- 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 - 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 - PTAB · Apr 25, 2024 · IPR2024-00009 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petition grounds, declined discretionary denial, and granted joinder with IPR2023-00724.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Director Vidal 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. Petitioner has filed such a stipulation. Reply 2 (“Petitioners stipulate that, if instituted, they will not pursue in the parallel district court proceeding the same grounds as in the Petition or any grounds that could have reasonably been raised therein”). 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 current statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See 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.10” 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
“response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter parties review under section 314. As the moving party, Petitioner bears the burden of proving that it is 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 - PTAB · Mar 19, 2024 · IPR2024-00181 · APJ Timothy G Majors · IPR · Institution
The Board instituted inter partes review of claims 1–29 and granted Inari’s contingent motion to join the Bayer 1038 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1038 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1038 IPR, Paper 12. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’745 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1038 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Furthermore, a motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
- Other 314aOther
“prevailing, as it is substantively identical to the successful petition upon which we instituted the Bayer 1038 IPR. However, institution of an inter partes review is discretionary. See 35 U.S.C. § 314(a) (authorizing institution of an inter partes review under particular circumstances, but not requiring institution under any circumstances); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”); SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (“[Section] 314(a) invests the Director with discretion on the question whether to institute review . . . .” (emphasis omitted)); Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). I would exercise that discretion here and deny the Petition. The Bayer 1038 IPR is governed by the petition filed by Bayer. See Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020) (“The already-instituted IPR to which a person may join as a party is governed by its own petition and is confined to the claims and grounds challenged in that petition.”). However, “[t]he instant Petition is substantively identical to the petition filed by Bayer, challenging the same claims of the ’745 patent on the same grounds and relying on substantively identical expert testimony.” Pet. 3. Thus, institution based on the instant Petition creates a second inter partes review that is duplicative of the Bayer 1038 IPR. As we are already granting Inari’s request to join the Bayer 1038 IPR as a petitioner, I see no benefit to granting Inari’s Petition to institute a second inter partes review. I would deny Inari’s Petition.” slip op. at 11
Discretionary denialPatents in suitUS 11,299,745 - PTAB · Mar 19, 2024 · IPR2024-00180 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR of claims 1–29 based on a reasonable likelihood of success and granted Inari’s motion to join the Bayer 1037 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1037 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1037 IPR, Paper 12. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’283 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1037 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Furthermore, a motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
NonePatents in suitUS 11,149,283 - PTAB · Mar 19, 2024 · IPR2024-00179 · APJ Timothy G Majors · IPR · Institution
The Board instituted review of claims 1–34 on all four asserted grounds and granted Inari’s motion to join the Bayer 1036 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1036 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1036 IPR, Paper 11. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’555 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1036 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
NonePatents in suitUS 10,947,555 - PTAB · Jan 31, 2024 · IPR2024-00298 · APJ Ryan H Flax · IPR · Institution
Instituted IPR on claims 1–30 of the ’572 patent on all asserted grounds and granted Biocon’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Therefore, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 9
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. We determine whether to grant joinder on a case-by-case basis, taking into account the particular facts of each case, substantive and procedural issues, and other considerations. When exercising that discretion, we are mindful that patent trial regulations, including the rules for joinder, must be construed to secure the just, speedy, and inexpensive resolution of every proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: (1) set forth the reasons joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; and (3) 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); see also, USPTO, America Invents Act (AIA) Frequently Asked Questions,” available at: uspto.gov/patents/laws/americainvents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partesreview_3244 (last visited February 2, 2022). B.” slip op. at 10
NonePatents in suitUS 11,253,572 - PTAB · Jan 30, 2024 · IPR2024-00260 · APJ Ryan H Flax · IPR · Institution
Instituted review of claims 1–30 on all asserted grounds and granted Celltrion’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is similarly likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Based on the record before us, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner certifies and we agree that the Petition is substantively identical to that of IPR’884, where we found Samsung had met its burden to show a reasonable likelihood it would prevail at trial in establishing at least one challenged claim unpatentable under the asserted grounds. Mot. 5; see generally IPR’884 DI. Petitioner also certifies, and we agree, that it relies on the same evidence here as in IPR’884. Mot. 5. Patent Owner waives its right to file a preliminary response in this proceeding, for the sake of efficiency. See Paper 7, 2. Petitioner also certifies that it will be a “silent understudy” to Samsung in IPR’884 if the proceedings are joined, thus, there will be no impact to the schedule of that instituted trial. Mot. 5–6. Moreover, Petitioner asserts that, structured in this way, the joined proceeding will simplify briefing and discovery (i.e., they will be singular, rather than occurring in two proceedings). Id. at 6–7.” slip op. at 12
NonePatents in suitUS 11,253,572 - PTAB · Jan 16, 2024 · IPR2024-00201 · APJ John G New · IPR · Institution
The Board instituted review of claims 10–12, 17–19, 21, 25–28, and 33 on three §103 grounds, and granted Biocon’s motion to join IPR2023-00739.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“concluded that Samsung had demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See, generally, -00739 IPR, Paper 9 (“Inst. Dec.”). The present Petition advances essentially identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning as in our -00739 Institution Decision, and conclude that Petitioner is similarly likely to prevail in demonstrating the unpatentability of the same challenged claims.” slip op. at 7
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“(c) JOINDER. — If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: (1) set forth the reasons joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; and (3) 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); see also, USPTO, America Invents Act (AIA) Frequently Asked Questions,” available at: uspto.gov/patents/laws/americainvents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partes-review_3244 (last visited February 2, 2022). We are persuaded by Petitioner’s arguments that joinder in these circumstances is appropriate. Petitioner undertakes to act as a “silent understudy” in the joined inter partes reviews and to take no active role in the joined inter partes reviews, unless Samsung ceases to act as a party. Mot. 6–7. The challenged claims and grounds of the Petition are identical to those of the -00739 IPR. Id. at 7. Petitioner’s Motion is timely and should have no effect upon the trial schedule established for the -00739 IPR. Id. at 8.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“As for the Fintiv factors, we considered Patent Owner’s arguments in the Institution Decision of the -00739 IPR, and we find the substantially same arguments in Patent Owner’s Opposition no more persuasive upon repetition. See Inst. Dec. 55–61. Again, we emphasize that although trial may have concluded in the district court litigation, as well as in the -01226 IPR, there nevertheless remains a substantial number of ’601 patent claims that have been challenged only in the -00739 IPR. We conclude that this fact warrants exercise of our discretion to institute inter partes review and to grant Petitioner’s Motion for Joinder of the present inter partes review with the -00739 IPR.” slip op. at 9
Discretionary denialPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00532 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach Grounds 2–6.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. As an initial matter, we are not persuaded by Patent Owner’s reliance on Sanofi and Eli Lilly. See PO Resp. 9. In Sanofi, a non-precedential decision, the Federal Circuit held that the preamble to the claims at issue, reciting “[a] method of increasing survival comprising administering to a patient in need thereof” was limiting upon the claims, in conformance with the court’s prior decisions in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). Sanofi, 757 F. App’x at 992–93. Furthermore, the court held that, because the preamble was limiting, and recited a “method of increasing survival” the proposed claims would now clearly require “increasing survival.” Id. at 994. The preamble to claim 1 of the ’681 patent, however, recites no such “increase” with respect to efficacy, but merely recites “A method for treating an angiogenic eye disorder in a patient,” and the remainder of the claim requires no specific efficacy requirement. Nor does Eli Lilly support Patent Owner’s position. In Eli Lilly, the court upheld the Board’s conclusion that the preamble reciting “a method for treating headache in an individual” was limiting upon the claims. Eli Lilly, 8 F.4th at 1343. However, it noted, in upholding the Board’s conclusion, the Board also “found that while the claims encompass a clinical result, they do not require such a result.” Id. (emphasis added). We also find that the similar language of the preamble to challenged claim 1 of the ’681 patent, although encompassing clinical efficacy, does not require it, let alone a “high degree of efficacy.”” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“the preamble’s recitation of a “method for treating” requires a high level of efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar argument because it required improperly importing limitations into the claims. See Ex. 3001, 22. Specifically, the Board found that: [W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification 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 such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly, although the claims “encompass a clinical result, they do not require such a result.” Eli Lilly, 8 F.4th at 1343. We consequently reject” slip op. at 35
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration. Ex. 1001, col. 3 ll. 34–44. Petitioner also notes that the Specification further explains that “the immediately preceding dose” means “in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001, col. 3, ll. 54–59; Ex. 1002 ¶¶ 44–45). 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.” slip op. at 37
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“As Petitioner states, Patent Owner relies upon these Exhibits as objective secondary evidence of non-obviousness. See, e.g., PO Resp. 65– 69. However, and as we explain below, because we find that the challenged claims are anticipated by Dixon, we do not reach Patent Owner’s arguments that the claims are non-obvious (Grounds 4–6) or its contentions regarding secondary considerations of non-obviousness. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (holding that “secondary considerations are not an element of a claim of anticipation”). Consequently, we dismiss Petitioner’s motion to dismiss the Financial Documents as moot.” slip op. at 10
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681
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