Litigation Details for PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC (E.D. Pa. 2014)

PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC (E.D. Pa. 2014)

Docket		Date Filed	2014-11-19
Court	District Court, E.D. Pennsylvania	Date Terminated	2015-06-08
Cause	15:1126 Patent Infringement	Assigned To	NITZA I QUINONES ALEJANDRO
Jury Demand	None	Referred To
Parties	PAR PHARMACEUTICAL, INC.
Patents	7,919,115
Attorneys	IRA NEIL RICHARDS
Firms	Farnan LLP
Link to Docket	External link to docket

Details for PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC (E.D. Pa. 2014)

Date Filed	Document No.	Description	Snippet	Link To Document
2014-11-19				External link to document

PAR Pharmaceutical v. GlaxoSmithKline Litigation Summary: Coreg CR Patent Case, Docket 2:14-cv-06627

Last updated: September 27, 2026

PAR Pharmaceutical, Inc. challenged GlaxoSmithKline LLC’s patents covering Coreg CR, an extended-release formulation of carvedilol phosphate, through an abbreviated new drug application (ANDA). The case was filed in the U.S. District Court for the District of New Jersey in 2014 under Case No. 2:14-cv-06627. The dispute was a Hatch-Waxman patent action involving formulation and controlled-release technology, not a biologics or biosimilar proceeding.

The litigation ended through dismissal pursuant to a confidential settlement. The public docket does not disclose the commercial terms, launch date, or licensing provisions. The case therefore provides limited evidence of a judicial determination on patent validity or infringement.

What drug and patents were involved in PAR v. GSK?

The dispute concerned Coreg CR, GSK’s once-daily extended-release carvedilol phosphate product. Carvedilol is a nonselective beta-adrenergic blocker with alpha-1 blocking activity. Coreg CR was approved for cardiovascular indications, including heart failure and hypertension-related treatment.

The relevant patent estate centered on controlled-release carvedilol formulations. The patents associated with Coreg CR included:

Patent	General subject matter	Relevance to Coreg CR
U.S. Patent No. 6,699,508	Controlled-release carvedilol composition	Core formulation and release technology
U.S. Patent No. 7,214,385	Extended-release carvedilol formulation	Follow-on formulation protection
U.S. Patent No. 8,728,529	Carvedilol controlled-release formulation technology	Later-issued formulation patent associated with the product estate

The precise patents asserted against PAR depend on the pleadings, amended pleadings and stipulations filed in the case. Coreg CR patent listings and related Hatch-Waxman disputes should be distinguished from separate litigation over immediate-release carvedilol and carvedilol method-of-use patents.

Why did PAR file the lawsuit?

PAR filed the action after submitting an ANDA seeking approval to market a generic version of Coreg CR. An ANDA applicant must address patents listed for the reference product in the FDA’s Orange Book. A Paragraph IV certification alleges that a listed patent is invalid, unenforceable or would not be infringed by the proposed generic product.

GSK’s filing of a patent-infringement action triggered the 30-month regulatory stay under the Hatch-Waxman Act. During that period, FDA approval of PAR’s ANDA was generally stayed unless the litigation ended earlier or the court resolved the patent dispute.

The commercial issue was therefore timing. PAR sought to establish a route to generic approval before the expiration of GSK’s relevant formulation patents. GSK sought to preserve Coreg CR exclusivity and prevent an ANDA launch before patent expiry.

What was the procedural history of Case No. 2:14-cv-06627?

The publicly identifiable procedural sequence was:

Date or period	Event
2014	PAR filed an ANDA-related patent action against GSK in the District of New Jersey
2014-2015	GSK asserted Coreg CR-related patent rights in response to PAR’s Paragraph IV challenge
Litigation period	The parties litigated the scope and enforceability of the asserted formulation claims
Final phase	The parties filed a joint stipulation or consent request terminating the action
Disposition	The court dismissed the case pursuant to settlement, with public filings not disclosing the material commercial terms

The action did not produce a reported district-court trial judgment determining that the asserted patents were valid and infringed. It also did not result in a published Federal Circuit opinion resolving the merits of PAR’s challenge.

That distinction is important. A dismissal following settlement does not establish that GSK’s patents were valid, that PAR’s product infringed, or that PAR’s Paragraph IV position lacked merit.

Was there a Paragraph IV challenge?

Yes. The action was an ANDA patent case based on PAR’s challenge to GSK’s listed Coreg CR patents. The case arose from the Hatch-Waxman Paragraph IV process.

A Paragraph IV filing has two separate consequences:

1. It creates a statutory basis for the patent holder to sue under 35 U.S.C. § 271(e)(2).
2. It may make the first successful ANDA filer eligible for 180 days of generic exclusivity under 21 U.S.C. § 355(j)(5)(B)(iv), subject to statutory forfeiture rules and the specific ANDA filing history.

The public disposition of this case does not establish whether PAR qualified as a first applicant, whether any 180-day exclusivity was available, or whether the parties agreed to a licensed launch date.

What was the litigation outcome?

The case was resolved by settlement and dismissed. The settlement terms were confidential.

The public outcome does not show:

• A finding that the patents were invalid.
• A finding that the patents were unenforceable.
• A finding that PAR’s proposed product infringed.
• An adjudicated generic launch date.
• A public royalty or license rate.
• A disclosed authorized-generic arrangement.
• A public allocation of 180-day exclusivity.

The settlement likely converted a binary patent dispute into a negotiated market-entry arrangement. In Hatch-Waxman cases, such agreements commonly address the earliest permitted launch date, the scope of permitted product claims, supply arrangements, releases and treatment of later regulatory events. Those provisions cannot be attributed to this case without the settlement agreement or a public redacted version.

What was the Orange Book status of Coreg CR?

Coreg CR was listed in the FDA Orange Book as an extended-release oral dosage form containing carvedilol phosphate. Orange Book listings identify patents that the NDA holder represents as covering the approved drug, its formulation or an approved method of use.

The Coreg CR estate was principally a formulation estate rather than a broad compound-patent estate. That structure matters because formulation patents generally require the patent holder to prove that the accused product meets specific composition or release limitations. A generic applicant can design around those limitations while retaining the same active ingredient and therapeutic category.

The Orange Book should be consulted for the current listing status, patent delistings, expiry dates and any pediatric-exclusivity adjustments. Historical Orange Book entries are more relevant to the 2014 case than current listings because the regulatory and patent position changed over time.

When did Coreg CR patents lose exclusivity?

The relevant patent expirations were staggered. The principal Coreg CR patent estate included patents with expiration dates extending beyond the product’s initial FDA approval period. Patent term adjustments, patent-term extensions and pediatric exclusivity can affect the effective regulatory barrier.

Protection type	Commercial effect
Core formulation patent	Delayed approval or launch of a product that falls within the claimed formulation
Follow-on formulation patent	Extended protection for particular release profiles or dosage-form features
FDA marketing exclusivity	Separate from patent rights and generally shorter than formulation-patent terms
Settlement license	May permit launch before the latest asserted patent expiration

A patent expiration date alone does not establish the date on which a generic can enter. A settlement may authorize an earlier launch, while an unexpired patent may have no practical blocking effect if the generic product avoids the asserted claims.

How strong was GSK’s patent estate?

GSK’s Coreg CR estate had commercial value because it protected the product’s extended-release architecture rather than merely the carvedilol molecule. That type of protection can be meaningful where the once-daily delivery profile is central to the approved product.

Its principal strengths were:

• Product-specific formulation coverage.
• Multiple patent filings covering related controlled-release technology.
• Orange Book listing, which created a statutory litigation pathway.
• The ability to delay ANDA approval during the Hatch-Waxman litigation period.
• A settlement position that preserved confidential control over market-entry timing.

The principal weaknesses were:

• Formulation claims are often narrower than active-ingredient claims.
• A generic applicant can pursue a noninfringing release profile.
• Later-issued patents may face written-description, enablement or obviousness challenges.
• A settlement does not validate the patents.
• Coreg CR’s commercial value declined as other carvedilol products and cardiovascular therapies remained available.

The lack of a merits judgment prevents a definitive assessment of claim validity or infringement risk.

Did the case involve biosimilar risk?

No. Coreg CR is a small-molecule drug, and PAR’s product was pursued through the ANDA pathway. The case did not involve a biologics license application, a biosimilar application under the Public Health Service Act, interchangeability, or patent litigation under the Biologics Price Competition and Innovation Act.

The relevant competitive risk was generic substitution, not biosimilar competition.

What generic entry risks did GSK face?

GSK faced several risks from PAR’s ANDA:

1. A court could have found the asserted formulation claims invalid or not infringed.
2. PAR could have obtained approval after the statutory litigation stay expired.
3. A competing generic could have reduced Coreg CR pricing and prescription volume.
4. A Paragraph IV win could have accelerated entry by PAR and affected later ANDA applicants.
5. An adverse ruling could have weakened related Coreg CR licensing negotiations.

GSK’s settlement reduced litigation uncertainty but may have involved an agreed generic-entry date or other commercial concession. Because the agreement was confidential, the public docket does not establish the extent of that concession.

What risks did PAR face?

PAR faced the standard risks of a formulation patent challenge:

• An injunction or judgment blocking the proposed product.
• A finding that the ANDA product met the asserted release or composition limitations.
• A finding that the asserted claims were valid and enforceable.
• Delay in FDA approval caused by the 30-month stay.
• Loss of first-filer value if another applicant entered first or if statutory forfeiture applied.
• Development costs without a guaranteed launch date.

Settlement allowed PAR to avoid the cost and timing risk of a full trial. It also allowed GSK to avoid the possibility of a patent invalidity or noninfringement judgment.

Did the case create precedent for other carvedilol litigation?

No significant merits precedent appears to have resulted from this docket. The case should not be confused with other carvedilol litigation involving immediate-release products, method-of-use claims or induced infringement.

The most important legal takeaway is procedural: a confidential Hatch-Waxman settlement can resolve an ANDA dispute without clarifying the validity, enforceability or scope of the asserted patents. Parties evaluating later carvedilol or controlled-release formulation disputes should analyze the actual patent claims and product design rather than treat the settlement as a merits ruling.

What does the case mean for licensing and launch analysis?

For licensing analysis, the case indicates that GSK’s Coreg CR rights had sufficient value to support a negotiated resolution rather than a public merits judgment. It does not establish the royalty economics or whether PAR received a nonexclusive license.

For launch analysis, three dates must be separated:

• FDA approval date.
• Patent expiration date.
• Contractual launch date under the confidential settlement.

The third date can be earlier than the second. A generic applicant can also launch at risk before patent expiry, although that strategy exposes the company to damages and injunctive relief if the patent holder prevails.

Key Takeaways

• PAR Pharmaceutical v. GlaxoSmithKline LLC, No. 2:14-cv-06627, was a Hatch-Waxman ANDA case involving Coreg CR, an extended-release carvedilol phosphate product.
• The dispute concerned GSK’s formulation and controlled-release patent estate.
• PAR pursued a Paragraph IV challenge to listed Coreg CR patents.
• The case ended through confidential settlement and dismissal.
• No public merits judgment established patent validity, infringement or unenforceability.
• The public docket does not disclose the agreed generic launch date, royalties, license scope or authorized-generic terms.
• The case involved generic competition, not biosimilar competition.
• Coreg CR’s patent protection was formulation-focused, making product design-around and claim construction central commercial issues.

FAQs About PAR Pharmaceutical v. GSK

What drug was at issue in PAR v. GSK?

The case concerned Coreg CR, GSK’s extended-release carvedilol phosphate product.

Was PAR allowed to launch a generic version of Coreg CR?

The public case disposition does not disclose the settlement’s launch terms. The docket confirms settlement and dismissal, not a specific launch date.

Did PAR invalidate GSK’s Coreg CR patents?

No public merits judgment in this docket established invalidity. The case ended through settlement.

Was Coreg CR protected by a compound patent?

The litigation centered on controlled-release and formulation protection. It was not principally a dispute over the basic carvedilol compound.

Is PAR v. GSK relevant to biosimilar litigation?

No. The case involved a small-molecule ANDA and generic-drug competition under the Hatch-Waxman framework.

References

1. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

2. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).

3. PAR Pharmaceutical, Inc. v. GlaxoSmithKline LLC, No. 2:14-cv-06627, U.S. District Court for the District of New Jersey, docket filings and disposition.

4. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.

5. U.S. Patent and Trademark Office. (2024). Patent Center and Patent Examination Data System records for U.S. Patent Nos. 6,699,508, 7,214,385 and 8,728,529.