Opinion ID: 809417
Heading Depth: 4
Heading Rank: 1

Heading: The Parma Reference

Text: The district court determined that the Parma reference does not render the ’499 and ’458 patents obvious. 13 POZEN INC v. PAR PHARMA Pozen, 800 F. Supp. 2d at 815-16. We agree. Parma is an epidemiological survey assessing various migraine treatments entitled, “The Treatment Of Migraine: A Study In General Medicine.” 6 One of the tables, labeled “Table VI. 6 At trial, Pozen presented, and the district court allowed into evidence, a declaration from one of the coauthors of the Parma reference, referred to as the “Tognoni declaration,” which stated: While my article speaks of [combination therapy] of many pairs of drugs, including NSAIDs and sumatriptan, this is not meant as a reference to administering those two drugs at the same time. . . . it refers to the common practice of that time of migraine patients taking drugs separately in sequence, with a required gap in time between administrations of the drugs to determine the efficacy of the first drug before trying additional drugs. J.A.158512. DRL argues that the declaration is inadmissible as hearsay and irrelevant, and in admitting it the district court abused its discretion. DRL’s Br. at 52. Pozen argues that the declaration is admissible under the residual hearsay rule, Fed. R. of Evid. 807. See Pozen’s Br. at 30. We review evidentiary determinations under the law of the regional circuit. Lexion Med. v. Northgate Techs., Inc., 641 F.3d 1352, 1358 (Fed. Cir. 2011). The Fifth Circuit reviews decisions to admit or exclude evidence for abuse of discretion. United States v. Phillips, 219 F.3d 404, 409 (5th Cir. 2000). “The residual hearsay exception is to be used only rarely, in truly exceptional cases.” United States v. Walker, 410 F.3d 754, 757 (5th Cir. 2005) (citations and internal quotation marks omitted). To admit evidence under the residual hearsay rule, there must be at least circumstantial guarantees of trustworthiness. Id. at 758. The Fifth Circuit has found there are equivalent circumstantial guarantees of trustworthiness when the declaration is made under oath and the declarant is subject to the penalties of perjury, the testimony was preserved on videotape, and the witnesses were subject to crossexamination. Id. Here, Tognoni made a written statePOZEN INC v. PAR PHARMA 14 Combinations: 2 drugs,” listed “FANS + sumatriptan” (FANS is the Italian abbreviation for NSAIDs) among fifteen other drug combinations for the treatment of migraines. Another table, labeled “Table VIII. ‘Unsatisfactory’ treatments,” lists percentages of patients unsatisfied with various monotherapy treatments; included in that list is “sumatriptan.” Table VI. Combinations: 2 drugs (53 cases, type 1 and 2) FANS + flunarizine 13 FANS + antiemetics 5 FANS + antidepressants 6 FANS + ergotamines 2 FANS + analgesics 2 FANS + sumatriptan 2 FANS + FANS 1 FANS + other drugs 1 Ergotamines + benzodiazepine 1 Ergotamines + antidepressants 1 ment under penalty of perjury, but was never subjected to cross-examination, which may be enough under Fifth Circuit law to guarantee trustworthiness. However, even if it is trustworthy, this is not an exceptional case and thus does not warrant the residual hearsay exception. See Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008). 15 POZEN INC v. PAR PHARMA Ergotamines + other drugs 3 Sumatriptan + flunarizine 2 Sumatriptan + beta-blockers 1 Analgesic + analgesic 2 Various combinations 11 J.A.242118. Table VIII. “Unsatisfactory” treatments (migraine type 1 and 2) Monotherapy Unsatisfactory % treatments FANS 118 44 37.9 Sumatriptan 37 16 43.2 Analgesics 89 49 66.0 Ergotamine 18 14 77.7 derivatives J.A.242119. Appellants’ expert testified that Parma teaches simultaneous administration of various drug combinations, and someone skilled in the art would look at “Table VIII. ‘Unsatisfactory’ treatments” and be motivated to either administer another agent or administer a combination therapy. Pozen, 800 F. Supp. 2d at 816. The district court gave more weight to Pozen’s expert who testified that a person skilled in the art would have interpreted Parma to disclose a sequential administration of various drug POZEN INC v. PAR PHARMA 16 combinations. Id. As the tables reproduced above illustrate, Parma revealed the types of treatments used and documented the number of unsatisfactory treatments reported. Parma only specifies the unsatisfactory results of monotherapy treatment in Table VIII; it does not indicate the relative successes of various combination treatments listed in Table VI. 7 Furthermore, the district court found that Parma does not disclose anything about the combination of “FANS + sumatriptan” in particular reducing migraine relapse or producing longer lasting efficacy, nor does it disclose the dosage of the combination treatment. Id. Although the district court abused its discretion by admitting the Tognoni declaration, see supra 13 n.6, it was harmless error, there was not clear and convincing evidence that the ’499 and ’458 patents are obvious over the Parma reference.