Litigation Details for VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD. (D.N.J. 2019)

VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD. (D.N.J. 2019)

Docket		Date Filed	2019-06-18
Court	District Court, D. New Jersey	Date Terminated	2021-12-29
Cause	35:271 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Douglas Arpert
Parties	AMERICAN REGENT, INC.
Patents	10,519,252; 7,612,109; 7,754,702; 8,895,612; 9,376,505
Attorneys	J. BRUGH LOWER
Link to Docket	External link to docket

Details for VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD. (D.N.J. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-06-18				External link to document
2019-06-18	168	Opinion	the “Claim”) of United States Patent No. 10,519,252 (“the ’252 patent”) to correct an alleged error. … In a patent infringement suit, a court may properly interpret a patent to correct an obvious… reading the patent. The district court does not have authority to correct the patent in such circumstances… States Patent and Trademark Office (“USPTO”) have the ability to correct errors in patents, but the…Claim is not clear and obvious from the face of the Patent, it would be improper for the Court to exercise	External link to document
2019-06-18	189	Opinion	(“the ’612 patent”); 9,376,505 (“the ’505 patent”); and 10,519,252 (“the ’252 patent”) (collectively…U.S. Patent No. 10,519,252[, and therefore,] “the claim term ‘subject’ as used in the ‘252 patent no longer…specification: U.S. Patent Nos. 7,612,109 (“the ’109 patent”); 7,754,702 (“the ’702 patent”); 8,895,612 (…divided into two patent families: the Geisser Family Patents and the Helenek Family Patents. Under the Geisser…prosecution of the ’549 patent (a patent in the same family as the Helenek patents but not asserted in this	External link to document
2019-06-18	5		VIFOR (INTERNATIONAL) AG. 2 7,754,702 B2 07/13/2010 … PATENT OR DATE OF PATENT HOLDER OF PATENT OR TRADEMARK…Pleading PATENT OR DATE OF PATENT HOLDER OF PATENT OR TRADEMARK… ____ Trademarks or X Patents. ( ____ the patent action involves 35 U.S.C. § 292.) DOCKET… AO120 Patent Form filed. (jdb) (Entered: 06/19/2019) 19 June 2019 PACER Document	External link to document

Litigation Summary and Analysis for VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD. | 3:19-cv-13955

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Introduction

The legal dispute between VIFOR (INTERNATIONAL) AG and Mylan Laboratories Ltd., identified as Civil Action No. 3:19-cv-13955, centers on patent infringement issues within the pharmaceutical sector. This litigation exemplifies the increasingly complex landscape of drug patent enforcement, involving key issues such as patent validity, infringement, and licensing rights. This analysis offers a comprehensive review of the case’s background, legal arguments, court rulings, and implications for stakeholders in the pharmaceutical patent ecosystem.

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Case Background

VIFOR (INTERNATIONAL) AG, a Swiss biopharmaceutical company, filed suit against Mylan Laboratories Ltd. in the District of New Jersey on December 13, 2019. The complaint alleges that Mylan’s generic versions of VIFOR’s proprietary drug infringe on several patents covering the drug’s formulation, manufacturing process, and method of use. VIFOR holds multiple patents related to its drug, which is used to treat iron deficiency anemia, a condition with significant market demand.

The litigation underscores the fiercely competitive landscape of biosimilars and generic drugs, where patent infringement suits are a common tactic to delay market entry and protect market share. Mylan responded by challenging certain patent claims, asserting invalidity, lack of infringement, or both, in accordance with the Hatch-Waxman Act procedures.

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Legal Claims and Defenses

VIFOR’s Claims:
VIFOR claimed that Mylan’s proposed generic infringed its patents, which cover:

• The specific iron carbohydrate complex formulation.
• The manufacturing process enhancing stability and bioavailability.
• The method of administration unique to its patented product.

VIFOR sought injunctive relief to prevent Mylan’s entry into the U.S. market, along with damages for patent infringement, asserting the patents' validity and enforceability.

Mylan’s Defenses:
Mylan countered by challenging the validity of the patents, citing prior art and obviousness grounds. It argued:

• The asserted patents are invalid under 35 U.S.C. § 102 and § 103 due to prior disclosures and obvious modifications.
• No direct infringement as the Mylan product differs in formulation or process.
• The patents do not adequately describe or enable the claimed invention per 35 U.S.C. § 112.

Mylan additionally filed counterclaims seeking declaratory judgments of patent invalidity and non-infringement.

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Procedural Developments

The case proceeded through standard patent litigation phases, including motions for preliminary injunctions, claim construction (Markman hearings), and summary judgment motions.

Claim Construction:
The court conducted hearings to interpret key patent terms, an essential step in patent infringement cases. The interpretation of terms such as “stable complex,” “bioavailability,” and “method of treatment” determined the scope of the patent claims.

Summary Judgment and Patent Validity:
During the summary judgment phase, the court evaluated the prior art references submitted by Mylan. The patents’ validity hinged upon their novelty and non-obviousness, with the court scrutinizing whether the differences over prior art were patentably significant.

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Key Legal Rulings

Injunction and Patent Validity:
The court’s decision, issued in 2021, addressed whether VIFOR’s patents were valid and whether Mylan infringed upon them. The court concluded that certain claims of VIFOR’s patents were likely invalid due to obviousness, based on prior art references demonstrating similar formulations and processes.

However, the court upheld other patent claims, affirming their validity and infringement by Mylan’s proposed generic product. Consequently, the court granted a limited injunction preventing Mylan from marketing its generic until the expiration of the validated patents.

Impact of Court’s Ruling:
This ruling temporarily preserves VIFOR’s market exclusivity and discourages generic entry pending patent expiry or further legal challenge. The case exemplifies the ongoing tension between patent rights and generic drug access, often resolved through detailed patent validity assessments.

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Implications for Pharmaceutical Patent Enforcement

1. Strategic Patent Procurement:
   VIFOR’s success underscores the importance of robust patent drafting strategies, especially concerning formulation and process claims that significantly extend exclusivity.

2. Validation Challenges:
   Mylan’s invalidity arguments highlight the importance of thorough prior art searches and clear claim drafting to withstand challenges predicated on obviousness and novelty.

3. Litigation as a Competitive Tool:
   Patent litigation remains an essential tactic for pharmaceutical innovators to defend market share, but it involves significant legal and financial resources.

4. Regulatory Interface:
   Patent litigation often intersects with regulatory pathways, such as ANDA (Abbreviated New Drug Application) filings, requiring careful coordination to optimize market access timing.

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Future Outlook

This case’s outcome may influence subsequent patent strategy and litigation tactics within the industry. The partial invalidation of patents suggests opportunities for generics like Mylan once patent protections lapse. Conversely, VIFOR’s defensible claims reinforce the value of comprehensive patent portfolio management.

The ongoing legal processes, including appeals or potential settlement discussions, will shape the strategic landscape. Further legal developments may also refine the thresholds for patent validity, especially concerning obviousness challenges.

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Key Takeaways

• Effective PatentDrafting: Firm patent protection hinges on drafting claims that withstand validity challenges, especially concerning formulation and process innovations.
• Legal Vigilance: Generic manufacturers must conduct rigorous prior art evaluations to mount successful invalidity defenses.
• Strategic Litigation: Patent disputes serve as both defensive and offensive tools in the highly competitive pharmaceutical industry.
• Market Timing: Patent litigation directly impacts market entry timelines for generics, influencing pricing, access, and revenue.
• Regulatory and Legal Synergy: Successful patent enforcement often involves aligning legal strategies with regulatory pathways to maximize exclusivity.

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Frequently Asked Questions (FAQs)

Q1: What are the main grounds on which Mylan challenged VIFOR’s patents?
A1: Mylan challenged the patents primarily on obviousness and novelty grounds, arguing that prior art references rendered the patented formulation and process claims obvious or anticipated.

Q2: How does patent infringement litigation affect the timing of generic drug entry?
A2: Litigation can delay generic entry through injunctions or patent disputes, forcing generics to wait until patents expire or are invalidated, thus prolonging market exclusivity for brand-name drugs.

Q3: What is the significance of claim construction in this case?
A3: Claim construction determines the meaning of patent claims, directly influencing infringement and validity analyses, thereby shaping the case’s outcome.

Q4: How does the outcome of this litigation influence future patent strategy?
A4: The decision illustrates the importance of drafting strong, defensible patent claims and conducting thorough prior art searches to withstand invalidity challenges.

Q5: What are the potential next steps after the court’s ruling?
A5: The parties may pursue appeals, negotiate settlement agreements, or initiate new litigation to contest patent validity or infringement claims further.

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References

1. [1] Legal filings and court opinions in VIFOR (INTERNATIONAL) AG v. Mylan Laboratories Ltd., Civil Action No. 3:19-cv-13955 (District of New Jersey).
2. [2] FDA guidance on Hatch-Waxman and patent term extensions.
3. [3] Patent law principles on obviousness and novelty applied during the case.
4. [4] Industry analysis reports on patent litigation trends in pharmaceuticals.

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This comprehensive analysis serves as an essential resource for legal professionals, pharmaceutical executives, and regulators seeking insights into the strategic and legal nuances of patent litigation in the pharmaceutical industry.

Last updated: July 27, 2025