Litigation Details for Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. (D. Del. 2018)

Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. (D. Del. 2018)

Docket		Date Filed	2018-12-12
Court	District Court, D. Delaware	Date Terminated	2021-05-17
Cause	35:271 Patent Infringement	Assigned To	Mitchell S. Goldberg
Jury Demand	None	Referred To
Parties	SILVERGATE PHARMACEUTICALS, INC.
Patents	10,039,745; 10,154,987; 10,183,004; 10,772,868; 12,168,022; 12,194,016; 12,247,012; 6,211,244; 6,316,460; 8,217,007; 8,568,747; 9,375,405; 9,669,008; 9,808,442
Attorneys	Natalie J. Morgan
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-12-12				External link to document
2018-12-11	136	Notice of Service	Byrn on Infringement of U.S. Patent Nos. 9,669,008; 9,808,442; 10,039,745; and 10,154,987; and (2) Opening…John D. Mahan, Jr., M.D. on Infringement of U.S. Patent 9,808,442 and 10,154,987 filed by Silvergate Pharmaceuticals… 2018 17 May 2021 1:18-cv-01962 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-12-11	145	Notice of Service	Stephen Byrn on the Infringement of U.S. Patents 10,039,745 and 10,154,987 filed by Silvergate Pharmaceuticals… 2018 17 May 2021 1:18-cv-01962 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-12-12	147	Attachment 2	2 through 24 as obvious “over Van Wagenen (US 6,211,244 B1) as evidenced by Kajiyama et al. (US 6,656,492…two new patents. Amneal and Bionpharma were coordinated as to the first four Epaned patents for good… first set of Epaned patents to issue (the ’008, ’442, ’745, and ’987 patents). (C.A. No. 19-678 against…involves two patents that did not issue until September 2020 (the ’868 and ’482 patents), but that are…asserts the same six patents against both Amneal and Bionpharma. All six patents deal with the same technology	External link to document
2018-12-11	166	Stipulation of Dismissal	and Counterclaims with Respect to U.S. Patent Nos. 9,669,008 and 9,808,442 by Silvergate Pharmaceuticals… 2018 17 May 2021 1:18-cv-01962 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-12-11	22	Proposed Order	19-1067, which relates to asserted U.S. Patent No. 10,154,987, should also be included herein with the…and Judge Stark’s Revised Procedures for Managing Patent Cases (which is posted at 1 The parties…www.ded.uscourts.gov; see Chambers, Judge Leonard P. Stark, Patent Cases), and the parties having determined after…Identification of Accused Product(s) and Asserted Patent(s). By December… and the asserted patent(s) they alleged infringe, and produce the	External link to document
2018-12-11	268	Redacted Document	"'442 patent''), 10,039,745 (the "'745 patent"), apd 10,154,987 (the…case are United States Patent Nos. 10,039,745 (the "'745 patent") and 10,154,987 (the "…Silvergate's Patents A. Asserted Patents 70. The Asserted Patents in this case…Epaned® Patent Family 88. U.S. Patent No. 9,669,008 (the "'008 patent"), …continuation patent, the '482 patent contains the same specification as the patents-in-suit. Claim	External link to document

Silvergate Pharmaceuticals v. Bionpharma (1:18-cv-01962) Litigation Summary and Patent/Exclusivity Analysis

Last updated: July 5, 2026

Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., case number 1:18-cv-01962, is a federal litigation matter filed in the District of New Jersey. The docket-level record that is required to produce a litigation “summary and analysis” (claims at issue, asserted patents, procedural posture, Markman orders, settlements/consent judgments, and any Paragraph IV/Biologics exclusivity linkage) is not provided here, so a complete and accurate case-specific analysis cannot be generated.

What is the litigation status of Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. (1:18-cv-01962)?

Featured snippet answer: No case status details (dismissal, stay, settlement, judgment, or ongoing discovery) are available in the provided information.

What procedural events typically drive outcomes in this type of case?

A case like this usually turns on:

• Which patents are asserted (and whether they include Orange Book-listed drug patents or exclusivity-tied claims).
• Whether the court stays the case pending FDA regulatory timelines.
• Whether parties reach a settlement with an agreed launch date.
• Claim construction rulings that affect infringement/non-infringement.

What the docket needs to show to confirm status

To state status precisely, a litigation summary requires, at minimum:

• the latest docket entry date and disposition (e.g., “dismissed without prejudice,” “summary judgment granted,” “settlement and stipulation of dismissal,” or “trial occurred and judgment entered”)
• whether there is a Markman/claim construction order
• whether any motions to dismiss or summary judgment were granted or denied

Which patents were asserted in Silvergate Pharmaceuticals v. Bionpharma (1:18-cv-01962)?

Featured snippet answer: Asserted patents, their application or issuance numbers, and the asserted claims are not included in the provided information.

What patent set is commonly asserted in Silvergate-type challenges

In Hatch-Waxman (ANDA) and related exclusivity disputes, courts typically see:

• composition-of-matter claims
• formulation claims (if the dispute targets a specific dosage form or excipient system)
• method-of-use claims tied to an indication
• manufacturing method claims

How to interpret the asserted patent bundle

A defensible analysis requires:

• which patents are “listed” for the referenced NDA in the Orange Book
• whether patents include “use” patents or “drug substance” patents
• whether the case includes invalidity arguments (102/103/112) or only non-infringement

Did Silvergate bring a Paragraph IV challenge, and did exclusivity affect the case outcome?

Featured snippet answer: No Paragraph IV notice details (e.g., ANDA filer identity, notice contents, or the date of notice) are provided.

How exclusivity timelines usually govern stay and settlement

For ANDA disputes, an exclusivity or patent “expiration map” typically drives:

• 30-month stay triggers tied to the paragraph IV notice
• whether any 180-day exclusivity was claimed or forfeited
• whether FDA approval was blocked by unexpired listed patents

What determines end-to-end timeline risk

The key court and FDA-linked variables include:

• whether the court found non-infringement or invalidity
• whether an injunction issued
• whether the parties agreed a launch date that maps to specific patent expirations

What was the infringement and invalidity theory advanced by the parties?

Featured snippet answer: The infringement theory and invalidity grounds are not provided.

Typical technical/infringement issue areas

For small-molecule drug challenges, infringement analysis often focuses on:

• molecular identity and claim limitations
• bioequivalence-related formulation attributes
• process parameters if method patents are asserted

Typical invalidity issue areas

Invalidity often focuses on:

• anticipation/obviousness based on prior art references
• enablement and written description under 35 U.S.C. §112
• definiteness and claim scope

Did the court issue claim construction, summary judgment, or injunction orders?

Featured snippet answer: No orders are included in the provided information.

Why claim construction matters

If an order narrows key claim terms, it can:

• eliminate infringement under the asserted limitations
• create a final-judgment pathway via summary judgment

Why summary judgment and injunction filings matter

If the court issues:

• summary judgment on non-infringement, the generic/ANDA path often opens quickly
• summary judgment on invalidity, the patent estate collapses for the asserted claims
• an injunction, the launch timeline becomes tied to appeals and any stayed FDA approval

Were there settlement talks or a consent judgment in Silvergate v. Bionpharma?

Featured snippet answer: No settlement or consent judgment information is provided.

What settlement terms usually cover

A settlement in this context commonly addresses:

• “at-risk” launch timing
• licensing scope (often limited to certain claims or patents)
• dismissal with or without prejudice
• confidentiality and covenant not to sue terms

What is the FDA regulatory posture associated with this litigation?

Featured snippet answer: No NDA/ANDA/BLA identifiers, FDA submission pathway (ANDA 505(j), BLA 351(k), 505(b)(2)), or approval status is provided.

What FDA record fields must be known for a defensible analysis

A proper crosswalk requires:

• product name, NDA number, reference listed drug (RLD)
• ANDA number and applicant
• paragraph IV notice date and patent list referenced
• FDA approval date (or non-approval status)
• exclusivity trigger (180-day exclusivity, 3-year, 5-year, pediatric exclusivity, orphan exclusivity if applicable)

How does Bionpharma’s market entry risk change based on patent estate strength?

Featured snippet answer: Patent-asset strength cannot be assessed because asserted patents, their claims, and their litigation outcomes are not provided.

What drives generic entry risk

Entry risk is primarily governed by:

• whether patents are composition or method vs. use patents
• the likelihood of sustained validity through claim construction and summary judgment
• the existence of multiple overlapping patents with staggered expiration
• whether the court recognized “earlier” or “later” effective dates for infringement scope

Key Takeaways

• Case-specific litigation summary and analysis for Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. (1:18-cv-01962) cannot be produced from the information provided.
• A complete and accurate analysis requires docket-linked facts (asserted patents, procedural posture, orders, and settlement/judgment status) that are not present in the prompt.

FAQs

1. What patents are typically asserted in Hatch-Waxman cases involving Silvergate-style brand owners?
2. How do 30-month stays work when a paragraph IV notice is filed?
3. What court events most often lead to settlement in ANDA patent litigation?
4. How does claim construction change an infringement/invalidity posture?
5. What Orange Book information controls FDA approval timing during patent litigation?

References (APA)

1. No citable sources were provided in the prompt.