- Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,407,213 - Hospira, Inc. v. Genentech, Inc.Institution deniedPTAB · Jul 27, 2017 · IPR2017-00739 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–11 and 14–17 under § 325(d), finding the priority issue and Nabholtz ground had been considered during prosecution.
RulingsInstitution decision- BurdenDecided for patent owner
“Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“established priority for those claims based upon the parent application’s specific disclosure of using growth inhibitory agents as part of the present invention. (Ex. 1119-5 at 179 (citing Ex. 1121 at 20 (16:11- 24), 39 (35:6-14), 41 (37:9-18).) Based upon that disclosure, the examiner agreed that the claims reciting a combination with “a further growth inhibitory agent” were supported by, and thus entitled to priority to, the parent applications. (Ex. 1119-5 at 41; id. at 292-93; Ex. 1119- 6 at 245.) Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner
“combination are needed to demonstrate that they can be usefully combined,’” flatly contradicts Patent Owner’s position that the ’649 Application and ’346 Provisional Application adequately disclose the claimed invention. Pet. 17–18 (citing Ex. 1119-5, 308–09). We do not find Petitioner’s argument persuasive. As an initial matter, Petition fails to address the “Wands” factors in its enablement analysis. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“As discussed in section II(B), above, the Examiner considered fully the written description and enablement issues underlying Applicant’s claim to priority in allowing the claims to issue, and Petitioner has not presented new evidence or arguments that would convince us that the Examiner’s determination was unreasonable. The Examiner’s decision to withdraw the rejection under 35 U.S.C. § 102(b) over Nabholtz was expressly predicated on that priority determination, which removed Nabholtz as prior art. In Ground I of this Petition, Petitioner also asserts that the claims are unpatentable under § 102(b) over Nabholtz, thus raising “the same or substantially the same prior art or arguments previously [] presented to the Office” as contemplated under 35 U.S.C. § 325(d). Under the circumstances of this case, we exercise our discretion under § 325(d) and decline to institute inter partes review based on Ground I.” slip op. at 18
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 7,892,549 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Galderma Laboratories, Inc.Institution deniedPTAB · Feb 16, 2016 · IPR2015-01778 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because the petitioner did not show a reasonable likelihood that claims 1, 7, 8, 14, 15, and 20 were unpatentable over the asserted references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“CONCLUSION Petitioner does not convince us that non-provisional parent applications of the ’506 patent (as represented by the specification of the ’506 patent) fail to provide adequate written descriptive support for the challenged claims. Accordingly, we do not agree with Petitioner’s contention that the ‘506 patent is not entitled to the benefit of the April 5, 2002, filing date of the earliest of those applications under 35 U.S.C. § 120 such that Ashley ’572, Ashley ’267, and/or ORACEA would qualify as prior art.10 Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1, 7, 8, 14, 15, and 20 are unpatentable in view of the asserted references. ORDER Accordingly, it is ORDERED that the Petition is denied as to all challenged claims of the ’506 patent.” slip op. at 17
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“We do not find Petitioner’s arguments persuasive. As an initial matter, we note that Petitioner has not established that the term “acne rosacea” was “antiquated and outdated” as of the earliest filing date of the chain of applications leading to issuance of the ’506 patent. Nor does Petitioner establish that one of ordinary skill in the art would not have understood that term to indicate rosacea—a condition commonly known to encompass inflammatory papules and pustules, albeit not comedones. See Pet. 22; Prelim. Resp. 18–19; Ex. 1004 ¶ 13; Ex. 1034, 144. To the extent a dermatologist would not, as Petitioner argues, “have lumped [acne vulgaris and rosacea] together in a single genus,” does not persuade us that written description is lacking. An inventor may choose to be his own lexicographer and give terms uncommon meanings if “done with reasonable clarity, deliberativeness, and precision.” See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the present case, we find no ambiguity in the ’506 patent’s definition of the invention as directed to the treatment of “all known types of acne,” including both acne vulgaris and rosacea. See Ex. 1001, 4:31–43. The ’506 patent characterizes the genus acne as “a disorder of the skin characterized by papules, pustules . . . and other blemishes or skin lesions,” and notes that rosacea evinces specific characteristics of “inflammatory lesions (erythema) and permanent dilation of blood vessels (telangiectasia).” Id. at 4:23–30, 41–43. We are not persuaded that written description is lacking because not all of the symptoms attributed to the genus acne apply to rosacea, or that a symptom specific to rosacea (i.e, telangiectasia) may only be treated surgically. See Pet. 23. Rather, we find it sufficient that the specification teaches the treatment of papules and pustules of the genus “acne”—expressly defined by the inventor as including rosacea.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“CONCLUSION Petitioner does not convince us that non-provisional parent applications of the ’506 patent (as represented by the specification of the ’506 patent) fail to provide adequate written descriptive support for the challenged claims. Accordingly, we do not agree with Petitioner’s contention that the ‘506 patent is not entitled to the benefit of the April 5, 2002, filing date of the earliest of those applications under 35 U.S.C. § 120 such that Ashley ’572, Ashley ’267, and/or ORACEA would qualify as prior art.10 Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1, 7, 8, 14, 15, and 20 are unpatentable in view of the asserted references.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“i. Rosacea The parties agree that the ’506 patent identifies rosacea (“acne rosacea”) as a form of acne. Pet. 30–31; Prelim. Resp. 7. Although Petitioner contends that one of ordinary skill in the art would not classify rosacea as a form of acne (Pet. 22; Ex. 1004 ¶¶ 12, 13), we apply the inventor’s clearly expressed definition that “acne include[s] . . . acne rosacea” (Ex. 1001 4:31–41). With respect to the symptoms of rosacea, however, neither party contends that uncommon meanings apply. Pet. 30– 31; Prelim. Resp. 6–8. We therefore construe rosacea as a form of acne having symptoms including papules, pustules, erythema, and telangiectasia, where the predominant lesions are papules and pustules. See Ex. 1001, 4:23–43; Ex. 1004, ¶¶ 7, 19 (“‘The predominant lesions [in rosacea] are papules and pustules.’ ([Ex. 1056] at 680; see also Exh. 1046, at 852, 958; Exh. 1047, at 1023, 1175.).”” slip op. at 9
Claim construction§ 102 anticipation§ 112 disclosurecites PhillipsPatents in suitUS 8,603,506
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.