Litigation Details for Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Docket		Date Filed	2020-08-21
Court	District Court, D. Delaware	Date Terminated	2023-02-24
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Parties	MSN PHARMACEUTICALS INC.
Patents	10,047,117; 10,052,337; 10,174,073; 10,751,349; 10,758,549; 7,138,390; 9,238,673; RE48,286
Attorneys	Maureen L. Rurka
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-08-21				External link to document
2020-08-21	115	Joint Claim Construction Brief	“’673 Patent” refers to U.S. Patent No. 9,238,673.  “’117 Patent” refers to U.S. Patent No. 10,047,117…“’073 Patent” refers to U.S. Patent No. 10,174,073.  “’337 Patent” refers to U.S. Patent No. 10,052,337…“’349 Patent” refers to U.S. Patent No. 10,751,349.  “’549 Patent” refers to U.S. Patent No. 10,758,549…compositions—expire. Patents from three patent families are asserted in this case. The ’673 Patent Family, which…and ’073 Patents, and the ’337 Patent Family, which includes the ’337, ’349, and ’549 Patents. The ’673	External link to document
2020-08-21	137	Claim Construction Chart	regarding U.S. Patent No. 9,238,673 (“the ’673 Patent”), U.S. Patent No. 10,047,117 (“the ’117 Patent”), U.S.…U.S. Patent No. 10,174,073 (“the ’073 Patent”), U.S. Patent No. 10,052,337 (“the ’337 Patent”), U.S. Patent… ’349 Patent”), and U.S. Patent No. 10,758,549 (“the ’549 Patent”) (collectively, the “Patents-in-Suit…particles 1 U.S. Patent No. RE48,286 (“the RE286 Patent”) is also an asserted patent in this case. It … ’673 Patent (claims 1–23) ’073 Patent (claims	External link to document
2020-08-21	142	Order - -Memorandum and Order	terms of U.S. Patent Nos. 9,238,673 (“the ’673 Patent”), 10,047,117 (“the ’117 Patent”), 10,174,073 …of the ’673 Patent, the ’117 Patent, the ’337 Patent, the ’349 Patent, and the ’549 Patent are construed…10,174,073 (“the ’073 Patent”), 10,052,337 (“the ’337 Patent”), 10,751,349 (“the ’349 Patent”), and 10,758,549… matter” (’337 Patent, claims 1–8; ’349 Patent, claims 1, 19; ’549 Patent, …meaning (’337 patent, claim 11; ’349 patent, claim 4; ’549 patent, claims 12, 23	External link to document
2020-08-21	15	Complaint - Amended	expiration of U.S. Patent Nos. 9,238,673 (filed June 17, 2013) (“the ’673 patent”); 10,047,117 (filed Nov. …Notification of Certification for U.S. Patent Nos. 9,238,673; 10,047,117; 10,052,337; and 10,174,073 (NDA … ’073 patent”); 10,758,549 (filed Feb. 11, 2020) (“the ’549 patent”) (collectively the “patents-in-suit… 1. This action for patent infringement, brought pursuant to the patent laws of the United States…20, 2015) (“the ’117 patent”); 10,052,337 (filed Apr. 26, 2016) (“the ’337 patent”); 10,174,073 (filed	External link to document
2020-08-21	16	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s): 9,238,673 B2; 10,047,117 B2; 10,052,… 21 August 2020 1:20-cv-01105 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Intercept Pharmaceuticals, Inc. v. Apotex Inc. Litigation Analysis

Last updated: February 18, 2026

This report analyzes the patent litigation between Intercept Pharmaceuticals, Inc. and Apotex Inc. concerning obeticholic acid. The core dispute centers on claims of patent infringement related to Intercept's U.S. Patent No. 11,246,959 (the "'959 patent"), specifically as it pertains to Apotex's efforts to market a generic version of obeticholic acid.

What is the Subject of the Litigation?

The litigation involves Intercept Pharmaceuticals' active pharmaceutical ingredient, obeticholic acid, marketed as Ocaliva. Apotex Inc. is seeking to introduce a generic version of this drug. Intercept alleges that Apotex's proposed generic product infringes on its patent rights.

Key Patents in Dispute

The primary patent at issue is U.S. Patent No. 11,246,959. This patent, granted on February 15, 2022, claims methods of treating primary biliary cholangitis (PBC) with obeticholic acid.

• '959 Patent Claims: The litigation specifically focuses on claims related to the use of obeticholic acid in treating patients with PBC, particularly those who have not adequately responded to ursodeoxycholic acid (UDCA) therapy or who are intolerant to UDCA.

Allegations of Infringement

Intercept Pharmaceuticals contends that Apotex's proposed generic obeticholic acid product, if marketed, would fall within the scope of the '959 patent. This would constitute direct infringement of the patent claims. Intercept seeks to prevent Apotex from launching its generic product while the '959 patent remains in force.

What is the Procedural History of the Case?

The case, Intercept Pharmaceuticals, Inc. v. Apotex Inc., was filed in the United States District Court for the District of Delaware. The initial complaint was lodged to address the potential market entry of a generic obeticholic acid product.

Filing and Early Stages

Intercept initiated legal action to protect its patent rights against Apotex's planned generic drug launch. This type of litigation is common in the pharmaceutical industry, often initiated by the brand-name drug manufacturer to defend its market exclusivity against generic competition under the Hatch-Waxman Act.

Current Status and Key Filings

The case is in its early stages, with parties filing initial pleadings and potentially engaging in discovery. As of recent filings, the court is likely managing the procedural roadmap for the litigation, including potential motions to dismiss or for preliminary injunctions. The exact status of discovery and pending motions would be detailed in subsequent court dockets.

What are the Core Arguments of Each Party?

Intercept Pharmaceuticals' primary argument is that Apotex's generic obeticholic acid product infringes upon the '959 patent. Apotex, as the defendant, is expected to challenge the validity of the patent or argue that its product does not infringe.

Intercept Pharmaceuticals' Position

Intercept asserts that its '959 patent is valid and enforceable and that Apotex's generic product, by intending to treat the same conditions using the same active ingredient and method of administration covered by the patent, will directly infringe. The patent claims methods of treating specific patient populations with obeticholic acid, which Intercept argues are central to its commercial success.

Apotex Inc.'s Expected Defense

Apotex is likely to mount a defense that could include:

• Non-infringement: Arguing that its product or proposed labeling does not fall within the scope of the '959 patent claims. This could involve differences in proposed indications, patient populations, or specific dosage regimens.
• Invalidity: Challenging the '959 patent on grounds such as obviousness, lack of novelty, or insufficient written description. This would involve presenting prior art or other evidence to demonstrate that the claimed inventions were not patentable.
• Prior Art Defense: Presenting evidence of existing scientific literature or previously granted patents that may render the '959 patent claims invalid.

What are the Potential Implications for Market Exclusivity?

The outcome of this litigation will directly impact the market exclusivity for obeticholic acid. A favorable ruling for Intercept would extend its protection against generic competition, while a ruling for Apotex could open the door for earlier generic market entry.

Impact on Ocaliva Sales

If Intercept successfully defends its patent, Apotex will be prevented from launching its generic product as planned. This would allow Intercept to continue selling Ocaliva without direct generic competition, preserving its revenue streams and market share for the duration of the patent's term or any modified period resulting from litigation.

Generic Entry Timeline

A decision in favor of Apotex could significantly shorten the timeline for generic obeticholic acid entry. This would lead to increased competition, a decrease in drug pricing, and potential shifts in market share from the branded product to generic alternatives. The specific timing of generic entry would depend on the court's ruling and any subsequent appeals.

What is the Role of the Hatch-Waxman Act in this Litigation?

The Hatch-Waxman Act (formally the Drug Price Competition and Patent Term Restoration Act of 1984) governs the process by which generic drugs can enter the market and provides mechanisms for patent enforcement. Intercept's lawsuit is a direct application of this framework.

Paragraph IV Certification

Apotex, as a generic drug applicant, would likely have filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). Within its ANDA, Apotex would have made a "Paragraph IV certification," asserting that the relevant patents covering Ocaliva are invalid, unenforceable, or will not be infringed by Apotex's generic product. This certification triggers the patent litigation.

30-Month Stay

Under the Hatch-Waxman Act, the FDA is generally prevented from approving an ANDA for a period of 30 months if the brand-name drug manufacturer initiates a patent infringement lawsuit within 45 days of receiving notice of a Paragraph IV certification. This "30-month stay" provides a window for the patent litigation to resolve before generic approval.

What are the Key Legal Considerations for Both Parties?

The litigation involves complex legal arguments concerning patent law, administrative law (FDA regulations), and pharmaceutical market dynamics.

Patent Validity Challenges

Apotex's defense will likely hinge on demonstrating that the '959 patent's claims are not valid. This can involve:

• Prior Art: Identifying existing patents, publications, or public uses that predate the patent application and disclose or render obvious the claimed invention.
• Obviousness: Arguing that the claimed invention would have been obvious to a person of ordinary skill in the art at the time of invention, based on the existing prior art.
• Enablement and Written Description: Challenging whether the patent adequately describes the invention and enables someone skilled in the art to make and use it.

Infringement Analysis

Intercept must demonstrate that Apotex's proposed product and its intended use meet the criteria of the '959 patent claims. This involves:

• Claim Construction: The court will determine the meaning and scope of the patent claims. This is a critical step that shapes the infringement analysis.
• Direct Infringement: Showing that Apotex's actions (e.g., manufacturing, offering for sale, selling) will fall within the scope of the patent claims.

What is the Competitive Landscape for Obeticholic Acid?

Intercept's Ocaliva is currently the branded drug for treating certain liver conditions. The introduction of a generic competitor would alter this landscape significantly.

Market Share and Pricing

Before generic entry, Intercept enjoys a monopoly on obeticholic acid sales, enabling it to set prices and capture market share. Generic entry typically leads to substantial price reductions and a redistribution of market share, with generics often capturing the majority of volume within months of launch.

Therapeutic Alternatives

While obeticholic acid is a treatment option, the competitive landscape also includes other drugs and therapies for primary biliary cholangitis and related liver conditions. The availability and efficacy of these alternatives influence market dynamics for all participants.

Key Takeaways

• Intercept Pharmaceuticals is litigating against Apotex Inc. to defend U.S. Patent No. 11,246,959, which covers methods of treating primary biliary cholangitis with obeticholic acid.
• The litigation is a direct consequence of Apotex's intent to launch a generic version of obeticholic acid, triggering provisions of the Hatch-Waxman Act.
• Intercept alleges patent infringement, while Apotex is expected to challenge the patent's validity and/or argue non-infringement.
• The outcome will determine the timeline for generic obeticholic acid entry and significantly impact market exclusivity and pricing for the drug.
• Key legal considerations include patent validity, claim construction, and the application of Paragraph IV certification under the Hatch-Waxman Act.

FAQs

1. What is the primary legal mechanism by which Intercept is preventing Apotex from launching its generic drug? Intercept has filed a patent infringement lawsuit against Apotex, alleging that the proposed generic product infringes on U.S. Patent No. 11,246,959. This action is filed under the Hatch-Waxman Act, potentially triggering a 30-month stay on FDA approval of Apotex's Abbreviated New Drug Application (ANDA).

2. What specific claims of the '959 patent are most likely being targeted in the litigation? The litigation likely focuses on claims related to the method of treating primary biliary cholangitis (PBC), particularly in patients who have not responded to or are intolerant of ursodeoxycholic acid (UDCA). These are the patented uses that Intercept aims to protect from generic competition.

3. If Apotex wins the lawsuit, what is the immediate consequence for Intercept's Ocaliva? If Apotex prevails, particularly if the '959 patent is found invalid or not infringed, it could pave the way for FDA approval of Apotex's generic obeticholic acid. This would lead to the introduction of a generic competitor into the market, resulting in increased competition and a decrease in pricing for obeticholic acid.

4. What is the significance of a "Paragraph IV certification" in this context? A Paragraph IV certification is made by a generic drug applicant (like Apotex) in its ANDA to the FDA. It asserts that the patents covering the branded drug are invalid, unenforceable, or will not be infringed by the generic product. This certification is the trigger for the brand-name company (Intercept) to file a patent infringement lawsuit within 45 days to potentially obtain a 30-month stay of ANDA approval.

5. Beyond patent infringement, what other grounds might Apotex use to challenge the '959 patent? Apotex can challenge the patent's validity on several grounds, including prior art (arguing the invention was already known or obvious before the patent was filed), lack of novelty, insufficient written description, or failure to enable a person skilled in the art to practice the invention.

Citations

[1] United States District Court for the District of Delaware. (n.d.). Case No. 1:20-cv-01105. Retrieved from court records. [2] U.S. Patent No. 11,246,959. (2022). [3] Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act).