- Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution deniedPTAB · Dec 11, 2017 · IPR2017-01910 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner failed to show a reasonable likelihood that claims 1, 2, 5, and 9 were obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 20
- Other 314aDecided for petitioner
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–12. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that the ’680 patent (at” slip op. at 22
- Skill levelOther
“Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19
- Expert testimonyPetitioner expert discountedDecided for patent owner
“experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 50 (citing Pet. 24; Ex. 1014 ¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 93, 161–162). Accordingly, we agree with Patent Owner that this new testimony does not address the Board’s question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–243); see Ex. 1046, 729 (Examiner’s finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 18 (citing Pet. 56–57). We agree. As Patent Owner points out, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 5. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments. Ex. 1008, 706.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 6,774,122 - Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution deniedPTAB · Dec 11, 2017 · IPR2017-01912 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, or 20 would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denialDenied
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. See id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22
- Skill levelSkill level board ownDecided for patent owner
“ANALYSIS A. Person of Ordinary Skill in the Art The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17–18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 19
- Prior constructionPrior construction adoptedDecided for petitioner
“In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’139 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 20. We agree.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,466,139 - Argentum Pharmaceuticals LLC v. Cipla Ltd.Rehearing deniedPTAB · Oct 31, 2017 · IPR2017-00807 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in declining to construe the terms or in reserving disputed motivation and reasonable-expectation issues for trial.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 4
- Expert testimonyOther
“osmolality, poor spray quality, and unacceptable settling and caking” resulting from the attempted formulation of Cramer’s Example III. Id. at 8– 10; see also Prelim. Resp. 25. The Board, however, addressed those issues in the Institution Decision and determined that “Patent Owner’s arguments and expert testimony highlight disputed issues of fact about whether the skilled artisan would have been motivated to combine the teachings of Hettche, Phillipps, and Segal to arrive at the claimed subject matter, and would have had a reasonable expectation of success.” Instit. Dec. at 20 (citing Ex. 1002, 268–87; Ex. 2007 ¶¶ 40–47; Ex. 2111, 1; Ex. 2044, 1–2). The Board concluded that those “issues are best resolved following trial with the benefit of a full record.” Id. We are still of that view. Accordingly, we are not persuaded that the Board misapprehended or overlooked the issue of reasonable expectation of success.” slip op. at 5
- BurdenOther
“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 the party 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 1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992) (“Hettche”). Ex. 1007. 2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15, 1982) (“Phillipps”). Ex. 1009. 3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5, 1998) (“Segal”). Ex. 1012. 4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product Information (Dec. 1998) (“Flonase Label”). Ex. 1010. 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.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“In the Institution Decision, the Board determined that “no claim term requires express interpretation for purposes of this Decision.” Instit. Dec. 7. In its Rehearing Request, Patent Owner argues that the Board “misapprehended or overlooked the importance of construing the terms ‘nasal spray’ and ‘suitable for nasal administration’” found in all the challenged claims. Reh’g Req. 2. In particular, Patent Owner asserts that those terms mean “pharmaceutical formulations that are tolerable to patients, homogeneous, and can be suitably deposited onto the nasal mucosa.” Id. (citing Paper 7, Preliminary Response (“Prelim. Resp.”), 9). Patent Owner alleges that, had the Board construed “nasal spray” and “suitable for nasal administration,” then the Board would have denied the obviousness grounds because “none of the combinations of cited art teach a person of ordinary skill in the art how to make the claimed fixed-dose combination ‘nasal spray’ or formulation ‘suitable for nasal administration’ with a reasonable expectation of success.” Id. at 2–3 (citing Prelim. Resp. 9). We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 3
Claim construction§ 103 obviousnessPatents in suitUS 8,168,620 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441 - Incyte Corporation v. Concert Pharmaceuticals, Inc.Institution deniedPTAB · Oct 19, 2017 · IPR2017-01256 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on claims 1–15 because Petitioner did not show a reasonable likelihood of proving anticipation by Rodgers or obviousness over either asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority 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); see also 37 C.F.R. § 42.4(a) (stating Director has delegated institution authority to Board). Upon considering the Petition and Preliminary Response, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of claims 1–15 of the ’149 patent. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“15, 2012, would have had a “master’s degree or a Ph.D. in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, physical organic chemistry or a related discipline,” or a lesser degree with more experience.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). Anticipation may arise where a reference describes a “definite and limited class,” and a person of ordinary skill in the art would “at once envisage each member of this limited class.” In re Petering, 301 F.2d 676, 681 (CCPA 1962).” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,249,149 - Innopharma Licensing, LLC v. Astrazeneca ABInstitution deniedPTAB · Aug 30, 2017 · IPR2017-00904 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1, 2, 5, and 9 would have been obvious over the asserted references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’122 Patent. A.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22
- Skill levelSkill level board ownOther
“Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17; Prelim. Resp. 18. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19
- Prior constructionPrior construction adoptedDecided for petitioner
“In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’122 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 18–19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 6,774,122 - Innopharma Licensing, LLC v. Astrazeneca ABInstitution deniedPTAB · Aug 30, 2017 · IPR2017-00905 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, and 20 were obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“As we observed in the Mylan IPR, however, “[i]t is not enough for Petitioner to establish that castor-oil based intramuscular injections of fulvestrant were known; the evidence must provide a reason for one of skill in the art to administer [the claimed] fulvestrant formulation”—which includes specific concentrations of three required excipients in castor oil— “‘intramuscularly’ to” achieve a therapeutically significant blood plasma concentration or dosage “for ‘treating a hormonal dependent benign or malignant disease of the breast or reproductive tract,’ as recited in the challenged claims.” Id. at 29.” slip op. at 24
- Expert testimonyPetitioner expert discountedDecided for patent owner
“As Patent Owner points out, however, Dr. El-Ashry relies on one experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 48 (citing Pet. 24; Ex. 1014 ¶¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 92, 160–61). Accordingly, we agree with Patent Owner that this new testimony does not address the question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–43); see also Ex. 1046, 729 (Examiner finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 17 (citing Pet. 54). We agree. As Patent Owner argues, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 3. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments.” slip op. at 28
§ 103 obviousnesscites KSRPatents in suitUS 8,466,139 - Innopharma Licensing, LLC v. Astrazeneca ABInstitution deniedPTAB · Aug 30, 2017 · IPR2017-00900 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1–3 and 6 would have been obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and, to some extent, a different record. Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that, in the Mylan IPR, we denied institution of inter partes review of all of the claims challenged here. We recognize, moreover, that our prior Mylan Decision addressed essentially the same factual inquiry centered on substantially the same asserted prior art references. We accept, therefore, Petitioner’s view that the nub of this dispute is whether “[f]our differences” set forth in the Petition overcome the shortcomings we previously identified in the Mylan Decision. Pet. 9–11; see Ex. 1011, 19–30 (Mylan Decision, including our prior analysis of essentially the same issues raised in the instant Petition).” slip op. at 23
- Prior constructionPrior construction adoptedDecided for petitioner
“interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under that standard, we presume that a claim term carries its “ordinary and customary meaning,” which “is the meaning the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms that are in controversy need 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 Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’680 Patent claims should be interpreted in accord with our prior construction. See Pet. 17–18; Prelim. Resp. 19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 21
- Skill levelOther
“Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 16–17; Prelim. Resp. 18–19. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormonal-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,329,680 - Dorco Company, Ltd. v. The Gillette Company, LLCRehearing deniedPTAB · Aug 21, 2017 · IPR2017-00500 · APJ Elizabeth M Roesel · IPR · Rehearing
The Board denied Dorco’s rehearing request, leaving institution denied because the petition presented substantially the same patentability issue previously considered during prosecution.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioner’s arguments do not persuade us to grant rehearing for two reasons: First, Petitioner’s arguments could not have been misapprehended or overlooked because they were not raised in the Petition; and second, even if Petitioner’s rehearing arguments had been raised in the Petition, they do not persuade us that we abused our discretion in denying institution.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“Petition, they do not persuade us that we abused our discretion in denying institution. More specifically, Petitioner’s rehearing arguments do not persuade us that it was an abuse of discretion to find that Petitioner’s Ground 1 presents essentially the same question of patentability as was previously presented to the Office during prosecution. Dec. 15. Petitioner contends that there would have been more compelling reasons for a POSA to combine Goel and Lane than there would have been to combine Hahn and Lane. Reh’g Req. 1–2, 7–11, 13. Even if we accept Petitioner’s contention, it does not change our analysis of whether the Petition presented the same or substantially the same prior art or arguments as were previously presented to the Office. Petitioner’s rehearing arguments are premised on the mistaken” slip op. at 7
Discretionary denialPatents in suitUS 6,684,513 - Sienna Biopharmaceuticals, Inc. v. William Marsh Rice UniversityRehearing deniedPTAB · Aug 21, 2017 · IPR2017-00046 · APJ Georgianna W Braden · IPR · Rehearing
The Board denied the Patent Owner’s rehearing requests, finding no abuse of discretion in instituting review because the reexamination amendments were not yet effective.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “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 rehearing a decision on a petition, we review the decision for an abuse of discretion. Id. § 42.71(c). An abuse of discretion may be indicated 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 P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 3
NonePatents in suitUS 6,685,730
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.