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In re Certain Consolidated Roflumilast Cases

United States District Court, D. New Jersey

August 31, 2017

IN RE: CERTAIN CONSOLIDATED ROFLUMILAST CASES

          MEMORANDUM OPINION AND ORDER

          DOUGLAS E. ARPERT United States Magistrate Judge

         Currently before this Court are two related applications: 1) the request of certain defendants for leave to serve second amended invalidity contentions, and 2) the request of certain defendants for leave to file amended pleadings to allege unenforceability of three of the asserted patents for inequitable conduct. Plaintiffs have filed a separate motion to dismiss certain of Defendant Mylan's counterclaims [dkt. no. 167] which is pending before U.S. District Judge Freda L. Wolfson.

         I. Certain defendants' application for leave to serve second amended invalidity contentions.

         Defendants Apotex, Torrent, Hetero, Strides, Breckenridge, Prinston and MSN (collectively, “the Movants”) seek permission to serve second amended invalidity contentions with respect to U.S. Patent Nos. 8, 536, 206 (“the ‘206 patent”), 8, 504, 064 (“the ‘064 patent”) and 8, 618, 142 (“the ‘142 patent”) (collectively, “the Patents”) in order to assert invalidity under 35 U.S.C. §102(f) for derivation and improper inventorship. See the Movants' letter to the Court dated January II, 2017 (“Ltr. d. 1/11/17") [dkt no. 152]. In short, the Movants contend that the named inventors of the Patents derived their invention from the work of Dr. Herman Amschler, the named inventor of another asserted patent (U.S. Patent No. 5, 712, 298), and that none of the named inventors contributed to the conception of the subject matter of the Patents. The Movants argue that their application is timely, supported by good cause, and will not prejudice Plaintiffs. Id.

         Plaintiffs have opposed the Movants' application arguing that the Movants were not diligent in moving to amend their contentions and that Plaintiffs will be prejudiced if the application is granted. See Plaintiffs' letter to the Court dated January 27, 2017 (“Ltr. d. 1/27/17"). The Movants replied to Plaintiffs' opposition in a letter to the Court dated January 31, 2017 (“Ltr. d. 1/31/17") [dkt. no. 160].

         A. Legal Standard

         The instant application is governed by Local Patent Rule 3.7 pursuant to which leave to amend a party's contentions may be granted “by order of the Court upon a timely application and showing of good cause.” L. Pat. R. 3.7. A party seeking to amend its contentions bears the burden of demonstrating diligence in discovering the basis for the proposed amendment as well as moving promptly to amend when new evidence is discovered. Merck Sharp & Dohme Corp. v. Sandoz, Inc., C.A. No. 12-3289 (PGS), 2014 WL 997532, at *3 (D.N.J. Jan. 6, 2014). The moving party must also establish that the amendments will not unduly prejudice the non-moving party. Astrazeneca AB v. Dr. Reddy's Labs, Inc., C.A. No. 11-2317 (JAP), 2013 WL 1145359, at *5 (D.N.J. Mar. 18, 2013).

         B. Analysis

         1. The Movant's application is supported by good cause and is not untimely.

         The Movants contend that through the depositions of Drs. Zingel and Mueller and Mr. Palosch in late 2016 they learned “critical facts” that support the derivation and improper inventorship defenses contained in their proposed amended contentions. Further, the Movants argue that these facts were “non-public” and unavailable prior to those depositions. Ltr. d. 1/11/17 at pp. 5-7. As to derivation, the Movants state, they “needed to confirm that none of the named inventors actually contributed to the conception of [the Patents'] claims.” Id. at p. 6. As to improper inventorship, the Movants state, the depositions revealed additional information concerning the respective roles of Dr. Amschler and the named inventors in the conception and reduction to practice of the subject matter of the Patents. Id.

         To the contrary, Plaintiffs maintain that “as of Plaintiffs' production on April 20, 2016, [the Movants] had all the information they rely on in their proposed amendment.” See Ltr. d. 1/27/17 at p. 4. Further, Plaintiffs argue, “nothing that came out of this fall's inventor depositions added new information to what was in the documents.” Id. Consequently, Plaintiffs argue, the Movants' “diligence should be measured from receipt of the documents in April 2016" and not the date of the inventors' depositions. Id. On this basis alone, Plaintiffs argue, the Movants' application should be denied. Id. at p. 5.

         In response, the Movants argue that it was “impossible for [the Movants] to assert in good faith their derivation and improper inventor defenses before the conclusion of the Mueller and Palosch depositions” because they lacked evidence establishing critical elements of those defenses. See Ltr. d. 1/31/17 at pp. 3-8.

         The Court finds that once the depositions were complete and the transcripts were obtained, the Movants promptly presented their new defenses and proposed amended invalidity contentions to Plaintiffs on December 15, 2016. Plaintiffs responded on January 6, 2017 and the Movants' application followed on January 11, 2017. This Court has previously determined that, as in this case, additional discovery, including depositions, may be necessary to reveal, develop or confirm that sufficient evidence exists to support a party's proposed amendments. See Helsinn Healthcare S.A. v. Dr. Reddy's Labs, Ltd., CA No. 11-3962 (MLC), 2013 WL 3336859, at *4 (D.N.J. July 2, 2013); Warner Chilcott Company, L.L.C. v. Lupin, Ltd., CA No. 11-7228 (JAP), 2013 WL 4494949 (D.N.J. Aug. 19, 2013). Here, the Movants may have previously obtained some documentary evidence which would tend to support their amended contentions. However, the inventors' depositions were ...


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