Janssen Files Redacted Public Version of Its Opening Brief in Support of Its Motion for Preliminary Injunction Against Amgen in BPCIA Ustekinumab Case

As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar.  Last week, Janssen filed a public version of its opening brief in support of its motion.  According to the brief, Janssen seeks a preliminary injunction based only on two manufacturing patents:  US.  Patent Nos. 9,216,168 (the “’168 patent”) and 9,475,858 (the “’858 patent”).  The ’168 patent claims a “method of controlling ‘glycans’” by using cell culture medium comprising a specified amount of putrescine, while the ‘858 patent claims a “method of controlling ‘C-terminal variants’” by using cell culture medium comprising a specified amount of arginine.

In its brief, Janssen argues that all four preliminary injunction factors favor an injunction.  Relying on an expert declaration from Dr. Matthew Croughnan, Janssen argues that it is likely to succeed on the merits because Amgen’s ABP 654 will infringe at least claim 23 of the ‘168 patent and claim 33 of the ‘858 patent.  Relying on an expert declaration from John Jarosz and a declaration from Janssen’s Vice President of Immunology Portfolio Strategy, Brian Smith, Janssen also argues that it will suffer irreparable harm if Amgen is not enjoined because the result of Amgen’s launch of ABP 654 would be “long-lasting loss of market share across all indications,” “irreversible price erosion,” and harm to Janssen’s goodwill and reputation. Finally Janssen argues that the balance of equities favors an injunction because STELARA accounts for a substantial percent of J&J’s U.S. pharmaceutical sales whereas the chief harm to Amgen is “preventing its ability to profit by selling an infringing product,” and an at-risk launch would harm the public interest by undermining the patent system that is intended to promote innovation.

Late last week, the parties filed a Stipulation and Proposed Discovery Plan and Schedule for Janssen’s Preliminary Injunction Motion.  According to the stipulation, Amgen’s answering brief would be due May 22, 2023, Janssen’s reply brief would be due July 10, 2023, Amgen’s sur-reply would be due August 21, 2023.  The stipulation allows for several rounds of discovery, including depositions, in between the rounds of briefing.  In the stipulation, Janssen requests a PI hearing “[a]s soon as possible…to facilitate resolution by 10/31/2023,” while Amgen states that it believes a hearing “should not be necessary.”  On Monday, the court ordered the parties to submit a revised stipulation by 03/21/2023.  The order notes that if the parties want a decision by 10/31/2023, briefing must be complete by 07/21/2023, and that claim construction issues should be addressed in the briefs.  The parties have not yet filed a revised stipulation in response to the Court’s order.

UPDATE:  On March 23, 2023, the parties submitted a revised stipulation with a briefing scheduling that was adopted by the Court in an order the same day.  Briefing on Janssen’s preliminary injunction motion is to be completed by July 21, 2023.  The Court also set a motion hearing for August 4, 2023.

Stay tuned to Big Molecule Watch for further updates about this litigation.