- Apotex Inc. / Apotex Corp. v. Celgene CorporationRehearing deniedPTAB · Apr 30, 2020 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution on all challenged claims under § 325(d) for grounds I and II and for failure to establish printed-publication status for ground III.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13, 4 2020) (precedential). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. If the same or substantially the same art or arguments were previously presented to the Office, we then consider whether petitioner has demonstrated the Office erred. Id. In evaluating the Petition and accompanying evidence in light of the Becton, Dickinson factors, we determined that grounds I and II were “based on substantially the same prior art and arguments previously presented to the office,” and that Petitioner had “neither sufficiently pointed out how the Examiner erred, nor provided additional evidence or facts that warrant reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly, we exercised our discretion under 35 U.S.C. §325(d) and denied institution of grounds I and II on that basis.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Apr 17, 2020 · PGR2018-00062 · APJ Grace Karaffa Obermann · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving intact the Final Written Decision holding claims 1–30 unpatentable based on Varenna and other references.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Upon a request for rehearing, we review our 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.” 37 C.F.R. § 42.71(d). “The request 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.” Id. We deny the Request for Rehearing based on application of those principles.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“persons of skill in the art could have located it.” Req. Reh’g 1 (emphasis in original). On the contrary, we addressed with particularity the substantial evidence tending to show that Varenna “was ‘sufficiently accessible to the public interested in the art’ and ‘disseminated or otherwise made available’ to the interested public before the critical date.” Dec. 9 (quoting Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016)). In our Decision, we properly credited “indicia on the face of [the] reference, such as printed dates and stamps,” which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, Paper 29 at 17–18 (citing Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018)). Those indicia included not only details of the copyright notice, indicating publication of Varenna “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” but also additional legends, including “the statement ‘Advance Access publication 30 November 2012,’” and a conventional edition identifier from the journal Rheumatology. Id. at 9–10 (quoting Ex. 1005). Patent Owner advanced no evidence tending to cast doubt on that publication date. Although the burden of proof never shifted to Patent Owner on the issue of Varenna’s public availability, where Patent Owner declined to advance counter evidence on point, the Board did not err by crediting the indicia, which appear on the face of Varenna, as part of the totality of evidence bearing on the issue.” slip op. at 6
- Strike new argumentNew argument consideredDecided for petitioner
“The precedential decision in Hulu is instructive here, and specifically recognizes “limited opportunities” that “exist for the petitioner to present new evidence” pertaining to the question of public availability. Hulu, Paper 29 at 14. One opportunity expressly identified in Hulu is “in a reply to the patent owner response” where “the patent owner challenges a reference’s status as a printed publication.” Id., Paper 29, 14–15. That is precisely the circumstance here. Patent Owner shows no reversible error in our finding that Dr. Robinson’s Declaration, submitted with Petitioner’s Reply, responds to arguments raised for the first time in Patent Owner’s Response. Dec. 13 (comparing Reply 3–7 and Ex. 1031, with Resp. 12–15). In any event, in our alternative holding, we explain why substantial evidence supports our finding of public availability, “[e]ven if we set aside Dr. Robinson’s Declaration.” Dec. 9. This is not a situation where Petitioner submitted Reply evidence that changed the theory of the patent challenge or, as Patent Owner suggests, represents a circumstance comparable to raising “a new obviousness argument” not advanced in the Petition. Req. Reh’g 11 (quotation omitted); see Pet. vii (identification of Varenna and its alleged publication date of “Nov. 2012”), 3–4 (bridging paragraph, asserting that Varenna was “published in 2012”), 33 (asserting that “Varenna 2012 is one of dozens of references” presented during patent prosecution). Moreover, no prejudice attended allowance of the Reply evidence, where we also allowed Patent Owner a Sur-Reply to address that evidence. Dec. 13. Patent Owner takes issue with the Board’s observation that “Patent Owner was afforded an opportunity (fully taken) to file a Sur-Reply on issues raised in Dr. Robinson’s Declaration.” Id. (citing Sur-Reply 2–11). Patent Owner points out that the Sur-Reply included “only a short paragraph” countering that Declaration, but acknowledges that this circumstance was the result of Patent Owner’s own assessment of the relative importance of the evidence. Req. Reh’g 2–3 n.2. Patent Owner’s strategic calculation, regarding how much space or effort to devote to countering Dr. Robinson’s testimony, does not denigrate the opportunity afforded in the Sur-Reply, or reveal reversible error in the Decision.” slip op. at 8
- BurdenDecided for petitioner
“The Board did not, as Patent Owner argues, “shift[] the burden of proof to Patent Owner to prove that Varenna was not disseminated or otherwise made available to the public.” Id. at 1 (emphasis in original). On the contrary, the Board reasonably weighed the objective proof of public availability against Patent Owner’s bare attorney arguments on point. See Dec. 8–15 (reasoning that the indicia of public accessibility appearing on the face of Varenna, combined with Patent Owner’s conduct during patent prosecution and information submitted under oath in Dr. Robinson’s Declaration, outweigh Patent Owner’s conclusory attorney arguments, which are supported by no objective proof). The objective evidence points in one direction; namely, that Varenna is what it appears to be, a copy of a journal article published in Rheumatology by the Oxford University Press in November of 2012. Id. Patent Owner shows no reversible error in the Decision relating to the Board’s assignment of Petitioner’s burden of proof, any inferences drawn from the evidence of record, or the alternative holding that Dr. Robinson’s testimony bolsters the substantial evidence of record showing that Varenna was publicly available at the time of the invention.” slip op. at 10
§ 102 anticipationPatents in suitUS 9,707,245 - Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution deniedPTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - Merck Sharp & Dohme Corp. v. Pfizer Inc.Rehearing deniedPTAB · May 4, 2018 · IPR2017-02138 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Pfizer’s rehearing request, leaving institution of review on claims 11–15 and 20–37 unchanged because the petition made a threshold showing that Pfizer 2012 was publicly accessible.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
§ 102 anticipationPatents in suitUS 9,492,559 - PTAB · Aug 1, 2017 · IPR2016-01565 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving claims 6–8, 10–18, 24, and 25 uninstituted because the Petition did not show the Januvia Label and Huettner were printed publications.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The 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.” Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined 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. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“a trial is based on “the information presented in the petition.” 35 U.S.C. § 314(a). Under 35 U.S.C. § 311(b), in an inter partes review, a petitioner may only challenge the claims of a patent based on “prior art consisting of patents or printed publications,” and the petitioner has the initial burden of production to show that an asserted reference is prior art to the challenged claims under a relevant subsection of 35 U.S.C. § 102. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015); Dec. 16. As explained in our Decision, we have often required a petitioner to make a threshold showing that the reference relied upon was publicly accessible as a printed publication prior to the effective filing date of a challenged patent to satisfy the initial burden of production. See, e.g., Apple Inc. v. DSS Tech. Mgmt., Inc., Case IPR2015-00369, slip op. at 5 (PTAB Aug. 12, 2015) (Paper 14) (noting that petitioner has the burden to make a threshold showing that a reference is “printed publication” prior art under 35 U.S.C. §§ 102 and 311(b)); Frontier Therapeutics, LLC v. Medac Gesellschaft Für Klinische Spezialpräparate MBH, Case IPR2016-00649, slip op. at 22 (PTAB September 1, 2016) (Paper 10). We further explained that “[a] given reference is ‘publicly accessible’ ‘upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)); Dec. 17.” slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“To the extent Petitioner now argues that “the declaration testimony of Dr. Davidson and the facial indicia on Huettner are sufficient” to make a threshold showing that Huettner was publically accessible as of the relevant date (Reh’g Req. 13), we are not persuaded. We note that Dr. Davidson testifies, without elaboration, that “Huettner was published in June 2007.’” Ex. 1002 ¶ 56. Petitioner, however, did not rely on Dr. Davidson’s testimony on this issue in the Petition. Moreover, even if Dr. Davidson’s testimony had been relied on, Petitioner does not point to any evidence—nor can we discern any in Dr. Davidson’s Declaration—that would reasonably suggest that Dr. Davidson has personal knowledge as to when and how Huettner was made available to the public. Accordingly, Dr. Davidson’s conclusory declaration of Huettner’s publication date is entitled to little or no weight. See Dell, Inc. v. Selene Commc’n Techs., LLC, Case IPR2014- 01411, slip op. at 22–23 (PTAB Feb. 26, 2015) (Paper 23) (explaining that an expert declaration is not enough to prove a prior art reference’s publication date where the expert declaration merely repeats assertions made by the petitioner).” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied merits
“Decision on Institution, and Petitioner’s Request for Rehearing, we are not persuaded that we erred in declining to institute trial on claims 6–8, 10–18, 24, and 25. Petitioner, having failed to meet its burden of providing a threshold showing that the Januvia Label and Huettner are printed publications under 35 U.S.C. §§ 102 and 311(b), did not demonstrate a reasonable likelihood of prevailing in its assertion that the subject matter of claims 6–8, 10–18, 24, and 25 of the ’156 patent would have been obvious over the Januvia Label, Huettner, and Mikhail or the Knowledge of one of ordinary skill in the art..” slip op. at 8
§ 102 anticipationPatents in suitUS 8,853,156 - Bioeq IP AG v. Genentech, Inc.Institution deniedPTAB · Feb 22, 2017 · IPR2016-01608 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Petitioner failed to show a reasonable likelihood that any challenged claim was unpatentable over Seeger alone or with the additional references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Therefore, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing that Seeger anticipates claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39. Consequently, we decline to institute an inter partes review of claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39 based on this ground. C.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the Specification provides an explicit definition for the claim phrase “reducing the metabolic rate.” The Specification states, “[a]s used herein, ‘reducing metabolic rate’ or ‘shifting down metabolic rate’ means altering the host cell culture such that the host” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“persuaded that Petitioner has not established that Seeger discloses reducing the metabolic rate of the cultured recombinant host cells at the time of induction of polypeptide expression, as required by the challenged claims, for the reasons discussed by Patent Owner. In particular, Petitioner relies upon the disclosure of the ’602 patent describing reducing metabolic rate in cells already in a reduced growth state by reducing the rates of oxygen uptake and the corresponding rates of uptake of a carbon/energy source. Pet. 32–36 (citing Ex. 1001, 4:15–18). However, Petitioner has not addressed adequately how Seeger’s method of inducing expression by increasing temperature from 30 to 42○C may have affected the metabolic rate. Id. at 32–36.” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“dependent claims. Pet. 27. Petitioner relies upon Seeger alone as disclosing the elements of the independent claims from which those challenged claims depend. Id. at 43–57. Indeed, Petitioner does not address the elements recited in the independent claims in any of the obviousness grounds. Id. To relied upon only to address additional elements of dependent claims, and are not asserted to cure any deficiencies of Seeger with respect to elements of the independent claims. Id. at 46–58. Therefore we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing in showing the unpatentability of dependent claims 7–8 and 31–32 over Seeger, dependent claims 10, 12, 23, 34, and 36 over Seeger and Makrides, or dependent claims 11, 13–14, 18, 35, and 37–38 over Seeger and Cabilly, under 35 U.S.C. § 103(a), for the same reasons discussed regarding the independent claims from which they depend. Consequently, we decline to institute an inter partes review of claims 7–8, 10–14, 18, 23, 31–32, and 34–38 based on the respective ground challenging those claims.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 6,716,602 - Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Some claims unpatentablePTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision
Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10
- Skill levelOther
“We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18
Patent outcomesUS 7,754,702 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,754,702 - 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 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution deniedPTAB · Aug 17, 2016 · PGR2016-00008 · APJ Toni R Scheiner · PGR · Institution
The Board denied institution because Petitioner did not show that claims 1–19 lacked written-description support or violated the AIA on-sale bar.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall not be instituted unless “the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate that it is more likely than” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what 7 Patent Owner additionally provides Appendix A to the Preliminary Response. Appendix A purportedly maps the requirements of claims 1–19 to the specification. 11 is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)Not shown unpatentableNot shown unpatentable
“A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . . As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1). Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar.” slip op. at 18
§ 102 anticipation§ 112 disclosurePatents in suitUS 9,173,942 - Bioactive Laboratories v. BTG International Inc.Rehearing deniedPTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears 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)Institution denied meritsInstitution denied
“After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 8,048,414
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.