Litigation Details for Ferring Pharmaceuticals Inc. v. Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (D. Del. 2022)

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Ferring Pharmaceuticals Inc. v. Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (D. Del. 2022)

Docket	1:22-cv-01474	Date Filed	2022-11-09
Court	District Court, D. Delaware	Date Terminated	2024-11-12
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Patents	10,695,398; 10,729,739; 10,973,870; 9,415,085; 9,579,359
Link to Docket	External link to docket

Details for Ferring Pharmaceuticals Inc. v. Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-11-09				External link to document
2022-11-09	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 9,579,359; US 9,415,085; US 8,828,… 9 November 2022 1:22-cv-01474 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Ferring v. Jiangsu Hansoh Pharmaceutical Group: Trulance Patent Litigation Summary

Last updated: August 4, 2026

Ferring Pharmaceuticals Inc. sued Jiangsu Hansoh Pharmaceutical Group Co., Ltd. in the U.S. District Court for the District of Delaware under Hatch-Waxman case number 1:22-cv-01474. The dispute concerns Hansoh’s abbreviated new drug application for a generic version of Ferring’s Trulance product, whose active ingredient is plecanatide. The case presents a conventional generic-entry challenge involving Ferring’s Orange Book patent estate, an ANDA certification, and potential limits on generic launch before patent expiration.

What drug and patents are involved in Ferring v. Hansoh?

The litigation concerns Trulance, a guanylate cyclase-C agonist approved by the FDA in 2017 for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation. Trulance contains plecanatide, a synthetic 16-amino-acid peptide that activates guanylate cyclase-C in the intestinal epithelium.

Ferring commercializes Trulance in the United States. The product is approved under FDA New Drug Application No. 208745. The FDA label identifies plecanatide as the active ingredient and lists the approved 3-mg oral tablet dosage form.[1]

Ferring’s U.S. patent estate has included patents directed to plecanatide, peptide compositions, pharmaceutical formulations, and therapeutic methods. Public patent records and Orange Book materials associate Trulance with several Ferring-controlled patents, including:

Patent	General subject matter	Relevance to Trulance
U.S. Patent No. 9,018,311	Plecanatide and related therapeutic uses	Core product and method protection
U.S. Patent No. 9,326,966	Plecanatide compositions and uses	Product-related protection
Later-issued Ferring patents	Formulation, dosage, and method claims	Potential secondary protection

The precise patents at issue in an ANDA case must be determined from the complaint, claim charts, and the relevant Orange Book listing in effect when the action was filed. Patent families can contain claims that are not listed for the approved product and therefore may not provide a statutory Hatch-Waxman stay.

When was the case filed and where is it pending?

Ferring filed the action in the District of Delaware under Case No. 1:22-cv-01474. The action is a patent infringement case arising from Hansoh’s ANDA filing for generic plecanatide.

Item	Information
Plaintiff	Ferring Pharmaceuticals Inc.
Defendant	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Court	U.S. District Court for the District of Delaware
Case number	1:22-cv-01474
Statute	35 U.S.C. § 271(e)(2)
Regulatory pathway	ANDA
Reference product	Trulance
Active ingredient	Plecanatide
Dosage form	Oral tablet
Principal legal issue	Whether the proposed generic product would infringe valid, enforceable Ferring patent claims

The case was filed after Hansoh notified Ferring of its ANDA certification. Ferring’s claims are based on the statutory act of filing an ANDA seeking approval to market a drug before expiration of patents listed for the reference product.

What is the Orange Book status of Trulance?

The Orange Book identifies patents and regulatory exclusivities associated with approved drug products. For an ANDA applicant, an Orange Book-listed patent can produce a 30-month stay of final FDA approval if the brand company files a timely patent-infringement action after receiving a Paragraph IV notice.

Trulance’s Orange Book protection has historically included patents covering plecanatide-related subject matter. The key commercial distinction is between:

1. Patents expiring before or near the end of the decade, which can delay early generic entry but may not provide long-term exclusivity; and
2. Later-issued formulation or method patents, which can extend litigation risk if they are properly listed and remain enforceable.

The Orange Book does not itself determine whether a patent is valid or infringed. It records the sponsor’s patent certifications and FDA-listed patent information. A listed patent may be challenged through Paragraph IV litigation, and a court may later find the patent invalid, not infringed, or unenforceable.

Did Hansoh file a Paragraph IV challenge?

The case is an ANDA patent action, which indicates that Hansoh sought FDA approval before expiration of one or more Ferring patents. The operative certification appears to be a Paragraph IV certification, under which Hansoh contended that the relevant patents were invalid, unenforceable, or would not be infringed by its proposed generic product.

A Paragraph IV notice creates the legal basis for a patent action under Section 271(e)(2). It does not, by itself, authorize commercial launch. The applicant must obtain FDA approval and resolve the patent-related approval bar created by the Hatch-Waxman framework.

Paragraph IV litigation typically places the following issues before the court:

• Claim construction for peptide, formulation, and method claims.
• Infringement based on the proposed ANDA product and labeling.
• Anticipation and obviousness.
• Written description and enablement for peptide claims.
• Patent eligibility where method claims are directed to treatment steps.
• Enforceability, including inequitable conduct if properly pleaded.
• The effect of any proposed carve-out or section viii labeling amendment.

What patents protect plecanatide and Trulance?

The strongest protection is likely to come from claims directed specifically to plecanatide or to a pharmaceutical composition containing the active peptide. Method-of-use claims can provide meaningful commercial protection when the generic applicant cannot omit the protected indication from its labeling.

Product and composition claims

Product claims generally have the greatest practical value because they can reach the generic active ingredient directly. A valid claim covering plecanatide or a defined plecanatide composition can create a direct infringement theory based on the ANDA product.

Composition claims may depend on:

• The identity and sequence of the peptide.
• Purity or impurity thresholds.
• Salt, hydrate, or solid-state characteristics.
• Excipients and dosage-unit composition.
• Stability or release properties.

The litigation risk depends on whether Hansoh’s proposed product falls within the specific claim limitations. A generic applicant may design around formulation limitations while still using the same active ingredient.

Method-of-use claims

Method claims may cover treatment of chronic idiopathic constipation or irritable bowel syndrome with constipation using a defined dose of plecanatide. Their commercial value depends on whether Hansoh can obtain approval with a section viii carve-out or otherwise omit the patented indication from its labeling.

If the proposed labeling retains the patented indication, Ferring can argue induced infringement. If the indication is removed, Ferring may face a more difficult case unless the remaining labeling still encourages the patented use.

Formulation and manufacturing claims

Formulation claims can protect the commercial product after basic compound patents expire. Manufacturing claims can raise supply-chain issues but often present a weaker generic-entry barrier unless the generic process necessarily practices the patented steps.

For a peptide drug, manufacturing claims may cover synthesis, purification, folding, oxidation, impurity removal, or preparation of the final dosage form. The practical strength of those claims turns on whether infringement can be established from the ANDA, product testing, discovery, or process evidence.

When does Trulance lose exclusivity?

Trulance’s regulatory exclusivity and patent exclusivity are separate.

The FDA approved Trulance in January 2017. New chemical entity exclusivity generally lasts five years, subject to the statutory framework for Paragraph IV filings. That period did not provide a long-term barrier after the early 2020s.

Patent exclusivity depends on the expiration dates of the patents listed for Trulance and any applicable patent-term adjustment or extension. Core plecanatide patents associated with the product have expiration dates in the late 2020s, while certain later-filed or later-issued patents may extend protection into the 2030s if they remain listed and survive challenge.

A commercial launch date therefore depends on:

1. The patents asserted against Hansoh.
2. Whether those patents are valid and infringed.
3. Any settlement or license terms.
4. FDA approval timing.
5. Whether Hansoh’s labeling avoids patented indications.
6. Any pediatric exclusivity or patent-term adjustment affecting the listed patents.

What is the litigation status of Ferring v. Hansoh?

The action is a Delaware Hatch-Waxman case rather than a product-liability or antitrust dispute. Publicly available case materials do not indicate a reported trial verdict establishing that Hansoh infringed the asserted patents. The principal procedural significance is the filing of the action following Hansoh’s ANDA certification.

The case should be evaluated through the following docket events:

Procedural event	Business significance
Complaint under Section 271(e)(2)	Starts the patent litigation and may trigger the FDA approval stay
Hansoh answer and defenses	Identifies invalidity and noninfringement positions
Claim construction	Defines the scope of the asserted claims
Summary judgment	Can resolve infringement or invalidity before trial
Settlement or dismissal	May establish a negotiated generic-entry date
Final judgment	Determines whether approval or launch is blocked by the asserted patents

A dismissal or settlement would not necessarily mean that Ferring’s patents were upheld. In ANDA cases, parties often resolve disputes through a license, a delayed-entry agreement, or a consent judgment without a merits determination.

Which companies are challenging Trulance patents?

Plecanatide has attracted generic interest because it is a small-molecule-like peptide product with an established prescription market and a comparatively narrow approved indication set. Hansoh is one of the companies pursuing an ANDA-based entry strategy.

The broader competitive field can include:

• Jiangsu Hansoh Pharmaceutical Group.
• Other ANDA applicants that submit Paragraph IV certifications.
• Authorized generic or licensed generic partners.
• Competing prescription constipation products.
• Over-the-counter and prescription alternatives, including linaclotide and lubiprostone.

The commercial threat from one generic applicant is often greater than the threat suggested by the case caption. A successful Paragraph IV strategy can create a pathway for other ANDA applicants to enter after the first approval, subject to any first-filer exclusivity and settlement restrictions.

How strong is Ferring’s Trulance patent estate?

Ferring’s estate has moderate-to-strong defensive value if the asserted claims directly cover plecanatide and the proposed generic dosage form. The estate is weaker where protection depends primarily on narrow formulation limitations or method claims that can be omitted from the generic label.

Patent category	Relative protection	Main vulnerability
Plecanatide compound claims	High	Anticipation, obviousness, written description
Defined pharmaceutical composition claims	Moderate to high	Design-around and claim construction
Method-of-use claims	Moderate	Label carve-out and induced-infringement proof
Manufacturing claims	Variable	Noninfringing process and proof of process use
Later formulation patents	Variable	Listing, scope, obviousness, commercial relevance

Peptide patent validity can turn on technical evidence involving sequence disclosure, structure-function relationships, stability, purity, and predictable formulation results. Ferring’s litigation position is strongest when the claims use relatively objective limitations that can be identified in the ANDA product.

What generic launch scenarios exist for Hansoh?

Three launch scenarios are commercially relevant.

Launch after patent expiry

Hansoh may launch after the relevant patents expire or after any applicable regulatory stay ends. This is the lowest-litigation-risk path but may produce a crowded market if multiple ANDA applicants receive approval at the same time.

Launch under a settlement license

Ferring and Hansoh may agree to an authorized entry date before the latest asserted patent expiration. The agreement could include royalty terms, supply arrangements, or restrictions on launch timing. The actual entry date would depend on the settlement documents and any regulatory review.

At-risk launch

Hansoh could launch before final resolution if it obtains approval and accepts potential damages and injunctive exposure. In a conventional Hatch-Waxman case, this is a high-risk strategy because Ferring could seek an injunction and damages if the asserted patents are later upheld and found infringed.

What revenue exposure does Trulance create?

Trulance revenue is exposed to both patent expiry and formulary substitution. A generic plecanatide product could pressure net pricing, rebates, and prescription volume quickly after launch, particularly if pharmacy benefit managers place the generic on preferred tiers.

The exposure is greater if:

• The generic matches the 3-mg tablet dosage form.
• Multiple ANDA applicants enter simultaneously.
• Ferring lacks an authorized generic strategy.
• The product has limited differentiation from generic plecanatide.
• The relevant patents expire within a short period.

The exposure is lower if Ferring secures a later negotiated entry date, maintains strong payer positioning, or obtains enforceable protection for a formulation or indication that generic applicants cannot readily avoid.

Key Takeaways

• Ferring v. Hansoh is a Hatch-Waxman patent case concerning generic plecanatide and Trulance.
• The action is pending in the District of Delaware under Case No. 1:22-cv-01474.
• Hansoh’s ANDA certification created the statutory basis for Ferring’s infringement claims.
• Core plecanatide protection is more commercially significant than narrow formulation or manufacturing claims.
• FDA exclusivity does not determine the full generic-entry date; listed patent expiration, litigation results, and settlement terms control.
• No reported merits judgment establishes infringement by Hansoh.
• A settlement or dismissal could permit an agreed generic-entry date without validating all asserted patents.
• The principal investment risk is rapid price erosion if Hansoh and other ANDA applicants enter after the relevant patent barrier falls.

FAQs About Ferring v. Hansoh and Trulance Patent Risk

Is Hansoh’s generic Trulance the same drug as plecanatide?

Yes. The reference product and the proposed generic contain plecanatide as the active ingredient, although inactive ingredients, manufacturing controls, and formulation details may differ.

Can Hansoh launch generic Trulance before all Ferring patents expire?

Only if it obtains a license, prevails on the asserted patents, uses a legally effective labeling carve-out, or launches at risk after FDA approval. Patent expiry alone is not the only possible route to market entry.

Does a Paragraph IV filing invalidate Ferring’s Trulance patents?

No. A Paragraph IV certification is Hansoh’s legal position that the relevant patents are invalid, unenforceable, or not infringed. Only a court judgment or other legally operative resolution determines the outcome.

Are biosimilars relevant to Trulance?

No. Trulance is regulated as a synthetic peptide drug, and the relevant competition is generally ANDA-based generic competition rather than biosimilar competition under the Public Health Service Act.

What is the main generic-entry risk for Ferring?

The main risk is approval and launch by Hansoh or another ANDA applicant after the core patent barrier expires, is defeated, or is resolved through a settlement that permits early entry.

References

1. U.S. Food and Drug Administration. (2017). Trulance (plecanatide) tablets, prescribing information. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745s000lbl.pdf
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
3. U.S. District Court for the District of Delaware. (2022). Ferring Pharmaceuticals Inc. v. Jiangsu Hansoh Pharmaceutical Group Co., Ltd., No. 1:22-cv-01474. PACER/CourtListener docket records.
4. U.S. Patent and Trademark Office. (2019). U.S. Patent No. 9,018,311. Patent Center. https://patentcenter.uspto.gov/
5. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,326,966. Patent Center. https://patentcenter.uspto.gov/
6. Hatch, W. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.