Plexxikon Inc. v. Novartis Pharmaceuticals Corporation

Background

The order addresses four motions in limine, which are requests to limit evidence or argument at trial. The court stated that it would rule on the remaining motions in limine on a rolling basis.

Plexxikon’s asserted patents arose from its work on selective inhibitors of B-Raf, a protein whose mutations frequently cause cancer. That work led to Zelboraf and to two series of compounds: an azaindole-based series and a monocyclic heteroaryl-based series. The monocyclic heteroaryl-based patents are asserted in this case; the azaindole-based patents are not. Tafinlar practices the asserted patents, while Zelboraf and Braftovi share some molecular elements but are covered by different patents. The parties agreed that Tafinlar infringes the asserted patents without dispute.

Novartis’s Motion in Limine No. 2

Novartis sought to prevent Plexxikon from mentioning or offering evidence about patents or patent claims that were not asserted in this case as evidence that the asserted patents are valid. The court granted the motion. It ruled that the fact that others obtained similar patents was not relevant to patentability and that evidence about unrelated patents would likely cause confusion and waste time under Federal Rule of Evidence 403.

The court allowed a limited exception. If Novartis’s witnesses suggested that broad patents were invalid merely because they were broad, Plexxikon could use the witnesses’ prior inconsistent statements, including statements from Novartis’s witnesses, to impeach them. The court otherwise excluded evidence of unrelated patents for this purpose.

Novartis’s Motion in Limine No. 3

Novartis sought to limit evidence about compounds not covered by the asserted patents. The court granted the motion as described in the order. During Plexxikon’s case-in-chief, Plexxikon could not describe the “core molecular structure” as its invention or use evidence about Zelboraf or Braftovi to equate those products or their properties with the asserted patents.

The court nevertheless allowed Plexxikon to explain its development story concerning selective B-Raf inhibitors and to present evidence about the relative importance of subcomponents to the effectiveness of the claimed compounds. Plexxikon could rely on supporting experiments, including experiments arising from testing Zelboraf, but could not specifically describe Zelboraf or Braftovi’s chemical structures when doing so.

Regarding secondary considerations of non-obviousness, Plexxikon could not directly rely on Zelboraf’s commercial success to rebut Novartis’s obviousness argument. If Novartis attributed Tafinlar’s success to features other than the shared molecular elements, Plexxikon could offer evidence that Zelboraf succeeded without those features, but only after submitting a proposed limiting instruction telling the jury not to attribute Zelboraf’s success to the asserted patents.

Regarding damages, Plexxikon could introduce evidence of the Roche license for Zelboraf and explain the importance of the claimed invention to Tafinlar’s effectiveness. Unless Novartis opened the door by challenging the technical comparability of the licensed products, Plexxikon could not otherwise discuss Zelboraf’s chemical structure.

Novartis’s Motion in Limine No. 4

Novartis sought to prevent Plexxikon from offering evidence or argument suggesting that GlaxoSmithKline or Novartis copied Plexxikon’s inventions. The court granted the motion except for the limited uses described in the order.

For independent development, Plexxikon could cross-examine witnesses about whether GlaxoSmithKline relied on research and development contributed by Plexxikon. Plexxikon could not refer to collaboration discussions with GlaxoSmithKline or GlaxoSmithKline’s testing of Zelboraf samples because those matters involved different products and inventions.

For damages, if Novartis argued that the asserted patents had little value because they were merely a “toll gate” needed for freedom to operate, Plexxikon could present evidence that GlaxoSmithKline and Novartis studied Plexxikon’s publications and patent applications, including features later included in the asserted claims, to develop lead compounds.

For secondary considerations of non-obviousness, Plexxikon could use evidence that GlaxoSmithKline incorporated a claimed fluorine feature after reviewing Plexxikon’s patent applications. The court ruled that copying a precise claimed feature could be relevant even if the accused product did not copy an entire embodiment of the claims.

For willful infringement, however, the court excluded the copying evidence. It found that the evidence’s value was substantially outweighed by the risk of unfair prejudice and confusion because the alleged conduct concerned related products and patents, not the asserted patents. The court also stated that awareness of a patent portfolio did not establish knowledge of a specific patent.

Plexxikon’s Motion in Limine No. 1

Plexxikon sought to prevent Novartis from presenting invalidity evidence or arguments not included in its invalidity contentions, including arguments that Zelboraf was prior art or that uncharted publications anticipated or made the asserted claims obvious.

The court denied the motion. It ruled that the status of Zelboraf and related publications as prior art was relevant to Novartis’s arguments that the shared molecular structure was not the novel or inventive aspect of the asserted claims. The court found that Novartis had not conclusively shown at this stage that Zelboraf or the related publications were prior art, but it allowed Novartis to try to establish that at trial.

The court explained that the Patent Local Rules’ requirement to identify invalidity references applied to references Novartis contended anticipated each asserted claim or made it obvious. Novartis instead intended to use Zelboraf and related publications to rebut Plexxikon’s contention that it discovered the shared molecular structure and to address secondary considerations of non-obviousness. That use was not barred by the Patent Local Rules, assuming the evidence was timely and adequately disclosed under the applicable rules and scheduling order.

Disposition

The court granted Novartis’s Motion in Limine No. 2, granted Novartis’s Motion in Limine No. 3 as described above, granted Novartis’s Motion in Limine No. 4 except as described above, and denied Plexxikon’s Motion in Limine No. 1. The court directed the parties to be prepared to discuss how to implement the order at the pretrial conference.