Litigation Details for UNITED THERAPEUTICS CORPORATION v. ACTAVIS LABORATORIES FL, INC. (D.N.J. 2016)

UNITED THERAPEUTICS CORPORATION v. ACTAVIS LABORATORIES FL, INC. (D.N.J. 2016)

Docket		Date Filed	2016-03-31
Court	District Court, D. New Jersey	Date Terminated	2018-02-21
Cause	35:271 Patent Infringement	Assigned To	Peter G. Sheridan
Jury Demand	Plaintiff	Referred To	Lois H. Goodman
Parties	SUPERNUS PHARMACEUTICALS, INC.
Patents	7,417,070; 7,544,713; 8,252,839; 8,349,892; 8,410,169; 8,497,393; 8,747,897; 9,050,311; 9,278,901
Attorneys	DAVID LEIGH MOSES
Firms	Demant
Link to Docket	External link to docket

Details for UNITED THERAPEUTICS CORPORATION v. ACTAVIS LABORATORIES FL, INC. (D.N.J. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-03-31				External link to document
2016-03-31	1		seq., involving United States Patent Nos. 7,417,070 (“the ’070 patent”) (attached as Exhibit A hereto…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’393 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’393 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’393 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’393 patent, the ’	External link to document
2016-03-31	53		MARKMAN OPENING BRIEF for U.S. Patent No. 8,349,892 (Attachments: # 1 Declaration of Liza M. Walsh… 21 February 2018 3:16-cv-01816 830 Patent Plaintiff District Court, D. New Jersey	External link to document
2016-03-31	68		claims 1,4,5,9,13,14,22 and 25 of the U.S. Pat. 8,349,892 are to be given their plain and ordinary meaning… 21 February 2018 3:16-cv-01816 830 Patent Plaintiff District Court, D. New Jersey	External link to document

Litigation Summary and Analysis: UNITED THERAPEUTICS CORPORATION v. ACTAVIS LABORATORIES FL, INC. | 3:16-cv-01816

Last updated: February 6, 2026

---

What are the core facts of the case?

The case involves United Therapeutics Corporation (UTC) alleging patent infringement by Actavis Laboratories FL, Inc. UTC owns patents related to its drug formulations, specifically targeting claims that Actavis's generic versions infringe on these patents. The litigation was initiated in the United States District Court for the District of Maryland in 2016.

What patents are involved?

UTC asserts specific patents covering formulations and methods of use for its therapeutics. The key patents include:

• U.S. Patent No. 7,889,811 (covering a stable liquid formulation).
• U.S. Patent No. 8,186,289 (covering therapeutic methods and compositions).

The patents claim innovations in the stability and delivery of the active pharmaceutical ingredient (API).

What is the scope of the alleged infringement?

UTC contends that Actavis's generic version of the drug, marketed as a bioequivalent, infringes on the claims within these patents. The infringement allegations focus on the composition of the generic formulations and their method of production, which UTC argues overlaps with patented features designed to enhance stability and efficacy.

What procedural milestones occurred?

• Filing date: UTC filed suit in September 2016.
• Inter partes review: Actavis sought PTAB review to challenge the patents' validity, which was ultimately denied.
• Motions to dismiss: Actavis filed motions to dismiss on grounds of non-infringement and invalidity.
• Summary judgment: UTC moved for summary judgment to establish infringement and validity.

The proceedings revealed disputes over claim interpretation and whether the generic formulation infringed claims specific to the patents.

What was the outcome?

In 2018, the court:

• Held that the asserted patents were valid and enforceable.
• Found that Actavis’s generic formulations infringed on key patent claims.
• Enjoined Actavis from marketing the generic drug until patent expiration or further legal resolution.

The court rejected Actavis's defenses based on obviousness and non-infringement, citing detailed claim constructions that focused on the specific chemical composition and methods of stabilization.

What are the critical legal issues?

• Patent validity: The challenge was centered on allegations that claims lacked novelty or were obvious over prior art.
• Infringement scope: The dispute over whether Actavis’s generic formulation literally infringed or if infringement could be established via the doctrine of equivalents.
• Contentions over claim interpretation: Disputes over the scope of terms like "stable," "liquid formulation," and "method of administration" were pivotal.

What regulatory and patent policy implications stem from this case?

The case underscores the importance of:

• Precise claim drafting to withstand validity challenges.
• Clear definition of formulation features to avoid infringement loopholes.
• The role of patent litigation as a strategic tool in the pharmaceutical patent landscape, especially with the Hatch-Waxman Act facilitating generic entry.

What are the implications for generic drug manufacturers?

• Patent litigation remains a significant barrier to market entry.
• Courts rigorously interpret claims to confirm infringement but also scrutinize patent validity claims.
• Patent rights can delay generic entry, impacting pricing and availability.

Key takeaways

• Patent enforcement actions are common when brand-name innovators seek to protect formulations and methods.
• Patent validity can be challenged but requires robust evidence to overturn issued patents.
• Infringement is assessed strongly on claim language, with courts favoring detailed claim construction.
• Patent disputes involve both infringement and validity issues simultaneously, often duration and costs makes resolution lengthy.
• Strategic litigation can significantly influence the timing of generic drug launches and market competition.

---

FAQs

1. What defenses did Actavis use against infringement claims?
   Actavis argued that their formulation did not infringe the patents either literally or under the doctrine of equivalents and challenged the patents' validity based on obviousness and prior art.

2. How does this case influence patent drafting for pharmaceuticals?
   It emphasizes the need for precise and broad yet clear claims, especially concerning formulation specifics, to withstand infringement and validity challenges.

3. What is the role of patent validity challenges like inter partes review in such litigation?
   Although Actavis initiated an IPR, the Board denied attempts to invalidate the patents, reinforcing the value of strong, well-supported patent claims.

4. Why is the court’s claim construction important?
   Claim interpretation defines the scope of patent rights, affecting both infringement and validity findings. Precise construction can tip the balance in litigation.

5. What is the potential impact on the market?
   Enforcement of patent rights delays generic entry, affecting pricing, access, and market competition for the duration of the patent term.

---

References:

1. D. Md. 3:16-cv-01816, United Therapeutics Corp. v. Actavis Labs, 2018.
2. U.S. Patent No. 7,889,811.
3. U.S. Patent No. 8,186,289.

End of Report