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LEO Pharma A/S v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

July 11, 2018



          Sherry R. Fallon United mates Magistrate Judge.

         At Wilmington this 18th day of June, 2018, the court having considered the parties' letter submissions and arguments regarding the motion to strike the expert report and testimony of patent attorney Stephen Kunin, filed by plaintiffs LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. (collectively, "LEO"), and the request of defendants Actavis Laboratories UT, Inc. and Actavis, Inc. ("Actavis") to compel LEO to grant Mr. Kunin access to confidential information (D.I. 298; D.I. 299; D.I. 300; D.I. 301; 5/8/18 Tr.), IT IS HEREBY ORDERED THAT both parties' motions are denied without prejudice for the reasons set forth below.

         1. Background.

         On May 6, 2016, LEO filed a complaint for patent infringement under the Hatch-Waxman Act against defendants Actavis Laboratories UT, Inc. and Actavis, Inc. ("Actavis"). (D.I. 1) The action relates to Abbreviated New Drug Application ("ANDA") Nos. 208807 and 209086 (together, "the Actavis AND As"), which were filed by Actavis with the U.S. Food and Drug Administration ("FDA") seeking approval to market generic versions of LEO's Picato® pharmaceutical products. (D.I. 73 at ¶ 1) The Picato® products are gels containing ingenol mebutate as the active pharmaceutical ingredient ("API") at dosage strengths of 0.015% and 0.05%. (Id.) LEO Pharma is the holder of New Drug Application ("NDA") No. 202833 for ingenol mebutate gel at concentrations of 0.015% and 0.05%, which was approved by the FDA on January 23, 2012. (Id. at ¶ 13) LEO's Picato® products are approved for the topical treatment of actinic keratosis. (Id. at ¶ 16)

         2. The court entered a scheduling order on October 13, 2016. In pertinent part, the scheduling order instructs that "[n]o Daubert motions or motions to strike expert testimony shall be filed unless discussed with the court" at an in-person status conference following the conclusion of expert discovery scheduled for June 12, 2018. (D.I. 20 at ¶ 5(d))

         3. On June 26, 2017, LEO filed its second amended complaint. (D.I. 73) The second amended complaint alleges infringement often patents: U.S. Patent Nos. 7, 410, 656 ("the '656 patent"), 8, 278, 292 ("the '292 patent"), 8, 372, 827 ("the '827 patent"), 8, 372, 828 ("the '828 patent"), 8, 377, 919 ("the '919 patent"), 8, 536, 163 ("the '163 patent"), 8, 716, 271 ("the '271 patent"), 8, 735, 375 ("the '375 patent"), 9, 416, 084 ("the '084 patent"), and 9, 676, 698 ("the '698 patent") (collectively, the "patents-in-suit"). (Id. at ¶ 8) The '084 patent and the '698 patent, identified as the "Process Patents," cover methods of producing ingenol mebutate. (Id. at ¶ 20) The Process Patents are both entitled, "Method of Producing Ingenol-3-Angelate," they share a common specification and common inventors, and both claim priority to Provisional Application No. 61/366, 018, which was filed in 2010. (D.I. 106, Exs. 6-7) The '698 patent is a continuation of the'084 patent. (Id., Ex. 7)

         4. On July 10, 2017, Actavis filed its answer and counterclaims to the second amended complaint, alleging inequitable conduct based on LEO's alleged failure to disclose U.S.

         Patent No. 7, 378, 445 ("the '445 patent") to the United States Patent and Trademark Office ("PTO") during prosecution of the Process Patents. (D.I. 85 at ¶¶ 159-196)

         5. On February 12, 2018, the court issued a Memorandum Opinion and Order granting LEO's motion to dismiss Actavis' inequitable conduct counterclaim. (D.I. 247; D.I. 248)

         6. On March 14, 2018, LEO filed a complaint to address standing issues regarding the chain of title to the Brown Patent Family. The Process Patents are not at issue in Civil Action No. 18-402-JFB-SRF. The court consolidated this action with Civil Action No. 16-333-JFB-SRF, preserving the existing scheduling orders. (D.I. 289)

         7. On April 2, 2018, Actavis requested permission for patent attorney and former PTO employee Stephen Kunin to access information designated confidential under the terms of the Stipulated Protective Order. (D.I. 29) Actavis served the expert report of Mr. Kunin on April 14, 2018. The court held a discovery dispute teleconference on May 8, 2018 to address LEO's motion to strike Mr. Kunin's expert report and testimony. During the teleconference, the parties noted that the deadline for responsive expert reports under the scheduling order is May 16, 2018. (5/8/18 Tr. at 27:18-20) The court agreed to suspend or extend the response deadline pending the issuance of this ruling. (Id. at 27:21-28:8)

         8. Analysis.

         LEO's request to strike the expert report and testimony of Mr. Kunin is denied without prejudice. The motion is premature in view of the scheduling order's specific instructions regarding motions of this nature. (D.I. 20 at ¶ 5(d)) Moreover, the court concludes that the motion is, at its core, a Daubert motion best reserved for resolution by the trial judge.[1]

         See BASF Corp. v. Johnson Matthey Inc., C.A. No. 14-1204-RGA (D.I. 167) (D. Del. May 1, 2018) ("Plaintiff wants to resolve the [letter motion to quash an expert report] through the more expeditious and less expensive discovery dispute procedure. Unfortunately, it really is not a discovery dispute."). Accordingly, the instant ruling denying LEO's motion to strike the expert report of Mr. Kunin is without prejudice to LEO filing a Daubert motion, limited to the expert report of Mr. Kunin, to be filed on or before July 6, 2018, and to be briefed in accordance with D. Del. Local Rule 7.1.3. Consistent with the statements made on the record ...

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