Only U.S. Patent No. 7, 598, 083 (“the ‘083 patent”) remains at issue in Janssen’s suit against Celltrion and Hospira in the District of Massachusetts (C.A. No. 1:15-cv-10698) relating to a biosimilar of Janssen’s Remicade® (infliximab). The parties have been engaging in litigation under the Biologics Price Competition Innovation Act (“BPCIA”). Janssen alleges that Celltrion’s cell culture media that had been used to make Celltrion’s biosimilar Inflectra® infringes the ‘083 patent under the doctrine of equivalents. Issues of damages have been bifurcated, and the upcoming trial will only involve questions of liability and potential injunctive relief. Both parties filed trial briefs with a February 13 trial date in mind, although the Court has recently indicated it may push trial to February 20 to allow time to resolve the numerous outstanding issues. (Dkt. 475.) A summary of the publicly available arguments of each party is provided below.
The ‘083 patent relates to Janssen’s proprietary cell culture media, known as MET 1.5, which Janssen decided against using for Remicade® because it would cause disruption in changing from other existing media. Janssen alleges that the Celltrion Media infringes the ‘083 patent under the doctrine of equivalents. Janssen argues that the evidence and testimony of its expert witness will show on an element-by-element basis that (1) the Celltrion Media are “insubstantially different” from the compositions claimed in the ‘083 patent; and (2) the Celltrion Media satisfy the “function/way/result” test. Janssen will also present data from scientific experiments showing that none of the differences in concentration between the Celltrion Media and the ‘083 patent claims lead to substantial differences in cell culture performance as measured by: cell growth, cell viability, or drug production.
Janssen intends to prove Celltrion is liable for direct infringement under section 271(a) by showing that (1) the third-party cell culture media supplier HyClone Labs made the Celltrion Media as Celltrion’s agent, or that (2) HyClone made the Celltrion Media under a contract with Celltrion under Celltrion’s direction and control. In the alternative, Janssen claims that Celltrion induced infringement. Janssen claims Celltrion took affirmative steps to cause the manufacture of Celltrion Media and suggests that the move to produce the Celltrion Media in Singapore (as opposed to in the United States as previously) was expedited after receiving Janssen’s expert witness’ report to avoid infringement of the ‘083 patent, evidencing Celltrion’s willful blindness to its previous infringement. Janssen also contends that Hospira and Celltrion are engaged in a joint venture and concludes that Hospira induced infringement of the ‘083 patent.
Celltrion begins by putting the case in “historical context,” arguing that although the case started with 6 patents, including a patent covering infliximab, Janssen is down to asserting only a mere “cell food patent that it does not even use” and yet it is requesting the same broad relief.
Celltrion alleges that the ‘083 patent is invalid for (1) lacking written description and “overreaching”, (2) obviousness, and (3) indefiniteness. Celltrion also claims that Janssen lacks standing to assert the ’083 patent.
Celltrion also disagrees with almost every theory on liability and relief outlined by Janssen. For example, Celltrion states that the doctrine of equivalents case depends on “fundamentally flawed testing” (trying to prove that 12 different ingredients outside of the claimed ranges were equivalent to the claimed ranges) and ensnares prior art. In particular, Celltrion states that the expert witness’ scientific experiments are “fatally, legally flawed” in that the experiments failed to test the accused Celltrion Media or the composition exactly as claimed. In addition, Celltrion claims that Janssen’s doctrine of equivalents theory impermissibly vitiates claim limitations and violates the public notice function of patents. Celltrion also contends that Janssen has insufficient evidence of direct infringement or inducement.
The parties dispute a number of other issues, including, inter alia, whether there is any relevant copying evidence, whether the Supreme Court’s Akamai v. Limelight decision regarding “direction and control” can apply to indirect infringement or whether it is limited to only divided infringement, and whether there was any violation of the BPCIA exchange procedures and, if so, whether there is any jury issue. Many of the issues laid out in the parties’ trial briefs, including the available relief, are the subject of other pending motions. Likewise, there are pending motions in limine and Daubert motions that could drastically reshape trial, or potentially eliminate the need for trial altogether. The Court is prepared to have hearings this week and next week to resolve the myriad outstanding issues. (Dkt. 475.)
As Inflectra® is only the second biosimilar to be approved by the FDA and the second biosimilar to enter the U.S. market, we expect that the outcome of this trial may impact future litigation in this area, especially relating to cell media and manufacturing patents. Janssen and other reference product sponsors have serious financial interests in asserting and maintaining their manufacturing patents. For example, although Janssen reported an 8.7% increase in sales for 2015 (for a total of $4.45 billion), Janssen could face a loss in sales of Remicade® between 10-15% for 2017 as a result of competition with Inflectra®.
We will continue to monitor and provide further updates.
Authors: Jenny Shmuel, Jasmine Whyte, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Jasmine M. Whyte is a Technology Specialist, Patent Agent in the New York office of Fish & Richardson. Prior to joining the firm, Dr. Whyte (née De Cock) earned her Ph.D. in Biology from Dr. Robert Weinberg’s laboratory at the Whitehead Institute for Biomedical...
Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and...