Litigation Details for BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD. (N.D.W. Va. 2022)

BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD. (N.D.W. Va. 2022)

Docket		Date Filed	2022-03-09
Court	District Court, N.D. West Virginia	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Thomas Shawn Kleeh
Jury Demand	None	Referred To
Parties	SALIX PHARMACEUTICALS, INC
Patents	10,011,637; 11,142,549; 11,319,346; 11,834,521; 12,146,003; 7,041,786; 7,799,897; 8,637,451; 9,610,321; 9,616,097; 9,919,024; 9,925,231
Attorneys	Garrett Matthew Spiker
Firms	Finnegan Henderson Farabow Garrett & Dunner, LLP
Link to Docket	External link to docket

Details for BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD. (N.D.W. Va. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-03-09				External link to document
2022-03-09	55	Memorandum & Opinion	‘024 patent”), 9,925,231 (“the ‘231 patent”) and 10,011,637 (“the ‘637 patent”).) As part of… United States Patents Nos. 7,041,786 (“the ‘786 patent”), 7,799,897 (“the ‘897 patent”), 8,637,451 (… (“the ‘451 patent”), 9,610,321 (“the ‘321 patent”), 9,616,097 (“the ‘097 patent”), 9,919,024 (“the ‘…approval to market a drug while that drug is on-patent is patent infringement. 35 U.S.C. § 271(e)(2); see …infringing upon the original drug’s patent by waiting out the patent’s term. If so, the applicant includes	External link to document
2022-03-09	91	Amended Complaint	the ’097 patent”), 9,919,024 (“the ’024 patent”), 9,925,231 (“the ’231 patent”) and 10,011,637 (“the ’…786 patent, the ’321 patent, the ’097 patent, the ’024 patent, the ’231 patent or the ’637 patent. …786 patent, the ’321 patent, the ’097 patent, the ’024 patent, the ’231 patent and the ’637 patent; … of the ’786 patent, the ’321 patent, the ’097 patent, the ’024 patent, the ’231 patent and the ’637 … of the ’786 patent, the ’321 patent, the ’097 patent, the ’024 patent, the ’231 patent and the ’637	External link to document
2022-03-09	149	Memorandum	the ’097 patent unless otherwise noted. 2 U.S. Patent Nos. 10,011,637 (“’637 patent”); 11,142,549…9,616,097 (“’097 patent”); 9,610,321 (“’321 patent”); 9,919,024 (“’024 patent”), and 9,925,231 (“’231 patent…BACKGROUND Two patent families are at issue for claim construction. One patent family shares a common…the “purified plecanatide patents”).2 With respect to both patent families, non-party Synergy…originally filed the patent applications (in the 2010-2013 timeframe) and prosecuted the patents. Synergy also	External link to document
2022-03-09	199	Order on Motion to Strike AND Memorandum & Opinion AND Order on Motion to Dismiss for Failure AND Order on Motion for Judgment on the Pleadings	’231 patent”), 10,011,637 (“the ’637 patent”), 11,142,549 (“the ’549 patent”), and 11,319,346 (“the ’346…2 includes the ’321 patent, the ’097 patent, the ’024 patent, and the ’231 patent, which disclose and…Mylan 1 The patents-in-suit are United States Patent Nos. 7,041,786 (“the ’786 patent”), 9,610,321 (… (“the ’321 patent”), 9,616,097 (“the ’097 patent”), 9,919,024 (“the ’024 patent”), 9,925,231 (“the ’231…Id. These patents fall into three patent families. Family 1 includes the ’786 patent, which discloses	External link to document

BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD.: A Comprehensive Litigation Summary and Analysis

Background of the Litigation

The litigation in question, BAUSCH HEALTH IRELAND LIMITED et al v. MYLAN LABORATORIES LTD. et al, case number 1:22-cv-00020, is a patent infringement lawsuit brought under the Hatch-Waxman Act. This case involves Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. (collectively, Plaintiffs) suing Mylan Laboratories Limited and its affiliated entities (collectively, Defendants) for alleged patent infringement related to the drug Trulance® (plecanatide oral tablets)[1][3][5].

The Hatch-Waxman Act and Its Relevance

The Hatch-Waxman Act is a federal law that allows generic drug manufacturers to seek approval from the FDA to market generic versions of brand-name drugs before the expiration of the brand-name drug's patents. Under this act, a generic drug applicant must submit an Abbreviated New Drug Application (ANDA) and certify to the FDA that the patents associated with the brand-name drug are either invalid or will not be infringed by the manufacture, use, or sale of the generic drug. The applicant must also send a "Paragraph IV notice letter" to the patent holder detailing the factual and legal basis for their opinion that the patent is invalid or not infringed[1][3][5].

Key Allegations and Motions

In this case, the Plaintiffs alleged that Mylan infringed the patents-in-suit by filing its ANDA and seeking approval to sell generic forms of Trulance®. Mylan denied all infringement allegations in its answer. The Plaintiffs argued that Mylan's Paragraph IV notice letter did not include non-infringement arguments for every asserted claim of the patents-in-suit and therefore, Mylan should be limited to the defenses raised in the notice letter. The Plaintiffs filed a motion for judgment on the pleadings, asserting that Mylan could not deviate from the defenses in its notice letter[1][3][5].

Court Decision and Rationale

The Northern District of West Virginia denied the Plaintiffs' motion for judgment on the pleadings. The court held that it possesses no authority to penalize any perceived deficiencies in Mylan's Paragraph IV notice letter under the Hatch-Waxman Act and therefore would not limit Mylan to the theories raised in the notice letter. This decision aligns with Federal Circuit precedent and other district court decisions, which have consistently held that generic drug applicants are not limited to the defenses raised in their Paragraph IV notice letters[1][5].

Implications of the Decision

The court's decision is significant because it reaffirms the flexibility that generic drug companies have in developing their defenses during litigation. Despite the requirement to serve a notice letter explaining why the patents-at-issue are invalid or not infringed, generic companies can supplement these defenses in the ordinary course of litigation. This ruling is consistent with earlier decisions from the District of Delaware and the Northern District of Illinois, which also rejected attempts to limit Hatch-Waxman litigations strictly to the defenses raised in notice letters[1][5].

Venue and Jurisdiction

The case was initially filed in the Northern District of West Virginia, a venue that has seen an increase in Hatch-Waxman litigations involving local pharmaceutical companies like Viatris Inc. (formerly Mylan Pharmaceuticals). The court's decision to deny the motion to dismiss and allow the case to proceed in this venue underscores the importance of this jurisdiction in resolving patent infringement disputes under the Hatch-Waxman Act[3][5].

Role of Affiliated Entities

The litigation also involved discussions on the roles of various Mylan entities, such as Mylan Inc., Mylan API U.S. LLC, and Viatris Inc. The court examined whether these entities could be considered "submitters" of the ANDA under 35 U.S.C. § 271(e), which requires participation in the preparation of the ANDA. The court found that merely intending to benefit from the approval of an ANDA is not sufficient; an entity must also participate in the preparation of the ANDA to be considered a submitter[3].

Conclusion on Defenses and Litigation Strategy

The decision in BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD. highlights the strategic importance of the Paragraph IV notice letter in Hatch-Waxman litigation. While the notice letter is a critical document that outlines the generic applicant's position on patent validity and infringement, it does not constrain the applicant's ability to develop additional defenses during the litigation process. This flexibility is crucial for generic drug companies as they navigate the complex landscape of patent infringement litigation.

Key Takeaways

• Flexibility in Defenses: Generic drug companies are not limited to the defenses raised in their Paragraph IV notice letters and can develop additional non-infringement and invalidity contentions during litigation.
• Hatch-Waxman Act Requirements: The act requires generic applicants to submit a detailed notice letter, but this does not restrict their ability to expand their defenses in court.
• Venue Significance: The Northern District of West Virginia is a significant venue for Hatch-Waxman litigations, particularly involving local pharmaceutical companies.
• Entity Roles: Only entities that participate in the preparation of the ANDA can be considered submitters under 35 U.S.C. § 271(e).

FAQs

Q: What is the Hatch-Waxman Act, and how does it relate to generic drug approvals?

The Hatch-Waxman Act allows generic drug manufacturers to seek FDA approval for generic versions of brand-name drugs before the expiration of the brand-name drug's patents. It requires the generic applicant to certify that the patents are invalid or will not be infringed.

Q: What is the significance of the Paragraph IV notice letter in Hatch-Waxman litigation?

The Paragraph IV notice letter is a detailed statement from the generic applicant explaining why they believe the patents-at-issue are invalid or not infringed. However, it does not limit the applicant's ability to develop additional defenses during litigation.

Q: Can generic drug companies raise new defenses during litigation that were not included in their Paragraph IV notice letter?

Yes, according to the court decision in BAUSCH HEALTH IRELAND LIMITED v. MYLAN LABORATORIES LTD., generic drug companies can develop and raise additional non-infringement and invalidity defenses during the litigation process.

Q: What determines whether an entity is considered a submitter of an ANDA under 35 U.S.C. § 271(e)?

An entity must participate in the preparation of the ANDA to be considered a submitter. Merely intending to benefit from the approval of the ANDA is not sufficient.

Q: Why is the Northern District of West Virginia significant in Hatch-Waxman litigation?

The Northern District of West Virginia has seen an increase in substantive Hatch-Waxman litigation involving local pharmaceutical companies like Viatris Inc., making it a crucial venue for resolving these disputes.

Cited Sources

1. District Court Denies Motion for Judgment in Patent Infringement Lawsuit Under Hatch-Waxman Act - BIPC.
2. US7041786B2 - Guanylate cyclase receptor agonists for the treatment of various diseases - Patents Google.
3. Bausch Health Ir. Ltd. v. Mylan Labs. - Casetext.
4. BAUSCH HEALTH IRELAND LIMITED et al v. MYLAN LABORATORIES LTD. et al - Law360.
5. Another Win for Generics: Hatch-Waxman Defendants May Develop Non-Infringement Defenses Beyond Their Notice Letters - Crowell.