Non-obviousness affirmed in Pozen v. Par
In Pozen v. Par the CAFC affirmed the ED Texas district court’s decision because it did not err in finding the patents-in-suit not invalid and in- fringed.
The residual hearsay rule appears in a footnote:
At trial, Pozen presented, and the district court allowed into evidence, a declaration from one of the co- authors of the Parma reference, referred to as the “Tog- noni declaration,” which stated:
6
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 effi- cacy 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 circum- stantial guarantees of trustworthiness when the declara- tion 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 cross- examination. Id. Here, Tognoni made a written state-
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).
Teaching away:
The district court determined that Catarci discourages combining sumatrip- tan and naproxen to achieve the claimed efficacy benefits, teaching away from the invention. Id.; see In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (A reference teaches away when “a person of ordinary skill, upon reading the refer- ence, would be discouraged from following the path set out in the reference, or would be led in a direction diver- gent from the path that was taken by the applicant.”); see also Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011) (explaining that a jury could find that prior art taught away from one solution because all prior art taught a different solution).
Concerning written description:
Section 112, paragraph 1 of the Patent Act, requires that the specification contain a written description of the invention. 35 U.S.C. § 112, ¶ 1. The purpose of the writ- ten description requirement is to ensure adequate disclo- sure of the invention. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. Following a bench trial, we review compliance with the written description requirement, a question of fact, for clear error. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1332 (Fed. Cir. 2008).
AND
The ’499 patent specification meets the written de- scription requirement because the specification describes the invention in such a way that it is understandable to a person of ordinary skill in the art. See Ariad, 598 F.3d at 1351. As this court has explained, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue . . . . Nonetheless, the disclosure . . . must convey with reason- able clarity to those skilled in the art that . . . [the inven- tor] was in possession of the invention.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); see LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (“[T]he patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before . . . . Placed in that context, it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to con- vince a person of skill in the art that the inventor pos- sessed the invention and to enable such a person to make and use the invention without undue experimentation.”).
On limits:
However, although the claim language itself is a qualitative measure, the claim construction pulls directly from the specification to give the term “substantially all” a quantitative definition, specifically, “at least 90%, and preferably greater than 95%,” ’183 patent col.2 ll.62-65, and this court has previously concluded that the doctrine of equivalents is not foreclosed with respect to claimed ranges, see Adams Respiratory, 616 F.3d at 1291-92. In Kemin Foods, the court construed “substantially free from other carotenoids” to mean “significantly less than 10% of other carotenoids” based, in part, on the specification stating that “[g]enerally, the concentration of other carotenoids in the starting material should be 10% or less.” Kemin Foods, L.C. v. Pigmentos Vegetales Del Centro S.A. de C.V., 464 F.3d 1339, 1349 (Fed. Cir. 2006). The court determined that because Kemin did not argue that “sig- nificantly less than 10%” has a precise upper limit a reasonable person could determine that a concentration of 6.14%-9.86% does not infringe under the doctrine of equivalents. Id. Similarly, in this case, Pozen never stated that “at least 90%, and preferably greater than 95%” should be an absolute floor. Under the doctrine of equivalents a tablet layer with 85% of the agent can be fairly characterized as an insubstantial change from a tablet layer with 90% of the agent.
The residual hearsay rule appears in a footnote:
At trial, Pozen presented, and the district court allowed into evidence, a declaration from one of the co- authors of the Parma reference, referred to as the “Tog- noni declaration,” which stated:
6
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 effi- cacy 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 circum- stantial guarantees of trustworthiness when the declara- tion 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 cross- examination. Id. Here, Tognoni made a written state-
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).
Teaching away:
The district court determined that Catarci discourages combining sumatrip- tan and naproxen to achieve the claimed efficacy benefits, teaching away from the invention. Id.; see In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (A reference teaches away when “a person of ordinary skill, upon reading the refer- ence, would be discouraged from following the path set out in the reference, or would be led in a direction diver- gent from the path that was taken by the applicant.”); see also Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011) (explaining that a jury could find that prior art taught away from one solution because all prior art taught a different solution).
Concerning written description:
Section 112, paragraph 1 of the Patent Act, requires that the specification contain a written description of the invention. 35 U.S.C. § 112, ¶ 1. The purpose of the writ- ten description requirement is to ensure adequate disclo- sure of the invention. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. Following a bench trial, we review compliance with the written description requirement, a question of fact, for clear error. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1332 (Fed. Cir. 2008).
AND
The ’499 patent specification meets the written de- scription requirement because the specification describes the invention in such a way that it is understandable to a person of ordinary skill in the art. See Ariad, 598 F.3d at 1351. As this court has explained, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue . . . . Nonetheless, the disclosure . . . must convey with reason- able clarity to those skilled in the art that . . . [the inven- tor] was in possession of the invention.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); see LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (“[T]he patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before . . . . Placed in that context, it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to con- vince a person of skill in the art that the inventor pos- sessed the invention and to enable such a person to make and use the invention without undue experimentation.”).
On limits:
However, although the claim language itself is a qualitative measure, the claim construction pulls directly from the specification to give the term “substantially all” a quantitative definition, specifically, “at least 90%, and preferably greater than 95%,” ’183 patent col.2 ll.62-65, and this court has previously concluded that the doctrine of equivalents is not foreclosed with respect to claimed ranges, see Adams Respiratory, 616 F.3d at 1291-92. In Kemin Foods, the court construed “substantially free from other carotenoids” to mean “significantly less than 10% of other carotenoids” based, in part, on the specification stating that “[g]enerally, the concentration of other carotenoids in the starting material should be 10% or less.” Kemin Foods, L.C. v. Pigmentos Vegetales Del Centro S.A. de C.V., 464 F.3d 1339, 1349 (Fed. Cir. 2006). The court determined that because Kemin did not argue that “sig- nificantly less than 10%” has a precise upper limit a reasonable person could determine that a concentration of 6.14%-9.86% does not infringe under the doctrine of equivalents. Id. Similarly, in this case, Pozen never stated that “at least 90%, and preferably greater than 95%” should be an absolute floor. Under the doctrine of equivalents a tablet layer with 85% of the agent can be fairly characterized as an insubstantial change from a tablet layer with 90% of the agent.
posted by Lawrence B. Ebert at 11:40 AM
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