This is our second update on the litigation (you can see the prior analyses here and here, in addition to a parallel post on our companion blog concerning patent office practice) involving Janssen Biotech, Inc. (“Janssen”), Celltrion Healthcare Co. and Celltrion, Inc. (“Celltrion”), and Hospira Inc. (“Hospira”); but, judging by the course of things, it will not be the last. There have been several developments since our last post, detailed below. Most recently, the parties submitted a joint status report detailing the various pending motions.

Our last update occurred shortly after Janssen had filed a new lawsuit against Celltrion and Hospira alleging infringement of U.S. Patent No. 7,598,083 (“the ’083 patent”) under 35 U.S.C. §§ 271(a) and (b), as well as a claim for artificial infringement under 271(e)(2)(C). Shortly thereafter, the parties agreed to a stipulation that was entered by the Court which, among other things, consolidated the claims for infringement of the ’083 patent into Case No. 17-cv-11008, the “2017 Action.”

Standing Resolved

In January 2017, Defendants alleged for the first time (in what was already at that time a long-running litigation) that Janssen lacked standing to bring suit on the ’083 patent. See this post. Specifically, the Defendants argued that the inventors had assigned their rights to a host of Johnson & Johnson companies, and not just Centocor (Janssen’s predecessor). As such, those entities would be necessary parties, dooming Janssen’s lawsuit. The Court resolved that question in its October 31, 2017 opinion, ruling that Janssen alone held the rights to the ’083 patent and therefore had standing to bring suit. The Court began its analysis with the language of the relevant contracts—the inventors’ employment agreements with Centocor, each of which assigned rights in inventions to the “Company.” But, as Defendants argued, the agreements defined “Company” to include not only Centocor, but also Johnson & Johnson and its other subsidiaries. The Court was blunt in its view of the agreements, finding them “poorly drafted” and therefore ambiguous.

The Court therefore turned to the parties’ “intent” and the “surrounding circumstances” to determine whether the assignment was to Centocor alone or to the entire Johnson & Johnson family. Specifically, the Court examined extrinsic evidence, including Janssen’s patent database and several other assignment documents executed between the inventors and Janssen. Ultimately, the Court found that there was no evidence to rebut the understanding that the agreement was solely between the inventors and Janssen, and therefore found that Janssen alone had standing to bring the lawsuit. The case continued.

But More Disputes Remain

Although the question of standing has been resolved, there still remain several open motions, including a summary judgment motion that would dismiss Hospira from the case. To summarize, Celltrion and Hospira have partnered in the marketing of the biosimilar product. Celltrion has contracted out the manufacture of the allegedly infringing cell culture media. Janssen alleges that Hospira has joined with Celltrion in a “joint enterprise” and in the process has directly and indirectly infringed the ’083 patent. Hospira disagrees, contending the theory is unfounded both legally and factually. Nonetheless, there is no question that the case will proceed with or without Hospira as a defendant.

In addition to the summary judgment motion, the Defendants have moved to strike (what they claim) is a procedurally improper and legally unfounded counterclaim by Janssen. Specifically, Janssen added a counterclaim under 35 U.S.C. § 271(f)(1), arguing that Defendants have “caused to be supplied” all or a portion of the allegedly infringing cell culture media from the U.S. to Singapore. That is, whereas the Defendants had purchased the allegedly infringing cell culture media in the U.S., operations changed such that the product is now made (and purchased) in Singapore. Janssen contends that in the process of moving the operation from the U.S. to Singapore, Defendants committed infringement pursuant to § 271(f)(1). The Defendants argue that the claim is lacking (on both the facts and the law) and that Janssen raised it in an improper manner. Therefore, they argue the counterclaim should be stricken.

Finally, the court is set to hear a series of pending Daubert motions and several motions addressing third-party discovery.

While the infliximab litigation began in 2014, a final resolution appears unlikely in the near future.