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; 10,232,003; 10,279,012; 10,279,014; 10,772,868; 12,168,022; 12,194,016; 6,168,016; 6,211,244; 6,316,460; 8,183,002; 8,217,007; 8,222,015; 8,568,747; 9,242,011; 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

Biologic Drugs cited in Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc.

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	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	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	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, Inc. v. Bionpharma Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

Silvergate Pharmaceuticals, Inc. (Silvergate) and Bionpharma Inc. (Bionpharma) were embroiled in a significant patent infringement lawsuit, filed under Case Number 1:18-cv-01962 in the United States District Court for the District of Delaware. This litigation revolves around the alleged infringement of several U.S. patents held by Silvergate, stemming from Bionpharma's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA).

The Parties Involved

• Silvergate Pharmaceuticals, Inc.: A corporation organized under the laws of Delaware, with its principal place of business in Woburn, Massachusetts. Silvergate is a wholly-owned subsidiary of Azurity Pharmaceuticals, Inc. and is dedicated to developing high-quality pediatric-appropriate medicines[1][3][4].
• Bionpharma Inc.: Also a corporation organized under the laws of Delaware, with its principal place of business in Princeton, New Jersey. Bionpharma is involved in the development, manufacturing, and sale of generic copies of branded pharmaceutical products for the U.S. market[1][3][4].

Nature of the Action

The lawsuit was initiated by Silvergate against Bionpharma for alleged patent infringement under 35 U.S.C. § 271(e)(2), specifically related to Bionpharma's filing of ANDA No. 212408. This ANDA sought FDA approval for a generic version of Silvergate's oral solution, known as Epaned®, which is covered by Silvergate's New Drug Application (NDA) No. 208686[3][4].

Patents in Question

Silvergate initially alleged that Bionpharma's ANDA would infringe on several of its U.S. patents, including:

• U.S. Patent No. 9,669,008 (the "'008 patent")
• U.S. Patent No. 9,808,442 (the "'442 patent")
• U.S. Patent No. 10,039,745 (the "'745 patent")
• U.S. Patent No. 10,154,987 (the "'987 patent")[1][3][4].

Doctrine of Equivalents (DOE)

As the litigation progressed, Silvergate narrowed its claims to focus on the '745 and '987 patents. Since Bionpharma did not literally infringe on these patents, Silvergate argued for infringement under the Doctrine of Equivalents (DOE). This doctrine allows for the finding of infringement if the accused product performs substantially the same function in substantially the same way to achieve substantially the same result as the patented invention[1][3][4].

Legal Bars Asserted by Bionpharma

Bionpharma countered Silvergate's DOE arguments by asserting several legal bars:

• Prosecution History Estoppel: This bar prevents a patent holder from asserting a broader scope of protection than what was granted during the patent prosecution process.
• Disclosure-Dedication: This bar applies when a patent holder discloses but does not claim a particular feature, thereby dedicating it to the public.
• Claim Vitiation: This bar prevents the expansion of patent claims to cover subject matter that was not originally claimed[1][3][4].

Court Proceedings and Findings

The case involved a five-day remote bench trial in February 2021, which was consolidated with another case against Amneal Pharmaceuticals, LLC. Post-trial briefings and proposed findings of fact were submitted by both parties.

The Court's findings were as follows:

• Prosecution History Estoppel: The Court held that Silvergate was barred by prosecution history estoppel from asserting DOE infringement of the "buffer limitation."
• Failure to Prove Equivalence: The Court determined that Silvergate failed to prove that Bionpharma's proposed product contained an equivalent to the "buffer" of the claims.
• Disclosure-Dedication: The Court found that Silvergate had disclosed and dedicated to the public the accused equivalent of the "preservative limitation"[1][3][4].

Conclusion of the Court

Based on these findings, the Court concluded that Silvergate's claims under the Doctrine of Equivalents were not valid. Therefore, Bionpharma's ANDA product did not infringe on Silvergate's '745 and '987 patents.

Key Takeaways

• The case highlights the importance of careful patent prosecution and the limitations imposed by prosecution history estoppel and disclosure-dedication.
• It underscores the challenges in asserting infringement under the Doctrine of Equivalents, especially when literal infringement is not present.
• The decision emphasizes the need for precise and thorough documentation during the patent application process to avoid potential legal bars.

FAQs

What was the basis of the lawsuit filed by Silvergate Pharmaceuticals against Bionpharma Inc.?

The lawsuit was filed under 35 U.S.C. § 271(e)(2) for alleged patent infringement related to Bionpharma's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Silvergate's Epaned® product.

Which patents were at the center of the dispute?

The dispute centered around U.S. Patent Nos. 9,669,008, 9,808,442, 10,039,745, and 10,154,987, with the focus ultimately narrowing to the '745 and '987 patents.

What is the Doctrine of Equivalents (DOE), and how was it applied in this case?

The Doctrine of Equivalents allows for the finding of infringement if the accused product performs substantially the same function in substantially the same way to achieve substantially the same result as the patented invention. Silvergate argued for infringement under DOE since Bionpharma did not literally infringe on the patents.

What legal bars did Bionpharma assert to counter Silvergate's DOE arguments?

Bionpharma asserted prosecution history estoppel, disclosure-dedication, and claim vitiation as legal bars to prevent Silvergate from prevailing on its DOE theories.

What was the outcome of the court proceedings?

The Court found that Silvergate was barred by prosecution history estoppel and failed to prove equivalence, and that Silvergate had disclosed and dedicated the accused equivalent of the "preservative limitation" to the public. Therefore, Bionpharma's ANDA product did not infringe on Silvergate's '745 and '987 patents.

Sources Cited:

1. Silvergate Pharmaceuticals, LLC v. Bionpharma Inc., Case 1:19-cv-01067-MSG, Document 255, Filed 04/29/21.
2. Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., Case 1:18-cv-01962, Document 1, Filed 06/07/19.
3. Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., Case 1:19-cv-01067-UNA, Document 1, Filed 06/07/19.
4. Silvergate Pharmaceuticals, LLC v. Bionpharma Inc., Case 1:19-cv-01067, Opinion, Filed 04/27/21.