Drugmakers Settle U.S. Patent Dispute Over Clone of Humira -- WSJ

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 [e-mail]

(END) Dow Jones Newswires

May 15, 2019 02:47 ET (06:47 GMT)

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