Last updated: June 22, 2026
Biogen International GMBH v. Stason Pharmaceuticals, Inc. (8:17-cv-01133): Litigation Summary, Claims at Issue, and Case-Timeline Analysis
Executive summary: The record available for Biogen International GMBH v. Stason Pharmaceuticals, Inc., No. 8:17-cv-01133 supports only a high-level listing of the case caption and docket number, without enough case-specific content (claims asserted, patents-in-suit, asserted Orange Book listings, procedural history, or outcomes) to produce an accurate litigation summary or infringement/invalidity analysis.
What is Biogen International GMBH v. Stason Pharmaceuticals, Inc. 8:17-cv-01133 and why is it in district court?
Short answer: This appears as a federal civil action filed in the U.S. District Court under case number 8:17-cv-01133 with Biogen International GMBH as plaintiff and Stason Pharmaceuticals, Inc. as defendant. No additional, case-specific allegations or legal theories can be confirmed from the information provided.
What court and jurisdiction does 8:17-cv-01133 sit in?
Short answer: The action is identified only by the docket number and party names. No jurisdiction, venue details, or presiding judge information is provided in the input.
What legal cause of action is typically at issue in this case type?
Short answer: For this docket profile, typical drivers include patent infringement connected to regulated drug supply. But the specific statutory basis (e.g., 35 U.S.C. §§ 271(e)(2), 271(a), or Hatch-Waxman/§ 505(b)(2) related theories) and the instrumental facts cannot be validated from the supplied data.
What patents were asserted in Biogen International GMBH v. Stason Pharmaceuticals, Inc. (8:17-cv-01133)?
Short answer: The patents-in-suit are not specified in the information provided, so the patent estate and claim scope cannot be reconstructed.
How many patents cover the product at issue?
Short answer: Not determinable from the provided details.
Which patent families were likely targeted (composition, formulation, method-of-use, process)?
Short answer: Not determinable from the provided details.
Which drug and FDA listing triggered the litigation in 8:17-cv-01133?
Short answer: The active ingredient, NDA/BLA/ANDA, and FDA Orange Book listing(s) tied to the litigation are not identified.
What is the Orange Book status for the drug linked to this case?
Short answer: Not determinable without the drug/label and listed patents.
Was the dispute driven by Paragraph IV, Paragraph I, or other FDA pathway triggers?
Short answer: Not determinable from the provided details.
What claims and defenses were argued in the case?
Short answer: The record needed to summarize infringement theories, claim construction positions, invalidity grounds, and equitable defenses is not included in the provided information.
Claim construction and validity arguments typically included
Short answer: These include issues such as anticipation/obviousness, written description/enablement, indefiniteness, prosecution history, and non-infringement. The exact arguments in this docket cannot be confirmed from the supplied data.
What is the litigation timeline for 8:17-cv-01133 from filing to resolution?
Short answer: No filing date, claim-building events, Markman schedule, summary judgment dates, trial dates, or final disposition dates are provided.
Key procedural milestones that must be extracted from the docket
Short answer: A complete timeline would normally include complaint filing, service, answer, amended pleadings, scheduling order, Rule 12 motions, Markman order, expert disclosure deadlines, dispositive motions, and final judgment or settlement. None of these milestones are present in the provided input.
When did exclusivity expire and when was the earliest generic/biosimilar entry risk?
Short answer: This depends on the specific drug, patent expiry dates, and exclusivity listed in the Orange Book. The drug and listed patents are not identified, so exclusivity and entry risk cannot be calculated.
How strong is the patent estate for Biogen in this dispute?
Short answer: Not calculable without identifying the patents-in-suit, their filing/priority data, claim scope, and expiration posture.
Expiration, terminal disclaimers, PTA, and continuation impact
Short answer: Not determinable from the provided details.
What was the infringement analysis: literal infringement vs. equivalents?
Short answer: Not determinable from the provided details.
What generic launch or product design changes were implicated?
Short answer: Not determinable from the provided details.
Did the parties settle, and what terms were reflected in the public record?
Short answer: No settlement terms or disposition document identifiers are provided.
Was there a consent judgment or dismissal with prejudice?
Short answer: Not determinable from the provided details.
How does this case compare with other Biogen patent litigations against generics?
Short answer: Without knowing the drug and asserted patents, no meaningful comparison can be made.
Key Takeaways
- The input identifies Biogen International GMBH v. Stason Pharmaceuticals, Inc. under docket 8:17-cv-01133, but it does not include the case documents or case-specific facts required to deliver an accurate litigation summary and analysis.
- The patents-in-suit, drug/FDA listing trigger, claims asserted, defenses, procedural timeline, and outcome are not specified, so a substantive legal analysis cannot be produced from the provided information.
FAQs
- What does case number 8:17-cv-01133 indicate about the filing posture and timing?
- How do I identify the patents-in-suit for Biogen v. Stason from the docket?
- What Orange Book listings usually connect to Biogen patent infringement suits involving Stason-type ANDA filings?
- How should claim construction and indefiniteness rulings be weighed in Hatch-Waxman patent cases?
- What settlement patterns are common when a defendant agrees to design-around a formulation or method-of-use patent?
References (APA)
- Biogen International GMBH v. Stason Pharmaceuticals, Inc., No. 8:17-cv-01133 (U.S. District Court docket).
