- PTAB · Jul 30, 2024 · IPR2024-00201 · APJ John G New · IPR · Adverse judgment
After Patent Owner disclaimed all challenged claims, the Board entered adverse judgment against Patent Owner under 37 C.F.R. § 42.73(b).
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: … (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b). According to our reviewing court, 37 C.F.R. § 42.73(b) gives the Board authority to construe a patent owner’s actions in disclaiming all challenged claims in an instituted trial as a request for an adverse judgment. Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1349 (Fed. Cir. 2018). In the present inter partes review, Patent Owner has disclaimed all challenged claims of the ’601 patent, such that there are none left to be contested by the Petition. We consequently view Patent Owner’s filing of the Disclaimer, removing the last of the challenged claims from this inter partes review, and its request for termination of the proceeding, as a constructive request for adverse judgment against itself under § 42.73(b). Arthrex, 880 F.3d at 1349. Because there are no challenged claims left for the Petition to contest in this proceeding, adverse judgment against Patent Owner is granted.” slip op. at 2
NonePatents in suitUS 10,888,601 - PTAB · Jul 30, 2024 · IPR2023-00739 · APJ John G New · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner after it disclaimed all challenged claims of the ’601 patent.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: … (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b). According to our reviewing court, 37 C.F.R. § 42.73(b) gives the Board authority to construe a patent owner’s actions in disclaiming all challenged claims in an instituted trial as a request for an adverse judgment. Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1349 (Fed. Cir. 2018). In the present inter partes review, Patent Owner has disclaimed all challenged claims of the ’601 patent, such that there are none left to be contested by the Petition. We consequently view Patent Owner’s filing of the Disclaimer, removing the last of the challenged claims from this inter partes review, and its request for termination of the proceeding, as a constructive request for adverse judgment against itself under § 42.73(b). Arthrex, 880 F.3d at 1349. Because there are no challenged claims left for the Petition to contest in this proceeding, adverse judgment against Patent Owner is granted.” slip op. at 2
NonePatents in suitUS 10,888,601 - Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2024-00298 · APJ Ryan H Flax · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–30 after it disclaimed every challenged claim, terminating the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.72, “[t]he Board may terminate a trial without rendering a final written decision, where appropriate . . . .” Further, 37 C.F.R. § 42.73(b)(1) and (2) together state that, “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent [and] [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Thus, in disclaiming every claim in the ’572 patent, Patent Owner has constructively requested adverse judgement. Ex. 3005.” slip op. at 2
NonePatents in suitUS 11,253,572 - Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2024-00260 · APJ Ryan H Flax · IPR · Adverse judgment
Adverse judgment was entered against Patent Owner as to claims 1–30 after it disclaimed all challenged claims, and the proceeding was terminated.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.72, “[t]he Board may terminate a trial without rendering a final written decision, where appropriate . . . .” Further, 37 C.F.R. § 42.73(b)(1) and (2) together state that, “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent [and] [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Thus, in disclaiming every claim in the ’572 patent, Patent Owner has constructively requested adverse judgement. Ex. 3005. We grant Patent Owner’s request. Several exhibits filed in this proceeding were done so under seal as” slip op. at 2
NonePatents in suitUS 11,253,572 - Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2023-00884 · APJ Ryan H Flax · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–30 after their disclaimer and terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.72, “[t]he Board may terminate a trial without rendering a final written decision, where appropriate . . . .” Further, 37 C.F.R. § 42.73(b)(1) and (2) together state that, “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent [and] [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Thus, in disclaiming every claim in the ’572 patent, Patent Owner has constructively requested adverse judgement. Ex. 3005. We grant Patent Owner’s request. Several exhibits filed in this proceeding were done so under seal as” slip op. at 2
NonePatents in suitUS 11,253,572 - Symrise AG / Symrise Inc. v. Inolex Investment CorporationAdverse judgmentPTAB · Jun 24, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after it disclaimed all challenged claims: 1–7, 9–11, 24–26, 28, 29, 35, and 36.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.73(b), a party may request adverse judgment against itself at any time during a proceeding. The Board construes a “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial” as a request for adverse judgment. See 37 C.F.R. § 42.73(b)(2). Here, we instituted inter partes review of claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 of the ’803 Patent, and Patent Owner has statutorily disclaimed each of those claims. See Ex. 3002. Accordingly, we consider Patent Owner’s disclaimer of the challenged claims as a request for adverse judgment, and we grant that request.” slip op. at 2
NonePatents in suitUS 10,882,803 - Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” 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”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the 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) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - Sun Pharmaceutical Industries Ltd. / Sun Pharmaceutical Industries, Inc. v. Novo Nordisk A/SInstitutedPTAB · May 28, 2024 · IPR2024-00107 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Sun’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“The Director set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation or any alleged “behind the scenes” participation by Petitioner such as paying for experts, participating in expert reports or deposition preparation “in connection with any of the stipulated grounds.” See Paper 14, 1. Petitioner has filed such a stipulation. See Ex. 1099. Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the original statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Mylan IPR, Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.9” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462
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.