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Last Updated: April 9, 2025

Litigation Details for Salix Pharmaceuticals, Inc v. Mylan Pharmaceuticals, Inc. (N.D.W. Va. 2015)


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Small Molecule Drugs cited in Salix Pharmaceuticals, Inc v. Mylan Pharmaceuticals, Inc.
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Details for Salix Pharmaceuticals, Inc v. Mylan Pharmaceuticals, Inc. (N.D.W. Va. 2015)

Date FiledDocument No.DescriptionSnippetLink To Document
2015-06-26 117 These include: Patent No. 6,551,620 (“the ‘620 Patent”); Patent No. 8,337,886 (“…the ‘886 Patent”); Patent No. 8,496,965 (“the ‘965 Patent”); and 8,865,688 (“the ‘688 Patent”). The …CONSTRUING PATENT CLAIMS This patent infringement case involves four United States patents issued …‘620, ‘886, and ‘965 Patents, collectively referred to as the Otterbeck patents,1 contain two disputed…dispute one claim term in the ‘688 Patent. The Otterbeck patents cover a controlled External link to document
>Date Filed>Document No.>Description>Snippet>Link To Document
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Litigation summary and analysis for: Salix Pharmaceuticals, Inc v. Mylan Pharmaceuticals, Inc. (N.D.W. Va. 2015)

Based on the search results, here is a summary of the key points regarding the Salix Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. litigation:

  1. This was a Hatch-Waxman patent infringement case filed in the Northern District of West Virginia (case number 1:15-cv-00109-IMK).

  2. Salix sued Mylan for infringement of patents related to Salix's drug Xifaxan (rifaximin), which is used to treat irritable bowel syndrome with diarrhea (IBS-D) and hepatic encephalopathy (HE).

  3. The patents at issue included:

    • Patents directed to HE treatment
    • Patents directed to treating IBS-D using a 550 mg three times daily dosing regimen
    • Patents directed to a specific polymorph form of rifaximin
  4. The district court held a claim construction hearing and issued claim construction rulings.

  5. The case proceeded through summary judgment motions and a bench trial.

  6. Key issues included:

    • Obviousness of the claimed dosing regimens
    • Whether Mylan's proposed generic product would infringe
    • Validity of polymorph claims
  7. The case was appealed to the Federal Circuit (case numbers 17-2636, 18-1320).

  8. On appeal, there were disputes about whether Mylan's law firm (Katten Muchin Rosenman) should be disqualified due to conflicts of interest with Salix's parent company Valeant. The Federal Circuit ultimately disqualified Katten from representing Mylan.

  9. The Federal Circuit issued rulings on issues like obviousness of the dosing regimen claims and validity of the polymorph claims, though the full details of those rulings are not provided in the available search results.

  10. The case highlights issues common in Hatch-Waxman litigation, including claim construction, obviousness of dosing regimens, polymorph patents, and procedural issues like conflicts of interest for law firms representing generic challengers.

This summary provides an overview of the key aspects of the litigation based on the available information. The full Federal Circuit opinion would need to be reviewed for complete details on how all issues were ultimately resolved.

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