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Court denies all summary judgment motions in Genentech & U Penn HERCEPTIN suit

On May 14, 2012 the United States District Court for the Northern District of California dismissed a number of competing summary judgment motions in respect of U.S. Patent No. 6,733,752.  Genentech had brought a declaratory judgment suit seeking a declaration of non-infringement for its trastuzumab product, HERCEPTIN, and a declaration of invalidity of the ‘752 patent. The Trustees for the University Of Pennsylvania (“U Penn”) counterclaimed for infringement of the ‘752 patent.

HERCEPTIN is indicated, among other things, as an adjuvant treatment to reduce the risk of cancer recurrence in patients who have been diagnosed with primary breast cancer and who have been treated by surgical removal of their breast tumor(s).  The ‘752 patent is generally directed to a method of adjuvant cancer therapy using antibodies to prevent a form of breast cancer. Claim 1 of the ‘752 patent, reads as follows:

A method of inhibiting development into breast cancer cells of breast cells that overexpress p185 in an individual in need of such inhibition which comprises administering to said individual an antibody which competes with an antibody produced by cell line ATCC Deposit No. 10493 for binding to p185 and specifically binds to p185 in sufficient amount to down regulate the overexpressed p185 and inhibit the development of said breast cells that overexpress p185 into breast cancer cells.

The Court had previously construed the highlighted elements of claim 1 as follows:

 

breast cancer cells “cells from the breast that have malignant form and structure, the ability for uncontrolled growth, and the potential or ability to invade or metastasize.”
breast cells that overexpress p185 cells, the origin of which is breast tissue, that overexpress p185 and are not breast cancer cells
an individual in need of such inhibition an individual who(i) has a family history of neu-associated breast cancer or a genetic predisposition to neu-associated breast cancer but who has not developed neu-associated breast cancer; or

(ii) has had her/his neu-associated breast cancer tumors removed by surgical resection, or has been diagnosed as having neu-associated breast cancer enter remission.

Construction

Central to both parties’ summary judgment motions was whether isolated tumor cells (“ITCs”) in the bone marrow of early-stage breast cancer patients are “breast cancer cells” as this term had been construed by the Court.  U Penn presented evidence that HER2 overexpressing ITCs are found in the bone marrow of 20 to 40% of adjuvant patients.  Genentech framed the issue as whether ITCs fall within or outside the definition of “breast cancer cells” as construed. The Court, having already construed “breast cancer cells” in the earlier Markman Order, refused to re-construe “breast cancer cells” in order to account for ITCs.

Literal Infringement – “uncontrolled growth”

Genentech relied on expert evidence that ITCs are capable of uncontrolled growth. U Penn presented its competing expert evidence that ITCs do not have the potential for uncontrolled growth, including recent evidence suggesting that ITCs derive from non-cancerous atypical ductal hyperplasia. The Court concluded that there existed a genuine issue of a material fact, namely whether ITCs have the potential for uncontrolled growth, and denied the parties’ respective summary judgement motions on the issue of infringement.

Since there was a genuine issue of whether ITCs are “breast cancer cells”, the Court similarly denied U Penn’s motion for summary adjudication that “Herceptin can act on ITCs to inhibit them from becoming cancer cells.”

U Penn’s summary judgment motion on the doctrine of equivalents was also denied.

Inducement – Direct Infringement

Genentech also brought a summary judgment motion seeking to dismiss U Penn’s inducement claim. The Court, adopting a construction most favorable to the non-moving party, concluded that HERCEPTIN is administered, at least in some instances in an infringing manner. The Court also considered whether HERCEPTIN, used in the adjuvant setting, would be capable of “significant non-infringing uses”. The Court denied Genentech’s motion “because U Penn has presented sufficient evidence from which a jury could make a finding of direct infringement, summary judgment on this ground is improper.”

Inducement – Knowledge and Intent

Genentech also moved for summary judgment on the basis that U Penn had not presented evidence from which a reasonable jury could infer that Genentech possessed the requisite knowledge and intent to induce infringement. The Court, following Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003) agreed with Genentech that where a product has substantial noninfringing uses, intent to induce infringement cannot be inferred even when the alleged inducer has actual knowledge that some users of its product may be infringing the patent. The Court then went on to hold:

Nevertheless, while actual knowledge of potential infringement may not be sufficient to infer intent to induce infringement where a product also has substantial noninfringing uses, Federal Circuit cases more recent than Warner-Lambert have clarified that “liability for active inducement may be found ‘where evidence goes beyond a product’s characteristics or the knowledge that it may be put to infringing uses, and shows statements or actions directed to promoting infringement.’” Ricoh Co. v. Quanta Computer Inc., 550 F.3d 1325, 1341 (Fed. Cir. 2008) (quoting Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 935 & n.10 (2005) (“Grokster”)). In other words, even where a product has substantial noninfringing uses, an accused can still be liable for inducement if the patentee establishes the alleged inducer’s “‘affirmative intent that the product be used to infringe.’” AstraZeneca, 633 F.3d at 1059 (quoting Grokster, 545 U.S. at 936 (internal quotation marks and citations omitted)). Such affirmative intent can be proven by presenting “‘[e]vidence of active steps . . . taken to encourage direct infringement, such as advertising an infringing use or instructing how to engage in an infringing use.’” Id. (quoting Grokster, 545 U.S. at 936) (internal quotation marks and citations omitted)). In AstraZeneca, the Federal Circuit found that intent to induce could be inferred where the accused inducer was on notice that the product’s proposed label could cause at least some users to infringe the asserted

The Court distinguished Warner Lambert, where only 2.1% of uses were infringing, concluding:

From these facts, viewed in the light most favorable to U Penn, a jury could find that Genentech knew Herceptin acted on HER2+ ITCs in the Adjuvant Population, that this infringed the ’752 patent’s method claims, and that Genentech nonetheless continued to encourage this use of Herceptin.

Validity – Written Description

Genentech submitted that to the extent that the ‘752 patent covers a method for inhibiting the transformation of ITCs into cancer cells, a skilled person reading the application that lead to ‘752 patent, as of its filing date, would not have understood the inventors to have been in possession of this subject matter.  In support of its position, Genentech relied on the fact that the ‘752 patent is devoid of any evidence of ITC or non-cancerous p185 overexpressing breast cells outside the breast. The Court held that the absence of a reference to ITC or disseminated cells in the ‘752 patent would not automatically render Claim 1 invalid for lack of written description. When framed in the light most favorable to U Penn, the Court concluded that a reasonable jury could conclude that U Penn was in possession of a method of preventing ITC cells from turning into breast cancer cells and denied Genentech’s summary judgment motion.

A copy of the Court’s opinion may be found here.  The trial of this matter is schedules to begin on June 11, 2012.