• Dr. Reddy’S Laboratories, Inc. v. Pozen Inc.Institution denied
  PTAB · Oct 9, 2015 · IPR2015-00802 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution on claims 1–4, finding no reasonable likelihood of success because Plachetka was not prior art and the obviousness showing was deficient.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the Petition and Preliminary Response, we conclude that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any challenged claim of the ’285 patent. Therefore, we do not authorize an inter partes review for any claim of the ’285 patent.” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “For the reasons set forth above, Petitioner fails to convince us that the claims of the ’285 patent are not supported by at least the ’216 application. Therefore, the Plachetka Publication does not qualify as prior art under 35 U.S.C. § 102(b). Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1–4 are unpatentable as anticipated by the Plachetka Publication.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundMotivation not foundDecided for patent owner

    “An enteric-coated dosage form of omeprazole must be perfectly coated and acid resistant, since, if any drug leaks out of the dosage form in the stomach, it is almost immediately degraded. The same is the case if an acidic medium can diffuse into the dosage form through pin-holes or damage in the enteric-coating. We agree with the Patent Owner that Pilbrant teaches away from the claimed combination. Prelim. Resp. 36 (“Petitioner’s failure to acknowledge the complete disclosure of Pilbrant, which negates any motivation to use the non-enterically coated form of esomeprazole, despite the testimony of Petitioner’s own expert, is an incurable flaw in the Petition”). When a prior art reference teaches away from combining known elements, discovery of a successful means of combining them is more likely to be nonobvious. See KSR Internat’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), cited in In re Mouttet, 686 F.3d 1322, 1333-34 (Fed. Cir. 2012). We disagree with Petitioner’s conclusion that although one of skill in the art “might have believed” that enteric coated esomeprazole was generally the better option, “that does not exclude the use of non-enteric coated esomeprazole as still ‘good enough’ to be obvious, at least in a combination product where all the esomeprazole needs to do is raise the stomach pH to 3.5.” Pet. 51. Here, the very statement that Petitioner relies upon from Pilbrant to support its rationale to combine concerning preabsorption degradation of omeprazole caused Pilbrant to rule out the use of conventional oral dosage forms without an enteric coating. We agree with the Patent Owner that Petitioner’s “[m]otivation to combine in the face of an express teaching away must be found in the prior art itself and reliance on the teachings of the ’285 patent is impermissible hindsight.” Prelim. Resp. 37.” slip op. at 25

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

    “Both parties acknowledge that the claim requires a therapeutically effective amount of naproxen must be surrounded by a coating. Pet. 27; Prelim. Resp. 7. Petitioner’s interpretation, however, turns this requirement on its head. As Patent Owner notes, using the transitional term “comprising” means that additional components may be present, but does not change the elements that are stated in the claim. Prelim. Resp. 8 (citing Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285, 1305 (Fed. Cir. 2012)). Petitioner’s interpretation, however, would encompass a composition where the vast majority of the naproxen, i.e., a therapeutically effective amount, would be outside of the coating. This is not a reasonable interpretation of the claim. We agree with Patent Owner that the broadest reasonable interpretation of the term “comprising . . . naproxen surrounded by a coating” means “a therapeutically effective amount of naproxen is surrounded by a coating,” but do not agree with Patent Owner’s arguments that this claim term excludes any uncoated naproxen from the claim. As Petitioner notes, the Patent Owner has previously addressed the meaning of this limitation in response to invalidity contentions asserting lack of written description support and enablement, stating that the specification of the ’285 patent supports the interpretation “that, in addition to naproxen surrounded by a coating that inhibits its release unless the surrounding medium of the unit dosage form is at least 3.5, the disclosed dosage forms may include additional naproxen outside the coating.” Ex. 1010, 49 (Patent Owner’s responses to invalidity contentions for the ’285 patent) (relying on statements in the specification of the ’285 patent where the combination of an acid inhibitor and an NSAID may be in multi-layer tablet form and where the drug combinations may typically be prepared in admixture with conventional excipients). Patent Owner also has previously stated that the transitional term “comprising” does not exclude the presence of additional naproxen outside of the coating. Id. at 51. We agree. Although the claim term requires that a therapeutically effective amount of naproxen in a unit dosage form is surrounded by a coating, it does not exclude a unit dosage form that has an amount of naproxen outside of the coating that is not therapeutically effective. Therefore, we do not agree that the claims of the ’285 patent” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,557,285

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.