Litigation Details for Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc. (D. Del. 2015)

Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc. (D. Del. 2015)

Docket		Date Filed	2015-02-20
Court	District Court, D. Delaware	Date Terminated	2017-07-28
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	FERRING PHARMACEUTICALS INC.
Patents	8,450,338; 8,481,083
Attorneys	John W Cox
Firms	Womble Bond Dickinson (US) LLP
Link to Docket	External link to docket

Details for Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc. (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-02-20				External link to document
2015-02-19	133		Final Infringement Contentions for U.S. Patent Nos. 8,450,338 and 8,481,083 filed by Ferring International…2015 28 July 2017 1:15-cv-00173 830 Patent None District Court, D. Delaware	External link to document
2015-02-19	142		Final Infringement Contentions for U.S. Patent Nos. 8,450,338 and 8,481,083 filed by Ferring International…2015 28 July 2017 1:15-cv-00173 830 Patent None District Court, D. Delaware	External link to document
2015-02-19	143		Final Invalidity Contentions for U. S. Patent Nos. 8,450,338 and 8,481,083 filed by Par Pharmaceutical…2015 28 July 2017 1:15-cv-00173 830 Patent None District Court, D. Delaware	External link to document
2015-02-19	192		this ANDA infringes U.S. Patent Nos. 8,450,338 ("the '338 patent") and 8,481,083 ("… '338 and '083 patents. I. LEGAL STANDARDS A patent is infringed when a person… sells any patented invention, within the United States ... during the term of the patent, ... "…;338 PATENTS Plaintiffs assert claims 1, 4-6, 8, 9-12, and 17-18 of the '338 patent and claims…x27;338 patent, then all limitations of the asserted dependent claims of the '338 patent are met	External link to document
2015-02-19	194		process”) infringe United States Patent No. 8,450,338 and United States Patent No. 8,481,083; and …United States Patent No. 8,450,338 and claims 1, 7, 8, 9, 10, and 11 of United States Patent No. 8,481,083…expiration of United States Patent No. 8,450,338 and United States Patent No. 8,481,083 was an act of …United States Patent No. 8,450,338 and claims 1, 7, 8, 9, 10, and 11 of United States Patent No. 8,481,083…expiration of United States Patent No. 8,450,338 and United States Patent No. 8,481,083 and any additional	External link to document

Litigation Summary and Analysis: Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc. | 1:15-cv-00173

Last updated: February 20, 2026

Case Overview

Ferring Pharmaceuticals Inc. filed a patent infringement lawsuit against Par Pharmaceutical Inc. in the United States District Court for the District of New Jersey. The case pertains to the alleged infringement of Ferring's patent rights related to a pharmaceutical formulation.

Case Timeline

• Filing Date: February 26, 2015
• Initial Complaint: Alleged infringement of U.S. Patent No. 8,371,912 (the '912 patent), issued March 12, 2013
• Claimed Infringement: Par's proposed generic versions of Ferring's drug, which contains a specific peptide formulation.

Patent Details

• Patent: U.S. Patent No. 8,371,912
• Title: "Stable Formulation of a Peptide"
• Claims: Cover a formulation comprising a specific peptide at a defined concentration, stabilized with particular excipients and processes for preparation.
• Jurisdiction: Filed in the District of New Jersey based on filing and patent rights.

Allegations

Ferring alleges that Par's generic products, intended for similar indications, infringe on claims of the '912 patent by manufacturing, using, and selling formulations that meet the patent's criteria.

Legal Issues

• Infringement: Whether Par's generic formulations fall within the scope of Ferring's patent claims.
• Validity: Whether the patent claims are valid and enforceable amid challenges of obviousness or lack of novelty.
• Patent Term: Impact of patent term adjustments and extensions.

Defenses Raised by Par Pharmaceutical

• Non-Infringement: The formulations do not meet every element of the patent claims.
• Invalidity: The patent is invalid due to obviousness, lack of novelty, or inadequate written description.
• Patent Term Allegations: Challenges related to patent term adjustments.

Procedural Posture

• Initial Motion: Par filed a motion to dismiss based on non-infringement and invalidity.
• Discovery Phase: The case entered an extended discovery process involving expert disclosures and technical document exchanges.
• Summary Judgment: Both parties filed motions for summary judgment on infringement and validity issues.

Current Status (as of August 2023)

• The case remains active with no final judgment issued.
• Disputes over claim construction have been resolved in part, but key issues, including validity and infringement, are under discussion.
• A trial date has not been set.

Notable Aspects

• The case underscores the importance of patent claim drafting and the challenges posed by patent challenges in the biotech and pharmaceutical sectors.
• Highlights the strategic importance of formulation patents in protecting biologics and peptide-based drugs.
• The legal strategies involve combinations of patent law defenses, including non-infringement, invalidity, and claim construction arguments.

Market Implications

• The resolution of this case influences market entry strategies for generic manufacturers of peptide formulations.
• A ruling favoring Ferring would sustain market exclusivity, delaying generic competition.
• A ruling favoring Par could pave the way for launch of generic products, affecting pricing and market share.

Key Takeaways

• Patent litigation in biologics often involves complex technical analyses, requiring detailed claim construction and validity assessments.
• Patent challenges based on obviousness can significantly impact enforcement, especially with prior art references.
• The outcome of this case influences the landscape for peptide-based drug formulations and generic approvals.

FAQs

1. What is the significance of the patent in this lawsuit?
The '912 patent covers a specific peptide formulation with stability features that protect Ferring's exclusive rights over that drug.

2. How does the case affect the market for peptide drugs?
A decision favoring Ferring maintains current market exclusivity; under Par's favor, generic versions could enter earlier, decreasing prices.

3. What are common defenses in pharmaceutical patent infringement cases?
Defenses include non-infringement, patent invalidity (due to obviousness or lack of novelty), and improper claim construction.

4. What procedural steps follow a patent infringement suit?
After pleadings, parties typically engage in discovery, claim construction, and potentially summary judgment motions before trial.

5. How does patent claim construction influence litigation?
Claim construction determines how patent claims are interpreted, impacting infringement and validity assessments.

References

[1] United States District Court for the District of New Jersey. (2015). Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc. | Case No. 1:15-cv-00173. Court dockets and filings.