- Liquidia Technologies, Inc. v. United Therapeutics CorporationSome claims unpatentablePTAB · Oct 8, 2021 · IPR2020-00770 · APJ John E Schneider · IPR · Final written decision
Claims 1–5, 8, and 9 are unpatentable as obvious over Moriarty and Phares; claims 6 and 7 were not shown unpatentable over either asserted ground.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Here, we do not need to define the outer bounds of the term “pharmaceutical batch” because the parties’ dispute over this term centers on the issue of storage stability.7 Patent Owner argues “the correct construction 6 The parties use the terms “purification” and “isolation” interchangeably in the papers. We use the term “isolation” in this Decision. 7 The parties agree on the “pharmaceutical” aspect of the term. We note the ’901 patent defines “pharmaceutically acceptable” as “being useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable and includes being useful for veterinary use as well as human pharmaceutical use.” Ex. 1001, 5:27–31.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“[A]n invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office.” Graham, 383 U.S. 1, 33. “The prosecution history of a related patent can be relevant if . . . it addresses a limitation in common with the patent in suit.” Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305 (Fed. Cir. 2001); see also Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999) (“When multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation.”). Here, the Specification of the ’901 patent includes the same language “crude treprostinil salts can be stored as raw material at ambient temperature” addressed in the prosecution of the parent ’623 application. Ex. 1001, 17:5–6. More importantly, challenged claim 6 recites the same limitation “preparing a pharmaceutical product . . . after storage” the applicant expressly interpreted there. See Ex. 2028, 193. Because “the same claim limitation is at issue, prosecution disclaimer made on the same limitation in an ancestor application will attach,” the applicant’s interpretation of “storing”/“storage” during the prosecution of the ’623 application applies here. See Omega Eng’g, Inc., v. Raytek Corp., 334 F.3d 1314, 1333 (Fed. Cir. 2003). slip op. at 23
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013). Here, step (c) of challenged claim 1 requires “contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Ex. 1001, 17:27–29 (emphasis added). The claim language itself, thus, dictates that the solution formed in step (b), and not treprostinil isolated from step (b), is the starting material for forming a salt in step (c). The Specification of the ’901 patent supports our determination. Indeed, the Specification touts that one of the advantages of the disclosed process is that “the treprostinil salts can be synthesized from the solution of treprostinil without isolation,” because “[t]he impurities carried over from intermediate steps (i.e. alkylation of triol and hydrolysis of benzindene nitrile) are removed during the carbon treatment and the salt formation step.” Ex. 1001, 17:1–11. As a result, we agree with the argument presented in the Patent Owner Response that “claim 1 requires the solution in which treprostinil is formed be used directly in the next salt-forming step without isolating treprostinil in between.” See PO Resp. 11.” slip op. at 27
- Skill levelSkill level board ownOther
“pharmaceutical manufacturing.” Id. at 23. We find Patent Owner’s definition of the skill level too narrow. Patent Owner relies on the declaration of Dr. Pinal, who testifies that the ’901 patent is “focused on the production of pharmaceutical compositions and products, on a commercial batch-size scale.” Ex. 2002 ¶ 91; see also id. ¶ 92 (opining that organic and medicinal chemists do not have the “requisite skill set for the large-scale manufacture” of drugs); PO Resp. 24 (arguing an ordinarily skilled artisan is aware of “problems encountered in preparing a commercial-scale pharmaceutical product”).” slip op. at 29
Patent outcomesUS 9,604,901 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,604,901 - 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 - Symantec Corp. / Blue Coat Systems LLC v. Finjan, Inc.Some claims unpatentablePTAB · Mar 15, 2017 · IPR2015-01892 · APJ Charles J Boudreau · IPR · Final written decision
Claims 1, 2, and 6 are unpatentable over Swimmer under § 103; claims 5, 10, 11, 14, and 15 were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“consideration of the Preliminary Response (Paper 7) of Patent Owner, Finjan, Inc., we instituted a trial pursuant to 35 U.S.C. § 314(a) with respect to claims 1, 2, 5, 6, 10, 11, 14, and 15 and subsequently joined Case IPR2016-00890 with the instant case. Paper 9 (“Decision on Institution” or “Dec. on Inst.”); see also Paper 30 (copy of decision instituting inter partes review in Case IPR2016-00890 and granting motion for joinder; also filed as IPR2016-00890, Paper 8).” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“1 Case IPR2016-00890 has been joined with the instant proceeding.” slip op. at 1
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We determine that the differences in the declarants’ assertions are negligible and that both assessments are consistent with the ’494 patent and the referenced prior art. For the purposes of the analysis below, we adopt Dr. Medvidovic’s assessment.” slip op. at 22
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner
“As explained in Section III.B.4.a.i, supra, we are persuaded by Dr. Hall-Ellis’s testimony that Swimmer was publicly available at least as early as December 1995 and is, accordingly, prior art at least under 35 U.S.C. § 102(a),6 as well as that Exhibit 1005 represents an authentic 6 As further mentioned in Section II.B, supra, we determined in our Decision on Institution in Case IPR2016-00159 that the ’494 patent is not entitled to any earlier priority date than the November 6, 1997, filing date of the ’388 application, based on the record then before us in that case. See IPR2016- 00159, slip op. at 10–13 (PTAB May 13, 2016) (Paper 8). Because that date is more than one year after December 31, 1995, Swimmer would also be prior art under 35 U.S.C. § 102(b) based on the December 1995 publication date. copy of Swimmer and Exhibit 1010 represents an authentic copy of the Virus Bulletin Proceedings within the meaning of Federal Rule of Evidence 901. Further, Federal Rule of Evidence 401 provides that evidence is relevant if “it has any tendency to make a fact more or less probable than it would be without the evidence” and “the fact is of consequence in determining the action.” Both the Federal Circuit and the Board have recognized that there is a “low threshold for relevancy.” See, e.g., OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1407 (Fed. Cir. 1997); Laird Techs., Inc. v. GrafTech Int’l Holdings, Inc., Case IPR2014-00025, slip op. at 44 (PTAB Mar. 25, 2015) (Paper 45). There is no question on this record that Swimmer is relevant to the patentability of the challenged claims in this case. Accordingly, we deny Patent Owner’s Motion to Exclude as to Exhibits 1005 and 1010.” slip op. at 62
Patent outcomesUS 8,677,494 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,677,494
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.