By Kevin E. Noonan –

A change in the weather is known to be extreme
But what's the sense of changing horses in midstream?
I'm going out of my mind, oh, oh
With a pain that stops and starts
Like a corkscrew to my heart
Ever since we've been apart

"You're a Big Girl Now," Blood on the Tracks, Bob Dylan

In perhaps one of his most infelicitous lyrics* Bob Dylan inserted the adage that it is unwise to change horses in midstream.  This lesson comes to mind with regard to the Federal Circuit's decision late last year regarding an attempt to pursue a new theory of infringement just weeks before trial would commence (which attempt failed) in Astellas US LLC v. Hospira, Inc.

The case involved ANDA litigation brought by Gilead Sciences, Inc., Astellas US LLC and Astellas Pharma US, Inc. against Hospira for infringement of U.S. Patent Nos. 8,106,183; RE47,301; and 8,524,883 claiming a particular polymorph (termed Form A, a monohydrate) of regadenoson, an A2A adenosine receptor agonist that is a coronary vasodilator used to mimic cardiac stress and sold as Lexiscan®.  The formula for Hospira's generic regadenoson contained Form G as its active pharmaceutical ingredient (API) that would not infringe Astellas's asserted claim (the basis for Hospira's Paragraph IV certification), made by a process converting crude regadenoson to Form F (another polymorph) to Form G.  Plaintiff's initial theory of the case was that Hospira's generic drug nevertheless infringed the asserted claims, because Form A was made inadvertently by Hospira's third party supplier of an intermediate product and consequently the Form A polymorph was incorporated into Hospira's final generic product (on the basis that when these compounds "are exposed to a sufficient amount of water, including water in the air . . . and in reagents, they will convert to Form A").  In response to Hospira amending the Drug Master File (DMF) portion of its ANDA prior to trial (in an attempt to make Astellas's infringement showing harder to establish, wherein the new DMF recited that its manufacturing process had been optimized to "limit the presence of water"), Astellas asserted an alternative theory alleging that Form A arose as part of Hospira's compounding process in making its generic regadenoson.

The District Court granted Hospira's motion to strike Astellas's newly presented infringement contentions and expert testimony and evidence, with the case going to trial on Astellas's original infringement theory.  The District Court found Hospira did not infringe according to Astellas's original infringement contentions, and Astellas appealed solely on the issue of whether the District Court's preventing their assertion of their alternative infringement theory and contentions and expert evidence associated therewith was an abuse of discretion.

The Federal Circuit ruled that the District Court had not abused its discretion and affirmed the judgment in favor of Hospira, in an opinion by Judge Dyk joined by Judges Reyna and Cunningham.  The opinion notes that the District Court granted Astellas extra fact discovery in response to Hospira's change in its ANDA, but in addition to taking this discovery, Astellas submitted its new infringement contentions and expert evidence related to these contentions.  On the procedural issue of whether Astellas's motion was untimely, the Court recited the circumstances the panel relied upon in finding no abuse of discretion by the District Court.  These included testimony by Astellas's expert in the initial discovery phase that he was offering no opinion regarding whether Form A was made during Hospira's compounding process as well as several timing issues.  These included that Astellas proffered its alternative theory a year after the close of fact discovery and six months after expert discovery closed, and waited 14 months after Hospira's document disclosure, six months after learning of Hospira's ANDA change and two months after receiving Hospira's actual ANDA amendments.  In addition, Astellas waited "more than a month" after the District Court's grant of supplemental discovery prompted by Hospira's ANDA change.  Under these circumstances, the Federal Circuit stated that:

There was no reason, other than Astellas's own litigation choices, that the compounding infringement theory could not have been asserted earlier.

This is not a case where Astellas relied on new information disclosed in the ANDA amendment to craft a new theory of infringement.  Instead, Astellas simply decided that the ANDA amendment would make it harder to prove its original infringement theory and decided to try a new theory related to a process not changed by the amendment.

Based in a supplementary discovery order the District Court had issued against another defendant (who later settled) in this case who had amended its ANDA, the Federal Circuit considered the supplementary discovery order here to have been limited to Hospira's changes to its ANDA and was not broad enough to be used to develop Astellas's alternative infringement theories or proffer expert evidence in support thereof, as well as representations by Astellas to the District Court regarding the limited extent of this discovery.  On this issue the Federal Circuit based its affirmance of the District Court striking Astellas's alternative infringement contention and expert evidence on  the "great deference . . . given to a district court's interpretation of its own order," citing WRS, Inc. v. Plaza Entertainment, Inc., 402 F.3d 424 (3rd Cir. 2005).

The Federal Circuit similarly rejected Astellas's arguments that, timely or not, it was an abuse of the District Court's discretion to exclude its alternative theory of infringement.  Applying Third Circuit law, the Court considered whether Astellas had not satisfied the factors required in the Third Circuit under Meyers v. Pennypack Woods Home Ownership Assn, 559 F.2d 894 (3rd Cir. 1977):

(1) "the prejudice or surprise in fact of the party against whom the excluded witnesses would have testified" or the excluded evidence would have been offered; (2) "the ability of that party to cure the prejudice"; (3) the extent to which allowing such witnesses or evidence would "disrupt the orderly and efficient trial of the case or of other cases in the court"; (4) any "bad faith or willfulness in failing to comply with the court's order"; and (5) the importance of the excluded evidence.

Here, the Federal Circuit held that, while there was no finding under factor (4) of bad faith, the other factors supported the exercise of the District Court's discretion to preclude Astellas's alternative infringement theory.  These included clear evidence that Hospira was surprised by the alternative theory and was prejudiced thereby in view of the time remaining before trial, particularly in view of Astellas's expert's earlier testimony that he had no opinion regarding whether the Form A polymorph arose in Hospira's compounding process and there being insufficient time to perform the testing necessary to show that this conversion did not take place.  The Court also considered the prejudice to other parties to the litigation if the District Court postponed trial long enough for Hospira to complete this testing.  The opinion states that regarding factor (3) Astellas had not presented any persuasive evidence that the District Court erred in finding disruption of the court's calendar, and that Astellas had not shown that the evidence was sufficiently important to satisfy factor (5) (the opinion voicing reasons why the panel was not convinced that the excluded evidence would have been helpful for Astellas in establishing infringement).

Ultimately the decision came down to the District Court's discretion, and the Federal Circuit was unwilling to second guess that court absent more compelling evidence than Astellas was able to provide.

Astellas US LLC v. Hospira, Inc. (Fed. Cir. 2022)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Reyna, and Cunningham
Opinion by Circuit Judge Dyk

* Of course he also wrote this lyric on that album, so maybe it was just a phase:

They say I shot a man named Gray
And took his wife to Italy
She inherited a million bucks
And when she died they came to me
Can I help it if I'm lucky?

"Idiot Wind"