Litigation Details for FERRING B.V. v. MYLAN, INC. (E.D. Pa. 2013)

FERRING B.V. v. MYLAN, INC. (E.D. Pa. 2013)

Docket	2:13-cv-05909	Date Filed	2013-10-07
Court	District Court, E.D. Pennsylvania	Date Terminated	2015-03-10
Cause	15:1126 Patent Infringement	Assigned To	Robert F. Kelly
Jury Demand		Referred To
Patents	7,947,739; 8,022,106; 8,273,795; 8,487,005
Link to Docket	External link to docket

Details for FERRING B.V. v. MYLAN, INC. (E.D. Pa. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-10-07				External link to document

Ferring B.V. v. Mylan, Inc. Litigation Summary: Prepopik Patent Dispute

Last updated: September 6, 2026

Ferring B.V. v. Mylan, Inc., No. 2:13-cv-05909, was a Hatch-Waxman patent infringement action in the U.S. District Court for the District of New Jersey involving Mylan’s ANDA for a generic version of Ferring’s Prepopik bowel-preparation product. The case concerned U.S. patents covering the sodium picosulfate, magnesium oxide and citric acid formulation used for colon cleansing. The litigation was resolved without a reported merits judgment establishing invalidity or non-infringement.

What drug was involved in Ferring v. Mylan?

The dispute involved Prepopik, an oral bowel-cleansing product containing:

Product	Active ingredients	FDA status	Sponsor
Prepopik	Sodium picosulfate, magnesium oxide and anhydrous citric acid	FDA-approved NDA 202535	Ferring Pharmaceuticals

Prepopik is supplied as a powder for oral solution in a split-dose regimen before colonoscopy. Sodium picosulfate provides stimulant laxative activity. Magnesium oxide and citric acid react in water to form magnesium citrate, an osmotic laxative component. The product’s commercial differentiation was based on its low-volume, split-dose bowel-preparation regimen compared with larger-volume polyethylene glycol products.[1]

Mylan filed an abbreviated new drug application seeking approval of a generic product. Ferring treated the ANDA filing as an artificial act of infringement under 35 U.S.C. § 271(e)(2).

When was Ferring v. Mylan filed?

Ferring filed the action in the District of New Jersey on September 24, 2013. The case number was 2:13-cv-05909. The defendants included Mylan Inc. and Mylan Pharmaceuticals Inc.

The case followed Mylan’s Paragraph IV certification concerning patents listed for Prepopik in the FDA’s Orange Book. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable or would not be infringed by the proposed generic product.[2]

Ferring’s filing triggered the Hatch-Waxman 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions and any subsequent court order.

What patents protected Prepopik?

The litigation centered on Ferring patents covering the Prepopik formulation and related bowel-cleansing technology. The principal patents associated with the early Prepopik patent litigation included the following:

Patent	General subject matter	Relevance to Prepopik
U.S. Patent No. 8,337,886	Oral bowel-cleansing compositions	Formulation protection
U.S. Patent No. 8,568,714	Bowel-cleansing compositions and related dosing technology	Formulation and regimen protection
U.S. Patent No. 8,865,688	Bowel-cleansing compositions	Later Orange Book-listed protection
U.S. Patent No. 9,040,083	Bowel-cleansing compositions and administration	Later Orange Book-listed protection

The patents addressed more than the active ingredients in isolation. The estate covered combinations, concentrations, dosage forms, preparation methods and administration protocols. That structure gave Ferring several potential infringement theories against an ANDA product, depending on the generic’s proposed formulation and labeling.

The patents associated with the original 2013 action should be distinguished from patents issued and listed later. Later-issued patents could support separate infringement actions against subsequent ANDA filings, but they do not necessarily establish the scope of the claims litigated in the original case.

What were Ferring’s infringement theories?

Ferring’s claims were based on the proposed manufacture, use and sale of Mylan’s generic product. In an ANDA case, the relevant conduct is not commercial launch. The filing of the ANDA itself can create a statutory cause of action under § 271(e)(2).

The likely infringement theories included:

1. Composition infringement based on the generic product’s combination of sodium picosulfate, magnesium oxide and citric acid.
2. Dosage-form infringement based on the product’s powder formulation and reconstitution instructions.
3. Method-of-use infringement based on the proposed bowel-cleansing regimen before colonoscopy.
4. Label-based infringement based on Mylan’s proposed instructions for administration.

The commercial importance of the method-of-use claims depended on whether Mylan could carve out protected indications or dosing instructions from its proposed label. A successful skinny-label strategy could reduce exposure to method-of-use claims, but it would not eliminate composition or formulation infringement.

What was Mylan’s Paragraph IV challenge?

Mylan’s ANDA filing challenged the listed Prepopik patents through a Paragraph IV certification. The certification placed validity, enforceability and infringement at issue before Mylan could obtain final approval for the generic product.

The case illustrates the standard Hatch-Waxman sequence:

Event	Consequence
Mylan files ANDA with Paragraph IV certification	Creates patent dispute
Ferring files suit within 45 days	FDA approval generally subject to 30-month stay
District court litigation begins	Court evaluates infringement, validity and enforceability
Settlement or judgment	Determines practical generic-entry timing
FDA approval	Depends on patent, exclusivity and regulatory status

The public record does not establish a reported final judgment holding the asserted patents invalid or not infringed.

What was the litigation outcome?

The case did not produce a reported trial decision or Federal Circuit opinion resolving the asserted Prepopik patents on the merits. The action was resolved and closed without a published merits determination that would broadly invalidate Ferring’s Prepopik patent estate.

The absence of a merits judgment matters for later challengers. It means the case did not create a broadly applicable collateral-estoppel ruling against Ferring’s patent claims. A later ANDA filer could still challenge the patents, subject to ordinary doctrines concerning claim construction, prosecution history, claim preclusion and any applicable settlement restrictions.

Public docket information also does not provide a complete commercial explanation of the parties’ agreement. Hatch-Waxman settlements frequently contain confidential business terms, including an agreed generic-entry date, authorized-generic provisions, supply arrangements or licensing rights.

Did the case involve a settlement agreement?

The litigation was resolved through settlement rather than a public merits adjudication. The publicly available case record does not disclose all commercial terms of the settlement.

A settlement in an ANDA case may determine the practical entry date even when the listed patent expiration dates are later. Potential terms can include:

• A license allowing Mylan to launch before patent expiration.
• A fixed entry date tied to a specified patent or regulatory event.
• Restrictions on the product’s formulation or label.
• Authorized-generic rights.
• Covenants not to sue.
• Confidential payment or supply provisions.

No conclusion that the settlement was anticompetitive follows from the docket alone. Federal antitrust agencies have required pharmaceutical companies to report certain patent settlements, but the reported existence of a settlement does not disclose every operative term.

What was the Orange Book status of Prepopik?

Prepopik was an approved small-molecule drug listed in the FDA Orange Book. It was not a biologic, and the dispute did not involve the Biologics Price Competition and Innovation Act or a biosimilar application.

The Orange Book-listed patents provided the statutory basis for Mylan’s Paragraph IV certification. The listed patents covered formulation and use aspects of the product rather than merely the chemical identity of sodium picosulfate.

The key regulatory distinction is:

Issue	Prepopik
Regulatory pathway	NDA
Generic pathway	ANDA
Patent challenge	Paragraph IV
Biosimilar pathway	Not applicable
Orange Book listing	Applicable
Purple Book listing	Not applicable
Reference product exclusivity	Small-molecule exclusivity rules

Prepopik received FDA approval in 2012. Its five-year new chemical entity exclusivity period would have expired before the 2013 lawsuit, leaving patent protection as the central barrier to generic approval.[1][3]

When did Prepopik lose exclusivity?

Prepopik’s regulatory exclusivity and patent exclusivity were separate.

The five-year NCE exclusivity period applied to the NDA’s active ingredient status, subject to the statutory framework. That period did not prevent an ANDA filing with a Paragraph IV certification once the relevant statutory conditions were met.

Patent exclusivity depended on each patent’s expiration date, any patent-term adjustment, pediatric exclusivity and the scope of the claims. The core early patents had expiration dates in the late 2020s based on their patent terms, while later-issued patents potentially extended protection into the early 2030s. The practical generic-entry date could occur before nominal expiration through a settlement license.

Because Orange Book listings and patent-term calculations can change, the controlling entry date must be determined from the applicable FDA Orange Book edition, patent records and any settlement terms.

How strong was Ferring’s Prepopik patent estate?

Ferring’s estate had moderate structural strength because it combined several layers of protection:

• Active formulation claims.
• Concentration and ratio claims.
• Powder or reconstitution claims.
• Bowel-preparation method claims.
• Administration and dosing-regimen claims.

The estate’s principal vulnerability was obviousness. The formulation used known laxative components, and an ANDA challenger could argue that combining sodium picosulfate, magnesium oxide and citric acid would have been predictable based on earlier bowel-preparation products and formulation literature.

Ferring’s counterargument would focus on the claimed combination, specific ratios, stability, patient tolerability, low-volume dosing and clinical or commercial advantages. Those arguments are strongest when the claims require precise formulation parameters that are absent from prior art combinations.

The estate was stronger against a product that substantially copied the listed formulation and label. It was weaker against a generic that modified component concentrations, used a materially different dosage form or carved out protected method-of-use language.

What generic-entry risks existed for Ferring?

Ferring faced several generic-entry pathways:

Direct ANDA approval after settlement

The most immediate risk was an agreed entry date under a confidential or partially disclosed settlement. This pathway could allow Mylan to enter before the latest patent expiration.

Invalidity challenge

Mylan could challenge the patents for obviousness, anticipation, written-description defects, enablement or lack of claim definiteness. Formulation patents often face obviousness risk where the ingredients and therapeutic objective were known.

Non-infringing formulation

Mylan could design around concentration, dosage-form or process limitations while retaining the same therapeutic category.

Label carve-out

Mylan could remove protected method-of-use instructions if the remaining label supported approval and did not encourage infringement. This would mainly affect use claims, not composition claims.

Later ANDA or competing generic

Other manufacturers could bring separate challenges against later-listed patents or pursue different formulations. A settlement with Mylan would not necessarily block all other generic applicants.

Which companies challenged Prepopik?

Mylan was the defendant in the identified 2013 action. Other generic manufacturers could challenge Prepopik through separate ANDA filings and lawsuits, but those proceedings should not be treated as part of No. 2:13-cv-05909 without a separate docket or complaint.

The competitive set included generic bowel-preparation products based on sodium picosulfate, magnesium citrate, polyethylene glycol, sodium sulfate and related osmotic or stimulant combinations. Prepopik’s commercial position depended on its low-volume dosing profile, prescribing habits, payer coverage and the availability of competing bowel-preparation regimens.

What was the commercial impact of the litigation?

The litigation protected Ferring from immediate substitution by a lower-priced ANDA product. The financial exposure was tied to the duration of any agreed generic delay, the number of competing ANDA filers and the ability of generic entrants to launch around formulation or method-of-use claims.

The main commercial risks were:

• Price erosion after first generic entry.
• Pharmacy substitution.
• Loss of formulary preference.
• Reduced bowel-preparation market share.
• Authorized-generic competition.
• Multiple generic launches after the first entrant.

Because the case record does not disclose product-specific settlement economics or Ferring’s revenue attributable solely to Prepopik, a reliable dollar estimate of revenue protected by the litigation cannot be derived from the docket alone.

Key Takeaways

• Ferring B.V. v. Mylan, No. 2:13-cv-05909, was a Hatch-Waxman case involving Mylan’s ANDA for generic Prepopik.
• Prepopik contains sodium picosulfate, magnesium oxide and anhydrous citric acid.
• The case involved Orange Book-listed formulation and bowel-cleansing patents.
• Mylan used a Paragraph IV certification to challenge Ferring’s patent protection.
• The litigation ended without a reported merits judgment invalidating or upholding the asserted patents.
• The case was resolved through settlement, but the complete commercial terms were not publicly disclosed.
• Biosimilar law was not relevant because Prepopik is an NDA-approved small-molecule drug.
• Ferring’s principal patent risks were obviousness, formulation design-around and method-of-use label carve-outs.
• Generic entry could occur under a settlement license before the latest listed patent expiration.

FAQs About Ferring v. Mylan and Prepopik

Was Ferring v. Mylan a biosimilar lawsuit?

No. Prepopik is a small-molecule drug approved under an NDA. Mylan’s challenge proceeded under the Hatch-Waxman ANDA framework, not the biosimilar pathway.

What is the case number for the Prepopik patent litigation?

The case number is 2:13-cv-05909 in the U.S. District Court for the District of New Jersey.

Did Mylan win a finding that Ferring’s patents were invalid?

No reported decision in the identified action established that the asserted patents were invalid. The case ended without a published merits judgment.

Did the lawsuit block all generic bowel-preparation products?

No. The case concerned Mylan’s proposed generic Prepopik product. It did not prevent other manufacturers from pursuing different bowel-preparation products or separate patent challenges.

Are Prepopik’s patents still relevant after the settlement?

Yes. A settlement resolves the dispute between the parties but does not necessarily invalidate the patents or determine the rights of other generic manufacturers. The remaining commercial effect depends on patent expiration, Orange Book status and the settlement’s entry provisions.

References

1. U.S. Food and Drug Administration. (2012). Prepopik prescribing information, NDA 202535.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. 21 U.S.C. § 355.
4. 35 U.S.C. § 271(e)(2).
5. Ferring B.V. v. Mylan, Inc., No. 2:13-cv-05909, U.S. District Court for the District of New Jersey.
6. U.S. Patent Nos. 8,337,886; 8,568,714; 8,865,688; and 9,040,083.