Last Updated: July 28, 2026

Litigation Details for Biogen International GMBH v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2017)


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Small Molecule Drugs cited in Biogen International GMBH v. Mylan Pharmaceuticals Inc.
The small molecule drugs covered by the patents cited in this case are ⤷  Start Trial , ⤷  Start Trial , and ⤷  Start Trial .

Details for Biogen International GMBH v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2017)

Date Filed Document No. Description Snippet Link To Document
2017-06-30 External link to document
2017-06-30 1 Complaint “the ‘999 patent”), 7,619,001 (“the ‘001 patent”), 7,803,840 (“the ‘840 patent”), 8,759,393 (“the ‘393…- 376 Patent, # 2 Exhibit B - 999 Patent, # 3 Exhibit C - 001 Patent, # 4 Exhibit D - 840 Patent, # 5 …is an action for patent infringement of U.S. Patent Nos. 6,509,376 (“the ‘376 patent”), 7,320,999 (“the…393 patent”) and 8,399,514 (“the ‘514 patent”) arising under the patent laws of the United States, Title…5 Exhibit E - 393 Patent, # 6 Exhibit F - 514 Patent, # 7 Civil Cover Sheet)(lmm) (Entered: 06/30/2017 External link to document
2017-06-30 142 Status Report infringement of U.S. Patent Nos. 6,509,376 (“the ’376 patent”), 7,320,999 (“the ’999 patent”), 7,619,001 … (“the ’001 patent”), 7,803,840 (“the ’840 patent”), 8,759,393 (“the ’393 patent”) and 8,399,514 … the patents-in-suit. The ’393 patent has expired. It is Mylan’s position that this patent should be…partes review (“IPR”) of Biogen’s ’514 patent. Biogen’s Patent Owner’s Preliminary Response is due on…for regulatory patent term extension (“PTE”) on the ’376, ’999, ’001, and ’840 patents. Under the relevant External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Biogen International GmbH v. Mylan (No. 1:17-cv-00116): Litigation Summary, Claims at Issue, and Risk Analysis for US Generic/Patent-Orange-Book Strategy

Last updated: July 25, 2026

Biogen International GmbH sued Mylan Pharmaceuticals Inc. in the Northern District of West Virginia over alleged patent infringement tied to Mylan’s FDA submission for a Biogen product. Case No. 1:17-cv-00116 reached post-filing procedural milestones typical of Hatch-Waxman patent disputes and was litigated as a US patent infringement matter under the 35 U.S.C. § 271(e)(2) framework for ANDA-triggered infringement risk.

A complete, decision-grade litigation summary requires docket-resolved facts (asserted patents, claim construction outcomes, infringement findings, settlement or dismissal terms, and any appeal disposition). Those specific docket facts are not available in the provided input, so an accurate litigation summary cannot be produced without fabricating the record.

What patents did Biogen International GmbH assert in v. Mylan (1:17-cv-00116)?

Answer: Not determinable from the provided information.

Which Biogen drug and Orange Book patents were implicated

Answer: Not determinable from the provided information.

Were method-of-use, formulation, or device claims asserted

Answer: Not determinable from the provided information.

What was Mylan’s Paragraph IV theory in 1:17-cv-00116?

Answer: Not determinable from the provided information.

Was the dispute driven by ANDA or other FDA pathway

Answer: Not determinable from the provided information.

What certifications and “section viii” details were at issue

Answer: Not determinable from the provided information.

How did the court rule on preliminary relief or procedural motions?

Answer: Not determinable from the provided information.

Did Biogen seek a TRO or preliminary injunction

Answer: Not determinable from the provided information.

Key motion categories typically seen in Hatch-Waxman cases

Answer: Not determinable from the provided information.

What did claim construction decide in 1:17-cv-00116?

Answer: Not determinable from the provided information.

Claim construction impacts on infringement posture

Answer: Not determinable from the provided information.

Were indefiniteness or non-enablement raised

Answer: Not determinable from the provided information.

What was the litigation end state: settlement, dismissal, or final judgment?

Answer: Not determinable from the provided information.

If settled, what were the typical commercial terms

Answer: Not determinable from the provided information.

If dismissed, what were the legal grounds

Answer: Not determinable from the provided information.

What does 1:17-cv-00116 imply for generic entry risk against Biogen’s patent estate?

Answer: Not determinable from the provided information.

Timeline impact: when exclusivity/patents would have blocked launch

Answer: Not determinable from the provided information.

Potential “design-around” pathways

Answer: Not determinable from the provided information.

Which court outcomes mattered most for future litigations involving Mylan/other ANDA filers?

Answer: Not determinable from the provided information.

How outcomes affect later Paragraph IV suits

Answer: Not determinable from the provided information.

Whether the decision created issue-preclusion or persuasive reasoning

Answer: Not determinable from the provided information.

How does this case compare with other Biogen v. ANDA litigations?

Answer: Not determinable from the provided information.

Comparative strength signals

Answer: Not determinable from the provided information.

Comparative settlement patterns

Answer: Not determinable from the provided information.

Commercial exposure: what launch protection did Biogen obtain (or lose) in this matter?

Answer: Not determinable from the provided information.

Time-to-entry and shelf-risk

Answer: Not determinable from the provided information.

Revenue sensitivity to a Mylan entry

Answer: Not determinable from the provided information.

Key Takeaways

  • No defensible litigation record summary can be stated from the provided input.
  • No asserted patents, procedural rulings, claim construction, or disposition can be reported for No. 1:17-cv-00116 without docket-resolved facts.

FAQs

  1. Does Biogen v. Mylan 1:17-cv-00116 involve ANDA litigation under §271(e)(2)?
  2. Which asserted patents are typically listed first in Biogen’s complaints for cases like 1:17-cv-00116?
  3. What claim construction outcomes most often drive the infringement analysis in Hatch-Waxman cases involving Biogen products?
  4. How do settlement and dismissal orders usually affect FDA launch timing in §271(e)(2) cases?
  5. What Orange Book status changes would signal reduced risk after a final disposition?

References

  1. Not provided in the input.

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