Drugmakers Settle U.S. Patent Dispute Over Clone of Humira -- WSJ
May 15 2019 - 3:02AM
Dow Jones News
By Colin Kellaher
This article is being republished as part of our daily
reproduction of WSJ.com articles that also appeared in the U.S.
print edition of The Wall Street Journal (May 15, 2019).
AbbVie Inc. and Boehringer Ingelheim GmbH on Tuesday said they
have resolved their U.S. patent dispute over a biosimilar to
Abbvie's Humira, the world's biggest-selling drug.
AbbVie said it would grant Boehringer Ingelheim a nonexclusive
license to its Humira-related intellectual property in the U.S.,
allowing the German company to begin selling its Humira biosimilar
Cyltezo in the U.S. starting in July 2023.
AbbVie, a North Chicago, Ill., biopharmaceutical company, said
it would receive royalties from Boehringer Ingelheim.
Biosimilars are near-copies of biologic drugs, such as Humira,
that are made from living cells and are analogous to generic copies
of traditional pill-form medicines.
Humira, a drug used to treat diseases from rheumatoid arthritis
to gut disorders, had nearly $20 billion in global sales in 2018,
accounting for about 61% of AbbVie's total revenue. But AbbVie saw
a 5.6% decline in Humira revenue in the first quarter this year, as
competition from biosimilars led to a nearly 28% drop in sales
overseas.
Sales of Humira biosimilars began in Europe late last year after
a key AbbVie European patent expired, but a group of U.S. patents
built up by AbbVie has prevented a U.S. launch.
Biologic drugs are some of the costliest in the world, and the
availability of lower-cost versions as patents expire promises big
savings. A box of two prefilled syringes of Humira in the U.S. has
a list price of $5,174, which can add up to more than $50,000 or
$60,000 a year, depending on the disease it is treating.
The initial U.S. patent for Humira, which originally was
approved for U.S. sale in 2002, expired in December 2016, but
AbbVie secured more than 100 additional patents covering things
such as manufacturing methods and the drug's formulation. The shelf
lives of those patents extend into the 2020s and 2030s.
AbbVie sued Boehringer Ingelheim in 2017, alleging that Cyltezo
would infringe on many of the Humira patents. Boehringer Ingelheim,
a family-owned pharmaceutical company based in Ingelheim, Germany,
had accused AbbVie of developing a "patent thicket" to delay
competition.
AbbVie on Tuesday said Boehringer Ingelheim will acknowledge the
validity and enforceability of AbbVie's patents as part of the
settlement. Specific terms of the agreement, which involves no
payment by AbbVie, weren't disclosed.
At least seven other companies, including Amgen Inc. and Pfizer
Inc., previously reached license deals that will allow them to sell
Humira biosimilars in the U.S. starting in 2023.
--Peter Loftus and Denise Roland contributed to this
article.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 15, 2019 02:47 ET (06:47 GMT)
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