[co-author: Alex Pechette]

New developments arose on Tuesday in the dispute between Janssen and Celltrion over Celltrion’s biosimilar of Janssen’s Remicade® (infliximab).  On May 31, the district court overseeing the BPCIA litigation (D. Mass., C.A. No. 1:15-cv-10698 (“Celltrion I”)) entered Janssen’s amendment to the protective order, thereby opening the door for Janssen to use confidential information obtained in the BPCIA litigation for the purpose of pursuing other litigation.  Janssen acted quickly; on Tuesday, it filed two new complaints, one in the District of Utah and the other in the District of Massachusetts, alleging infringement of U.S. Patent No. 7,598,083 (“Chemically Defined Media Compositions”).  The Utah complaint is against HyClone Laboratories, Inc., which is owned by General Electric, and the Massachusetts complaint is against Celltrion.

At issue in both new suits is cell culture media made by HyClone that is “custom made . . . to grow the living cells that produce Celltrion’s . . . [allegedly infringing] infliximab biosimilar product.”  (See, e.g., Janssen v. Hyclone Complaint at 2.)  Of note, although Hyclone now supplies cell culture media for Celltrion, the complaints detail Hyclone’s early involvement in developing Janssen’s cell culture media later claimed in the ’083 patent.  In the current complaints, Janssen alleges that HyClone has engaged in its allegedly infringing conduct “[a]t Celltrion’s direction and under Celltrion’s control” such that HyClone was “acting as Celltrion’s agent.”  (Id. at 24.)  On that basis, Janssen alleges both direct infringement under 35 U.S.C. § 271(a) and induced infringement under § 271(b) in its complaint against Celltrion.  (Janssen v. Celltrion (D. Mass., C.A. No. 1:16-cv-11117 filed June 14, 2016) (“Celltrion II”) Complaint at 2.)

This turn of events is noteworthy for two reasons.

First, Janssen is relying on confidential manufacturing information that it obtained from Celltrion pursuant to the BPCIA, as well as additional confidential information obtained from Hyclone in a BPCIA litigation.  Celltrion argued in its briefing that allowing this use “could erode the incentive for biosimilar applicants to produce their confidential information—a production the Federal Circuit has now held is not mandated by the statute.”  (Celltrion I, D.I. 111 at 4 (citing Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1356-57 (Fed. Cir. 2015)).  However, by the time the Court allowed the use of the confidential information for these new suits, the parties were operating under a negotiated protective order in the district court litigation, not the confidentiality provisions of the BPCIA.  It is also yet to be determined whether the ability to use confidential information to pursue other litigation targets will substantially impact participation in the BPCIA framework given that failing to produce confidential information pursuant to the BPCIA entitles an RPS to file an infringement action, during the course of which such confidential information will ultimately be disclosed.

Second, the infringement actions against Celltrion and Hyclone are noteworthy because, in alleging infringement of the ‘083 patent, the complaints rely on the doctrine of equivalents to read onto an allegedly unprecedented 12 separate claim limitations. Claim 1 of the ’083 patent recites 61 ingredients, each with its own concentration range, and while “[m]ost of the ingredients are present in Celltrion’s cell culture media in concentrations that are literally within the claimed ranges,” 12 of them are not.  (Janssen v. HyClone Complaint; Celltrion II Complaint.)  To support its equivalence assertions, Janssen cites “a series of experiments” performed by experts retained by Janssen, wherein the experts “determine[d], on an ingredient-by-ingredient basis, what effect the literal differences from the claimed concentrations have on the performance of the Celltrion media in cell culture.”  The experts “cultured” (tested) a series of cell culture media that included a “replica” of Celltrion’s media and “variants of the replica, each one modified so that one of the elements (whose concentration in Celltrion’s media was outside the claimed range) literally fell within the range identified in claim 1 of the 083 patent.” Janssen’s experts “measured the concentration of living cells in the culture (the viable cell density, or ‘VCD’), the proportion of those cells that remained alive (the viability), and the amount of antibody produced by the cells (the titer).”  Plots of these test measurements were included in Janssen’s new complaints.  According to Janssen, the results “demonstrated that, with respect to each ingredient whose concentration in Celltrion’s media was outside the claimed range, on an element by element basis, the difference had no substantial effect on the performance of the media in cell culture.  Nor did the [sic] all of the concentration differences together have any substantial effect on the performance of the media in cell culture.”  (Janssen v. Hyclone complaint; Celltrion II Complaint.)

Janssen brought up these same test results (without accompanying data) in the BPCIA litigation in a letter to Judge Wolf.  (Celltrion I, D.I. 140.)  In response, Celltrion asserted it was “not aware of any court finding infringement under the doctrine of equivalents where there was more than just one missing limitation—much less a dozen, as Janssen admits here.”  (Celltrion I, D.I. 141.)  Celltrion further noted that “[i]f Janssen’s theory were correct—where all of its claims’ limitations could be ignored based on ‘months’ of ‘sophisticated scientific experiments’ allegedly proving them unimportant—nobody would have any idea what the ‘083 patent covered.”  (Id.) In other words, “[t]he patent could cover an infinite variety of cell culture media turning on the outcome of ‘months’ of experimentation.”  (Id.)  “Such disregard for the requirement of definiteness and the public notice function of patent claims,” argued Celltrion, “would defy the settled rule that ‘a potential competitor is entitled to fair notice of what will infringe a patent under the doctrine of equivalents, as well as literally.’”  (Id. (quoting Biogen, Inc. v. Berlex Labs., Inc., 113 F. Supp. 2d 77, 106 (D. Mass. 2000).)

We will continue to monitor these cases as they develop and provide further updates.