- Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3
§ 112 disclosurePatents in suitUS 10,993,942 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441
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.