- Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00050 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 17, 19, 20, and 22–29 on all petitioned grounds, finding a reasonable likelihood of success and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“II. STANDARD OF REVIEW A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was 1 US 7,888,328 B2, issued Feb. 15, 2011 (Ex. 1029, “Bodor”). 2 Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (Ex. 1008, “Rice”). addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise 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. 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).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having reconsidered the record before us, we are persuaded that Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis by administering cladribine to a patient in the same claimed total amounts for both induction and the maintenance period to support Petitioner’s challenge to claim 17.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Having considered the record, we agree with Petitioner that the Office erred in its evaluation of the cited art (now asserted) as required by Advanced Bionics. Advanced Bionics cautions that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Paper 6, 9. Here, both Examiner and Patent Owner interpret Bodor to disclose administering the same dose of cladribine in both the induction and maintenance phase. Claim 17 encompasses administering the same dose of cladribine – 1.7 mg/kg – in both the induction and maintenance phase. By interpreting claim 17 as requiring a maintenance dose that is lower than the induction dose, we agree with Petitioner that Examiner misapprehended the scope of claim 17. We, therefore, decline to exercise our discretion to deny institution under § 325(d).” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“the claims. “All that is required is that the total dose reach a stated level in each period, and Bodor discloses a total dose within that range for what a person of ordinary skill in the art would understand to be an average patient.” Req. Reh’g 14 (emphasis omitted) (citing Pet. 42–50). Dr. Greenberg testifies that Bodor’s total dosage of cladribine ranges from 100–140 mg in the two-month treatment period. Ex. 1005 ¶ 104. The issue, as presented by Petitioner, is that the ’903 patent claims simply use a different way of reciting a total dose of cladribine administered during the treatment phase when compared to the methods and dosage taught by Bodor. We agree with Petitioner that the method and cladribine dosage in the ’903 patent claims overlap with the method and dosage taught by Bodor. To determine the total amount of cladribine administered as claimed in the ’903 patent requires knowledge of the weight of the patient. In the Petition, Petitioner relied on a patient weighing 70 kilograms (≈ 154 pounds) to be an acceptable average human weight as understood in the medical community. Pet. 32 (citing Ex. 1005 ¶ 105). Patients, however, come in all shapes and sizes as recognized in the ’903 patent disclosure and further supported by Dr. Greenberg’s testimony and referenced exhibit. See Ex. 1001, 3:8 (“patients of about 52 and about 75 kilos); see also Ex. 1005 ¶ 106 (“the average weight of individuals in the United States is higher than the global average, with an overall average weight (men and women combined) of roughly 177 lbs in 2002.”); Ex. 1030 (“the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age increased from 140.2 pounds in 1960 to 164.3 pounds in 2002.”). To arrive at the average weight of 177 pounds means that there are patients in the population that are above and below that average. See generally Ex. 1030.” slip op. at 6
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,377,903 - Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00049 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 36, 38, 39, and 41–48 on all petition grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise 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. 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).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating multiple sclerosis by administering cladribine to a patient in the same claimed total amount for both the induction period and maintenance period to support Petitioner’s challenge to claim 36.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“To summarize, Bodor teaches two treatment regimens for treating multiple sclerosis with a cladribine-cyclodextrin complex. 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex . . . would be administered [orally] once per day for a period of five to seven days in the first month, repeated for another period of five to seven days in the second month, followed by ten months of no treatment. Alternatively the patient would be treated with 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex in the instant dosage form once per day for a period of five to seven days per month for a total of six months, followed by eighteen months of no treatment. Ex. 1029, 13:20–30. Petitioner acknowledges that Bodor does not explicitly suggest applying the same regimen again after a cladribine-free period but finds that repeating the treatment protocol is reasonably inferred. Pet. 33 (citing Ex. 1005 ¶¶ 109, 111–113), see id. at 48 (citing Ex. 1005 ¶¶ 168–170); Ex. 1029, 18:45–19:3, 20:1–20 (Examples 4 and 5 each describing that treatment days are separated by cladribine-free days); Ex. 1003 at 389; Ex. 1004 at 141. Bodor also teaches that the dosing regimen can be tailored to suit the needs of the patient. Specifically, Bodor teaches that “one of skill will appreciate that the therapeutically effective amount of cladribine administered . . . may be lowered or increased by fine tuning and/or by administering cladribine . . . with another active ingredient.” Ex. 1029, 13:31–35, see also id. 13:37–40 (“Therapeutically effective amounts may be easily determined . . . empirically by starting at relatively low amounts and by step-wise increasing with concurrent evaluation of beneficial effect.”). Based on these disclosures, we agree with Petitioner that it would be reasonable to infer from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated. Pet. 33; see also Ex. 1005 ¶¶ 109–123, 119 (“common practice in the industry when prescribing a second round of an” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 9
§ 103 obviousnessDiscretionary denialPatents in suitUS 7,713,947 - Incyte Corporation v. Concert Pharmaceuticals, Inc.Rehearing grantedPTAB · Apr 9, 2018 · IPR2017-01256 · APJ Tina E Hulse · IPR · Rehearing
The Board granted Incyte’s rehearing request and instituted review of claims 1–15 on Ground 3, finding it had applied overly restrictive standards for lead compound analysis and combining references.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
NonePatents in suitUS 9,249,149 - 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.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 And Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter combination, retracting reliance on Flechter’s efficacy data, and denied rehearing on the remaining issues.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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 foundReasonable expectation foundDecided for petitioner
“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.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with Flechter’s alternateday dosing schedule would conclude that such a regimen would likely exacerbate the frequency of injection site reactions, as Patent Owner asserts. See PO Resp. 36.” slip op. at 4
- Expert testimonyPatent owner expert discountedDecided for petitioner
“Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data, Patent Owner and its declarant, Dr. Tjalf Ziemssen, M.D., Ph.D., compare Flechter’s data reporting adverse events in its patients with Meiner’s data reporting adverse events in a different cohort of patients. PO Resp. 35–36; Ex. 2135 ¶ 89. From that comparison, Patent Owner argues that Flechter’s data allegedly teaches that alternate-day administration is less tolerable than daily administration. Reh’g Req. 8.” slip op. at 3
- 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
§ 103 obviousnessPatents in suitUS 8,969,302 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing
On rehearing, the Board modified its decision and held claims 1–20 unpatentable as obvious over Pinchasi with the 1996 SBOA and over Pinchasi with Flechter.
RulingsRehearing decision- RehearingGranted in part
“we entered a Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Patent Owner filed a request for rehearing of our decision. Paper 87. In a concurrently issued Order, we grant-in-part Patent Owner’s request and vacate our original decision. Paper 89. We hereby issue this modified Final Written Decision.” 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 foundDecided for petitioner
“Upon considering the evidence as a whole, we also find that an ordinary artisan would have been motivated to administer GA three times over a period of seven days to increase patient compliance. We note again that Pinchasi teaches administering 40 mg GA every other day, which equates to seven doses over two weeks. Ex. 1005, 9. Thus, the difference between the challenged claims (three doses over a period of seven days, or six doses over two weeks) and the prior art is one less injection every two weeks. 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 ¶ 101. The desirability of less frequent injections is supported by the 1996 SBOA, in which the reviewer recommended that Teva evaluate the necessity of daily injections as opposed to more infrequent intermittent administration of Copaxone®. Ex. 1007, 252.” slip op. at 13
§ 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 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter combination, 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 foundMixed
“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.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with the alternate-day dosing schedule in Flechter would, as Patent Owner asserts, conclude that 5 Meiner et al., Copolymer 1 in Relapsing-Remitting Multiple Sclerosis: a Multi-Centre Trial, in Frontiers in Multiple Sclerosis: Clinical Research and Therapy (Abramsky et al. eds., 1997) (Ex. 1009). such a regimen would likely exacerbate the frequency of injection site reactions. See PO Resp. 36.” slip op. at 4
- 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 8 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). 9 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). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner
“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 8 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). 9 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). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8
§ 103 obviousnessPatents in suitUS 8,232,250 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-01980 · APJ Tina E Hulse · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, vacated the original decision, and entered a modified final written decision.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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 foundDecided for patent owner
“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. 25–26). The cited pages 25–26 of our Decision address the misinterpretation of data in Flechter. Dec. 25–26. But, contrary to Patent Owner’s assertion, we do not conflate the efficacy data of Flechter with tolerability. Rather, we find that “we are not persuaded by Patent Owner’s argument that a person of ordinary skill in the art would interpret Flechter as showing that decreasing the dosing frequency would decrease the efficacy of the drug.” Dec. 25–26 (emphasis added). Although the cited portion of our Decision does not conflate efficacy with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3
- Expert testimonyPatent owner expert discountedPetitioner expert creditedDecided for petitioner
“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
- Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner
“regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 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”). 9 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”). evidence 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. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8
§ 103 obviousnessPatents in suitUS 8,399,413 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, and vacated the original final written decision.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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 foundDecided for patent owner
“with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3
- Expert testimonyPatent owner expert discountedDecided for petitioner
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 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”). 9 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”). evidence 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. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8
§ 103 obviousnessPatents in suitUS 8,399,413
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.