{"argument_date":"2017-04-26T00:00:00Z","arguments":[{"argument_date":"2017-04-26T00:00:00Z","heading":"What happened at the argument","official_detail_url":"https://www.supremecourt.gov/oral_arguments/argument_transcript/2016","official_transcript_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","paragraphs":["Ms. Maynard argued the lower court issued a federal judgment.","Ms. Maynard stated Congress provided for injunctive relief in the statute.","Mr. Waxman argued Congress used the word shall to mandate data sharing.","Mr. Waxman claimed applicants cannot disregard statutory mandates after using sponsor information."],"reargument":false,"sequence":1,"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 10, lines 10-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 10, lines 10-26"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 8-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 8-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 14-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 14-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 28-30"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 46-50","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 46-50"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 58, lines 40-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 58, lines 40-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 59, lines 22-28","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 59, lines 22-28"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 6, lines 18-32","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 6, lines 18-32"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 6, lines 40-46","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 6, lines 40-46"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 63, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 63, lines 28-30"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 7, lines 34-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 7, lines 34-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 7, lines 46-48","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 7, lines 46-48"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 8, lines 16-20","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 8, lines 16-20"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 8, lines 6-12","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 8, lines 6-12"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 9, lines 42-44","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 9, lines 42-44"}]}],"caption":"Sandoz Inc. v. Amgen Inc.","case_history":[{"changed_at":"2026-08-29T20:06:21.575297Z","explanation":"An official oral-argument transcript was verified.","status":"argued"},{"changed_at":"2026-08-29T20:06:21.601193Z","explanation":"An official oral-argument transcript was verified.","status":"argued"}],"case_status":"argued","dek":"Sandoz and Amgen dispute the timing of data exchange required before patent litigation can begin.","dek_sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"}],"dispositions":[],"latest_court_document_date":"2017-04-26T00:00:00Z","maturity":"official_transcript","official_detail_url":"https://www.supremecourt.gov/oral_arguments/argument_transcript/2016","official_disposition_urls":[],"official_docket_url":"https://www.supremecourt.gov/docket/docketfiles/html/public/15-1039.html","primary_docket":"15-1039","revisions":[{"correction_note":"Rewritten to the concise citizen-facing editorial standard.","created_at":"2026-08-30T18:36:09.338952Z","maturity":"official_transcript","revision_number":1},{"correction_note":"Migrated to the dated official Court activity contract without model use.","created_at":"2026-09-05T03:22:24Z","maturity":"official_transcript","revision_number":2}],"schema_version":"1.1","sections":[{"heading":"What this case is about","paragraphs":["Sandoz seeks to delay sharing proprietary data with Amgen. Amgen demands immediate data access to start patent litigation. The Court must interpret the statutory timeline for this exchange."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"}]},{"heading":"How the case got here","paragraphs":["The Supreme Court heard oral argument in this case on April 26, 2017."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 8-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 8-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 63, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 63, lines 28-30"}]},{"heading":"What each side wants","paragraphs":["Sandoz wants to delay sharing data with Amgen until the FDA approves the drug.","Amgen wants Sandoz to share data immediately to start patent litigation."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"}]},{"heading":"What each side says","paragraphs":["Sandoz argues the statute allows data sharing only after FDA approval.","Amgen argues the statute mandates immediate data sharing to resolve patent disputes."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"}]},{"heading":"What the justices asked","paragraphs":["Justice Sotomayor asked how long FDA approval takes after Phase II trials.","Justice Sotomayor asked when the FDA announces its intent to approve a drug."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 10, lines 10-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 10, lines 10-26"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 8-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 8-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 14-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 14-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 28-30"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 46-50","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 46-50"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 58, lines 40-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 58, lines 40-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 59, lines 22-28","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 59, lines 22-28"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 6, lines 18-32","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 6, lines 18-32"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 6, lines 40-46","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 6, lines 40-46"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 63, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 63, lines 28-30"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 7, lines 34-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 7, lines 34-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 7, lines 46-48","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 7, lines 46-48"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 8, lines 16-20","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 8, lines 16-20"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 8, lines 6-12","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 8, lines 6-12"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 9, lines 42-44","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 9, lines 42-44"}]},{"heading":"Why it matters","paragraphs":["This case defines the timeline for biosimilar patent litigation. It determines when generic makers must share data. It affects the speed of biosimilar market entry. It shapes the balance between patent rights and competition."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 32-38","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 56, lines 32-38"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 60, lines 38-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 60, lines 38-26"}]},{"heading":"What happens next","paragraphs":["This article currently covers the argument record. Use the official docket link for later case activity."],"sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 10, lines 10-26","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 10, lines 10-26"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 8-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 8-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 14-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 14-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 28-30","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 28-30"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 5, lines 46-50","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 5, lines 46-50"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 58, lines 40-18","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 58, lines 40-18"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 59, lines 22-28","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 59, lines 22-28"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 6, lines 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with the original drug sponsor?","title_sources":[{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 24, lines 4-40","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 24, lines 4-40"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 34, lines 32-6","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 34, lines 32-6"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 4, lines 20-24","official_url":"https://www.supremecourt.gov/oral_arguments/argument_transcripts/2016/15-1039_bqm1.pdf","page_label":"file page 4, lines 20-24"},{"evidence_type":"Transcript","label":"Official Supreme Court Transcript — file page 56, lines 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