- 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 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01488 · 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- 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 board ownDecided for patent owner
“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.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01374 · 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 because Kurrle and Queen 1990 were not prior art …
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. 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. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. 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. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion 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.” Tr. 15:4–16:4.12 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
- Prior constructionDecided for patent owner
“We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to 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. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision
The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22
Patent outcomesUS 6,407,213 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedOther
“Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37
Patent outcomesUS 6,407,213 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Pfizer, Inc. v. Biogen, Inc.All claims unpatentablePTAB · Oct 31, 2018 · IPR2017-01168 · APJ Erica A Franklin · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Moreau, Link, McNeil, Maloney, and Coiffier.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Having considered the evidence and arguments, we determine that, in light of the Specification, the broadest reasonable construction of the claim phrase directed to administering rituximab “in combination with stem cell transplantation,”7 means that the rituximab may be administered “at induction, in vivo purging, mobilization, conditioning, post-transplant reinfusion and at any other time during bone marrow or stem cell transplant for the purpose of improving the survival rate of transplant recipients,” as set forth in the Specification. Ex. 1001, 6:13–17. The Specification describes each of those “various stages of transplantation.” Id. at 6:17–63. In particular, the Specification explains that “‘[i]nduction’ is meant to refer to the initial therapies aimed at achieving induction of remission. Typically, induction involves the administration of some type of chemotherapy, i.e., CHOP.” Ex. 1001, 6:17–20. Thus, we agree with Petitioner that “the administration of the anti-CD20 antibody (e.g., rituximab) at the induction of CHOP chemotherapy but before the actual collecting or transplanting of stem cells” is encompassed in the claim phrase directed to administering rituximab “in combination with stem cell transplantation.” Indeed, Patent Owner acknowledges that “[e]ven administration of an anti-CD20 antibody at an induction stage of a stem cell transplantation regimen can fall within the scope of the claims.” PO Resp. 19.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We determine that construction of additional claim terms is not necessary for purpose of this Decision. See Vivid Techs., Inc. v. Am. Sci. & 7 Independent claim 1 recites “in combination with stem cell transplantation regimen,” and independent claim 5 recites “in combination with stem cell transplantation.” The parties’ proposed constructions treat those phrases the same. We do too, as the Specification uses “stem cell transplantation” and “stem cell transplantation regimen” interchangeably, wherein both phrases refer to the “various stages of transplantation.” See, e.g., Ex. 1001, 6:13–63. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms which are in controversy need to be construed).” slip op. at 8
- Skill levelSkill level board ownOther
“Based upon our consideration of the arguments and evidence, we determine that the record, as a whole, supports finding that a person having ordinary skill in the art of treating NHL, including DLCL, in elderly patients, would have at least an M.D. degree, with more than one year of experience treating patients with NHL as a practicing oncologist or hematologist, and would have had familiarity with published research and clinical trials directed toward treating NHL patients. In particular, Petitioner’s declarant, Dr. Ozer, confirmed that “one to three years” of experience satisfies Petitioner’s and his description of “several years of experience.” Ex. 2008, 15:11–15. Regarding the relevant medical field, Patent Owner asserts that the person of ordinary skill in the art is a “practicing oncologist,” but offers a hematologist as its declarant. PO Resp. 15–16 (citing Ex. 2011 ¶¶ 23–24). Despite that apparent contradiction, we determine that the record as a whole supports finding that a hematologist with the requisite experience treating NHL, including DLCL, also exemplifies a person having ordinary skill in the art. Indeed, Petitioner’s description of the person having ordinary skill in the art is not limited to a practicing oncologist, as Petitioner states the person “include[s] a practicing oncologist.” Pet. 9. Further, Petitioner’s declarant, Dr. Ozer, confirmed that a practicing hematologist with an M.D. degree and the required experience meets his definition of a person having ordinary skill in the art. Tr. 26:3–7. Additionally, we note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Based upon our review of the credentials of Drs. Ozer, Soiffer, and Kahl, we consider each of them to be qualified to provide an opinion on the knowledge of a person of ordinary skill in the art at the time of the invention.8 The relative weight that we assign such testimony, however, is subject to additional factors. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14, 2012) (“Opinions expressed without disclosing the underlying facts or data may be given little or no weight.”).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“disclosure of administering rituximab to a patient during a stem cell transplantation regimen. PO Resp. 23–24. However, such an express disclosure is not required to demonstrate obviousness. Rather, “a patent claiming the combination of elements of prior art” may be shown to be obvious if “the improvement is [no] more than the predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417; see also In re Rosselet, 347 F.2d 847, 851 (CCPA 1965) (“test of obviousness is not express suggestion of the claimed invention in any or all the references but rather what the references taken collectively would suggest to those of ordinary skill in the art”). Petitioner has shown persuasively how the combined teachings of the prior art would have motivated a person of ordinary skill in the art to administer rituximab with CHOP in Moreau’s stem cell transplantation patients for the reasons just discussed. Petitioner has particularly shown how the teachings of Link and McNeil would have provided a person of ordinary skill in the art a reason to add rituximab to CHOP in Moreau’s method, Pet. 44–47, and has further explained how Moreau would have suggested to the artisan that rituximab would be suitable for use in a stem cell transplantation, Pet. 47 (citing Ex. 1008, 10).” slip op. at 18
Patent outcomesUS 8,821,873 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,821,873 - Boehringer Ingelheim Pharmaceuticals, Inc. v. Genentech, Inc.Rehearing deniedPTAB · Jul 9, 2018 · IPR2017-02032 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, upholding institution on all challenged claims and all petition grounds under SAS and the Office’s Guidance.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Our decision to proceed on all grounds is based upon the policy set forth in the Guidance, in view of SAS, along with our determination that Petitioner has shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim in the petition. Regarding that determination, Patent Owner has not persuaded us that we have misapprehended or overlooked any matters. See 37 C.F.R. § 42.71(d).” slip op. at 5
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institution decision left claim 72 unchallenged. Paper 21, 1, 3. After Petitioner filed its rehearing request, the Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., 138 S. Ct. at 1359. In addition, the Office’s Guidance instructs that “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”8 See Guidance. As a result, we granted Petitioner’s rehearing request and instituted trial on all of 8 The Federal Circuit appears to have embraced the approach set forth in the Guidance. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (reading “the SAS opinion as interpreting the statute to require a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). the challenged claims and all of the grounds presented in the Petition. Paper 23, 5.” slip op. at 4
NonePatents in suitUS 6,407,213 - Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.
RulingsFinal written decision- Skill levelSkill level board ownOther
“with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21
- Expert testimonyOther
“Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed
“In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
Patent outcomesUS 9,283,239 unpatentable§ 112 disclosurePatents in suitUS 9,283,239 - Merck Sharp & Dohme Corp. v. Wyeth LLCAll claims unpatentablePTAB · Jun 8, 2018 · IPR2017-00390 · APJ Jacqueline T Harlow · IPR · Final written decision
Claims 7–9, 12, 13, 15, 16, 21, and 22 were held unpatentable as obvious over Chiron, Smith, and Elan, and over Prevenar and Chiron.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“claim term “polysaccharide” is set forth in the Specification. Pet. 28–29. In particular, the Specification defines “polysaccharide” as including “any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a ‘saccharide’, an ‘oligosaccharide’, a ‘polysaccharide’, a ‘liposaccharide’, a ‘lipo-oligosaccharide (LOS)’, a ‘lipopolysaccharide (LPS)’, a ‘glycosylate’, a ‘glycoconjugate’ and the like.” Ex. 1001, 16:32–38. Patent Owner similarly acknowledges that the term “polysaccharide” is expressly defined in the Specification. PO Resp. 12.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“meaning of the phrase. For example, the Specification explains that polysaccharides are “chemically activated (e.g., via reductive amination) to make the saccharides capable of reacting with the carrier protein.” Ex. 1001, 17:35–37. The Specification also explains that “[c]arrier proteins should be amenable to standard conjugation procedures.” Id. at 17:47–50. In particular, the Specification states, “[t]he chemical activation of the polysaccharides and subsequent conjugation to the carrier protein (i.e., a polysaccharide-protein conjugate) are achieved by conventional means.” Id. at 17:43–45. Moreover, as Patent Owner asserts, the Specification describes the polysaccharide-protein conjugates as an example of an “immunogenic composition.” Ex. 1001, 1:29–30. In light of those Specification descriptions, we determine that the broadest reasonable construction of the claim phrase “polysaccharide-protein conjugates” refers to an immunogenic composition resulting from reacting any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a saccharide, an oligosaccharide, a polysaccharide, a liposaccharide, a lipo-oligosaccharide, a lipopolysaccharide, a glycosylate, a glycoconjugate, and the like with a carrier protein that is amenable to standard conjugation procedures.” slip op. at 10
- Skill levelSkill level patent owner adoptedDecided for patent owner
“In the Institution Decision, we adopted Patent Owner’s description of the level of ordinary skill at that stage in the proceeding because it included a requirement for experience relating to polysaccharide-protein conjugates. Dec. Inst. 14. Based on the record as a whole, we determine that a declarant having significant experience relating to protein-silicone oil interactions also 15 offers useful information relating to the subject matter of the challenged claims. Thus, we also recognize those having ordinary skill in the art relating to silicone-induced interactions/aggregation in pharmaceuticals. Thus, we adopt Patent Owner’s description of one having ordinary skill in the art of formulating polysaccharide-protein conjugate immunogenic compositions. Further, we describe one having ordinary skill in the art of silicone-induced interactions/aggregation in pharmaceuticals as either (a) a Ph.D. degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least two years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals, or (b) a Master’s degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least four years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals.” slip op. at 15
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We credit Dr. Kalonia’s testimony that a skilled artisan would have used a siliconized container to store Chiron’s formulation with persuasive weight, as that testimony is supported by Smith’s disclosure, as discussed above. On the other hand, we find that Patent Owner’s assertions and the related opinions by its declarants, e.g., Drs. Morefield (Ex. 2122) and Thomson (Ex. 2125), that a person of ordinary skill would not have found it obvious to use siliconized containers to store Chiron’s formulations are inadequately supported. For example, Patent Owner relies upon Dr. Morefield’s testimony that a siliconized container would not have been used in Chiron’s Example 8 because (a) the example involved a saccharide stability study, and introducing a siliconized container would have injected 28 an unknown parameter into the experiment, and (b) the data demonstrates that the formulation was highly unstable. PO Resp. 25–26 (citing Ex. 2122 ¶¶ 39–42). However, Dr. Morefield has not provided any evidence to suggest that a siliconized container represented an “unknown” parameter. Rather, as evidenced by Smith and Elan, it was a known parameter, with a known solution. Nor has Dr. Morefield accurately characterized the data disclosed in Chiron’s Example 8 as demonstrating Chiron’s formulation was “highly unstable.” Chiron expressly concludes from the data in Example 8 that “[f]ree saccharide levels are thus stable for at least 1 month at 2–8°C, before and after packaging,” and that stability issues arose for two formulations, MenW125 and Men Y, only “[u]nder thermal stress conditions.” Ex. 1011, 15:3–6.” slip op. at 28
Patent outcomesUS 8,562,999 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,562,999 - Merck Sharp & Dohme Corp. v. Wyeth LLCSome claims unpatentablePTAB · Jun 8, 2018 · IPR2017-00380 · APJ Erica A Franklin · IPR · Final written decision
Claims 1–6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious over Prevenar and Chiron; claim 18 was not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Based on the record as a whole, we determine that the Specification sets forth with reasonable clarity, deliberateness, and precision the definition of the term “polysaccharide,” as accurately represented by Petitioner, and acknowledged by Patent Owner. With respect to the phrase “polysaccharide-protein conjugates,” the Specification does not provide a” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“similarly precise definition. However, the Specification generally describes such conjugates in a manner that is consistent with the plain and ordinary meaning of the phrase. For example, the Specification explains that polysaccharides are “chemically activated (e.g., via reductive amination) to make the saccharides capable of reacting with the carrier protein.” Ex. 1001, 17:35–37. The Specification also explains that “[c]arrier proteins should be amenable to standard conjugation procedures.” Id. at 17:47–50. In particular, the Specification states, “[t]he chemical activation of the polysaccharides and subsequent conjugation to the carrier protein (i.e., a polysaccharide-protein conjugate) are achieved by conventional means.” Id. at 17:43–45. Moreover, as Patent Owner asserts, the Specification describes the polysaccharide-protein conjugates as an example of an “immunogenic composition.” Ex. 1001, 1:29–30. In light of those Specification descriptions, we determine that the broadest reasonable construction of the claim phrase “polysaccharide-protein conjugates” refers to an immunogenic composition resulting from reacting any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a saccharide, an oligosaccharide, a polysaccharide, a liposaccharide, a lipo-oligosaccharide, a lipopolysaccharide, a glycosylate, a glycoconjugate, and the like with a carrier protein that is amenable to standard conjugation procedures.” slip op. at 10
- Skill levelSkill level patent owner adoptedDecided for patent owner
“In the Institution Decision, we adopted Patent Owner’s description of the level of ordinary skill at that stage in the proceeding because it included a requirement for experience relating to polysaccharide-protein conjugates. Dec. Inst. 13. Based on the record as a whole, we determine that a declarant having significant experience relating to protein-silicone oil interactions also offers useful information relating to the subject matter of the challenged claims. Thus, we also recognize those having ordinary skill in the art relating to silicone-induced interactions/aggregation in pharmaceuticals. Thus, we adopt Patent Owner’s description of one having ordinary skill in the art of formulating polysaccharide-protein conjugate immunogenic compositions. Further, we describe one having ordinary skill in the art of silicone-induced interactions/aggregation in pharmaceuticals as either (a) a Ph.D. degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least two years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals, or (b) a Master’s degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least four years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals.” slip op. at 15
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“inadequately supported by the testimony of Drs. Morefield (Ex. 2121) and Thomson (Ex. 2124). The portions of the declarations of Drs. Morefield and Thomson relied upon by the Patent Owner do not refer to any evidence to support their opinions that a histidine buffer would not be a beneficial addition to the Prevenar formulation. Rather, those discussions sound of unsubstantiated theoretical concerns, and are speculative at best. At worst, certain of those theories has been refuted in the art. For example, Petitioner directs us to the testimony of one of its declarants, Dr. HogenEsch, who has a Ph.D. in Pathology and Immunology. Reply 13–16. Dr. HogenEsch explains persuasively that, contrary to the speculation of Drs. Morefield and Thomson, “histidine buffer had specifically been reported . . . not to interact with aluminum adjuvant through ligand exchange.” Ex. 1122 ¶ 43. In support of this testimony, Dr. HogenEsch quotes a disclosure from US Patent No. 6,251,678 B17 explaining that, although phosphate-containing buffers are generally not preferred because they may interact with aluminum adjuvants, “the non interaction of histidine . . . buffers with aluminum adjuvant was demonstrated by zeta potential measurements of the surface charge of the aluminum adjuvant.” Id. (quoting Ex. 1109, 3:24–30). We find that the unsupported testimony offered by Patent Owner’s declarants to be outweighed by rebuttal testimony from Dr. HogenEsch and the express disclosures by Chiron relied upon by Petitioner. Generally, as Petitioner and Dr. Kalonia note, Chiron teaches that buffers are a standard component of vaccines. Pet. 40; Ex. 1009 ¶ 128 (citing Ex. 1011, 1:6–7). More specifically, as Petitioner asserts, Chiron teaches that adding histidine buffer to aluminum-adjuvanted pneumococcal CRM197 conjugate formulations comprising a sodium salt is advantageously biocompatible and” slip op. at 23
Patent outcomesUS 8,562,999 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,562,999
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.