- Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- BurdenMixed
“Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed
“Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19
Patent outcomesUS 8,252,316 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,252,316 - Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- Skill levelSkill level board ownOther
“The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Expert testimonyPetitioner expert creditedDecided for petitioner
“not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
Patent outcomesUS 8,679,524 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,679,524 - Monosol RX, LLC v. Arius Two, Inc.Rehearing deniedPTAB · Dec 19, 2016 · IPR2014-00376 · APJ Christopher L Crumbley · IPR · Rehearing
The Board denied Monosol’s rehearing request, leaving claims 1–7 not shown unpatentable because the request showed no prejudicial APA error in the Board’s multilayer construction of “bioerodable device.”
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that the premise of Monosol’s argument—that we changed theories in our Final Written Decision—is incorrect. Our Decision on Institution did not articulate a construction for “bioerodable device,” or even state that we were not providing an express construction because the plain and ordinary meaning of the term controlled. Rather, we noted that an explicit construction was not necessary at that stage of the proceeding, because it was not material to resolving the question before us at the time: whether Monosol had established the reasonable likelihood of success required by 35 U.S.C. § 314 to institute trial. Dec. on Inst. 10–11. In this sense, our determination in the Decision on Institution was similar to a trial court’s ruling on a motion for preliminary injunction, and the” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“In instituting trial, we construed various terms in the challenged claims, but determined that other terms, such as “bioerodable device,” did” slip op. at 3
- PTAB / AIA Trials › Discretionary denialDecided for patent owner
“Our denial of institution on particular grounds was based on the fact that we had determined to institute trial on other grounds, and Monosol had not explained why the grounds (such as anticipation by Heiber, or obviousness over Keith combined with Heiber or Schiraldi) were sufficiently distinctive from the instituted grounds. Dec. on Inst. 16, 20 n.2. We, therefore, exercised our discretion to deny these grounds as redundant of the instituted grounds. Id.” slip op. at 3
- BurdenDecided for patent owner
“construction of “bioerodable device” earlier—it would have presented evidence that the Heiber and Schiraldi references met that limitation. But Monosol could not have done so post-institution, because neither Heiber nor Schiraldi were part of any ground on which trial was instituted, and could not form any basis for our patentability determination. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,765 (Aug. 14, 2012) (“Any claim or issue not included in the authorization for review is not part of the trial.”). Relying on non-instituted prior art in the Final Written Decision— and thereby introducing factual assertions into the proceeding at the end of trial—would trade Monosol’s alleged APA violation for an actual one. See Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016).” slip op. at 10
Claim constructionDiscretionary denialPatents in suitUS 7,579,019 - Mylan Pharmaceuticals Inc. v. Astrazeneca ABInstitution deniedPTAB · Dec 14, 2016 · IPR2016-01325 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because Mylan did not show a reasonable likelihood of proving claims 1–20 obvious over McLeskey alone or with Howell 1996.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 “rely 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.” Id. 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 19
- Skill levelSkill level board ownDecided for patent owner
“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. 14–15; Prelim. Resp. 11–12. 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 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“patentable weight, the term “therapeutically significant” should be construed to mean “any blood plasma fulvestrant concentration greater than or equal to at least 2.5 ngml-1 that is achieved for at least 4 weeks after injection.” Pet. 17–18. Patent Owner does not argue that Petitioner’s proposed interpretation is unreasonable, but contends that the meaning of the term is clear from the Specification and context of the claim phrase itself. See Prelim. Resp. 16 (citing Ex. 2003 ¶ 68; Ex. 1001, 9:24–27 (expressly defining “therapeutically significant” fulvestrant blood plasma levels as “at least 2.5 ngml-1, ideally at least 3 ngml-1, at least 8.5 ngml-1, and up to 12 12 Our reasoning extends to the wherein clauses of dependent claims 2 and 10, also challenged by Petitioner at page 16, footnote 9, of the Petition. ngml-1 of fulvestrant [] achieved in the patient.”). We agree with Patent Owner. No express construction of this term is required.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“and 9, “wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks,” is merely a statement of intended result entitled to no patentable weight. Pet. 16–17. For the reasons set forth at pages 12–16 of Patent Owner’s Preliminary Response, we do not find Petitioner’s argument persuasive.12 For example, rather than merely stating the result of intramuscularly administering the recited formulation, as Petitioner argues, the wherein clause dictates both the administration duration and dose of the formulation, i.e., an amount sufficient to provide a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks. See Prelim. Resp. 15 (relying on Exhibits 2002 ¶ 37–39, Ex. 2001 ¶¶ 33–37, and citations therein). That these parameters are further limited in claims 2, 10 (“the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml-1”) further indicates that the wherein clauses provide defining characteristics. See Prelim. Resp. 15 (citing Ex. 2003 ¶ 60).” slip op. at 16
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 8,329,680 - Mylan Pharmaceuticals, Inc. / Amneal Pharmceuticals LLC v. Yeda Research And Development Co. Ltd.All claims unpatentablePTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–12 are unpatentable as obvious over Pinchasi and the 1996 FDA SBOA, and over Pinchasi and Flechter.
RulingsFinal written decision- Skill levelSkill level board ownOther
“The parties dispute the proper definition of a person of ordinary skill in the art. Petitioners contend that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or be a physician with experience in clinical pharmacology. Pet. 11. In its Preliminary Response, Patent Owner disagreed with Petitioners’ definition because it does not include experience with MS or GA, which, according to Patent Owner, are both requirements for a person of ordinary skill in the art. Prelim. Resp. 34.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“In an inter partes review, the Board interprets claim terms in an 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, 2144–46 (2016). Under that standard, and absent any special definitions, we 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). In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 6–9. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 6
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’302 patent. As support, Petitioners offer a Declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Petitioner. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Petitioners on July 17, 2007. Id. Because the uncontroverted evidence shows Petitioners were able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’302 patent (i.e., August 20, 2009). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We also determine that an ordinary artisan would have had a reason to modify Pinchasi’s dosing regimen of 40 mg of GA every other day to 40 mg of GA three times a week. We are persuaded by Dr. Green’s testimony that an ordinary artisan would have been motivated to adopt a three times per week dosing regimen to increase patient compliance. For example, Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 102. The desirability of less frequent injections is supported by the 1996 SBOA, which “recommend[ed] that [Teva] evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug.” Ex. 1004 ¶¶ 109–10; Ex. 1085 ¶ 17 (quoting Ex. 1007, 252).” slip op. at 15
Patent outcomesUS 8,969,302 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,969,302 - Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Rehearing
Patent Owner’s rehearing request was granted as to the Pinchasi–Flechter combination analysis; rehearing was denied on the remaining issues, and a modified final written decision was entered.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 6 (citing Dec. 29). Upon review of the Decision, we agree that the analysis in the cited portion of our Decision does not conflate efficacy with tolerability. See Final Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.C.5 of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“As explained above, we were not persuaded that the prior art suggested decreased tolerability. Indeed, in light of the prior art references each stating that the dosage regimens were well tolerated, we were persuaded that a person of ordinary skill in the art would have had a reason to combine the cited references to reach the claimed dosing regimen with a reasonable expectation of success.” slip op. at 7
- Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner
“Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,969,302 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.All claims unpatentablePTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and over Pinchasi and Flechter.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“On September 25, 2015, Amneal Pharmaceuticals LLC filed a Petition requesting an inter partes review of claims 1–20 of the ’250 patent in case IPR2015-01976. Amneal also filed a motion to join its case with this proceeding. IPR2015-01976, Paper 3. On December 28, 2015, we granted Amneal’s Petition and motion for joinder, terminated IPR2015-01976, and joined it with this case. Id., Paper 9.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“in the art. Petitioner contends that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or an M.D. with experience in clinical pharmacology. Pet. 13. In its Preliminary Response, Patent Owner asserted that a skilled artisan would have had knowledge of, and experience with, both MS and GA. Prelim. Resp. 33–34. In the Decision to Institute, we agreed with Patent Owner. Dec. 9. We noted that Dr. Green, one of Petitioner’s declarants, states that a person of ordinary skill in the art would have had “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither party contests our findings of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination. Thus, we reiterate that in addition to the qualifications specified by Petitioner, a person of ordinary skill in the art would also have experience treating MS with GA.” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“As an initial matter, we note that, in its Preliminary Response, Patent Owner challenged the status of the 1996 SBOA as a printed publication under 35 U.S.C. § 102(b). Prelim. Resp. 47–48. In the Decision to Institute, we determined that, based on the record available then, the 1996 SBOA constitutes prior art under § 102(b). Dec. 12–13. In its Response, Patent Owner does not dispute this finding. Having considered the complete record developed at trial, we reiterate that Petitioner has presented sufficient evidence (see Ex. 1007) to show that the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008). See Dec. 12–13. Thus, the 1996 SBOA constitutes prior art under § 102(b).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
Patent outcomesUS 8,232,250 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,232,250 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter motivation issue, denied rehearing on the remaining issues, vacated the prior Final Written Decision, and entered a modified decision concurrently.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“§ 42.71 (d), which requires the party requesting rehearing to “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.”” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed
“Patent Owner first asserts that we “misconstrued data in Flechter illustrating that alternate day dosing was as effective as daily dosing and found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 32). Upon review of the Decision, we agree. See Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.F of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable
“regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient” slip op. at 8
- Expert testimonyPatent owner expert discountedDecided for patent owner
“Dr. Ziemssen, however, qualifies this comparison and explains that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,232,250 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.All claims unpatentablePTAB · Dec 2, 2016 · IPR2015-01980 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and independently over Pinchasi and Flechter.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In our Decision to Institute, we agreed with Patent Owner that a person of ordinary skill in the art should have experience with MS and GA. Dec. Inst. 5. We noted that one of Petitioners’ declarants, Dr. Ari Green, states that a person of ordinary skill in the art would have “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither Petitioners nor Patent Owner contested our definition of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination, and we adopt Petitioners’ definition of a person of ordinary skill in the art, with the addition that that person would also have experience treating MS with GA.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 5–8. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’413 patent. As support, Petitioners offer a declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Mylan Pharmaceuticals Inc. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Mylan on July 17, 2007. Id. Because the uncontroverted evidence shows Mylan was able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’413 patent (i.e., August 20, 2008). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions, 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We also determine that an ordinary artisan would have had a reason to modify Pinchasi’s dosing regimen of 40 mg of GA every other day to 40 mg of GA three times a week. We are persuaded by Dr. Green’s testimony that an ordinary artisan would have been motivated to adopt a three times per week dosing regimen to increase patient compliance. For example, Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 100. The desirability of less frequent injections is supported by the 1996 SBOA, which “recommend[ed] that [Teva] evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug.” Ex. 1004 ¶¶ 101– 02; Ex. 1085 ¶ 17 (quoting Ex. 1007, 252).” slip op. at 15
Patent outcomesUS 8,399,413 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,399,413 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.All claims unpatentablePTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and over Pinchasi and Flechter.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“In our Decision to Institute, we agreed with Patent Owner that a person of ordinary skill in the art should have experience with MS and GA. Dec. Inst. 5. We noted that one of Petitioners’ declarants, Dr. Ari Green, states that a person of ordinary skill in the art would have “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither Petitioners nor Patent Owner contested our definition of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination, and we adopt Petitioners’ definition of a person of ordinary skill in the art, with the addition that that person would also have experience treating MS with GA.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 5–8. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’413 patent. As support, Petitioners offer a declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Mylan Pharmaceuticals Inc. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Mylan on July 17, 2007. Id. Because the uncontroverted evidence shows Mylan was able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’413 patent (i.e., August 20, 2008). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions, 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Moreover, Pinchasi discloses administration of the 40 mg dose every other day. Ex. 1005, 9:1−11. Thus, the difference between the challenged claims and the prior art is a dosing schedule that is decreased by one day every two weeks—i.e., the difference between every other day disclosed in the prior art and the requirement of three doses per week recited in the claims. Ex. 1004 ¶ 91. In this regard, Dr. Green testifies that setting a course of treatment for the same day each week, for example on Monday, Wednesday, and Friday, is an easier dosing schedule to follow than every other day, which would occur on different days of the week throughout the month. Id. ¶ 105. In light of the evidence as a whole, we are persuaded that an ordinary artisan would have understood the benefits of less frequent injections and, therefore, would have had a reason to reduce Pinchasi’s dosing regimen to three times per week. We are also persuaded by Dr. Green’s testimony and supporting evidence that a person of ordinary skill in the art would have had a reasonable expectation of success in administering 40 mg of GA three times a week. We credit Dr. Green’s testimony that an ordinary artisan would have considered GA to be a “forgiving drug.” Ex. 1085 ¶ 19. Dr. Green testifies that it was a standard instruction for patients who miss a dose to skip the dose rather than take a double dose. Ex. 1004 ¶ 90 (citing Ex. 1062, which states, “If you miss a dose [of GA], take it as soon as you remember. If you do not remember until the following day, skip the missed dose and continue with your regular dosing schedule.”); Ex. 1085 ¶ 19 (citing Ex. 1086, which states, “If you miss a dose, take your COPAXONE® as soon as you remember. If it is nearer to the time of your next scheduled dose, skip the missed dose and resume your usual dosing schedule.”)13. Dr. Green also explains that the wide range of likely efficacious doses suggests the forgiving nature of GA. Ex. 1085 ¶¶ 20–21. Flechter and Khan 2008/Caon 2009 disclose 20 mg of GA every other day (i.e., 70 mg per week), whereas Pinchasi discloses 40 mg of GA daily (i.e., 280 mg. per week). Ex. 1008; Ex. 1010; Ex. 1011; Ex. 1005, 9:2–11. Because 40 mg three times a week (i.e., 120 mg per week) is in the middle of the range of known effective weekly doses and is close to the FDA-approved 20 mg daily regimen (i.e., 140 mg 13 We note that Patent Owner has moved to exclude Ex. 1086. We deny Patent Owner’s motion, for the reasons stated in more detail below. per week), we are persuaded by Dr. Green’s testimony that a person of ordinary skill in the art would have reasonably expected 40 mg of GA three times a week to be successful. Ex. 1085 ¶ 21.” slip op. at 17
Patent outcomesUS 8,399,413 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,399,413
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