Earlier this month, in Phigenix, Inc. v. Genentech, Inc., the Federal Circuit affirmed a decision by the U.S. District Court for the Northern District of California striking the infringement opinion of Phigenix's expert and granting summary judgment of noninfringement based on a lack of evidence of both direct infringement and intent to induce infringement.  The District Court also denied summary judgment of invalidity of Phigenix's U.S. Patent No. 8,080,534.

The '534 patent, which is entitled "Targeting PAX2 for the Treatment of Breast Cancer," describes preventing or treating breast conditions (including breast cancer) by administering a composition that inhibits and/or enhances the expression of certain genes (PAX2 and DEFB1, respectively).  Claim 1 recites "[a] method for treating a breast condition" by administering a composition that inhibits PAX2 expression or activity, and/or expresses DEFB1.

Phigenix filed suit against Genentech for infringement of the '534 patent based on Genentech's product Kadcyla, alleging that Genentech induced infringement of the '534 patent by encouraging health care professionals to prescribe and administer Kadcyla to breast cancer patients who had previously received the chemotherapy drugs "trastuzumab and a taxane, separately or in combination."  After the District Court issued an order holding that the asserted claims of the '534 patent are not entitled to the priority date of a 2005 provisional application, Phigenix narrowed the relevant population to Kadcyla patients who were pretreated exclusively with trastuzumab and a taxane (i.e., trastuzumab, a taxane, and "and nothing else"), which Phigenix conceded comprise only about 4% of the total population of Kadcyla patients.  However, Phigenix did not move to amend its infringement contentions to reflect this narrower population (Genentech learned of Phigenix's narrowed population definition during its deposition of Phigenix's expert after the close of fact discovery and months after the District Court's order regarding priority to the 2005 provisional application).

Genentech responded to the narrowed patient population by moving to strike the infringement opinion of Phigenix's expert.  The District Court, agreeing with Genentech that Phigenix had failed to provide adequate notice of its narrowed infringement theory, struck Phigenix's expert infringement opinion and granted summary judgment of noninfringement based on the lack of direct infringement evidence.  The District Court also granted summary judgment of noninfringement based on a lack of evidence of specific intent to induce infringement under Phigenix's narrowed theory.  Phigenix appealed the District Court's decision to strike its expert's noninfringement opinion and grant of summary judgment of noninfringement.

In an opinion by Judge Stoll, joined by Judges Reyna and Bryson, the Federal Circuit determined that the District Court was within its discretion to exclude the infringement opinion of Phigenix's expert in response to Phigenix's failure to timely disclose its narrowed infringement theory.  The panel noted that Phigenix narrowed the relevant patient population from "Kadcyla patients who were pretreated with trastuzumab and a taxane" to "Kadcyla patients who were pretreated with trastuzumab and a taxane and nothing else," and did so not in response to new evidence or a claim construction.  More importantly, the opinion notes that "it is clear that Phigenix did not take any deliberate action to proactively put Genentech on notice that it had [narrowed the relevant patient population]."  The panel also noted that it agreed with the District Court "that such a dramatic narrowing at such a late stage in the litigation prejudiced Genentech because it 'markedly transformed the nature of the infringement theory, and consequently, impacted Genentech's ability to prepare a defense.'"

In affirming the District Court's decision to strike the noninfringement opinion of Phigenix's expert and grant of summary judgment of noninfringement, the Federal Circuit found unpersuasive Phigenix's arguments that the District Court had abused its discretion.  The panel first disagreed with Phigenix's argument that its revised infringement theory was not newly propounded because it fell wholly within the scope of its original infringement contentions.  The panel, however, agreed with the District Court "that the broader theory disclosed in Phigenix's infringement contentions is not sufficiently specific to disclose its narrowed theory."  The panel also disagreed with Phigenix that it had put Genentech on notice of its narrowed infringement theory during a challenge to the prior art status of a particular clinical trial.  The panel was also not persuaded by a number of district court decisions cited by Phigenix, which Phigenix argued allowed plaintiffs to narrow their infringement theories after propounding broader infringement contentions.  In response, the Court noted that "on the merits, these cases are readily distinguishable because the moving party in each demonstrated early notice, diligence, new evidence, and/or leave obtained from the district court—none of which apply here."  Finally, the Court disagreed with Phigenix's argument that the District Court's decision to strike the entirety of Phigenix's expert's opinion was "heavy-handed," that Genentech had not adequately explained how it was prejudiced by the revised infringement theory, that Genentech had failed to explain why a less severe sanction would not address the District Court's concerns, and that Genentech had not sought clarification of Phigenix's infringement contentions.  The Court countered that "Genentech adequately explained how it was prejudiced by Phigenix's untimely narrowing of its infringement theory."

Rejecting Phigenix's arguments that the District Court had abused its discretion in striking the noninfringement opinion of Phigenix's expert, and without its expert report, the panel determined that Phigenix's direct infringement case must fail, and therefore affirmed the District Court's grant of summary judgment of noninfringement.

Phigenix, Inc. v. Genentech, Inc. (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Circuit Judges Reyna, Bryson, and Stoll
Opinion by Circuit Judge Stoll