Janssen v. Celltrion: Motions to Exclude or Limit Evidence and Testimony from the Upcoming Trial

With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial.

Expert Testimony

Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert witnesses regarding infringement of the remaining patent in the case, the ’083 patent.  As Celltrion explains, Janssen concedes that the accused cell culture media do not literally infringe the ’083 patent, but have alleged that Celltrion infringes under the Doctrine of Equivalents (“DOE”).

Celltrion is seeking to exclude Janssen’s proposed expert opinions as legally improper for two reasons: (1) “Janssen’s experts rest their DOE opinions on exactly the kind of legally invalid, element-vitiating ‘theory of equivalence’ that is prohibited by the Supreme Court. Rather than focus on the purported ‘equivalence’ of what are in many instances drastically different concentrations for a specific ingredient, the experts evaluate the overall performance results (i.e., the ability of the food composition to grow cells) of a variety of whole media compositions,” and (2) the tests on which Janssen’s experts rely failed to compare “the accused product” and “the claims of the patent,” and instead compared media that differ from the accused product and the claimed product.

Janssen’s opposition to Celltrion’s motion can be found here.

Janssen has likewise filed a motion to limit the testimony of Celltrion’s proffered expert, asking the Court to preclude him from testifying as to (1) “purported legal limitations on the doctrine of equivalents,” (2) “equating the legal standards for application of the doctrine of equivalents and for obviousness,” (3) whether the asserted claims are obvious, and (4) whether the ’083 patent is invalid as indefinite.

Janssen argues that Celltrion’s proposed expert’s opinions “fail to address the central scientific propositions on which Janssen’s infringement and validity cases are based,” and are “rather disputes over legal principles, which should be resolved by the Court, not the jury.”

Celltrion’s opposition to Janssen’s motion can be found here.

Motions in Limine

The parties have also each filed several other motions in limine seeking to preclude the other side from introducing certain evidence before the jury at trial.

Celltrion has filed five motions in limine:

1. To “exclude all evidence and argument of alleged ‘copying’ by HyClone Laboratories, Inc.” Celltrion argues that such evidence would be legally irrelevant, “would substantially prejudice the Defendants given the natural ‘lay biases and pejorative flavor the word “copy” carries’,” and “would confuse and mislead the jury away from considering the proper infringement inquiry.”
2. To “exclude any evidence and argument regarding Remicade®, including, for example, information about what conditions it treats, how it benefits patients, its sales, and the expense of development.” Celltrion argues that such evidence would be irrelevant, and could cause confusion, prejudice, and a waste of time for the jury.  Celltrion argues that the ’083 patent relates to cell culture media, and “has nothing to do with Remicade®,” as “the ’083 patent does not include any reference to infliximab,” and Janssen “does not use an embodiment of the ’083 patent in the production of Remicade®.”
3. To “exclude all evidence related to discovery communications among outside counsel“, which, Celltrion states, Janssen has recently relied on in summary judgment briefing to support its theory that Celltrion specifically intended to induce infringement of the ’083 patent. Celltrion argues that “Janssen’s arguments based on discovery communications are irrelevant and should be excluded ….Routine discovery exchanges between trial counsel have nothing to do with any Defendants’ decision maker’s alleged guilty ‘knowledge’ of infringement.” (original emphasis). Celltrion adds an alternative request: if the Court permits Janssen to rely on informal discovery communications between outside counsel, Celltrion requests an opportunity to depose and call as a witness at trial Janssen’s outside counsel who was involved in the contested attorney communications and who, Celltrion asserts, “had a prior understanding of specific facts that Janssen now asserts had been hidden or concealed.”
4. To preclude “evidence and argument concerning Celltrion’s change from purchasing media compositions from Hyclone’s facility in Utah to purchasing media compositions from HyClone’s facility in Singapore.” Celltrion states that Janssen seeks to use such evidence to “support[] an inference of knowing infringement.”  Such evidence is inadmissible, Celltrion argues, under Federal Rule of Evidence 407, which states that “‘[w]hen measures are taken that would have made an earlier injury or harm less likely to occur,’ i.e., measures are taken to ‘avoid’ the alleged injury or harm, ‘evidence of the subsequent measures is not admissible to prove…culpable conduct.’”
5. To “preclude any evidence or argument by Janssen implying or suggesting that Defendants took any action to induce infringement before April 2016, which is when Janssen disclosed the experimental testing it alleges was necessary to form the requisite intent for inducement liability.” Celltrion argues: “because Janssen itself admits that the April 2016 experimental testing was necessary for determining alleged infringement, Janssen should be precluded from arguing that Defendants induced infringement before that date.”

Janssen has filed three other motions in limine:

1. To “exclude evidence or argument about the alleged price benefits to the public from Defendants’ biosimilar product, describing Inflectra as a generic drug, or concerning Janssen’s prices, revenues, and profits.”  Janssen argues that such evidence would be irrelevant, as “[i]n the liability phase of this case, the pricing and profits for the parties’ products have no bearing on any issue,” and that it “would only serve to prejudice the jury.”
2. To “exclude evidence or argument regarding prior unrelated proceedings in this case and other patents relating to infliximab or methods for using infliximab.”  Janssen argues that the Court’s prior “ruling on obviousness-type double patenting for the asserted claims of the ’471 patent has no bearing whatsoever on any issue” remaining in the case,” and as such is irrelevant.  Janssen argues that arguments referencing the invalidation of hte ‘471 patent “would do nothing but prejudice the jury and are improper.”
3. To “exclude evidence or argument of non-infringement based on the presence of unclaimed ingredients as contrary to the Court’s claim construction ruling.”  Janssen explains that during claim construction, the Court construed the term “cell culture media” in claim 1 of the 083 patent as meaning “nutritive media for culturing cells,” and in doing so “expressly reject[ed] Defendants’ argument that the claim should be construed to exclude their media merely because they include unclaimed proteins and chemically undefined ingredients.”  Janssen argues that based on this construction, “Defendants should not be permitted to make arguments or introduce evidence implying that the presence of unclaimed ingredients is indicative of non-infringement.”

Stay tuned for further developments from the Big Molecule Watch.

The post <i>Janssen v. Celltrion</i>: Motions to Exclude or Limit Evidence and Testimony from the Upcoming Trial appeared first on Big Molecule Watch.