• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2016-00091 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–30 were not shown unpatentable under § 103 over Sallmann and Ogawa; unexpected properties and objective evidence outweighed the showing of obviousness.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “On February 25, 2016, we instituted an inter partes review in IPR2016-00091 and granted the motion for joinder with IPR2015-01100, adding InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC, Mylan Pharmaceuticals, and Mylan Inc. to the Lupin petitioner (collectively “Petitioners”). Paper 22. Petitioners filed a Reply to the Patent Owner Response. Paper 35 (Public), Paper 37 (Parties and Board Only), (collectively, “Reply”).” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We agree with Petitioners. Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Patent Owner has not identified any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adopting the district court’s construction of the identified terms is necessary to resolve an issue in this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 9

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “development of pharmaceuticals, and would have a Ph.D. and several years of experience in the field.” Pet. 6. Patent Owner asserts, more broadly, that a person of ordinary skill in the art would have at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry or a related discipline with 3–5 years of work experience. PO Resp. 7 (citing Ex. 2082 ¶¶ 47–48 (Williams Decl.)). Based on the record as a whole, we find that Patent Owner’s description more appropriately encompasses the broad education that the person of ordinary skill in the relevant art may possess. Thus, we adopt that description. We note, however, that neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner

    “Given these prior art teachings, Petitioners persuade us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, therefore, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 11, and 19, the ’606 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1004, 5:19– 25. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.15 w/v %), fall within the stabilizing range set out in the ’606 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 11, and 19 of the ’606 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by each of those claims.” slip op. at 16

  Patent outcomesUS 8,927,606 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,927,606
• Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01099 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable because unexpected properties, industry praise, and commercial success outweighed the obviousness showing over Sallmann and Ogawa.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelSkill level board ownOther

    “As to the level of ordinary skill in this art, the parties’ expert witnesses advance somewhat different opinions. See Pet. 6 (citing Ex. 1005 ¶ 40 (Lawrence Decl.4)); see also PO Resp. 7 (citing Ex. 2082 ¶¶ 45–46 (Williams Decl.5)). Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Given these prior art teachings, Petitioner persuades us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 8, and 14, the ’290 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1001, 5:37– 38. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.1 w/v %), discussed above, fall within the stabilizing range set out in the ’290 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 8, and 14 of the ’290 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by claims 1, 8, and 14. Patent Owner’s arguments do not convince us to the contrary.” slip op. at 14

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “In sum, in light of the discussed comparisons, the advantageous properties inhering to tyloxapol-containing bromfenac formulations, and the supporting testimony of Patent Owner’s witnesses, we find that Patent Owner has advanced evidence sufficient to support its contentions that the compositions recited in claims 1, 8, and 14 of the ’290 patent exhibit unexpected properties.” slip op. at 24

  Patent outcomesUS 8,669,290 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,669,290
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2016-00089 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable because the unexpected properties and commercial success of the claimed formulations outweighed the obviousness showing over Sallmann and Ogawa.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)).” slip op. at 14

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelOther

    “witnesses advance somewhat different opinions. See Pet. 6–7 (citing Ex. 1005 ¶ 40 (Lawrence Decl.));5 see also PO Resp. 7 (citing Ex. 2082 ¶¶ 44– 45 (Williams Decl.)).6 Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on 5 Declaration of M. Jayne Lawrence, Ph.D., dated April 21, 2015 (Ex. 1005). 6 Declaration of Robert O. Williams III, Ph.D., dated February 22, 2016 (Ex 2082). the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “contention that an ordinary artisan would have considered Sallmann’s tyloxapol and Ogawa’s polysorbate 80 to be interchangeably useful in aqueous ophthalmic solutions. Pet. 38 (citing Ex. 1005 ¶¶ 334–336). Given her qualifications, experience, and explanation, we credit her testimony on this issue. See Ex. 1005 ¶¶ 3–15. Dr. Lawrence’s testimony in this regard, moreover, is supported by the Yasueda and Desai references cited in Dr. Lawrence’s Declaration.” slip op. at 13

  Patent outcomesUS 8,754,131 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,754,131
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01097 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable over Sallmann and Ogawa under § 103 because unexpected properties, industry praise, and commercial success outweighed the obviousness showing.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelOther

    “As to the level of ordinary skill in this art, the parties’ expert witnesses advance somewhat different opinions. See Pet. 6–7 (citing Ex. 1005 ¶ 40 (Lawrence Decl.));5 see also PO Resp. 7 (citing Ex. 2082 ¶¶ 44– 45 (Williams Decl.)).6 Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on 5 Declaration of M. Jayne Lawrence, Ph.D., dated April 21, 2015 (Ex. 1005). 6 Declaration of Robert O. Williams III, Ph.D., dated February 22, 2016 (Ex 2082). the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusDecided for patent owner

  Patent outcomesUS 8,754,131 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,754,131
• Tietex International, Ltd. v. Precision Fabrics Group, Inc.No claims unpatentable
  PTAB · Jan 27, 2016 · IPR2014-01248 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claims 1–22 were not shown unpatentable under § 103 over Radwanski, Rowan, and Murch because the petitioner did not establish the claimed thermal protective performance value.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Thus, in order to prevail, Petitioner must provide evidence establishing that the claimed TPP values are inherent in the prior art. Petitioner cannot, as an examiner can, establish unpatentability of the challenged claims based on the presumption that the structure of fabric that results from the combination of Radwanski, Rowan, and Murch would necessarily possess the claimed properties. Allowing Petitioner to rely solely on a presumption of inherency would improperly shift the burden to Patent Owner to establish that the claimed properties are not necessarily present in the prior art. Therefore, we are not persuaded that the Appeal Decision establishes “that one of ordinary skill in the art would have found it obvious to construct a flame retardant, intumescent fabric in accordance with the teachings of the prior art” with the claimed TPP value of at least 4.5 as Petitioner contends. Pet. 16.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “After considering Petitioner’s and Patent Owner’s positions, as well as their supporting evidence, we determine that Petitioner has not shown, by a preponderance of the evidence, that claim 1 of the ’639 patent, and claims 2– 10, 13–16, and 19–22 that depend, directly or indirectly, therefrom, would have been obvious over the combined teachings of Radwanski, Rowan, and Murch. Independent claims 11, 12, and 17 also require a TPP value of at least 4.5. Ex. 1001, 12:47–13:20, 14:1–18. Therefore, for the reasons set forth above, we also determine that Petitioner has not shown, by a preponderance of the evidence, that claims 11, 12, and 17, and dependent claim 18, would have been obvious over the combination of Radwanski, Rowan, and Murch. D. Secondary Considerations of Non-obviousness Patent Owner contends that secondary considerations of non- obviousness, including unexpected results, long-felt but unsolved need, and commercial success of the patented product “compel a determination of nonobviousness.” PO Resp. 49; see id. at 49–59. As discussed above, we find that Petitioner has not established that claims 1–22 of the ’639 patent would have been obvious over the combination of Radwanski, Rowan, and Murch. Thus, we need not address Patent Owner’s evidence regarding secondary considerations of non-obviousness.” slip op. at 17

  • Strike new argumentNew argument disregardedDecided for patent owner

    “In our judgment, Petitioner’s arguments and evidence in the Reply are outside the scope of a proper reply because they do more than merely address Patent Owner’s argument that Petitioner did not establish that fabrics made by the combination inherently would have the claimed TPP value; rather, they attempt to provide new evidence that was not set forth clearly in the Petition as to why the fabric resulting from the combination of Radwanski, Rowan, and Murch necessarily would have the claimed TPP values. Because Petitioner waited until the Reply to serve this evidence on Patent Owner, Patent Owner was denied the opportunity to file responsive evidence. Consideration by the Board of the arguments in the Reply and evidence presented in the Horrocks Declaration in support thereof would be unfair to Patent Owner. Petitioner could have presented this argument and evidence with the Petition, and has not contended or offered any evidence to show otherwise. Because Petitioner belatedly presented these new arguments and evidence to make its case that the TPP value is dictated by the structure of the fabric, we decline to consider the portions of the Reply and the Horrocks Declaration on this issue. See Office Trial Practice Guide, 77 Fed. Reg. at 48,767. Patent Owner had a chance to, and in fact did, cross-examine Dr. Horrocks, but had no further briefing opportunity to challenge Petitioner’s evidence. Although Patent Owner did file observations regarding the cross-examination of Dr. Horrocks, such observations are not designed for submitting substantive arguments. See id. at 48,768 (“An observation (or response) is not an opportunity to raise new issues, re-argue issues, or pursue objections.”). Considering the new arguments and evidence at this late stage would not serve the interests of justice. We have, however, reviewed and considered the arguments in the Petition and evidence therein, and are in agreement with Patent Owner that Petitioner has not provided adequate explanation or evidence to support its contention that the claimed TPP values are inherent in the prior art.” slip op. at 14

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “Secondary Considerations of Non-obviousness Patent Owner contends that secondary considerations of non- obviousness, including unexpected results, long-felt but unsolved need, and commercial success of the patented product “compel a determination of nonobviousness.” PO Resp. 49; see id. at 49–59. As discussed above, we find that Petitioner has not established that claims 1–22 of the ’639 patent would have been obvious over the combination of Radwanski, Rowan, and Murch. Thus, we need not address Patent Owner’s evidence regarding secondary considerations of non-obviousness.” slip op. at 18

  Patent outcomesUS 8,501,639 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,501,639
• Endo Pharmaceuticals Inc. v. Depomed, Inc.No claims unpatentable
  PTAB · Sep 21, 2015 · IPR2014-00656 · APJ Tina E Hulse · IPR · Final written decision

  The Board held claims 1, 2, 8, 9, 13–15, 43, 45, and 46 not unpatentable under § 103 because Petitioner did not establish a reason to combine the prior art with a reasonable expectation of …

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “Even if a person of ordinary skill in the art would understand that a controlled release dosage form is characterized by its rate-controlling drug release mechanism, the claim language does not expressly require a particular rate-controlling drug release mechanism. For example, the claim language does not recite that diffusion is the rate-controlling drug release mechanism of claim 1. Rather, the language of claim 1 states simply that drug is released by “dissolution and diffusion.” And, as explained by the Banker & Rhodes reference—which Patent Owner’s declarant relies heavily on—systems can be “dissolution rate-limited or diffusion-controlled.” Ex. 1025,7 589; see also id. at 581–82 (describing dissolution-controlled systems and diffusional-controlled systems); see also Ex. 2015 ¶ 44 (Dr. Hopfenberg discussing the Banker & Rhoades reference). Thus, based on the full record developed during trial, the broadest reasonable interpretation of the “dissolution and diffusion” term is not limited to diffusion-controlled drug release.” slip op. at 10

  • Skill levelSkill level board ownDecided for petitioner

    “C. The Level of Ordinary Skill in the Art In large part, the parties agree as to the level of ordinary skill in the art. Pet. 9; PO Resp. 13. Both agree that a person of ordinary skill in the art would be a person with at least a bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, and/or material science, as well as substantial experience in development of controlled release oral dosage forms involving polymeric materials. Pet. 9; PO Resp. 13. In light of the parties’ general agreement, we adopt that description of the level of ordinary skill in the art for purposes of this proceeding. In our analysis, we consider the applied prior art as representative of the level of ordinary skill in the art. D.” slip op. at 15

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “the evidence that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the drug formulations of the cited references. As Patent Owner notes, Petitioner’s declarant testified about several formulation considerations that impact drug release. PO Resp. 22. Such considerations include the drug to polymer ratio (Ex. 2023, 78:17– 23), type of polymer used (id. at 79:24–80:5), and particle size (id. at 99:10– 100:15). Dr. Wilson also testified that formulating a reliable gastric retentive controlled release dosage form is “very difficult.” Id. at 101:10– 15. Given this testimony from Petitioner’s own declarant, we credit the testimony of Patent Owner’s declarant, Dr. Hopfenberg, that “[m]atrices formulated with a given polymer in a dosage form can result in different release controlling mechanisms, depending on the details of the matrix formulation and drug solubility characteristics.” Ex. 2015 ¶ 163. Accordingly, we find that Petitioner does not address sufficiently why a person of ordinary skill in the art would believe it could modify the formulation of the Shell 1993 publication to incorporate the drug release profile of Baveja and/or the Shell ’790 patent without, for example, affecting the other desired properties of the Shell 1993 publication formulation (e.g., the swelling in a dimensionally unrestricted manner to a size that promotes gastric retention).” slip op. at 25

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “Petitioner has shown that each limitation of claim 1 is separately disclosed by at least one of the cited references. Our analysis, however, does not end there. A patent “is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Petitioner must also show that there was a reason to combine those elements to achieve the claimed invention with a reasonable expectation of success. See PAR Pharm., 773 F.3d at 1193. To make that determination, we can look to “interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art.” KSR, 550 U.S. at 418. We can also look to the nature of the problem to be solved. In re Gartside, 203 F.3d 1305, 1319 (Fed. Cir. 2000) (holding that suggestion to combine “may come from, inter alia, the teachings of the references themselves and, in some cases, from the nature of the problem to be solved”). After considering the parties’ arguments and evidence, however, we are not persuaded that Petitioner has shown by a preponderance of the evidence that a person of ordinary skill would have combined the teachings in the manner recited by the claims with a reasonable expectation of success.” slip op. at 20

  Patent outcomesUS 6,635,280 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,635,280
• Endo Pharmaceuticals Inc. v. Depomed, Inc.No claims unpatentable
  PTAB · Sep 21, 2015 · IPR2014-00654 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 2, 8, 9, 13–15, 43, 57, 58, 61, 62, and 66 were not held unpatentable under § 103 because Petitioner did not show a reason to combine the prior art with a reasonable …

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “Based on the evidence presented above, we are persuaded that Petitioner has shown that each limitation of claim 1 is separately disclosed by at least one of the cited references. Our analysis, however, does not end there. A patent “is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Petitioner must also show that there was a reason to combine those elements to achieve the claimed invention with a reasonable expectation of success. See PAR Pharm., 773 F.3d at 1193. To make that determination, we can look to “interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art.” KSR, 550 U.S. at 418. We can also look to the nature of the problem to be solved. In re Gartside, 203 F.3d 1305, 1319 (Fed. Cir. 2000) (holding that suggestion to combine “may come from, inter alia, the teachings of the references themselves and, in some cases, from the nature of the problem to be solved”). After considering the parties’ arguments and evidence, however, we are not persuaded that Petitioner has shown by a preponderance of the evidence that a person of ordinary skill would have combined the teachings in the manner recited by the claims with a reasonable expectation of success.” slip op. at 19

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “Upon considering the arguments and evidence, we determine that the broadest reasonable interpretation of (1) “releases said drug . . . by the dissolution and diffusion of said drug out of said matrix” is “releases the drug by dissolution of the drug in the matrix followed by diffusion of the drug out of the matrix”; and (2) “releases said drug into gastric fluid by the dissolving of said drug by said gastric fluid and either erosion of said matrix or diffusion of said dissolved drug out of said matrix” is “releases the drug into gastric fluid by dissolving the drug by the gastric fluid followed by erosion of the matrix or diffusion of the dissolved drug out of the matrix.”” slip op. at 13

  • Skill levelSkill level board ownDecided for petitioner

    “C. The Level of Ordinary Skill in the Art In large part, the parties agree as to the level of ordinary skill in the art. Pet. 9–10; PO Resp. 13. Both agree that a person of ordinary skill in the art would be a person with at least a bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, and/or material science, as well as substantial experience in development of controlled release oral dosage forms involving polymeric materials. Pet. 9–10; PO Resp. 13. In light of the parties’ general agreement, we adopt that description of the level of ordinary skill in the art for purposes of this proceeding. In our analysis, we consider the applied prior art as representative of the level of ordinary skill in the art. D.” slip op. at 15

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “23. Such considerations include the drug to polymer ratio (Ex. 2023, 78:17– 23), type of polymer used (id. at 79:24–80:5), and particle size (id. at 99:10– 100:15). Dr. Wilson also testified that formulating a reliable gastric retentive controlled release dosage form is “very difficult.” Ex. 2023, 101:10–15. Given this testimony from Petitioner’s own declarant, we credit the testimony of Patent Owner’s declarant, Dr. Hopfenberg, that “[m]atrices formulated with a given polymer in a dosage form can result in different release controlling mechanisms, depending on the details of the matrix formulation and drug solubility characteristics.” Ex. 2015 ¶ 164. Accordingly, we find that Petitioner does not address sufficiently why a person of ordinary skill in the art would believe it could modify the formulation of the Shell 1993 publication to incorporate the drug release profile of Baveja and/or the Shell ’790 patent without, for example, affecting the other desired properties of the Shell 1993 publication formulation (e.g., the swelling in a dimensionally unrestricted manner to a size that promotes gastric retention).” slip op. at 25

  Patent outcomesUS 6,340,475 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,340,475
• Purdue Pharma L.P. v. Depomed, Inc.No claims unpatentable
  PTAB · Jul 8, 2015 · IPR2014-00377 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1, 8–10, 13–15, 43, 45, and 46 were not held unpatentable because Petitioner did not establish obviousness under § 103.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “persuaded that Petitioner has established that each limitation of claim 1 was known in the art, as evidenced by the teachings of Baveja and the ’837 patent. A patent, however, “is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Petitioner must also show that there was a reason to combine those elements to achieve the claimed invention with a reasonable expectation of success. See PAR Pharm., 773 F.3d at 1193. To make that determination, we can look to “interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art.” Id. We can also look to the nature of the problem to be solved. In re Gartside, 203 F.3d 1305, 1319 (Fed. Cir. 2000) (holding that suggestion to combine “may come from, inter alia, the teachings of the references themselves and, in some cases, from the nature of the problem to be solved”). After considering the parties’ arguments and evidence, however, we are not persuaded that Petitioner has made a sufficient showing that a person of ordinary skill would have combined the teachings in the manner contended by Petitioner.” slip op. at 23

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “Under § 103(c)(1), the ’837 patent cannot preclude patentability unless it “qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102.” 35 U.S.C. § 103(c)(1) (emphasis added). As noted by Petitioner, the ’837 patent is also prior art under 35 U.S.C. § 102(a). Patent Owner does not dispute this. Thus, the plain language of § 103(c)(1) suggests that the ’837 patent is applicable as § 102(e) prior art for purposes of obviousness. Patent Owner’s complaint that the Petition did not identify the ’837 patent as § 102(a) prior art is immaterial to whether the reference, in fact, qualifies as § 102(a) prior art. Petitioner’s reliance on the ’837 patent as §102(e) art in the Petition was sufficient to place Patent Owner on full and fair notice that Petitioner was applying the reference in the grounds. Patent Owner does not persuade us that the alleged misidentification in any way prejudiced Patent Owner’s defense of its interests in this proceeding. Under these circumstances, we are not persuaded by Patent Owner’s argument that we should exclude the ’837 patent from the challenges asserted in this proceeding.” slip op. at 14

  • Skill levelSkill level board ownOther

    “D. The Level of Ordinary Skill in the Art In large part, the parties agree as to the level of ordinary skill in the art. Pet. 10; PO Resp. 11. Both agree that a person of ordinary skill in the art would be a person with a Ph.D. degree in at least pharmaceutical science, chemistry, or chemical engineering along with at least two years of industry experience in the development of controlled-release oral dosage forms. Pet. 10; PO Resp. 11. Both also agree that a person of ordinary skill in the art may have an equivalent level of skill through similar education, training, and industry experience. Pet. 10; PO Resp. 11. In light of the parties’ agreement, we adopt that description of the level of ordinary skill in the art for purposes of this proceeding.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “persuaded that Petitioner has established that each limitation of claim 1 was known in the art, as evidenced by the teachings of Baveja and the ’837 patent. A patent, however, “is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Petitioner must also show that there was a reason to combine those elements to achieve the claimed invention with a reasonable expectation of success. See PAR Pharm., 773 F.3d at 1193. To make that determination, we can look to “interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art.” Id. We can also look to the nature of the problem to be solved. In re Gartside, 203 F.3d 1305, 1319 (Fed. Cir. 2000) (holding that suggestion to combine “may come from, inter alia, the teachings of the references themselves and, in some cases, from the nature of the problem to be solved”). After considering the parties’ arguments and evidence, however, we are not persuaded that Petitioner has made a sufficient showing that a person of ordinary skill would have combined the teachings in the manner contended by Petitioner.” slip op. at 23

  Patent outcomesUS 6,635,280 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,635,280
• Purdue Pharma L.P. v. Depomed, Inc.No claims unpatentable
  PTAB · Jul 8, 2015 · IPR2014-00379 · APJ Tina E Hulse · IPR · Final written decision

  Claims 43, 54, 55, 57, 58, and 66 were not held unpatentable because Purdue failed to prove anticipation or obviousness by a preponderance of the evidence.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “We are not persuaded by Patent Owner’s arguments. The plain meaning of “until all of said drug is released” is evident. If we were to adopt Patent Owner’s argument that “all” can mean “less than all,” we would be ignoring the plain meaning of the term. Moreover, although Patent Owner is correct that certain other embodiments in the Specification plateau at less than 100% of drug release, we note that certain embodiments do plateau at 100%. See Ex. 1001, Fig. 1 (curve marked by filled diamonds); see also August Tech. Corp. v. Camtek, Ltd., 655 F.3d 1278, 1285 (Fed. Cir. 2011) (“The mere fact that there is an alternative embodiment disclosed in the [asserted patent] that is not encompassed by [our] claim construction does not outweigh the language of the claim, especially when [our] construction is supported by the intrinsic evidence.”) (citation omitted). Furthermore, as noted above, we have determined that, as properly construed, the phrase “releases substantially all” in claim 43 means “at least 80% of the drug has been released.” If we were to interpret “all” to mean the point at which the drug release profile plateaus—even if less than 80%— then it would be possible for a dosage form to release “all” of a drug, but not “substantially all” of the drug. Such an inconsistency within the claim would not be a reasonable construction of the term “all.” Accordingly, we decline to construe “until all of said drug is released” as broadly as Patent Owner requests and, instead, construe it according to its plain, ordinary meaning.” slip op. at 8

  • Skill levelSkill level board ownDecided for patent owner

    “C. The Level of Ordinary Skill in the Art In large part, the parties agree as to the level of ordinary skill in the art. Pet. 10; PO Resp. 10. Both agree that a person of ordinary skill in the art would be a person with a Ph.D. degree in at least pharmaceutical science, chemistry, or chemical engineering along with at least two years of industry experience in the development of controlled-release oral dosage forms. Pet. 10; PO Resp. 10. Both also agree that a person of ordinary skill in the art may have an equivalent level of skill through similar education, training, and industry experience. Pet. 10; PO Resp. 10. In light of the parties’ agreement, we adopt that description of the level of ordinary skill in the art for purposes of this proceeding.” slip op. at 11

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for patent owner

    “2. Analysis As an initial matter, Patent Owner argues that the ’803 patent is not prior art under 35 U.S.C. § 102(e) because the ’475 patent claims priority to U.S. Patent Application No. 08/870,509 (“the ’509 application”), which was filed on June 6, 1997. PO Resp. 19–20. Petitioner disagrees, stating the method claims of the ’475 patent were added in a later continuation-in-part application filed March 29, 1999, and are therefore not entitled to the benefit of the June 6, 1997, filing date of the ’509 application. Pet. Reply 1–2. At oral argument, Patent Owner conceded this point. Tr. 75:15–21 (stating “I believe we agree [the method claims are] entitled to a 1999 date”). Accordingly, we determine that the ’803 patent is prior art to the method claims at issue in this proceeding.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Under claim 43, a dosage form must remain substantially intact “until all of said drug is released.” Even if “maintain[ing] its physical integrity” did disclose a dosage form that remains “substantially intact,” Petitioner has not shown that maintaining the physical integrity of the dosage form for a “prolonged period of time” expressly or inherently discloses doing so “until all of said drug is released.” In other words, a “prolonged period of time” is not necessarily the same as the time period within which “all of said drug is released.”8 Thus, we are not persuaded that Petitioner has established that the ’803 patent discloses the “substantially intact” limitation of claim 43. Accordingly, after considering the parties’ arguments and evidence, we determine that Petitioner has not shown by a preponderance of the evidence that the ’803 patent anticipates claims 43, 54, 55, 57, 58, and 66 of the ’475 patent.” slip op. at 14

  Patent outcomesUS 6,340,475 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,340,475
• Purdue Pharma L.P. v. Depomed, Inc.No claims unpatentable
  PTAB · Jul 8, 2015 · IPR2014-00378 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1, 8–10, 13–15, 61, and 62 were not held unpatentable because Petitioner did not establish obviousness by a preponderance of the evidence.

  RulingsFinal written decision

  • Prior constructionPrior construction adoptedDecided for petitioner

    “1. Prior Construed Claim Terms We construed the following claim terms in the Decision to Institute. Claim Term Claim Construction “gastric fluid” 1 “[b]oth the fluid in the stomach and simulated or artificial fluids recognized by those skilled in the art as a suitable model for the fluid of the human stomach” (Dec. Inst. 6)” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments. The plain meaning of “until all of said drug is released” is evident. If we were to adopt Patent Owner’s argument that “all” can mean “less than all,” we would be ignoring the plain meaning of the term. Moreover, although Patent Owner is correct that certain embodiments in the Specification plateau at less than 100% of drug release, we note that certain other embodiments do plateau at 100%. See Ex. 1001, Fig. 1 (curve marked by filled diamonds); see also August Tech. Corp. v. Camtek, Ltd., 655 F.3d 1278, 1285 (Fed. Cir. 2011) (“The mere fact that there is an alternative embodiment disclosed in the [asserted patent] that is not encompassed by [our] claim construction does not outweigh the language of the claim, especially when [our] construction is supported by the intrinsic evidence.”) (citation omitted). Furthermore, as noted above, we have determined that, as properly construed, the phrase “releases substantially all” in claim 1 means “at least 80% of the drug has been released.” If we were to interpret “all” to mean the point at which the drug release profile plateaus—even if less than 80%— then it would be possible for a dosage form to release “all” of a drug, but not “substantially all” of the drug. Such an inconsistency within the claim would not be a reasonable construction of the term “all.” Accordingly, we decline to construe “until all of said drug is released” as broadly as Patent Owner requests and, instead, construe it according to its plain, ordinary meaning.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner

    “diffusion must control the rate of release of drug out of the matrix. After considering the parties’ arguments, we adopt Petitioner’s construction as the broadest reasonable interpretation consistent with the Specification. To construe the term, we start with the language of the claim. Claim 1 recites a “controlled-release oral drug dosage form” that “releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid.” We determine that nothing in the claim language requires that the drug release be “at a rate controlled by the rate of diffusion,” as Patent Owner asserts. To the extent Patent Owner suggests that its construction is dictated by the fact that the claim recites a “controlled-release” drug formulation for a highly soluble drug, we are not persuaded. In particular, we note that Patent Owner’s own declarant, Dr. Harold B. Hopfenberg, testified that those parameters do not necessarily require release by dissolution and diffusion:” slip op. at 10

  • Skill levelSkill level board ownDecided for patent owner

    “C. The Level of Ordinary Skill in the Art In large part, the parties agree as to the level of ordinary skill in the art. Pet. 7; PO Resp. 10. Both agree that a person of ordinary skill in the art would be a person with a Ph.D. degree in at least pharmaceutical science, chemistry, or chemical engineering along with at least two years of industry experience in the development of controlled-release oral dosage forms. Pet. 7; PO Resp. 10. Both also agree that a person of ordinary skill in the art may have an equivalent level of skill through similar education, training, and industry experience. Pet. 7; PO Resp. 10. In light of the parties’ agreement, we adopt that description of the level of ordinary skill in the art for purposes of this proceeding.” slip op. at 13

  Patent outcomesUS 6,340,475 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,340,475

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.