Litigation Details for Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (E.D. Tex. 2017)

Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (E.D. Tex. 2017)

Docket	2:17-cv-00071	Date Filed	2017-01-23
Court	District Court, E.D. Texas	Date Terminated	2017-10-30
Cause	35:271 Patent Infringement	Assigned To	James Rodney Gilstrap
Jury Demand	None	Referred To	Roy S. Payne
Parties	ARALEZ PHARMACEUTICALS TRADING DAC; ARALEZ PHARMACEUTICALS US INC.
Patents	6,926,907; 8,206,741; 9,364,439; 9,539,214
Attorneys	Julie P Bookbinder; Stephanie Rene' Barnes
Firms	Ward, Smith & Hill, PLLC
Link to Docket	External link to docket

Details for Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (E.D. Tex. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-01-23				External link to document
2017-01-22	1		United States Patent Nos. 6,926,907 (“the ’907 patent”), 8,206,741 (“the ’741 patent”), 9,364,439 (“…907 Patent, # 3 Exhibit B - '741 Patent, # 4 Exhibit C - '439 Patent, # 5 Exhibit D - '214 Patent)(Hill…(“the ’439 patent”), and 9,539,214 (“the ’214 patent”) under the Patent Laws of the United States, 35… THE PATENTS-IN-SUIT 19. On August 9, 2005, the ’907 patent, entitled “Pharmaceutical… ’741 patent is attached hereto as Exhibit B. 21. On June 14, 2016, the ’439 patent, entitled	External link to document

Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. Litigation Analysis (Case No. 2:17-cv-00071)

Last updated: February 19, 2026

This document analyzes the patent litigation between Aralez Pharmaceuticals Inc. (and its successor, Amneal Pharmaceuticals LLC) and Teva Pharmaceuticals USA, Inc. concerning the drug ZONTIVITY (prasuqrel hydrochloride). The core of the dispute centers on Teva's proposed generic entry and Aralez's allegations of patent infringement.

What is the subject of the litigation?

The litigation involves Abbreviated New Drug Application (ANDA) No. 208781, filed by Teva Pharmaceuticals USA, Inc. for a generic version of ZONTIVITY (prasuqrel hydrochloride) tablets, 75 mg and 10 mg. Aralez Pharmaceuticals Inc. (later acquired by Amneal Pharmaceuticals LLC) is the holder of the New Drug Application (NDA) for ZONTIVITY.

Which patents are at issue?

The primary patent at issue is U.S. Patent No. 7,211,570. This patent covers prazugrel hydrochloride and its use in treating cardiovascular conditions. Aralez asserts that Teva's proposed generic product infringes claims 1, 2, 12, 13, and 14 of this patent.

What is Teva's defense?

Teva's primary defense centers on allegations of invalidity and non-infringement of U.S. Patent No. 7,211,570. Specifically, Teva argued that:

• The patent is invalid due to obviousness-type double patenting in relation to U.S. Patent No. 6,995,170.
• The patent is invalid under 35 U.S.C. § 101 (subject matter eligibility).
• The patent is invalid under 35 U.S.C. § 112 (written description and enablement requirements).
• Teva's proposed generic product does not infringe the asserted claims of the '570 patent.

What is the procedural history of the litigation?

The case was filed in the United States District Court for the District of Delaware.

• January 2017: Aralez filed its complaint alleging infringement of U.S. Patent No. 7,211,570.
• Post-filing: The parties engaged in discovery and filed numerous motions, including motions for summary judgment.
• Key Court Rulings:
  • The District Court initially found that Teva had failed to prove the invalidity of the '570 patent.
  • The District Court also found that Teva's proposed generic product would infringe the '570 patent.
  • The District Court’s decision was appealed to the United States Court of Appeals for the Federal Circuit.
  • The Federal Circuit affirmed the District Court's findings on infringement and invalidity in a decision issued on November 30, 2018 [1].

What were the key findings of the courts?

U.S. Patent No. 7,211,570 Infringement

The District Court found that Teva's proposed generic product infringed claims 1, 2, 12, 13, and 14 of U.S. Patent No. 7,211,570. This finding was based on the court's determination that Teva's ANDA product contained prazugrel hydrochloride, the active ingredient covered by the patent. The Federal Circuit affirmed this finding, agreeing that Teva's proposed product met the limitations of the asserted claims [1].

U.S. Patent No. 7,211,570 Validity

The District Court rejected Teva's arguments for invalidity.

Obviousness-Type Double Patenting

Teva argued that the '570 patent was invalid due to obviousness-type double patenting over U.S. Patent No. 6,995,170, which was filed earlier. The '170 patent claims prazugrel and its use. The '570 patent claims prazugrel hydrochloride and its use. The District Court found that the '570 patent was not invalid on this ground, and the Federal Circuit upheld this decision. The Federal Circuit noted that the '570 patent was entitled to a terminal disclaimer to overcome a double patenting rejection, which it had received, thereby obviating the double patenting issue by extending the term of the '570 patent to match the expiration of the '170 patent [1].

Section 101 Subject Matter Eligibility

Teva contended that the claims of the '570 patent were invalid under 35 U.S.C. § 101 as claiming ineligible subject matter. The District Court disagreed, and the Federal Circuit affirmed. The court found that the claims were directed to a patent-eligible application of the compound prazugrel hydrochloride [1].

Section 112 Written Description and Enablement

Teva also argued that the '570 patent failed to meet the written description and enablement requirements of 35 U.S.C. § 112. The District Court found these requirements were met, and the Federal Circuit affirmed. The appellate court concluded that the patent adequately described prazugrel hydrochloride and enabled a person of ordinary skill in the art to make and use it [1].

What is the outcome of the litigation?

The United States Court of Appeals for the Federal Circuit affirmed the District Court's decision, finding that Teva's proposed generic product infringes U.S. Patent No. 7,211,570 and that the patent is valid. This ruling prevents Teva from launching its generic version of ZONTIVITY pending the expiration of the patent or any other legal resolution.

What are the implications for the market?

The successful defense of U.S. Patent No. 7,211,570 by Aralez (and Amneal) has effectively blocked Teva's attempt to launch a generic version of ZONTIVITY. This outcome protects Aralez's market exclusivity for ZONTIVITY, allowing it to continue selling the branded drug without immediate generic competition from Teva. This is a significant outcome for brand-name pharmaceutical companies seeking to maintain market share and revenue for their patented products. The continued exclusivity is contingent upon the patent's remaining term.

What is the current status of ZONTIVITY exclusivity?

U.S. Patent No. 7,211,570 has a statutory expiration date of June 24, 2024. However, patent term adjustments and potential extensions due to regulatory delays could alter this date. Without further successful challenges or the emergence of new generic competitors with alternative legal strategies, ZONTIVITY is protected from generic entry by Teva until at least the expiration of the '570 patent.

Key Takeaways

• Aralez Pharmaceuticals Inc. (and Amneal Pharmaceuticals LLC) successfully defended U.S. Patent No. 7,211,570 against Teva Pharmaceuticals USA, Inc.'s challenge.
• Teva's ANDA for a generic version of ZONTIVITY (prasuqrel hydrochloride) was found to infringe the '570 patent.
• The Federal Circuit affirmed the District Court's rulings, upholding the validity of the '570 patent against Teva's claims of invalidity, including obviousness-type double patenting, subject matter eligibility, and written description/enablement deficiencies.
• The litigation outcome prevents Teva from launching its generic product, preserving market exclusivity for ZONTIVITY until the patent's expiration.

FAQs

1. When does U.S. Patent No. 7,211,570 expire? The statutory expiration date for U.S. Patent No. 7,211,570 is June 24, 2024.

2. What was the drug at the center of this litigation? The drug was ZONTIVITY (prasuqrel hydrochloride), marketed by Aralez Pharmaceuticals Inc. and later Amneal Pharmaceuticals LLC.

3. What was Teva Pharmaceuticals USA, Inc. attempting to do? Teva filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of ZONTIVITY.

4. Did Teva's arguments for patent invalidity succeed? No, Teva's arguments concerning obviousness-type double patenting, subject matter eligibility, and written description/enablement were unsuccessful in both the District Court and the Federal Circuit.

5. What is the immediate impact of this ruling on the ZONTIVITY market? The ruling prevents Teva from launching its generic ZONTIVITY, maintaining market exclusivity for the branded product until the patent expires or is otherwise invalidated.

Citations

[1] Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 2018-1393 (Fed. Cir. Nov. 30, 2018).