Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 1 of 18 PageID #:5963
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
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`C.A. No. 1:16-cv-00651
`C.A. No. 1:17-cv-07903
`(Consolidated)
`
`Hon. Rebecca R. Pallmeyer
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`FRESENIUS KABI’S REPLY POST-TRIAL BRIEF
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`
`
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`v.
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`FRESENIUS KABI USA, LLC,
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`Plaintiff,
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`Defendant.
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`HOSPIRA, INC.
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`Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 2 of 18 PageID #:5964
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`TABLE OF CONTENTS
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`B.
`
`THE ASSERTED CLAIMS WERE OBVIOUS ................................................................ 1
`A.
`The Public Prior Art Demonstrates Claim 6 Would Have Been
`Obvious ................................................................................................................... 1
`1.
`The “About 2%” Limitation Is Inherent For 4 µg/mL ................................ 1
`2.
`The “About 2%” Limitation Was Reasonably Expected
`Based on the Compound and Stable Prior Art Products ............................. 4
`The Dexmed IND Demonstrates Claim 6 Would Have Been
`Obvious. .................................................................................................................. 7
`1.
`Farmos Is Actually the Inventor Under § 102(f) ........................................ 7
`2.
`The Invention Was On Sale Under § 102(b) .............................................. 8
`a.
`The 1994 Agreement Transferred Title to the IND ........................ 8
`b.
`The 2004 Agreement Was a Sale and Hospira Did
`Not Rebut the Law .......................................................................... 9
`The IND Was Sold For Commercial Purposes ............................... 9
`c.
`The IND Was Ready For Patenting .............................................. 10
`d.
`The IND Renders the Asserted Claims Obvious ...................................... 11
`3.
`CLAIM 6 IS NOT ENABLED ......................................................................................... 12
`A.
`Hospira Admitted the Preferred Embodiment Is Not Enabled ............................. 12
`B.
`Claim 6 Is Not Enabled to Its Full Scope ............................................................. 12
`CONCLUSION ................................................................................................................. 12
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`
`
`i
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`I.
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`II.
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`III.
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`Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 3 of 18 PageID #:5965
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`Cases
`
`TABLE OF AUTHORITIES
`
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003) ................................................................................................ 12
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ................................................................................................ 11
`Alloc, Inc. v. Pergo, Inc.,
`No. 02-C-736, 2008 WL 1968301 (E.D. Wis. May 1, 2008) ..................................................... 7
`ALZA Corp. v. Andrx Pharm., LLC,
`603 F.3d 935 (Fed. Cir. 2010) .................................................................................................. 12
`Atlas Powder Co. v. IRECO, Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) .................................................................................................. 4
`Burroughs Wellcome Co. v. Barr Labs., Inc.,
`40 F.3d 1223 (Fed. Cir. 1994) .................................................................................................... 7
`Eli Lilly and Co. v. Zenith Goldline Pharm., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) ................................................................................................ 10
`Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc.,
`894 F.3d 1374 (Fed. Cir. 2018) .................................................................................................. 4
`Ferag AG v. Quipp Inc.,
`45 F.3d 1562 (Fed. Cir. 1995) .................................................................................................... 9
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) .................................................................................................. 7
`Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc.,
`855 F.3d 1356 (Fed. Cir. 2017) .................................................................................................. 9
`Hospira, Inc. v. Amneal Pharm., LLC,
`285 F. Supp. 3d 776 (D. Del. 2018) ............................................................................................ 3
`In re Cygnus Telecomm. Tech., LLC, Pat. Litig.,
`536 F.3d 1343 (Fed. Cir. 2008) ................................................................................................ 10
`In re Goodman,
`11 F.3d 1046 (Fed. Cir. 1993) .................................................................................................. 12
`In re Hamilton,
`882 F.2d 1576 (Fed. Cir. 1989) ................................................................................................ 10
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .................................................................................................. 7
`In re Omeprazole Pat. Litig.,
`536 F.3d 1361 (Fed. Cir. 2008) ................................................................................................ 10
`
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`ii
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`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .................................................................................................. 4
`Millennium Pharmaceuticals, Inc. v. Sandoz, Inc.,
`862 F.3d 1356 (Fed. Cir. 2017) .............................................................................................. 1, 2
`OddzOn Prods., Inc. v. Just Toys, Inc.,
`122 F.3d 1396 (Fed. Cir. 1997) .............................................................................................. 7, 8
`PAR Pharm., Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .................................................................................................. 1
`Pfaff v. Wells Elecs., Inc.,
`525 U.S. 55 (1998) ...................................................................................................................... 8
`Polara Eng’g Inc v. Campbell Co.,
`894 F.3d 1339 (Fed. Cir. 2018) ................................................................................................ 10
`PPG Indus., Inc. v. Guardian Indus. Corp.,
`75 F.3d 1558 (Fed. Cir. 1996) .................................................................................................. 12
`Robert Bosch, LLC v. Pylon Mfg. Corp.,
`700 F. Supp. 2d 625 (D. Del. 2010) ............................................................................................ 7
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .............................................................................................. 2, 4
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .................................................................................................. 2
`U.S. v. Gen. Elec. Co,
`272 U.S. 476 (1926) .................................................................................................................... 9
`
`Statutes
`
`35 U.S.C. § 102(b) .......................................................................................................................... 9
`35 U.S.C. § 102(f) ........................................................................................................................... 7
`35 U.S.C. § 103(c) .......................................................................................................................... 8
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`iii
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`Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 5 of 18 PageID #:5967
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`In its response, Hospira chose to ignore claim 8 of the ’049 patent—the pH claim—even
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`though it was one of only two claims Hospira asserted at trial. As to claim 6 of the ’106 patent—
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`the stability claim—Hospira contests only the “about 2%” limitation. Hospira raises several new
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`arguments not part of the trial nor based on trial testimony. Yet it has no response to the fact that
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`all data sets at 4 µg/mL, plus Dr. Ogenstad’s statistical analysis, confirmed that the “about 2%”
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`stability limitation is an inherent property. The “about 2%” limitation would also have been
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`reasonably expected from the published prior art or from Farmos’s IND. Finally, Claim 6 is not
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`enabled if the 2% property is not inherent, and is not enabled to its full scope.
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`I.
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`THE ASSERTED CLAIMS WERE OBVIOUS
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`A.
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`The Public Prior Art Demonstrates Claim 6 Would Have Been Obvious
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`Hospira concedes a POSA would be motivated to combine the public prior art to make a
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`ready-to-use version of Precedex in glass. Fresenius Kabi also showed both that the “about 2%”
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`limitation is inherent and was reasonably expected, and either of those is enough to prove
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`obviousness. In response, Hospira’s formulation expert, Dr. Linhardt, said nothing about
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`obviousness except the possibility of oxidation under non-real-world conditions. If there were
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`anything more to Hospira’s attorney arguments, Dr. Linhardt would have addressed them.
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`1.
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`The “About 2%” Limitation Is Inherent For 4 µg/mL
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`The Court may rely on all available evidence to find a property inherent, regardless of
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`source or date. Hospira addressed none of the cases Fresenius Kabi cited for this proposition. FK
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`Br. at 16-17. Even Hospira’s cited case states “that the patent itself” can prove inherency. PAR
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`Pharm., Inc. v. TWi Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014). Hospira’s reliance on
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`Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., 862 F.3d 1356 (Fed. Cir. 2017), is misplaced.
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`The Federal Circuit’s “inventor’s own path” analysis addressed whether it would have been
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`obvious to use mannitol to create a new compound, not questioning the “natural result” of
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`combining bortezomib and mannitol. Id. at 1367-69. Here, all the prior art used Type I glass and
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`dexmed with saline for the same purpose that Hospira did. Hospira did not rebut Dr. Kipp’s
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`testimony that the “about 2%” limitation was expected, nor did it offer any evidence of secondary
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`considerations—the focus of the Federal Circuit’s analysis in Millennium. See id. at 1367-68.
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`Hospira also did not address Fresenius Kabi’s evidence that the 2% property is inherent
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`based on (1) actual data from 18 batches of Hospira’s 4 µg/mL product (confirmed by Dr. Kipp
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`and Dr. Ogenstad); (2) 36 batches of Fresenius Kabi’s 4 µg/mL product (confirmed by Ms. Mowli
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`and Dr. Ogenstad); and (3) Example 6 of the ’106 patent (confirmed by Dr. Roychowdhury). FK
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`Br. at 15-19. In the face of this evidence, Hospira asserts “FK turned a blind eye to numerous
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`sources of stability data” that presumably called into question the 2% limitation. Pl’s Br. at 10.
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`Its first such source? The “product development work from Hospira showing 2.3% loss.” Id. at
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`10; also id. at 21. But that was the same product development report that supported the only
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`example in the ’106 patent of the “about 2%” limitation. Trial Tr. 170:25-171:11
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`(Roychowdhury); JTX-51.33. Dr. Roychowdhury confirmed the development report and patent
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`example were the same, and that the 2.3% loss was “about 2%.” Trial Tr. 159:20-160:14, 192:7-
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`22. Yet Hospira now shockingly argues that the patent example does not meet the 2% limitation.
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`Hospira’s other supposedly overlooked data sources are from the 20 µg/mL IND
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`formulation, not the claimed 4 µg/mL. Because the obvious embodiment of a 4 µg/mL
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`concentration of dexmed in Type I glass and a coated stopper inherently results in a less than 2%
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`loss at 5 months, “about 2%” is an inherent property. See Santarus, Inc. v. Par Pharm., Inc., 694
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`F.3d 1344, 1354 (Fed. Cir. 2012). Hospira relies on Dr. Ogenstad for his assessment of the IND,
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`but he is not a POSA, so he cannot testify about “the scope and content of prior art,” including the
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`IND. Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1364 (Fed. Cir. 2008). All
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`2
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`others—Dr. Kipp, Dr. Roychowdhury, and the Farmos scientists who did the IND stability work—
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`disagreed with Dr. Ogenstad’s approach. Dr. Kipp explained that the IND data showed no change
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`over time, and that the regression lines were essentially flat. Trial Tr. 333:20-335:5, 336:1-11.
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`The Farmos scientists reached the same conclusions for the very same data: it was “stable for 2
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`years when stored at room temperature in a clear glass ampoule” and “not significantly changed.”
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`JTX-39.5; JTX-35.276. The ’106 patent itself is ultimate proof that Dr. Ogenstad’s analysis is
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`wrong: the patent had no statistical analysis, and according to Dr. Ogenstad, Hospira failed to
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`substantiate its own invention. Trial Tr. 790:11-791:14.
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`But even the IND data showed less than 2% loss at 5 months according to Dr. Ogenstad’s
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`regression analysis, and his “confidence intervals”1 depict the acceptable error range. Trial Tr.
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`753:17-20; PDX-44. Hospira does not address that Dr. Ogenstad’s entire analysis—per his own
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`admission—only demonstrated the scope of the word “about” in the claim term “about 2%.” Trial
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`Tr. 791:1-22. In response, Hospira states in a footnote that “2% +/- 3% includes negative
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`percentages which are impossible.” Pl’s Br. at 13 n.6. But it is not impossible: measurements do
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`go up and down. Trial Tr. 330:21-331:20, 334:3-16 (Kipp). In fact, Dr. Ogenstad testified that
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`regression lines with “positive slope” (i.e., increasing over time), still show “that the degradation
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`is not more than 2 percent.” Id. 767:20-768:7. A POSA would conclude that measurements within
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`the same band over time show no change—just as Dr. Roychowdhury testified. Id. 184:3-17.
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`Hospira also misapplies the law of obviousness and argues that Fresenius Kabi was
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`required to prove a negative: “FK was required to exclude the possibility that an embodiment of
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`1 Hospira refers to portions of the Remington reference that were never discussed at trial. But
`the use of confidence intervals in some contexts (there “predicting shelf life”) does not mean it is
`applicable here. JTX-20.10. Hospira refers to the Amneal case, but the evidence presented there
`was different, and the confidence interval issue was not related to inherency. Hospira, Inc. v.
`Amneal Pharm., LLC, 285 F. Supp. 3d 776, 811 (D. Del. 2018).
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`3
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`

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`claim 6 would fail the 2% limitation.” Pl’s Br. at 12. But Fresenius Kabi does not have to
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`invalidate every claimed embodiment; it only has to show that at least one claimed embodiment
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`is invalid. FK Br. at 8 (citing In re Klein and In re Cuozzo); see also Atlas Powder Co. v. IRECO,
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`Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999) (finding claimed range invalid based on prior art within
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`range). Hospira’s only support for its proposition, Endo Pharmaceuticals Solutions, Inc. v.
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`Custopharm Inc., 894 F.3d 1374 (Fed. Cir. 2018), concerned the inherent meaning of a term
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`(whether “castor oil” always meant “castor oil and benzyl benzoate”), not an inherent property of
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`the combination, and is therefore inapposite. Id. at 1377, 1382. Fresenius Kabi has met its burden.
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`2.
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`The “About 2%” Limitation Was Reasonably Expected Based on the
`Compound and Stable Prior Art Products
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`Contrary to Hospira’s assertion, Dr. Kipp addressed reasonable expectation of success in
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`his report. Trial Tr. 239:21-241:19; DTX 457 at ¶¶ 64, 96, 169. Hospira wrote in the pretrial
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`statement that “reasonable expectation of success” was a trial issue. D.I. 114-1 at 1. The Court
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`allowed Hospira to adduce responsive evidence (Trial Tr. 242:17-23), but Hospira chose not to.
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`Hospira again gets the law wrong when it cites Intelligent Bio-Systems, Inc. v. Illumina
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`Cambridge Ltd., 821 F.3d 1359, 1367-68 (Fed. Cir. 2016), to argue that one “may not prove a
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`claim limitation that is missing in the prior art solely by reference to a reasonable expectation of
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`success.” Pl’s Br. at 14. That case did not involve a claimed property, and instead dealt with
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`whether the prior art taught a physical step for a method. Id. at 1367. For a property that is merely
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`tacked on to an obvious combination, the property can be inherent or reasonably expected.
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`Santarus, 694 F.3d at 1354. Hospira did not address Santarus, but admits “about 2%” is a “claimed
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`property.” Pl’s Br. at 40.
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`In any event, the prior art described the 2% limitation. The Precedex Concentrate (100
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`µg/mL) and Dexdomitor (500 µg/mL) were both already low concentration products, and both lost
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`4
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`not more than 10% in 24 months. PTX-62.35, JTX-51.65, 67; Trial Tr. 162:14-163:4
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`(Roychowdhury). As Dr. Kipp explained, that works out to about 2% at 5 months. Trial
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`Tr. 316:18-25. Though Hospira argues this observation was “during closing argument and
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`contrary to its expert’s concession,” (Pl’s Br. at 16), it was in fact Dr. Kipp’s own testimony. And
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`though Hospira now speculates there might be slightly more or less than 2% loss (Pl’s Br. at 17),
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`even its speculation still does not overcome the “about 2%” limitation.
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`Not only were the prior art concentrations already low, but the undisputed testimony
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`showed that further lowering concentration would be expected to increase stability.2 While
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`Hospira tries to reimagine the testimony of Dr. Kipp and Ms. Mowli, even the portions it cites
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`show that reducing concentration could only help. Pl’s Br. at 22-23. Ms. Mowli testified that
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`higher concentrations are likely to be less stable “because there’s more of the active ingredient to
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`possibly interact.” Trial Tr. 734:25-735:11. And Hospira omits the testimony of Dr. Ibrahim, who
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`explained that higher concentrations mean “more chances to have interaction” with other materials.
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`Ibrahim Dep. Tr. 41:20-42:12. Hospira is left to repeat its refrain that losing 1 of 4 µg/mL is
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`mathematically higher than losing 1 of 100 µg/mL, without providing any evidence for why such
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`a loss was scientifically more likely. Pl’s Br. at 17. Even Hospira’s own expert, Dr. Linhardt,
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`testified that if there were degradation, it would not depend on concentration. Trial Tr. 825:2-11.
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`Next, Hospira points to the post-it note mathematical formula and contends that “data from
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`the Precedex Concentrate NDA for 100 µg/mL and 200 µg/mL samples” somehow showed “2%
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`loss in just one month if they had contained only 4 µg/mL dexmed.” Pl’s Br. at 10. But Dr. Kipp
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`2 Hospira again refers to portions of Remington that were never discussed at trial. Pl’s Br. at 18.
`But even if considered, Remington’s reference to increasing concentration for drug “that is
`hydrolyzing” (JTX-20.9) is irrelevant here, as Dr. Kipp explained dexmed is not subject to
`hydrolysis (Trial Tr. 322:3-323:24), which Dr. Linhardt did not dispute.
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`5
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`explained (unrebutted) that the formula could not be used to make the extrapolation Hospira was
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`attempting to make. Trial Tr. 413:11-21, 454:3-455:19, 467:20-468:6. The argument also ignores
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`the plethora of actual data at 4 µg/mL, which all showed less than about 2% loss at 5 months.
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`Hospira argues that “Dr. Kipp does not know whether dexmed follows first order or zero
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`order degradation.” Pl’s Br. at 18. Yet Hospira completely avoids Dr. Kipp’s testimony and
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`explanation that the difference between first-order or zero-order degradation was irrelevant
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`because there was no degradation at all in the 5-month time frame. The degradation mechanism
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`did not matter where there was no observable loss, and the data showed a loss of less than about
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`2% at five months. FK Br. at 17-18. It was “not at all” a “close call.” Trial Tr. 340:25-341:2.
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`Hospira asserts dexmed is not “rock stable” based on a new argument that vial size
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`supposedly “shows significant interaction between the glass and the dexmed.” Pl’s Br. at 21.
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`Hospira relies on Dr. Ogenstad for this argument, who at trial said that “it’s my understanding of
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`the physics” (Trial Tr. 777:15-778:1), but his testimony was unsupported and out of a
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`biostatistician’s field of expertise. And Dr. Ogenstad admitted that all data for all vial sizes that
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`used 4 µg/mL showed less than 2% degradation. Id. 779:2-10. Dr. Linhardt’s discussion of non-
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`real-world conditions does not call the real-world data into question. FK Br. at 19-20.
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`Hospira raises another new argument, again based on parts of documents not discussed
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`during trial, that Hospira ended up using nitrogen “to minimize oxidation.” Pl’s Br. at 20 (citing
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`JTX-51.43). Hospira leaves out the fact that the very same page shows that Hospira’s use of
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`nitrogen had nothing to do with dexmed stability at all: “[t]he cause for this impurity is the Nikka
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`Densok container integrity inspection equipment.” JTX-51.43.
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`At trial, and even though either approach is sufficient for invalidity, Fresenius Kabi proved
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`the “about 2% limitation” was an inherent property and it was reasonable to expect. The Kao case
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`6
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`Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 11 of 18 PageID #:5973
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`is instructive, which for two different limitations found two different bases for invalidity (one was
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`inherent and one was reasonably expected). In re Kao, 639 F.3d 1057, 1070-71 (Fed. Cir. 2011).
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`B.
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`The Dexmed IND Demonstrates Claim 6 Would Have Been Obvious.
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`1.
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`Farmos Is Actually the Inventor Under § 102(f)
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`Inventorship is based on who first conceived of the claimed invention, Burroughs
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`Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994), and Hospira does not
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`dispute Farmos first conceived of ready-to-use, low-concentration dexmed in a sealed glass
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`container. Nor does Hospira dispute that it received the IND. The named inventors admit they
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`did not conceive of the claimed idea. FK Br. at 24. Under § 102(f), Hospira’s named inventors
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`“did not [themselves] invent the subject matter sought to be patented.” 35 U.S.C. § 102(f).
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`The invalidating prior invention need only be communicated to the patentee, not to the
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`named inventors. Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1576 (Fed. Cir.
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`1997) (“communication of that conception to the patentee”) (emphasis added). For example, in
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`Alloc, Inc. v. Pergo, Inc., No. 02-C-736, 2008 WL 1968301 (E.D. Wis. May 1, 2008), the court
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`found that though there was “no evidence that disclosure was communicated directly to the named
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`inventors,” the disclosure invalidated the asserted claims. Id. at *4. Hospira’s cited decisions only
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`find that communication to the named inventors is sufficient to establish an invalidating
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`communication, but not that such communication is necessary. Hospira’s citation to Robert Bosch
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`also does not support its position because the enabling disclosure was created after the alleged
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`communication. Robert Bosch, LLC v. Pylon Mfg. Corp., 700 F. Supp. 2d 625, 643 (D. Del. 2010).
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`For policy reasons, no direct communication to the inventors should be required, to discourage
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`companies from acquiring prior art, and then using its teachings without showing the document to
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`the “inventors.” See OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1403 (Fed. Cir. 1997).
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`As a last-ditch effort, Hospira invokes § 103(c)’s “joint research efforts” provision (Pl’s
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`7
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`Case: 1:16-cv-00651 Document #: 145 Filed: 08/14/18 Page 12 of 18 PageID #:5974
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`Br. at 35-36), but that only applies to companies working together “at the time the claimed
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`invention was made.” 35 U.S.C. § 103(c) (emphasis added); OddzOn, 122 F.3d at 1403. Farmos’s
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`IND work was done in 1989, 15 years before Hospira existed; the two were not working jointly.
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`Section 103(c) cannot apply.
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`2.
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`The Invention Was On Sale Under § 102(b)
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`As an initial matter, Hospira’s attempt to limit the IND to only the Shafer protocol is
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`improper and misleading. Pl’s Br. at 24. The 1994 and 2004 Agreements resulted in the sale of
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`the entire contents of the IND, not one singular protocol. Every witness who addressed the issue—
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`including Hospira’s FDA expert—testified to the same thing. Sheinin Dep. Tr. 116:22-117:08.
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`In addition, the Supreme Court in Pfaff specifically rejected Hospira’s argument that only
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`a physical product triggers the on-sale bar, and held that “the on-sale bar is satisfied because the
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`drawings Pfaff sent to the manufacturer before the critical date fully disclosed the invention.”
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`Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67-68 (1998) (emphasis added). Like the drawings in Pfaff,
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`the IND fully disclosed Farmos’s prior invention and therefore triggers the on-sale bar. See, e.g.,
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`JTX-35.13-62, 223-298; Trial Tr. 257:12-258:9, 259:7-9, 261:9-10, 329:16-25, 330:7-10 (Kipp);
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`Sheinin Dep. Tr. at 93:17-21. The IND contains orders of magnitude more information than a
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`product by itself ever could. As Hospira admits, “the IND contains information that describes how
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`one might make [the prior art invention].” Pl’s Br. at 25.
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`a.
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`The 1994 Agreement Transferred Title to the IND
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`Hospira makes no sense when it tries to excuse away the admissions to the FDA. Hospira
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`says the FDA does not know the circumstances of an IND transfer. Pl’s Br. at 27. So what? The
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`parties to the agreement characterized the 1994 transaction to the FDA as changing “ownership.”
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`DTX 353_0001; DTX 350_0001; Trial Tr. 68:4-19, 69:15-25, 70:13-71:2 (Lankau).
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`Hospira’s license argument ignores key evidence. Even Mr. Seaton agreed that “typically
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`in a license agreement, one doesn’t transfer titles,” even though title did transfer to the IND here.
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`Trial Tr. 639:20-21; see U.S. v. Gen. Elec. Co, 272 U.S. 476, 489 (1926) (“a license giv[es]
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`the licensee no title in the patent”). Mr. Lankau’s ultimate conclusion—just like the contract itself
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`at § 9.4—confirmed the IND is treated separately from “Orion Know-How.” JTX-110.15, 41-42.
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`The provisions that relate to the IND itself control. Trial Tr. 126:12-127:24 (Lankau).
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`Yet even if the Court finds that the 1994 Agreement only licensed the IND to Abbott, the
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`IND is still prior art under § 102(b) because—as Fresenius Kabi showed in the opening brief and
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`Hospira failed to address—licenses can, and do, trigger the on-sale bar. FK Br. at 28-29.
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`b.
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`The 2004 Agreement Was a Sale and Hospira Did Not Rebut the
`Law
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`The 2004 Agreement constitutes a second sale of the IND. Hospira does not dispute that
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`Abbott and Hospira were separate companies for purposes of the separation and does not address
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`the Ferag case cited in Fresenius Kabi’s opening brief, which clearly held that a spin-off does
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`constitute a sale in circumstances analogous to the 2004 Agreement. FK Br. at 30 (citing Ferag
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`AG v. Quipp Inc., 45 F.3d 1562, 1566-67 (Fed. Cir. 1995)). Hospira’s cited cases do not stand for
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`the proposition that a corporate spin-off is immune from the on-sale bar. Pl’s Br. at 29.
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`c.
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`The IND Was Sold For Commercial Purposes
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`In arguing that the IND was sold for experimental purposes, Hospira confuses
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`confidentiality with control. A sale need not be publicly disclosed to trigger the on-sale bar.
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`Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356, 1367-68 (Fed. Cir. 2017). And
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`contrary to Hospira’s assertion, Farmos did not maintain control over the IND because Orion, then
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`Abbott, and then Hospira controlled the IND. DTX 353_0001, 02; DTX 350_0001; DTX
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`351_0002; JTX-40.1. Neither Eli Lilly nor Polara are applicable to the present case, as they (a)
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`were both related to the separate issue of prior use, not prior sale, and (b) involved the inventor
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`testing his invention. Eli Lilly and Co. v. Zenith Goldline Pharm., Inc., 471 F.3d 1369, 1380-81
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`(Fed. Cir. 2006); Polara Eng’g Inc v. Campbell Co., 894 F.3d 1339, 1349 (Fed. Cir. 2018). And
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`contrary to Hospira’s assertion, In re Hamilton holds that “[t]he experimental use doctrine
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`operates…to allow the inventor to refine his invention.” 882 F.2d 1576, 1581 (Fed. Cir. 1989).
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`d.
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`The IND Was Ready For Patenting
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`As a threshold issue, Hospira ignores that the Asserted Claims are not limited to
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`administration to humans; the parties stipulated that the term “subject” includes “a non-human
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`animal.” D.I. 63 at 3. It is undisputed that the IND was ready for patenting for animal subjects.
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`JTX-35.21-43; Trial Tr. 490:17-491:6, 505:14-506:17 (Maile); id. 707:15-19 (Ramsay); Sheinin
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`Dep Tr. at 57:15-24, 59:13-17, 59:20.
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`Hospira tries to frame the Shafer protocol of the IND as a “failed experiment” because
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`20 µg/mL administered without dilution caused side effects. Pl’s Br. at 31. But all sedatives have
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`side effects, and this would not have discouraged a POSA from using dexmed, either by changing
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`the concentration, dose, or rate. Trial Tr. 545:7-546:4 (Maile). Further, the side effects reported
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`were the same side effects that are still present on the FDA-approved dose of dexmed. DTX
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`335_0006-07; JTX-15.8; Trial Tr. 548:6-21, 550:8-551:7 (Maile).
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`More fundamentally, the Shafer protocol demonstrates that the product was completed;
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`otherwise it could not have been administered to people. Trial Tr. 546:15-25 (Maile). Hospira
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`does not even argue otherwise, and instead argues by assertion that a POSA would think the study
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`failed because of a problem with formulation stability. Pl’s Br. at 32, 36. But the IND contains
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`data and written conclusions confirming the stability for the 20 µg/mL formulation. JTX-35.276-
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`277. Once reduced to practice as in the IND, experimental use cannot negate the on-sale bar. In
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`re Cygnus Telecomm. Tech., LLC, Pat. Litig., 536 F.3d 1343, 1356 (Fed. Cir. 2008). Hospira’s
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`cited case, In re Omeprazole Pat. Litig., 536 F.3d 1361, 1372 (Fed. Cir. 2008), says the same thing,
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`although Hospira cites it for the proposition that clinical trials can be experimental if no one knows
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`if they work at all—but the IND proved the formulation and drug did work. JTX-35.45
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`(“Dexmedetomidine had a significant, dose-dependent sedative effect”).
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`As explained in the opening brief, FDA approval is not required for ready for patenting,
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`and the ’106 patent itself was filed before FDA approval for the Premix. FK Br. at 26, 32; Trial
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`Tr. 57:4-6. Hospira’s argument also contradicts reality: a subset of this IND testing was already
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`enough for an actual patent. The ’840 patent to Orion/Farmos (DTX 002) contains a dog study
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`and one clinical trial for medetomidine. Trial Tr. 505:9-24, 506:22-507:7 (Maile). The patent
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`issued with claims to the perioperative use of dexmed in mammals, including humans. DTX
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`002_0003 at 4:35-54 (claims). The same data cannot now be too experimental for patenting.
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`3.
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`The IND Renders the Asserted Claims Obvious
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`Hospira does not dispute that the IND disclosed 20 µg/mL dexmed in a ready-to-use glass
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`ampule. Nor does Hospira dispute the combination of the IND with Precedex Concentrate, which
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`already used 4 µg/mL and showed it to be safe and effective, was obvious.
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`Hospira attempts to argue that the IND taught away from developing dexmed at a
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`concentration lower than 20 µg/mL. Pl.’s Br. at 36. But Hospira waived this argument when it
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`represented to the Court that it would not rely on any secondary considerations. July 6, 2018
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`Hearing Tr. 56:15-23; Trial Tr. 303:7-9. “Teaching away” is a secondary consideration. Allergan,
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`Inc. v. Sandoz Inc., 796 F.3d 1293, 1305 (Fed. Cir. 2015). Regardless, the IND did not teach away:
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`it