pfizer inc. et al. v. teva parenteral medicines, inc., et al., c.a. no. 10-37-gms (d. del. nov. 21,...

8/3/2019 Pfizer Inc. et al. v. Teva Parenteral Medicines, Inc., et al., C.A. No. 10-37-GMS (D. Del. Nov. 21, 2011)

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC., PHARMACIA CORP., )PHARMACIA & UPJOHN COMPANY, )PHARMACIA & UPJOHN COMPANY LLC, )and C.P. PHARMACEUTICALS )INTERNATIONAL, C.V., )GENZYME CORPORATION, )) c.A. No. 1O-cv-37-GMSPlaintiffs, ))

v. ))TEV A PARENTERAL MEDICINES, INC., )TEV A PHARMACEUTICALS USA, INC., and )TEV A PHARMACEUTICALS INDUSTRIES, )))Defendants. )- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - )

ORDERWHEREAS, on June 10, 2011, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals

USA, Inc., and Teva Pharmaceutical Industries, Ltd. (collectively, "Teva"), the defendants in theabove captioned matter, filed a Motion for Leave to File an Amended Answer (D.I. 56) to addthe affirmative defense of obviousness-type double patenting with respect to U.S. Patent No.5,688,792 (the "'792 Patent");

WHEREAS Teva's motion was timely, pursuant to the unopposed Motion to Amend theScheduling Order (D.I. 52) that the court granted on May 9, 2011, such that Pfizer Inc.,Pharmacia Corp., Pharmacia & Upjohn Company, Pharmacia & Upjohn L.L.C., Pharmacia &Upjohn Company L.L.C., and C.P. Pharmaceuticals International, C.V. (collectively, "theplaintiffs") were on notice of such a potential amendment to the pleadings;


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WHEREAS, Teva's Motion for Leave to Amend was accompanied by two exhibits,which include its amended Answer and obviousness-type double patenting affirmative defense(D.L 56, Exhibits A-B);

WHEREAS, Teva's amended Answer bases its affirmative defense on allegations that, inlight of the depositions and fact discovery completed at the time of this filing, the '792 Patent isinvalid for obviousness-type double patenting over another of the plaintiffs' patents, U.S. PatentNo. 5,547,950 (the "'950 Patent") (D.I. 57 at 2);

WHEREAS Teva contends that the inclusion of its affirmative defense at this juncture isappropriate because: (1) the plaintiffs are aware that Teva aims to rely on the '950 Patent inasserting obviousness, given that Teva included a discussion of this patent in the "detailedstatement" it provided to the plaintiffs before the case was initiated, l as well as identified the'950 Patent as a document on which Teva intends to rely for obviousness (id. at 2; D.L 64 at 3);(2) discovery provided Teva with information which necessitated the assertion of this affirmativedefense to enable the court to decide all issues presented by this action (D.I. 57 at 2); (3) theinclusion of this affirmative defense will not require either party to engage in additionaldiscovery, as the defense is closely related to Teva's previously pled obviousness defense under35 U.S.C. 103 and extensive discovery has already been conducted on this issue (id. at 2-3;D.L 64 at 1); and (4) neither party will need to conduct additional discovery to support or defendagainst this affirmative defense because Teva has gathered all information it requires throughdiscovery and information publicly available and, further, that the plaintiffs possess sufficient

I Specifically, Teva states that it discussed how the '950 Patent rendered the '792 Patent obvious in the"detailed statement" it submitted to the plaintiffs in 2009. To this end, Teva argues that the "related legal theory" itattempts to introduce through its amended Answer here was already familiar to the plaintiffs and is now supportedby fact discovery such that amendment at this time is appropriate. (D.I. 57 at 2.)2


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information about the '950 Patent because this patent belongs to the plaintiffs and claimschemical compounds closely related to those in the patent in suit2 (D.I. 64 at 2);

WHEREAS Teva, in sum, asserts that its motion for leave to amend should be grantedbecause the proposed amendment and its timing: (1) do not affect the scheduling order; and (2)would not prejudice the plaintiffs (D.I. 57);

WHEREAS, on June 28, 2011, the plaintiffs filed their Answering Brief in Opposition toTeva's Motion for Leave to File an Amended Answer (D.!. 61), in which they assert: (1) thatTeva engaged in dilatory tactics by failing to introduce this affirmative defense until the last dateavailable for pleading amendments when Teva should have known, based on the nature of thisdefense, whether it intended to include it at the outset3 (id. at 2); (2) that Teva's dilatory tacticsare further evidenced by the fact that Teva did not ask the inventors a single question aboutdouble patenting during expert discovery, such that its inclusion of the defense at this juncture isnot based upon newly identified factual information4 (id.; id. at 6-7); (3) that the plaintiffs will be

2 In support of this argument, Teva asserts that the "resolution of this defense requires comparing theclaimed invention of the '950 Patent (as distinguished from the entire disclosure of the patent) with the claimedinvention of the patent in suit." (D.1. 64 at 2.) Moreover, Teva notes that the standard for its double patentingdefense is similar to the standard used to determined obviousness under 35 U.S.C. 103, its other defense in thisaction. See Procter & Gamble v. Teva, 566 F.3d 989, 999 (Fed. Cir. 2009) ("In general, obviousness analysisapplies to double patenting."). With respect to the plaintiffs' argument that they will need to reopen fact discoveryin order to adequately address this issue, Teva notes that it will not seek to reopen fact discovery and, further, that"the only deposition Pfizer took of Teva was on June 30, 20 II , after Teva's motion was filed and after Pfizer wasaware that Teva was asserting a double patenting defense." (D.1. 64 at 8.)

3 Specifically, the plaintiffs note that the obviousness-type double patenting defense does not require aheightened pleading standard, such that Teva did not have to engage in fact discovery before asserting the defense.(D.I. 61 at 2.) Moreover, the plaintiffs note that this defense is premised on a comparison ofthe two patents' claims,which is also information Teva possessed before the litigation started. (Id.) Finally, the plaintiffs state that Tevahad at least fifteen occasions when they could have asserted this defense prior to the instant motion, including whenit filed its Paragraph IV certification, Answer, Interrogatory responses, or during the deposition phase. (Id. at 2-4.)

4 In particular, the plaintiffs note that although Teva attributes its delay in adding the affirmative defense tothe fact that the defense was "solidified" by recent depositions, including the "final named inventor's deposition"(id. at 7), this "excuse fails" because: (1) the inventor testimony has no bearing on an obviousness-type doublepatenting defense because this defense is a "legal question which requires the court to construe and compare claimsand assess whether there is a patentable distinction" (id.); (2) Teva did not ask either inventor a single questionabout the '950 Patent as it compares to the '792 Patent (id.); (3) Teva did not notice a "single deposition until March18, 2011, less than two weeks before the original agreed-upon deadline to amend pleadings" (id. at 7-8); and (4)Teva has not explained why it waited until the pleading amendment deadline to file the instant motion (id. at 8).

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prejudiced by the inclusion of this defense because there has been no claim construction inconnection with it (id. at 3); and (4) that the plaintiffs will be prejudiced because Tevaintroduced this defense near the end of fact discovery and at the beginning of expert discovery,Ssuch that additional or extended fact and expert discovery may be necessary (id. at 9-11);

WHEREAS, in response to plaintiffs' assertion that Teva's delay in filing a motion toamend its Answer renders its current motion untimely and prejudicial, Teva reasserts: (1) that itsmotion was filed within the time set by the court-and according to a schedule unopposed by theplaintiffs-for the filing of such motions, such that the plaintiffs cannot argue that the motion isuntimely or prejudicial (DJ. 64 at 4); (2) that delay in amending a pleading is not unreasonablewhen a party, as Teva here, "moves to amend based on information obtained or confirmedthrough the discovery process,,6 (id.); and (3) that, because the plaintiffs argue that they believedthey were agreeing to amend the scheduling order to allow Teva more time to assert aninequitable conduct defense-a defense that would require additional witnesses and discovery toaddress the materiality and intent elements-the plaintiffs' opposition to this motion isdisingenuous (id. at 5);

WHEREAS, in response to the plaintiffs' contention that Teva should not be allowed toamend its Answer based on its asserted rationale because it did not ask the inventors about

5Teva filed its Motion for Leave to Amend on June 10, 20 II . (D.1. 56.) Fact discovery in this case wasdue on June 17,2011, per the court's scheduling order. Expert discovery commenced on September 23,2011, afterthe filing of this motion, with the final round of reports to be exchanged on that date. Since the instant motion'sfiling, expert discovery has been extended until November 30, 2011, per the court's November 3, 2011 oral order.6See Aerocrine AB v. Apieron Inc., No. 08-787-LPS, 2010 WL 1225090, at *9 (D. DeL March 30, 2010);Cordance Corp. v. Amazon.com, Inc., 255 FRD. 366,370-71 (D. DeL 2009). Teva states that the fact that it did notask the inventors about its double patenting defense is immateriaL (D.I. 64 at 4.) Specifically, Teva notes that"[sJince the inventors listed on the '950 patent are the same as those listed on the '792 patent in suit, Teva'sunderstanding of the details of the interrelationship between the two claimed inventions could not be confirmed untilthose inventors had been deposed." (Id.) Moreover, Teva indicates that most of the questioning at the inventors'depositions "went to . . . their understandings of the '950 patent and of its application to their invention." (Id.) Tevacontends that this line of questioning, coupled with the plaintiffs' awareness of Teva's obviousness defense and itsintent to use the '950 patent to assert obviousness, negates the plaintiffs' arguments that the instant amendment toadd the double patenting defense is either dilatory or prejudiciaL (Id.)

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double patenting at their depositions, Teva argues that this assertion is without merit because,due to the nature of its defenses of obviousness and obviousness-type double patenting, questionsabout one defense are directly relevant to the other? (id. at 4-5);

WHEREAS, Teva asserts, responding to the plaintiffs' claim that they will sufferprejudice by the inclusion of this defense because there was no claim construction,S that Claim 9of the '950 Patent does not need to be construed because, as even the plaintiffs have stated, claim9 is "five distinct compounds identified by compound name" (D.I. 64 at 8; D.l. 61 at 10);

WHEREAS, leave to amend should be "freely given when justice so requires,,,9 andcourts have the discretion to deny leave to amend when there exists such conditions as unduedelay, bad faith, dilatory motive, undue prejudice to the opposing party, or where the amendmentwould be futile lo;

WHEREAS, the non-moving party has the burden of proving that actual prejudice willresult from amendment to the pleadings 11, where dilatory motives and/or bad faith are not

7 Specifically, Teva notes: Much of the questioning [of the inventors] at [the] depositions went to their understanding of the '950 patent and of its application to their invention. Pfizer does not dispute that the questioning of the inventors was relevant to Teva's obviousness defense based on the '950 patent. . . . [However,] the issues of obviousness and obviousness-type double patenting are, as the names imply, closely related, and testimony about one is relevant to the other. (D.I. 64 at 4-5.)8 Specifically, the plainiffs contend that because courts assessing an obviousness-type double patentingdefense must, "as a matter of law[,] . . . construe[] the claim in the earlier patent and the claim in the later patent anddetermine[] the differences," Eli Lilly & Co., 251 F.3d 955, 968 (Fed. Cir. 2001), the court must construe the terms

in Claim 9 of the '950 Patent. (D.1. 61 at 10-11.)9See Fed. R. Civ. P. 15(a)(2).lOSee, e.g., Forman v. Davis, 371 U.S. 178, 182 (1962); In re Burlington Coat Factory Sec. Litig., 114 F.3d1410,1434 (3d Cir. 1997).II See Clark v. Williams, No. 07-239 JJR, 2008 WL 1803648, at '" 1 (D. Del. Apr. 18, 2008) (citing Kiser v.

Gen. Elec. Co., 831 F.2d 423,427-28 (3d Cir. 1987) (citations omitted)).12 See, e.g., Inline Connection Corp. V. AOL Time Warner, Inc., 237 F.R.D. 361, 369 (D. Del. 2006)(quoting Forman, 371 U.S. at 182)).

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WHEREAS, after having considered the parties' submissions, the court finds that none ofthe above-mentioned conditions exist in the present case 13 and that Teva's affirmative defense istimely;

IT IS HEREBY ORDERED that:Teva's Motion for Leave to Amend Its Answer (D.l. 56) is GRANTED. 14

Dated: November , 2011

13 The court concludes that the plaintiffs have failed to demonstrate that they will suffer actual prejudice asa result of Teva's amendment and inclusion of the affirmative defense of obviousness-type double patenting.Specifically, while Teva could have sought to amend its Answer to include this defense earlier, it filed this motionwithin the time allotted by the court-and unopposed by the plaintiffs-for such amendments. Moreover, the courtapproved timeline for such amendments did not limit the scope of the amendments allowed, such that the plaintiffs'assertion that they anticipated only an amendment to add an inequitable conduct defense does not necessitate theconclusion that the plaintiffs will suffer prejudice or that Teva's amendment represents a dilatory tactic. Further, thecourt concludes that, in light of Teva's already pleaded obviousness defense and reference to the '950 Patent as anobviousness reference it intends to use, Teva's inclusion of an obviousness-type double patenting defense at thistime could be anticipated by the plaintiffs.

14Teva filed a proposed amended Answer as Exhibit A to its motion. For administrative purposes,however, the court requires parties to submit the amended Answer as a separate document. Should the plaintiffsrequire an extension of time to complete expert discovery in light of the addition of this defense, the court willentertain and is amenable to such a motion.6

pfizer inc. et al. v. teva parenteral medicines, inc., et al., c.a. no. 10-37-gms (d. del. nov. 21,...

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