- Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · Jun 9, 2017 · IPR2016-00189 · APJ James T Moore · IPR · Final written decision
Claims 1 and 2 are unpatentable as obvious over Kempeni and van de Putte because the combined teachings would have motivated the claimed biweekly 40 mg subcutaneous regimen with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Dr. Baughman describes the ordinarily skilled artisan physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 26; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled artisan pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 26–27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101–103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding without challenge, and it is consistent with the level of ordinary skill in the art as reflected by the prior art of record.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Owner asserts that “[a]s of June 2001, a treating physician who satisfied the definition of a POSA[4] would have understood the claims to require meaningful therapeutic efficacy.” Resp. at 61 (citing Ex. 2065 ¶¶ 20, 92– 93). As support, Patent Owner points to the ’987 patent specification’s disclosure that “administration of D2E7 produces a meaningful improvement in a variety of clinical outcome measures” such as ACR20, ACR50, and SJC.5 Id. at 62. Patent Owner also contends that the specification of the ’987 patent provides “clinically meaningful outcome parameters” for the treatment of RA. Id. (citing Ex. 2065, ¶¶ 92–93). Patent Owner, therefore, again asserts that we should construe the phrase to mean that the treatment has “meaningful therapeutic efficiency.” We again decline to interpret the claim in this manner. Such a construction would add much uncertainty to the 4 We understand POSA to be used as shorthand for a Person of Ordinary Skill in the Art. 5 ACR is shorthand for the American College of Rheumatology improvement criteria. SJC stands for swollen joint count. Ex. 1001, 28:23;30:22. claim. Meaningful is a highly subjective term, depending on the outcome sought by a treating physician and what he or she might regard as meaningful as regards that outcome.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed
“Petitioner does not carry its burden to show that a person of ordinary skill in the art would have been so motivated. As explained above, in the Petition Petitioner asserts that the ordinary artisan would have doubled van de Putte’s 20 mg dose to 40 mg and weekly dosing interval to biweekly based on the single PK parameter of half-life. In support of that assertion, Dr. Baughman testifies that “half-lives are routinely used to develop the appropriate dosing frequency.” Ex. 1006 ¶ 66. Dr. Baughman’s testimony in that regard may be valid, but the record in this case does not include sufficient persuasive evidence from which we can make that determination. That is, neither Petitioner nor Dr. Baughman directs us to a monoclonal antibody drug with a dosing interval that corresponds to its particular half-life, or to other evidence supporting the assertion that skilled artisans routinely use half-lives to develop a dosing schedule. Accordingly, Dr. Baughman’s testimony on those issues is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We see the evidence somewhat differently. A reference teaches away from the claimed invention if it criticizes, discredits, or would have RA, the 40 mg subcutaneous dose also is insufficient, given the lower bioavailability of a drug after subcutaneous administration. Tr. 46:16–21. We address that contention below in discussing Patent Owner’s argument that Kempeni, and the prior art as a whole, teach away from the 0.5 mg/kg dose. See infra §§ II.C.3.b.(2)(ii)–(2)(iii). discouraged a person of ordinary skill in the art from “following the path set out in the reference,” or if a person of ordinary skill “would [have been] led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). The mere disclosure of alternative designs, however, does not teach away. In re Mouttet, 686 F.3d 1322, 1333–34 (Fed. Cir. 2012). Kempeni discloses several clinical studies that utilized different dosing protocols. DE003 was one of those clinical studies. In the DE003 study, patients received 0.5 to 10 mg/kg of D2E7 intravenously “every two weeks” until DAS (Disease Activity Score) responses could be rated as “good.” Ex. 1003, 2 (emphasis added). Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, as explained above, Kempeni expressly discloses such dosing frequency.11 We agree with Patent Owner that, for some portion of the treatment period, patients were treated only on flare up. Resp. 49; Ex. 1003, 2. That disclosure, however, does not negate Kempeni’s teaching of biweekly dosing. Nor does it fairly teach away from biweekly dosing. We also agree that some patients were “updosed” for “inadequate clinical response.” Resp. 50; Ex. 1003, 2–3. 11 Additional prior art references support the finding regarding Kempeni’s disclosure. For example, one reference describes the DE003 study as a clinical trial in which “D2E7 was given in doses of 0.5–10 mg/kg [intravenously] over 3–5 minutes every two weeks over a time period of now 1½ years.” Ex. 2114, 4. We find that such disclosure represents, at most, an alternative dosing schedule to the biweekly dosing Kempeni discloses, with patient variability accommodated. In any event, we find that persons of ordinary skill were not led in a direction divergent from that taken by Patent Owner. To the contrary, evidence in the record demonstrates that skilled artisans conducted studies dosing D2E7 subcutaneously in fixed doses, and on a biweekly schedule. Ex. 1004, 1 (disclosing that D2E7 was administered subcutaneously in fixed doses of 20, 40, and 80 mg); Ex. 1005, 3 (describing the DE010 study, in which patients initially were treated with 1 mg/kg D2E7 intravenously, 1 mg/kg D2E7 subcutaneously, or placebo, but thereafter received subcutaneous injections of 1 mg/kg D2E7 biweekly in the open label portion of the study).” slip op. at 24
Patent outcomesUS 9,073,987 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,073,987 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · Jun 9, 2017 · IPR2016-00188 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–4 are unpatentable as obvious over van de Putte and Kempeni because the prior art supplied motivation and a reasonable expectation of success for the claimed dosing regimen.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“art as of June 8, 2001—the priority date of the ’135 patent, of which the ’680 patent is a continuation. Petitioner and Dr. Baughman explain that a skilled artisan would possess the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies. Pet. 28; Ex. 1006 ¶ 15; Ex. 1007 ¶ 12, 13. Dr. Baughman describes the ordinarily skilled physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 28; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101– 103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding and it is reflected by the prior art of record.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). On the other hand, “a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). Here, the steps of the method, dosage amount, timing, route of administration, and active component are all specified in the body of the claim. The phrase “reducing the signs and symptoms of rheumatoid arthritis,” therefore, merely recites an intended use. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (statements of intended use typically do not limit the scope of a claim because they “usually do no more than define a context in which the invention operates”). Stated another way, the claims do not expressly recite any particular level of efficacy, meaningful or otherwise. Rather, the claims require administering the antibody in a particular dosage amount, by a particular route, at a particular interval—to a patient with moderately to severely active rheumatoid arthritis.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2. “40 mg dosage unit form” According to the ’680 patent, “dosage unit form” “refers to physically discrete units suited as unitary dosages for the mammalian subjects to be treated; each unit containing a predetermined quantity of active compound[.]” Ex. 1001, 23:9–12. Petitioner contends, “[b]ased upon this definition, a ‘40 mg dosage unit’ form would encompass a syringe filled with 40 mg of D2E7.” Pet. 17.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Patent Owner does not challenge Petitioner’s showing that the prior art discloses each element of claims 1–4. See generally PO Resp. Based on the full trial record, we determine that van de Putte and Kempeni collectively disclose each limitation of the challenged claims. That is, we agree with Petitioner that van de Putte discloses all of the elements of claims 1–4, with the exceptions of biweekly dosing, and administering the antibody in combination with methotrexate. As explained above, van de Putte discloses a study in which RA patients received weekly doses of 20, 40, or 80 mg of D2E7, or placebo, via subcutaneous self-administration over the course of three months. Ex. 1004, 1. D2E7, therefore, was administered in a pharmaceutically acceptable composition, in unit dosage form. Id. Further, D2E7 is a known recombinant human anti-TNFα antibody having the six CDRs and heavy chain constant region required by claims 1–4, and the amino acid sequences for the variable light and variable heavy chain regions required by claims 2 and 4. Ex. 1001, 3:40–42 (explaining that D2E7 is “described in U.S. Pat. No. 6,090,382, incorporated in its entirety herein by reference”); see Ex. 1008, 2:59–67. Petitioner also shows, by a preponderance of the evidence, that Kempeni accounts for the differences between van de Putte and the recited biweekly dosing frequency required by all of the challenged claims, as well as administering the antibody with methotrexate. Specifically, Kempeni describes a study in which patients received D2E7 via intravenous injection every two weeks for at least 6 months (i.e., 24 weeks), and also teaches that “D2E7 is safe and effective . . . in combination with methotrexate when administered by single and multiple intravenous and subcutaneous injections.” Ex. 1003, 2, 3.” slip op. at 15
Patent outcomesUS 9,017,680 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,017,680 - Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Pozen Inc.Rehearing deniedPTAB · May 24, 2017 · IPR2015-01774 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving its denial of institution on the §103 grounds for claims 1–6 and 13–15 unchanged because Petitioner showed no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“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 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, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“determined that Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of challenged claims 1–6 and 13–15 of U.S. Patent 8,852,636 B2 (Ex. 1001, “the ’636 patent”) on any of the five grounds advanced in the Petition (Paper 4, “Pet.”). Paper 15 (“Decision” or “Dec.”). Subsequently, Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively “Petitioner”) filed a Request for Rehearing (Paper 16, “Reh’g Req.” or “Request”) asking us to reconsider our Decision denying an inter partes review on two of the grounds advanced in the Petition: (1) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Chen1 and Gimet;2 and (2) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Gimet, Chandramouli,3 and Phillips.4” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“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 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, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 3
§ 103 obviousnessPatents in suitUS 8,852,636 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · May 16, 2017 · IPR2016-00172 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Kempeni and van de Putte because their combined teachings would have motivated the claimed dosing regimen with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“art as of June 8, 2001—the priority date of the ’135 patent. Petitioner and Dr. Baughman explain that a skilled artisan would possess the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies. Pet. 27; Ex. 1006 ¶ 15. Dr. Baughman describes the ordinarily skilled physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 27; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101–103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding and it is reflected by the prior art of record.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner
“The parties do not dispute our preliminary determination that the preamble phrase “[a] method for treating rheumatoid arthritis” is not limiting. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“As we explained in the Institution Decision, claims 1 and 5 do not recite any particular level of efficacy. Rather, they require administering the antibody for a time sufficient to treat RA. Inst. Dec. 9. Consistent with the claims, the specification uses the word “treat” in its customary and ordinary way. For example, the specification describes administering the antibody for therapeutic purposes to alleviate the symptoms and/or progression of the disorder. Ex. 1001, 24:25–60. The portions of the specification on which Patent Owner relies do not persuade us otherwise. The specification explains that the data in Figures 1B and 2–4 “indicate that subcutaneous, biweekly D2E7 treatment combined with methotrexate was significantly better than placebo in reducing the signs and symptoms of RA,” and that all of the doses “were statistically significantly more effective than placebo.” Ex. 1001, 30:25–30. A statement that the treatment is significantly better than placebo, however, does not mean that the treatment significantly reduced the signs and symptoms of RA, as Patent Owner argues.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed
“After reviewing the entire record developed during trial, we find that Petitioner does not carry its burden to show that a person of ordinary skill in the art would have been so motivated. As explained above, Petitioner asserts in the Petition that the ordinary artisan would have doubled van de Putte’s 20 mg dose to 40 mg and weekly dosing interval to biweekly based on the single PK parameter of half-life. In support of that assertion, Dr. Baughman testifies that “half-lives are routinely used to develop the appropriate dosing frequency.” Ex. 1006 ¶ 66. Dr. Baughman’s testimony in that regard may be valid, but the record in this case does not include sufficient evidence from which we can make that determination. That is, 8 Cmax is the highest blood level observed between doses and AUC is the total area under the concentration time curve that reflects the total amount of drug observed in the blood. Ex. 1006 ¶ 62; Ex. 2069 ¶ 35. neither Petitioner nor Dr. Baughman direct us to a drug with a dosing interval that corresponds to its half-life, or to other evidence supporting the assertion that skilled artisans routinely use half-lives to develop a dosing schedule. Accordingly, Dr. Baughman’s testimony on those issues is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 21
Patent outcomesUS 8,889,135 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,889,135 - PTAB · Apr 21, 2017 · IPR2016-01566 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Mylan’s rehearing request, finding no abuse of discretion in denying institution because the petition did not show a reasonable likelihood that the cited combination rendered claims 1–22 obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV. ORDER Accordingly, it is ORDERED that Petitioner’s request for rehearing is denied.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV.” slip op. at 6
- BurdenDecided for patent owner
“as it argues now in its request for rehearing, that we should apply a legal presumption of obviousness. In fact, the Petition did not cite Galderma, or numerous other opinions of the Federal Circuit, district courts, and the Board, which Petitioner now relies on in its request for rehearing. The Board could not have misapprehended or overlooked an argument that was not made and case law that was not cited in the Petition. In addition, we reiterate, as we stated in our Decision denying institution, in an inter parte review, Petitioner has the ultimate burden of persuasion to prove unpatentability. Dec. 8 (citing 35 U.S.C. § 316(e); Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015)). According to Petitioner, Galderma holds “Patent Owner has burden of overcoming obviousness presumption ‘where there is a range disclosed in the prior art, and the claimed invention falls within that range.’” Req. Reh’g 1 (quoting Galderma, 737 F.3d at 737–38). To the extent Petitioner argues for a presumption of obviousness that shifts the burden of persuasion to Patent Owner, such an argument is misplaced. See In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (stating that the “burden-shifting framework does not apply in the adjudicatory context of an IPR”).” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In contrast, here, Petitioner relies solely on the teachings of the ’510 publication—a preferred dose of 1 to 100 mg administered “1 to 4 times a day”— to arrive at the claimed dosage of 2.5 mg or 5 mg. The Petition simply does not provide the same type of evidence and context as those in Galderma, sufficient for us to apply the requested presumption.1” slip op. at 4
§ 103 obviousnessPatents in suitUS 9,173,859 - PTAB · Mar 17, 2017 · IPR2016-01563 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving trial instituted only for claims 1 and 10; it found the Petition lacked reasoned obviousness analysis for claims 2–9 and 11–26.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We will grant a request for rehearing if the requesting party demonstrates “an abuse of discretion” in the decision. 37 C.F.R. § 42.71(c). However, we will grant a request for rehearing only if the requesting party “specifically identif[ies] . . . the place where each matter [that we misapprehended or overlooked] was previously addressed.” Id. § 42.71(d). After considering Petitioner’s Rehearing Request, our Decision, and the evidence currently of record, Petitioner’s Rehearing Request is denied.” slip op. at 2
- BurdenNot shown unpatentable
“See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3), requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.”). In Harmonic, the Federal Circuit held that “it was Harmonic’s burden to explain to the Board how Haskell combined with Rossmere rendered the challenged claims unpatentable. With respect to claim 11 of the ’291 patent, Harmonic did not do so.” Id. Petitioner here also did not meet its burden with respect to claims 2–9 and 11–26 of the ’927 patent.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In Galderma, for example, the claim recited a “topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] . . . Shroot patents disclosed topical adapalene compositions for treating acne “in a preferred range of 0.01%–1%,” including exemplary formulations containing 0.001%, 0.1%, and 1%. Id. at 735–36. The court noted the Shroot patents were listed in the FDA’s Orange Book for “prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.” Id. at 735. The court further noted that other prior art references disclosed the use of 0.3% adapalene lotion in an animal model for acne treatment and taught the use of 0.3% adapalene for other skin conditions “without intolerable irritability.” Id. It was in the foregoing context that the court framed the issue as “whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.” Id. at 737–38. The Petition here simply does not provide the same type of context and analysis with regard to the claimed linagliptin dosages, sufficient for us to apply the requested presumption.3” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,673,927 - 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 - Coalition For Affordable Drugs Vii LLC v. Pozen Inc.No claims unpatentablePTAB · Feb 21, 2017 · IPR2015-01718 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–16 were not shown unpatentable over Plachetka, Graham, and Goldstein or Plachetka alone because the claimed comparative ulcer reduction was an unexpected difference in kind.
RulingsFinal written decision- BurdenNot shown unpatentable
“Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Pet. 17–18 (citing Ex. 1003 ¶ 83). Paragraph 83 of Dr. Shargel’s Declaration is virtually identical to the Petition. Neither Petitioner nor Dr. Shargel identifies the basis for these purported results in the Petition, or in the cited portion of the Declaration, much less the basis for the conclusion that an ordinary artisan “would have understood that a combination of lansoprazole and naproxen was more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA.” Pet. 18 (citing Ex. 1003 ¶ 83). As we stated in the Decision 20 of Institution, “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight”— accordingly, we are not persuaded by these conclusory and unsupported statements by Petitioner or Dr. Shargel. Dec. 15 (quoting 37 C.F.R. § 42.65(a)).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Nevertheless, the issue presented by Petitioner’s rationale is not whether the cited art would have suggested administering LDA to a patient already taking Plachetka’s unit dosage form. Rather, the salient issue is whether the art would have suggested that a patient already taking LDA in 13 addition to a non-aspirin NSAID—which Goldstein teaches was known to increase the incidence of gastric ulcers—would have benefited by taking the non-aspirin NSAID in the form of Plachetka’s coordinated unit dose form containing an acid inhibitor in addition to the NSAID. Having considered Petitioner’s and Patent Owner’s arguments and observations with respect to this aspect of the challenged claims, as well as evidence of record establishing that administering an acid inhibitor to a patient taking both LDA and a non-aspirin NSAID was known to reduce the incidence of NSAID-associated gastric ulcers, we determine that Petitioner has demonstrated that an ordinary artisan would have had a reason to administer Plachetka’s coordinated unit dosage forms to patients in need of NSAID therapy and at risk of developing gastric ulcers—including those patients also taking low dose aspirin—in order to reduce the incidence of gastric ulcers.” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner
“Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27
Patent outcomesUS 8,945,621 not shown unpatentable§ 103 obviousnesscites GrahamPatents in suitUS 8,945,621 - 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
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.