- Coalition For Affordable Drugs V LLC / Hayman Credes Master Fund, L.P. et al. v. Biogen Ma Inc.Rehearing deniedPTAB · May 12, 2017 · IPR2015-01993 · APJ Richard E Schafer · IPR · Rehearing
The Board denied the petitioner's rehearing request, leaving intact its decision that claims 1-20 were not shown unpatentable because unexpected results supported nonobviousness.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We considered Dr. Pleasure’s testimony in reaching our decision, but did not find it enlightening with respect to the unexpected results issue raised by Biogen. For the most part, Dr. Pleasure’s testimony is directed to the motivation and the reasonable expectation of success of the person having ordinary skill in the art to” slip op. at 2
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner
“With respect to the unexpected results issue, Dr. Pleasure testified only that: As explained above, one of ordinary skill in the art would not have found it unexpected that dosages of 240 mg DMF given BID and TID were similarly efficacious in treating MS. Pleasure Dec., Ex. 1045, ¶ 75. Petitioner’s sole argument on the issue was: “[a]s demonstrated above, success was expected, not unexpected.” Pet. Reply, Paper 46, p. 24. Neither Petitioner’s Reply, nor Dr. Pleasure’s testimony addressed Biogen’s specific arguments and evidence of unexpected results. Thus, Petitioner’s argument and evidence failed to provide a basis for us to question the sufficiency of Biogen’s evidence to show that the degree of efficacy of the 480 mg/day dose would have been unexpected to one having ordinary skill in the art. As we noted in our Final Decision, “[o]bjective indicia of non-obviousness ‘may often establish that an invention appearing to have been obvious in light of the prior art was not.’” Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013).” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,399,514 - Adama Makhteshim Ltd. v. Finchimica S.P.A.Rehearing deniedPTAB · Jun 16, 2016 · IPR2016-00577 · APJ Sally Gardner Lane · IPR · Rehearing
The Board denied Patent Owner’s rehearing request and left institution of review of claims 1–12 unchanged, finding Petitioner was not estopped from asserting the challenged grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Patent Owner requests “partial rehearing” of the Decision. Patent Owner argues that Decision was incorrect where the Board determined that Petitioner is not estopped from challenging the claims of the ’559 patent on grounds 1 and 3 asserted in the Petition. (Paper 9, Request, at 1). Patent Owner does not argue that the Board otherwise erred in determining that there is a reasonable likelihood that Petitioner would prevail.” slip op. at 2
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for petitioner
“We do not agree. The record indicates that the Board did not authorize Petitioner’s original request to file motions for unpatentability based on references cited in grounds 1 and 3 which included EP ’117. Instead the Board indicated that the motions were not authorized at that time but that Petitioner could renew its request when the interference proceeded to a priority determination. (Interference 105,995, Paper 21 (Ex 1023), Levin Motions List, at 3:3–4:8 and Paper 38 (Ex 1026), Order Setting Times, at 4:12-15). An email communication dated 31 July 20151 that is cited in the” slip op. at 3
NonePatents in suitUS 8,304,559 - Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyRehearing deniedPTAB · May 27, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving institution of inter partes review of claims 1–15 in place based on a reasonable likelihood of obviousness.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We are not persuaded that we overlooked or misapprehended a matter in relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“[i]n general, we consider Petitioner’s argument to be persuasive based on the record before us because Cohen teaches a specific dosage of CTLA4Ig and it is reasonably likely that those of ordinary skill in the art would have been able to determine an effective concentration for a subcutaneously administered formulation from that dosage. Dec. 10. We noted further that given the effective dosage reported in Cohen, the absence of any specific information about CTLA4Ig indicating that an ordinary artisan could not have determined an effective concentration for subcutaneous administration using routine optimization, and the absence of evidence of secondary considerations, we are persuaded at this point in the proceeding that the recited concentration is likely to be an unpatentable modification. Id.” slip op. at 4
- Expert testimonyPetitioner expert creditedDecided for petitioner
“relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2
Discretionary denialcites KSRPatents in suitUS 8,476,239 - Sata GmbH & Co. KG v. Anest Iwata CorporationRehearing deniedPTAB · May 17, 2016 · IPR2015-01790 · APJ Jennifer S Bisk · IPR · Rehearing
The Board denied SATA’s rehearing request, leaving institution denied for claims 15–22 because the petition did not adequately explain how the evidence supported the proposed grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision[,]” which party “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4
- BurdenDecided for patent owner
“Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“35 U.S.C. § 311(b) states that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Petitioner does not explain how the Final Written Decision of IPR2013-00111 or “the bulk of the entire proceedings” of that case qualify as either a patent or a printed publication under the statute. In particular, to qualify as a printed publication under § 102, a reference “must have been sufficiently accessible to the public interested in the art” at the time the patent application at issue was filed. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009) (internal quotation marks omitted). The results of IPR2013-00111 were, by definition, not available until well after the ’387 patent issued.” slip op. at 3
§ 102 anticipationPatents in suitUS 6,494,387 - Coalition For Affordable Drugs V LLC. v. Biogen Ma Inc.Rehearing deniedPTAB · Oct 23, 2015 · IPR2015-01136 · APJ Fred E Mckelvey · IPR · Rehearing
The Board denied the Petitioner’s rehearing request, leaving in place its decision not to institute because the petition did not establish a reasonable likelihood of success on the asserted obviousness theories.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“to be” on page 9 of the Decision. We gave more weight to pre-litigation statement by Kappos than to post-litigation conclusory expert testimony. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (holding that Board did not abuse its discretion in giving more weight to documentary evidence vis-à-vis witness testimony). Furthermore, as Patent Owner points out, the word “appear” is also synonymous with “seem” (http://www.merriam-webster.com/dictionary/appear), and is consistent with our statement that what counts is what is described, not what appears or seems to have been tested. Decision, page 9.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Decision misapprehended or overlooked Dr. Linberg’s statement that the Kappos 2005 dose-ranging study would not have been undertaken unless BG00012 had been determined to be therapeutically active in treating patients with MS and that the Decision cites no substantial evidence for interpreting Kappos in a fundamentally different way. The reference to “substantial evidence” is curious since “substantial evidence” is an appellate standard of review for fact finding. The argument should have been that our finding was not supported by a preponderance of the evidence. In any event, Petitioner, in effect, attempts to reargue a case it attempted to make out in the petition and fails to point out how we misunderstood Dr. Linberg’s testimony. Petitioner failed to explain adequately in the Petition why one of ordinary skill in the art, based on Kappos, would have understood that DMF was useful for treating multiple sclerosis (MS).” slip op. at 3
- Strike new argumentNew argument disregardedOther
“stating a fact, i.e., that DMF had been determined to be effective, which is why there would have been a reasonable expectation of success. The argument concerning reasonable expectation of success, as pointed out by Patent Owner in the opposition, is new and therefore could not have been overlooked. Keebler Co. v. Murray Bakery Products, 866 F.2d 1386, 1388 (Fed. Cir. 1989) (prescience is not a required characteristic of the board and the board need not divine all possible afterthoughts of counsel that might be asserted for the first time on appeal). Moreover, in our view Petitioner has not pointed out where there is a clear statement in Kappos 2005 that those skilled in the art knew that DMF was useful in treating MS.” slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“to be” on page 9 of the Decision. We gave more weight to pre-litigation statement by Kappos than to post-litigation conclusory expert testimony. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (holding that Board did not abuse its discretion in giving more weight to documentary evidence vis-à-vis witness testimony). Furthermore, as Patent Owner points out, the word “appear” is also synonymous with “seem” (http://www.merriam-webster.com/dictionary/appear), and is consistent with our statement that what counts is what is described, not what appears or seems to have been tested. Decision, page 9.” slip op. at 3
NonePatents in suitUS 8,399,514
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.