allure of biosimilars is clear, with insurers and other payers
counting on the steep discounts. U.S. pharmacy benefit managers are
already trimming brand-name drugs from their rosters.
With Novartis Chief Executive Joe Jimenez predicting biosimilar
discounts of up to 75 percent, in part based on developments in
Europe, makers of innovative drugs are fighting tooth and nail to
protect their higher-priced products for as long as possible.
For instance, AbbVie has sued in Delaware claiming patent protection
for its arthritis drug Humira, the world's best-selling prescription
medicine, until at least 2022 as it seeks to delay an Amgen replica
that won U.S. approval last week.
Meanwhile, Amgen has gone to another U.S. federal court seeking to
protect its own arthritis medicine, Enbrel, from a Novartis
biosimilar until 2029.
With lawsuits pitting Big Pharma against Big Pharma piling up,
lawyers said the legal landscape has gotten a lot more complex.
"One of the biggest surprises has been the number of innovator
biopharma companies, like Amgen, now developing biosimilars to
compete with the products of other innovator companies," said Don
Ware, an expert on biosimilars at U.S. law firm Foley Hoag in
Boston.
“This creates conflicts for law firms like ours, because suddenly
the clients we advise are adverse to each other," Ware said. "And it
makes it hard for the companies to retain top outside counsel
without having to give them conflict waivers.”
Sanofi, Merck, Eli Lilly, Pfizer, Johnson & Johnson and Biogen are
also embroiled in lawsuits over biosimilars.
NOT BITTER ENEMIES
Even so, some analysts say the lawsuits are business as usual and
are unlikely to spill over into other areas, including research
partnerships.
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Novartis and Amgen may be at each other's throats in court over the
Swiss drugmaker's Enbrel copy, but the two are still cooperating on
a drug for migraines.
"It's not like these companies are bitter enemies," Zuercher
Kantonalbank analyst Michael Nawrath said. "These court cases are
simply the last resort of original drug makers to wring a few more
months or a year of exclusivity from their blockbusters."
Conflicts pitting big drugmakers against each other may have been
inevitable after Europe in 2006 and the United States in 2010
created separate biosimilar approval rules.
After all, Big Pharma's financial clout and expertise made large,
sophisticated drugmakers the natural candidates to manufacture
complex biosimilar copies that cost hundreds of millions to bring to
market, far more than for generic off-patent copies of simpler,
small molecule drugs.
Some smaller companies and generics makers have jettisoned
biosimilar programs after originally underestimating hurdles to
entry, Richard Francis, head of Novartis's Sandoz division that
makes biosimilars, said earlier this year.
Just this week, Shire abandoned two biosimilar candidate drugs that
accompanied its Baxalta takeover, copies of Amgen's Enbrel and
AbbVie's Humira, to focus on rare diseases.
"The realization of what it's going to take to stay in this market
and be successful has led to a change in the landscape and the
players in it," Francis said.
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