Key Points

• Final Pretrial Orders in the DNJ are highly detailed and often specify all substantive and procedural aspects of trial, including detailed presentation of evidence.
• Motions in limine based in part on prejudice may be less likely to succeed in the context of a bench trial as compared to a jury trial.
• The outcomes of motions in limine and finalization of the pretrial order may have significant results that can drive settlement just before trial.

A judge’s final pretrial orders in an ANDA patent litigation are more than a procedural formality. They govern what evidence is presented, what witnesses and experts may testify, and the order of proof. In the DNJ, Final Pretrial Orders laying out all issues for trial are joint submissions by the parties that can run hundreds of pages (or more) depending on the number of patents at issue as well as the subject matter.

Typically in the DNJ, the parties work together to prepare a draft final pretrial order and submit it to the Magistrate Judge, after which a final pretrial conference is conducted with the Magistrate Judge. The pretrial order becomes final upon being signed by the Magistrate Judge and then is used by the District Judge (and the parties) to govern trial. In addition, the parties will file motions in limine in the lead-up to trial. Resolution of the motions in limine and disputed issues in the pretrial order can have a significant effect on how trial will proceed and have the potential to reshape the settlement calculus of a case.

A recent trio of orders from the District of New Jersey illustrates the point. With a bench trial just days away in Catalyst Pharmaceuticals, Inc. v. Annora Pharma Private, Ltd., U.S. District Judge Michael E. Farbiarz denied two motions in limine (MILs) and resolved competing proposals for the order of proof and closing arguments. Within days of the orders, the parties settled.

The rulings — which rejected challenges to the relevance of testing performed on expired drug samples and to the admissibility of publication-date evidence for a key prior art reference — underscore how evidentiary motions and the fine-grained mechanics of the DNJ's pretrial order process can alter the strategic landscape of a case.

Relevance of Testing on Expired Samples

Plaintiffs’ MIL Number 1 sought to preclude defendants “from raising, discussing, arguing, mentioning, introducing or otherwise making reference to any evidence or argument concerning the expiration of defendants’ batch samples.” Plaintiffs had requested samples of defendants’ proposed ANDA products for testing in discovery. Defendants ultimately produced samples in September 2023, which were set to expire in April 2024. Plaintiffs did not test the samples until after they had expired. Plaintiffs requested additional samples that had been subject to “accelerated and intermediate” stability testing. Defendants objected, and the Court ultimately denied a motion to compel the production of additional samples, in part because plaintiffs already had samples in their possession on which to conduct stability testing.

Because plaintiffs had tested only the expired samples, they sought to preclude defendants from arguing the testing of the expired samples was not relevant because the expired samples were not representative of the ANDA product. Defendants countered that they had not conceded the relevance of the expired samples during the prior discovery dispute, further noting that if the plaintiffs failed to test those batch samples for impurities prior to their expiration, “that is a mess of Plaintiffs own making.” Defendants further argued that because they were preparing for a bench trial, there was little to no harm of prejudice.

The Court denied MIL No. 1 “largely for the reasons stated by the defendants.” ECF 259. The Court noted that the prior “discovery dispute did not cover the same issues — the full factual picture has not been meaningfully put before the Court.” The Court further emphasized that the plaintiffs’ unfairness argument “may impact weight,” but that at a bench trial especially, “it provides no sufficient reason to preclude.”

Preclusion of Documents as Hearsay and Inauthentic

Plaintiffs additionally sought to preclude defendants from introducing and relying on “unauthentic and inadmissible hearsay statements” regarding the alleged publication date of the Firdapse Public Assessment Report (EMEA reference) from the European Medicines Agency website (EMA webpage) and citations in two of the asserted patents.

The publication date of the EMEA reference, a reference central to defendants’ invalidity arguments, was relevant to show it was publicly available as of the patents’ June 30, 2011 priority date and thus could qualify as prior art.

First, plaintiffs argued that a “28/01/2010” publication date on the EMA webpage was merely an out of court statement offered to prove the EMEA reference was publicly available on that date, and therefore inadmissible hearsay. Further, defendants’ expert had no personal knowledge of the public availability of the EMEA reference and thus could not authenticate the document, and no hearsay exception applied.

Second, plaintiffs likewise argued that the “Jan. 28, 2010” publication date stated in the asserted patents (disclosing the same reference) was also hearsay, noting that although a patent can fall under the public record exception to hearsay, it does not follow that all statements within a patent and file history are not hearsay. As to authentication, plaintiffs argued that defendants failed to provide evidence that the EMEA reference is what defendants claimed.

Defendants responded that the EMEA reference is a public record from the European Medicines Agency (Europe’s equivalent to the FDA) and therefore subject to the public record hearsay exception. Defendants emphasized precedent finding website printout information from government websites admissible under the public record hearsay exception, distinguishing the cases relied upon by plaintiffs as pertaining to private websites. Defendants further argued that the EMA webpage is self-authenticating under Federal Rule of Evidence 902(5).

Defendants further marshalled several arguments regarding the citations in the patents: that they fell under the public records exception because the patents were issued by the U.S. government; that plaintiffs’ submission of the EMEA reference with a specified publication date in Information Disclosure Statements to the USPTO during prosecution of the asserted patents constituted an opposing party admission; and that exclusion would “improperly prevent consideration of highly probative evidence.”

The Court denied plaintiffs’ MIL No. 2 “largely for the reasons set out” by defendants, except as to defendants’ argument that “the asserted importance of the information is not a material consideration.” The Court indicated that there are “any number of ways to buttress or to challenge the relevant date. Wayback machine information. Testimony from people who became generally aware of certain facts at certain times. Etc.” The Court soundly rejected plaintiffs’ arguments to the contrary, holding “the hearsay objection is not persuasive. And the authentication objection is baseless.”

Competing Pretrial Order Proposals

Finally, the Court addressed competing submissions in the final pretrial order from the parties regarding the order of proof at the bench trial. The parties agreed to start with plaintiffs’ opening statements, defendants’ opening statements, plaintiffs’ evidence of infringement, and defendants’ evidence of non-infringement. However, the parties disagreed on the order of presentation for invalidity and closing arguments.

Specifically, the parties disagreed as to the timing of defendants’ presentation of evidence on objective indicia of non-obviousness. Plaintiffs proposed that this occur immediately after defendants’ presentation of evidence of invalidity, which would be followed by plaintiffs’ presentation of validity, including objective indicia of non-obviousness. Defendants, on the other hand, proposed that their presentation of evidence on objective indicia of non-obviousness take place after plaintiffs presented their evidence of objective indicia of non-obviousness. The Court indicated a preference for plaintiffs’ proposal: defendants present their evidence on invalidity including evidence of objective indicia of non-obviousness before plaintiffs present their evidence on validity including objective indicia of non-obviousness, without any rebuttal by defendants after Plaintiffs’ presentation.

The parties also disagreed regarding closing arguments. Plaintiffs proposed they occur following the presentation of evidence or after post-trial briefing while defendants proposed they be held after post-trial briefing.

The Court indicated that closing arguments would proceed directly after the presentation of evidence. The Court further specified that closing arguments would proceed in specific time frames that would be “strictly observed” as follows:

[C]losing arguments will take place immediately after the close of the evidence as to ’893 and ’128 and then again immediately after the close of the evidence as to ’088. Format. Party 1 will argue for ten minutes. Then Party 2 will argue for ten minutes. Party 1 will then get 5 minutes to explain why Party 2’s best argument is wrong. Party 2 will get 5 minutes to respond. Party 1 will then get 5 minutes to explain why Party 2’s second-best argument is wrong. Party 2 will get 5 minutes to respond. Party 2 will then get 5 minutes to explain why Party 1’s best argument is wrong. Party 1 will get 5 minutes to respond. Party 2 will then get 5 minutes to explain why Party 1’s second-best argument is wrong. Party 1 will get 5 minutes to respond. Each party will get 15 minutes for opening argument on May 18, and again on May 26.

Just two days after these orders were issued, and 12 days before trial was set to begin, the parties entered into a consent agreement dismissing the case as a result of settlement.

Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.