- Amerigen Pharmaceuticals Limited v. Shire LLCRehearing deniedPTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Amerigen’s rehearing request, leaving claims 1–3, 5, 8, 9, and 11 uninstituted because Mehta did not disclose the claimed release limitation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Amerigen’s arguments with these principles in mind.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“These arguments are not persuasive. First, Petitioner cites no authority for the proposition that a generic disclosure, such as that discussed above, is an express disclosure of every possible permutation of that generic disclosure. Second, even if we were to accept, for the sake of argument, that Mehta’s combined disclosures constitute an express disclosure of a composition capable of delayed release of “essentially all [of the drug] . . . within about 60 minutes,” non-instituted claims 1–3, 5, 8, 9, and 11 further require that the delayed release is enteric (i.e., the composition releases the second dose of the drug in the intestines, not the stomach). As we noted in the Decision, however, Mehta does not use the word “enteric,” nor does Mehta discuss delivery of the delayed dose to the intestines. Dec. 28. Nevertheless, we considered the possibility that Mehta might inherently disclose a composition that releases into the intestine not less than 80% of the second dose of the drug within about 60 minutes of the delayed release. Accordingly, we turned to Mehta’s Examples 1–5, but determined that not one of the exemplified delayed release compositions achieved a release of “essentially all” of the drug from a delayed release coating within about 60 minutes—regardless of whether the delay was long enough to be considered enteric.3 Id. at 24. As we noted in the Decision,” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“This argument is not persuasive. We considered, for example, Dr. Elder’s testimony that one of ordinary skill in the art would expect “that the number of variables and number of experimental runs to optimize the coating for the amphetamine would present no unusual problems of technology or expense” because one “can use statistical experimental design to optimize a formulation within the 21 trials that Mehta discloses to design one for amphetamine salts” (Ex. 1005 ¶ 471), as well as Dr. Elder’s testimony that one would expect “that routine optimization of the coating using the parameters identified by Mehta would provide enough guidance for controlling the release timing” (id. ¶ 512). Nevertheless, we found the actual results reported by Mehta to be more compelling. As we stated in the Decision: [N]one of Mehta’s delayed release formulations that could be considered to be enteric by virtue of their delay periods (i.e., those with delays of 4 or 5 hours) had release rates of “essentially all” of the drug anywhere near the required time period. Even if Mehta could be read to suggest that a delay of 4 or 5 hours followed by a release of essentially all of the delayed dose within 60 minutes would be desirable, we are not persuaded that Mehta’s disclosure that “the amount of drug released is influenced by: amount of coating, ratio of the two 4 Amerigen supported its challenges with the Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph., executed September 30, 2015 (“Elder Declaration”) (Ex. 1005). polymers, amount of talc, and curing time” is adequate guidance for one of ordinary skill in the art to achieve such a dosage form. In general, Mehta demonstrates that longer delays are accompanied by longer release times, with formulations that could be considered to provide enteric release (i.e., a release after a 4 or 5 hour [delay]) having 85% release times of 8 or more hours. Dec. 33–34 (citing Ex. 1003, Table 1).” slip op. at 8
§ 102 anticipation§ 103 obviousness - Daicel Corporation v. Celanese International CorporationRehearing grantedPTAB · Jun 26, 2015 · IPR2015-00171 · APJ Linda M Gaudette · IPR · Rehearing
Rehearing was granted in part, instituting review of claims 42–44, 47–51, 53, 55, and 56 for anticipation and claim 57 for obviousness.
RulingsRehearing decision- RehearingRehearing, grantedGranted in part
“the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown Mr. Cooper’s testimony is supported by underlying factual evidence, and is not based solely on an unsupported assumption and the Miura Declaration, we determine Mr. Cooper’s testimony provides persuasive support for Petitioner’s contention that DME is inherently present in an overhead distillation stream of the ’095 patent process, and that claim 42 is anticipated by the ’095 patent. We have also reviewed the Petition’s analysis of dependent claims 43, 44, 47–51, 53, 55, and 56, and conclude Petitioner has provided sufficient explanation and evidence to support a reasonable likelihood that the additional limitations of these claims are described in the ’095 patent. See Pet. 27–35. In sum, at this stage of the proceeding, Petitioner has established a reasonable likelihood that it would prevail on the merits in showing claims 42–44, 47–51, 53, 55, and 56 are anticipated by the ’095 patent. Therefore, the Request for Rehearing is granted and trial is instituted as to this challenge.” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureReference is prior artInherency foundInstituted
“the Petition, and overlooked the fact that Mr. Cooper’s opinion is also based on his own calculations and data in two published articles. See Ex. 1003 ¶ 99. Specifically, Mr. Cooper approximates reactor DME equilibrium concentrations in the ’095 patent examples and explains how these approximations were obtained using readily available data, specifically identifying data in two published articles. Ex. 1003 ¶ 99 (citing Exs. 1029, 1030). Mr. Cooper goes on to explain why, based on the reactor contents and distillation conditions in the ’095 patent examples, DME and acetaldehyde would be present in the overhead distillation streams. Id. ¶¶ 101–102. Because Petitioner has shown Mr. Cooper’s testimony is supported by underlying factual evidence, and is not based solely on an unsupported assumption and the Miura Declaration, we determine Mr. Cooper’s testimony provides persuasive support for Petitioner’s contention that DME is inherently present in an overhead distillation stream of the ’095 patent process, and that claim 42 is anticipated by the ’095 patent. We have also reviewed the Petition’s analysis of dependent claims 43, 44, 47–51, 53, 55, and 56, and conclude Petitioner has provided sufficient explanation and evidence to support a reasonable likelihood that the additional limitations of these claims are described in the ’095 patent. See Pet. 27–35. In sum, at this stage of the proceeding, Petitioner has established a reasonable likelihood that it would prevail on the merits in showing claims 42–44, 47–51, 53, 55, and 56 are anticipated by the ’095 patent. Therefore, the Request for Rehearing is granted and trial is instituted as to this challenge.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not found
“terms, and we agree, for purposes of this decision, that claim 42 does not require a specific quantity of DME in the distillation overhead. We do not agree with Petitioner, however, that the Singh and ’507 patent disclosures are identical with respect to the addition of water to distillation column 22. As indicated in our Decision, both Singh and the ’507 patent describe adding small amounts of water to column 22 for the purpose of inhibiting impurity formation. See Dec. 5–6. The ’507 patent, however, includes additional description of adding water to column 22 for the purpose of producing DME in the distillation overhead. See id. at 7 (citing Ex. 1002, col. 11). This additional description of adding water to produce DME in the distillation overhead does not refer back to the description of adding water as an inhibitor (see Ex. 1002, 10:9–32), or otherwise indicate that the small amounts of water used to inhibit impurity formation in the ’507 patent and Singh processes would produce DME in a distillation overhead. In addition, for the reasons explained in our Decision (Dec. 25–26), Petitioner has not persuaded us that the prosecution history of the ’507 patent includes an admission by Patent Owner that the addition of any amount of water to the distillation step would result in DME in an overhead stream. See Req. Reh’g 10. In sum, Petitioner has not convinced us that our Decision was based on an erroneous claim interpretation or that we overlooked evidence that the addition of any amount of water in the steps common to the Singh and the ’507 patent processes would necessarily result in the presence of DME in a distillation overhead. With respect to Petitioner’s assertions regarding Akinori, we note the Petition relied on Akinori as evidence that DME was necessarily produced in the ’095 patent process. See Pet. 43. Petitioner did not explain how Akinori was relevant to show the presence of DME in the distillation overhead of Singh. For the above reasons, the Request for Rehearing is denied as to the challenge based on Singh in view of the ’095 patent and Akinori.” slip op. at 7
§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,076,507
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.