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Trs. of the Univ. of Pa. v. Eli Lilly & Co.

Trs. of the Univ. of Pa. v. Eli Lilly & Co.

United States District Court for the Eastern District of Pennsylvania

November 19, 2021, Decided; November 19, 2021, Filed

Civ. No. 15-6133

Opinion

ORDER

Plaintiff, The Trustees of the University of Pennsylvania, allege that the administration of Erbitux followed by radiation infringed upon U.S. Patent No. 7,625,558 (the '558 Patent). (Doc. No. 1 at ¶¶ 23, 46, 52, 58.) Claim 13 of the '558 Patent is the sole remaining asserted claim. (Doc Nos. 63-15, 82.) Defendants move for summary judgment of invalidity [*8]  (Doc. No. 180), summary judgment of noninfringement (Doc. No. 181), and partial summary judgment of no willful infringement. (Doc. No. 182.) For the reasons that follow, I will deny Defendants' Motions in their entirety.

I. BACKGROUND

Penn filed its patent application on July 8, 1998, describing "methods of treating an individual who has an erbB protein mediated tumor." (Doc. No. 1 at ¶ 16, Doc. No. 1; '558 Patent at 1, Doc. No. 1-1.) On December 1, 2009, the United States Patent and Trademark Office issued to Penn Patent Number 7,625,558 Patents containing claims for methods of treating cancerous tumors by "administering a cytostatic antibody that inhibits tumor cell growth," and by then exposing that cell to radiation. (Doc. No. 1 at ¶ 17; '558 Patent.)

Erbitux, which is manufactured and sold by Defendants, is an FDA approved treatment for Squamous Cell Carcinoma of the Head and Neck (SCCHN). (Doc. No. 1-2). The active ingredient in Erbitux is Cetuximab, an antibody that binds to epidermal growth factor receptor (EGFR), which is an erbB-family protein. (Id.; Doc. No 206 at ¶ 21.) The Erbitux label states that it is "indicated in combination with radiation therapy." (Doc. No. 183 at ¶ 68.)

On November 13, 2015, Penn brought this action, alleging [*9]  Defendants infringe "at least" 35 of the '558 Patent's 41 Claims by marketing and selling Erbitux. (Doc. No. 1 at ¶ 45, 46.) The matter was assigned to Judge Robert Kelly. Penn did not explicitly allege infringement of Claims 8, 13, 15, 18, 31, or 41. (Id.) Defendants filed a Petition for an inter partes review (IPR) at the USPTO of Claims 1-7, 9-12, 14, 16, 17, and 19-31 of the '558 Patent, and this case was stayed during the IPR proceedings and following appeals before the USPTO and Federal Circuit. (Doc. Nos. 23, 60, 62.) The Patent Trial and Appeal Board invalidated each of the challenged claims in the IPR. (Doc. No. 61-1 at 59.) Additionally, Judge Kelly granted Defendants' Motion to Dismiss as to Penn's assertion of infringement of Claims 32-40 of the '558 Patent as being improper multiple dependent claims. (Doc. Nos. 52, 53.) Each of Penn's originally asserted claims were thus either invalidated or dismissed.

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2021 U.S. Dist. LEXIS 257587 *; 2021 WL 7918978

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, Plaintiff, v. ELI LILLY AND COMPANY, et al., Defendants.

Prior History: Trs. of the Univ. of Pa. v. Eli Lilly & Co., 2016 U.S. Dist. LEXIS 70442 (E.D. Pa., May 31, 2016)

CORE TERMS

infringement, tumor, cell, mediated, antibody, inhibits, summary judgment, kinase, patent, homodimer, Specification, experimentation, invalid, erbB, species, written description, willful, invention, genus, induced, radiation, light most favorable, administering, skill, noninfringement, proliferation, disclosure, demonstrates, Parties, reasonable inference