Bloomberg Law
September 28, 2017
By Susan Decker and Cynthia Koons, Bloomberg News
AbbVie Inc. reached a deal with Amgen Inc. that will allow a copy of blockbuster arthritis drug Humira to be sold in Europe next year — but a U.S. version won’t hit shelves until more than four years later.
Financial terms of the agreement weren’t disclosed. Amgen will pay AbbVie patent royalties when it begins sales of its drug, called Amgevita, in Europe on Oct. 16, 2018. The U.S. version, called Amjevita, will come to market on Jan. 31, 2023.
Settling with Amgen removes one possible legal threat for AbbVie, which gets almost two-thirds of its revenue from Humira, the world’s top-selling medicine with $16 billion in 2016 sales.
While the patent on the drug’s active ingredient expired last year, Abbvie has claimed to own more than 100 additional patents that would keep rivals off the market.
A trial in the Amgen dispute, involving 10 patents, was scheduled for November 2019, in what could have been just the first wave of litigation between the two companies.
Biotechnology drugs like Humira are made from living organisms, so it’s more difficult to make copies of them than it is to develop generic versions of traditional drugs.
The legal authority to get biosimilars approved by the FDA was passed by Congress in 2010, and the courts haven’t settled key legal issues over how the process works. In the interim, companies have been battling each other in court over intellectual-property rights. As a result, few so-called biosimilars have entered the U.S. market, and those that have been cleared haven’t done much to drive down prices.
Breathing Room
The settlement “provides incremental reassurance” that a biosimilar of Humira won’t hit the U.S. market before 2023, giving AbbVie time to develop new medicines and become less reliant on one drug, Jeffrey Holford, an analyst with Jefferies LLC, said in a note to clients. He estimated Amgen will pay royalties of around 10 percent of its sales.
AbbVie shares advanced 5.6 percent to $89.50 at 9:55 a.m. in New York. Shares of Amgen rose 0.6 percent to $186.07.
Often in settlements over traditional drugs, the first company to settle will get a promised lead time that it can be on the market before anyone else. It’s unknown if there’s such an agreement in this case, Umer Raffat, an analyst with Evercore ISI, said in a note to clients.
Officials with the two companies couldn’t immediately be reached for comment.
Raffat said one reason for the settlement may have been that the U.S. Patent Trial and Appeal Board had rejected Amgen challenges to two patents on the formulation of Humira before the agency, which could have made it harder for Amgen to win in court.
Boehringer Ingelheim has received U.S. Food and Drug Administration approval for its biosimilar to Humira, but hasn’t begun sales because of patent litigation. The current suit against Boehringer involves eight patents, though AbbVie said it’s identified a total of 74 patents that may be infringed by Boehringer’s copy.
Other companies are working to develop their own copies of Humira and some, including Coherus Biosciences Inc. and Novartis AG’s Sandoz, have been filing challenges with the patent office, which uses an easier legal standard to invalidate a patent.
“Whilst consensus is rapidly moving towards our thesis that U.S. biosimilars are unlikely to launch prior to this, there are many biosimilar developers working on Humira and we expect ‘noise’ on this issue from time to time,” Holford said.
–With assistance from Catherine Larkin and Tatiana Darie.
https://biglawbusiness.com/abbvie-settles-legal-fight-against-amgen-over-humira-copycat/
