Amgen

UPDATE 2-Amgen patents on top-selling arthritis drug Enbrel upheld, shares rise
(Adds comments, details from decision, background, case
citation, byline)
By Jonathan Stempel
July 1 (Reuters) - A U.S. appeals court on Wednesday upheld
two patents for Amgen Inc's multibillion-dollar
rheumatoid arthritis drug Enbrel in a defeat for Novartis AG
, which has been trying to sell its own version.
The 2-1 decision by the U.S. Federal Circuit Court of
Appeals in Washington, D.C. gives Amgen 31 years of exclusive
rights to Enbrel, with protection for the patents extending to
November 2028 and April 2029.
Sandoz, a unit of Switzerland-based Novartis, said it may
ask the U.S. Supreme Court to review the decision, which upheld
an August 2019 ruling by a federal judge in New Jersey.
In early afternoon trading, Amgen shares were up $16.28, or
6.9%, at $252.14 on the Nasdaq.
Enbrel is Amgen's largest drug, generating $5.23 billion, or
22%, of the company's $23.4 billion of revenue in 2019.
Launched in 1998, Enbrel is used to treat adults with
moderate to severe active rheumatoid arthritis.
Amgen's patents cover etanercept, an active ingredient in
Enbrel, and a process to make that protein. Enbrel was developed
by Immunex Corp, which Amgen acquired in 2002.
Sandoz had won U.S. regulatory approval in 2016 for a
"biosimilar" version of Enbrel, known as Erelzi, but has been
unable to sell it in the United States.
The Novartis unit argued that Amgen's patents described
concepts contained in previous patents and should therefore be
invalidated because they were "obvious."
But the appeals court said Sandoz's argument amounted to
"merely disagreements with the district court's weighing of the
evidence."
U.S. District Judge Claire Cecchi in Newark, New Jersey, had
upheld the patents' validity. [nL4N2554VW]
Michael Yee, a Jefferies analyst who rates Amgen "buy," said
Wednesday's decision removed a "key overhang" for Amgen, likely
freeing it from imminent competition for Enbrel.
Amgen is based in Thousand Oaks, California, while Novartis
has offices in East Hanover, New Jersey.
The Federal Circuit handles intellectual property appeals.
The case is Immunex Corp et al v Sandoz Inc et al, U.S.
Federal Circuit Court of Appeals, No. 20-1037.

(Reporting by Jonathan Stempel in New York; Additional
reporting by Lewis Krauskopf in New York and Jan Wolfe in
Washington, D.C.; Editing by Bill Berkrot and Dan Grebler)
((jon.stempel@thomsonreuters.com; +1 646 223 6317; Reuters
Messaging: jon.stempel.thomsonreuters.com@reuters.net))