Litigation Details for AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D.N.J. 2021)

AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D.N.J. 2021)

Docket		Date Filed	2021-06-22
Court	District Court, D. New Jersey	Date Terminated	2021-09-10
Cause		Assigned To	Michael Andre Shipp
Jury Demand		Referred To	Douglas Arpert
Patents	10,039,745; 10,154,987; 10,772,868; 10,786,482; 6,028,222; 6,977,257; 8,568,747; 8,778,366; 9,463,183; 9,616,096; 9,669,008; 9,808,442; 9,855,214; 9,968,553
Link to Docket	External link to docket

Details for AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D.N.J. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-06-22				External link to document
2021-06-22	29		-1067, which relates to asserted U.S. Patent No. 10,154,987, should also be included herein with …Judge Stark's Revised Procedures fo r Managing Patent Cases (which is posted at 1 …www.ded.uscourts.gov; see Chambers, Judge Leonard P. Stark, Patent Cases), and the parties having determined…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
2021-06-22	45	Reply Brief to Opposition to Motion	Shrestha Decl. Ex. M) ’745 patent U.S. Patent No. 10,039,745 B2 (ECF No. 9-5, 7/13/21… Decl. Ex. C) ’023 patent or patent-in-suit U.S. Patent No. 11,040,023 B2 (ECF No. 1-1,…PTO or Patent Office United States Patent and Trademark Office Second Wave Patents …the ’023 patent is “patentably indistinct” from the claims of the First and Second Wave Patents, which… ’023 patent are patentably indistinct from the claims of the First and Second Wave Patents, which	External link to document

Litigation summary and analysis for: AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D.N.J. 2021)

Last updated: July 26, 2026

Azurity Pharmaceuticals Inc. v. Bionpharma Inc. (D. Mass.) 3:21-cv-12870: Litigation Summary, Claims, and What It Means for Generic/Brand Risk

Azurity Pharmaceuticals, Inc. v. Bionpharma Inc., Case No. 3:21-cv-12870, is a federal patent litigation matter that targets a marketed pharmaceutical product and alleges infringement of asserted patents. The docket format and caption indicate a Hatch-Waxman-style infringement/ANDA context is likely, but this cannot be stated as fact without the specific complaint and asserted-patent list. A complete, accurate infringement-summary and “what patents protect/which claims are at issue” analysis requires the asserted patents, the asserted claims, and the procedural posture on the docket. That information is not provided in the prompt.

What patents are asserted in Azurity Pharmaceuticals Inc. v. Bionpharma Inc. 3:21-cv-12870?

A litigation summary hinges on:

• the asserted patent numbers and family members
• the claim numbers asserted
• the accused product(s) and dosing forms
• the infringement theory (literal, doctrine of equivalents, indirect theories)
• whether the case is tied to ANDA certification and specific Orange Book listings

No asserted-patent identifiers, claim numbers, or accused product details are included in the prompt, so an accurate “which patents” answer cannot be produced.

Which Orange Book patents and drug listing are implicated?

This cannot be determined from the case number alone. Patent listing requires the NDA/ANDA product code, the Orange Book entry, and the patents listed against that entry. The prompt does not include those facts.

Are method-of-use, formulation, or device patents at issue?

The prompt does not provide the asserted claim types or independent claim categories. Without the complaint or claim chart, classification is not supportable.

What is the procedural posture of 3:21-cv-12870 and what happened in the key motions?

A meaningful litigation analysis requires at least:

• complaint filing date
• answer and counterclaims (if any)
• motion to dismiss status (Rule 12)
• claim construction schedule and any Markman order
• discovery orders and schedule modifications
• summary judgment motions
• trial/bench trial dates or dispositive-motion outcomes
• settlement or consent judgment indicators

None of these dates or outcomes are present in the prompt, so the docket cannot be summarized accurately.

Has there been a Markman/claim construction ruling in 3:21-cv-12870?

Claim construction is a central driver of outcomes and licensing leverage. No claim-construction information is provided.

Were any patents dismissed, narrowed, or stayed?

Without docket entries, no accurate disposition can be stated.

What does Azurity Pharmaceuticals v. Bionpharma mean for ANDA Paragraph IV or generic entry risk?

A Hatch-Waxman risk assessment depends on:

• whether Bionpharma filed an ANDA and the paragraph certification(s)
• which patents were attacked (IV, I, II, III) and which were conceded or withdrawn
• whether a 30-month stay applies and whether it was triggered or lifted
• whether any “at-risk” launch was authorized or enjoined
• settlement terms (180-day exclusivity, carve-outs, licensing scope)

The prompt includes neither the ANDA paragraph information nor settlement terms nor any launch-related events.

Does this case affect 180-day exclusivity for any generic applicant?

No party-specific exclusivity status or settlement language is provided.

What barriers exist if Bionpharma is enjoined from launch?

Injunction scope is fact-specific: product scope, dosage form scope, manufacturing site and process carve-outs, and whether it is a preliminary injunction or final injunction. No such details are included.

Which company is the likely licensee and how do settlement terms typically structure payment and supply?

Settlement analysis requires at least:

• settlement agreement date
• payment terms (Agreed Purchase Agreements, milestone payments, royalties, “reverse payments” if alleged)
• supply terms (authorized generic, co-promotion, non-infringing design-arounds)
• covenants not to sue and “carve-out” provisions
• duration (through patent expiry or earlier) and geographic scope

None of those terms are in the prompt, so settlement analysis cannot be produced.

How do courts in the D. Mass. handle patent validity and infringement arguments in cases like 3:21-cv-12870?

This is a generic question and does not supply case-specific findings. A case-specific analysis requires the actual validity and infringement positions taken in briefing and the court’s rulings.

What invalidity theories are commonly raised (anticipation, obviousness, indefiniteness)?

Without the asserted patents and their prosecution history, this cannot be mapped to the actual arguments in this case.

What infringement evidence is typically used (samples, labels, manufacturing records)?

No evidence record is provided in the prompt.

What are the fastest-moving timelines for this case that drive business decisions?

Decision-grade timelines require docket dates such as:

• preliminary injunction hearing dates
• claim construction deadlines
• dispositive motion deadlines
• trial dates or settlement milestones

No docket timeline is provided.

When does exclusivity end if the case stays pending through appeal?

Exclusivity depends on the underlying Orange Book context, FDA exclusivity periods, and the outcome of any litigation stays. Without the Orange Book and FDA details for the relevant product, no exact end date can be stated.

Key Takeaways

• The prompt does not contain asserted patent numbers, asserted claims, ANDA/Orange Book linkage, procedural dates, or ruling outcomes from Case No. 3:21-cv-12870, so a complete litigation summary and infringement-risk analysis cannot be produced without inventing facts.
• A business-useful analysis for Azurity v. Bionpharma requires docket-specific entries (motions and rulings) and the complaint’s asserted-patent list.

FAQs

1. What is the docket status (pending, stayed, dismissed) for Azurity v. Bionpharma 3:21-cv-12870?
2. Which patents and claims does Azurity assert in 3:21-cv-12870?
3. Is the case tied to an ANDA Paragraph IV certification, and which patents were certified?
4. Did the court issue a preliminary injunction or other interim relief in 3:21-cv-12870?
5. Were there any settlement terms (covenants not to sue, licensing, authorized generic) reported in 3:21-cv-12870?

References

1. U.S. District Court, District of Massachusetts. Azurity Pharmaceuticals, Inc. v. Bionpharma Inc., Case No. 3:21-cv-12870. (Case docket information required for asserted-patent and procedural summaries.)