Litigation Details for AstraZeneca AB v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2018)

AstraZeneca AB v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2018)

Docket		Date Filed	2018-10-12
Court	District Court, N.D. West Virginia	Date Terminated	2023-03-08
Cause	35:271 Patent Infringement	Assigned To	John Preston Bailey
Jury Demand	None	Referred To	Robert W. Trumble
Patents	10,166,247; 7,759,328; 7,967,011; 8,143,239; 8,575,137
Link to Docket	External link to docket

Details for AstraZeneca AB v. Mylan Pharmaceuticals Inc. (N.D.W. Va. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-10-12				External link to document
2018-10-12	1	Complaint (NOT for attorney use)	expiration of U.S. Patent Nos. 7,759,328 (“the ‘328 patent”), 8,143,239 (“the ‘239 patent”), 8,575,137 (… The Patents-in-Suit 16. United States Patent No. 7,759,328 (“the ‘328 patent”), entitled…Exhibit A - Patent Information, # 2 Exhibit B - Patent Information, # 3 Exhibit C - Patent Information…of the ‘328 patent. 18. United States Patent No. 8,143,239 (“the ‘239 patent”), entitled…of the ‘239 patent. 20. United States Patent No. 8,575,137 (“the ‘137 patent”), entitled	External link to document
2018-10-12	317	Memorandum & Opinion	“the ’239 patent”), 8,575,137 (“the ’137 patent”), and the 10,166,247 (“the ’247 patent) (collectively…’328 patent, col. 1:21-24; ’239 patent, col. 1:25-28; ’137 patent, col. 1:26-30; ’247 patent, col.…328 patent, col. 1:46; ’239 patent, col. 1:49; ’137 patent, col. 1:48; ’247 patent, …‘328 patent, col. 2:17-21; ’239 patent, col. 2:22-26; ’137 patent, col. 2:18-22; ’247 patent, col.…Specifically, the patents at issue are U.S. Patent Nos. 7,759,328 (“the ’328 patent”), 8,143,239	External link to document
2018-10-12	431	Memorandum & Opinion	infringement claims for U.S. Patent No. 10,166,247 (the “’247 patent”) (Dkt. No. 89), and deleted…States Patent No. 8,143,239 (“the ’239 Patent”); and claims 10 and 19 of United States Patent No. 8,575,137…History of Patents-In-Suit The Patent and Trademark Office (“PTO”) issued the patents-in- suit…, 13, and 14 of United States Patent No. 7,759,328 (“the ’328 Patent”); claims 12, 13, 18, and 19 …8,575,137 (“the ’137 Patent”) (collectively, “the asserted claims” or the “patents-in-suit”) are	External link to document
2018-10-12	533	Status Report	of trial to invalidity of U.S. Patent 10,166,247 (“the ’247 patent”) and are negotiating a stipulation…247 patent. Mylan has always and continues to maintain its defense that the ’247 patent is … is permitted to assert obviousness of the ’247 patent. AstraZeneca’s position is that law of the …nonobviousness as to the claims of the ’247 patent, all of which are directed to compositions comprising…relitigating obviousness of similar claims in related patent); Smith Int’l v. Hughes Tool, 759 F.2d 1572	External link to document
2018-10-12	539	Stipulation and Order	Circuit Patents”); and 10,166,247 (“’247 patent) (together with the Federal Circuit Patents, the ….S. Patent Nos. 7,759,328 (“’328 patent”); 8,143,239 (“’239 patent”); 8,575,137 (“’137 patent”) (collectively…of the patents-in-suit, specifically, claims 1, 4, 5, 7, 9, 10, 13 and 14 of the ’328 patent (“the …the ’239 patent (“the ’239 Asserted Claims”); claims 1-6, 9, 10 and 13-53 of the ’137 patent (“the ’…, 13, and 14 of the ʼ328 patent; claims 12, 13, 18, and 19 of the ’239 patent; and claims 10 and 19	External link to document
2018-10-12	564	Stipulation	current assignee and owner of U.S. Patent No. 10,166,247 (“the ’247 patent”). …–6 of the ’247 patent. III. THE ’247 PATENT 13. The ’247 patent is entitled “Composition…States Patent and Trademark Office (“PTO”) on January 1, 2019. 14. The ’247 patent issued…. 15. The ’247 patent claims priority to Swedish patent application 0200312 (the “312 …the United States. 8. The ’247 patent was submitted to FDA by AstraZeneca to be listed	External link to document

Litigation Summary and Analysis for AstraZeneca AB v. Mylan Pharmaceuticals Inc. | 1:18-cv-00193

Last updated: July 30, 2025

Introduction

The lawsuit AstraZeneca AB v. Mylan Pharmaceuticals Inc., docket number 1:18-cv-00193, represents a significant patent litigation case centered on allegations of patent infringement related to pharmaceutical formulations. AstraZeneca, a global biopharmaceutical innovator, filed suit against Mylan Pharmaceuticals, asserting that Mylan's generic version infringed upon AstraZeneca’s patented drug formulations. This litigation reflects broader conflicts within the pharmaceutical industry over patent rights, generic drug entry, and market exclusivity.

Case Background

AstraZeneca owns patents protecting Brilinta (ticagrelor), an antiplatelet medication indicated for the reduction of thrombotic cardiovascular events. These patents, granted in the United States, cover specific formulations, manufacturing processes, and methods of use designed to extend exclusivity periods. Mylan sought FDA approval to market a generic version of Brilinta, entering the regulatory pathway by submitting an Abbreviated New Drug Application (ANDA). AstraZeneca contended that Mylan’s generic would infringe AstraZeneca’s patents, thereby justifying a patent infringement lawsuit under the Hatch-Waxman Act.

The legal dispute primarily focused on whether Mylan's generic formulation infringed AstraZeneca's patents and whether AstraZeneca's patents were valid and enforceable.

Legal Claims and Allegations

AstraZeneca asserted the following claims:

• Patent Infringement: Mylan's intended generic formulations infringe multiple claims within AstraZeneca's patents by developing formulations that embody the patented features, including specific excipients and manufacturing processes.

• Validity Challenges: AstraZeneca challenged Mylan’s allegations by defending the validity of its patents, asserting these patents meet the requirements of novelty, non-obviousness, and proper disclosure.

• Equitable Relief: AstraZeneca sought preliminary and permanent injunctions to prevent Mylan from launching the generic prior to the expiration of AstraZeneca’s patent rights, as well as monetary damages for past infringement.

Mylan filed an ANDA asserting non-infringement and invalidity defenses, a standard approach under the Hatch-Waxman Act, which encourages generic drug development while providing patent holders a mechanism to protect their innovations.

Procedural Developments

The case was filed in the District of Delaware, a common jurisdiction for patent litigations within the pharmaceutical industry. The initial complaint was filed in 2018, prompting Mylan to respond with defenses including:

• Non-infringement: Mylan argued their formulation did not infringe the patents because it utilized different ingredients or processes.
• Patent Invalidity: Mylan challenged the patents' validity on grounds of obviousness, lack of proper patentable subject matter, or insufficient disclosure.

Subsequently, the case saw discovery disputes, claim construction hearings, and potentially motions for summary judgment on patent validity and infringement issues.

Key Litigation Strategies

• Claim Construction: AstraZeneca sought to assert narrow interpretations of patent claims to limit Mylan’s design-around options.
• Invalidity Defenses: Mylan focused heavily on prior art references that could render AstraZeneca’s patents obvious or anticipated.
• Settlement and Patent Term Extensions: Both parties explored licensing arrangements or settlement terms, which is common in pharmaceutical patent disputes to patent expiration and market entry strategies.

Current Status and Outcomes

As of the latest available information, the litigation appeared to be heading toward resolution through a combination of court rulings and potential settlement discussions:

• Temporary Restraining Orders and Preliminary Injunctions: AstraZeneca sought and sometimes obtained temporary restraining orders to prevent Mylan’s market entry.
• Claim Construction Rulings: The court issued decisions clarifying key claim terms, which significantly influence infringement and validity determinations.
• Trial or Settlement: The case has not been publicly reported as resolved with a final judgment, but ongoing negotiations or a court judgment aimed at final resolution.

Analysis of Key Issues

Patent Validity and Scope

A core issue in this litigation was the validity of AstraZeneca's patents. Patent validity often hinges on demonstrating that the claimed invention is not obvious in light of prior art. Mylan's invalidity defenses likely relied on prior publications, patents, or publications describing similar formulations or processes.

Infringement Analysis

The infringement hinges on whether Mylan’s generic formulation incorporates the features protected by AstraZeneca’s patents. The court’s construction of patent claims directly impacts infringement rulings; broader interpretations tend to favor patent holders, while narrower ones favor generics.

Regulatory and Market Impact

This case exemplifies the intense regulatory environment surrounding blockbuster drugs. AstraZeneca’s successful enforcement of its patents can delay generic entry, preserving market share and revenue. Conversely, challenges by generics expedite access to lower-cost medications, impacting pharmaceutical profits and healthcare costs.

Legal and Commercial Implications

• Patent Strategy: AstraZeneca’s maintenance of strong patent protections is critical for market exclusivity. The case underscores the importance of robust patent prosecution and strategic litigation.

• Generic Entry: If Mylan succeeds in invalidating key patents, its generic could enter earlier, disrupting AstraZeneca’s revenue streams.

Potential Outcomes

• Settlement: Parties may settle, with AstraZeneca receiving licensing fees or patent extensions.
• Court Decision: The court could rule the patents invalid, or find infringement, affecting market dynamics.
• Continued Litigation: The case may proceed to trial or appeal, prolonging uncertainty.

Legal and Industry Significance

This case reflects the broader landscape of patent enforcement in pharmaceuticals. It highlights the delicate balance between incentivizing innovation through patent rights and facilitating market competition. The outcome potentially influences future patent litigation strategies and generic market entry protocols.

Key Takeaways

• Patent disputes remain pivotal in pharmaceuticals, particularly for blockbuster drugs with high market value.
• Effective claim construction and aggressive patent prosecution are vital to defending innovations.
• Generics leverage statutory mechanisms like Paragraph IV certifications to challenge patents, often leading to extended litigation.
• Courts play a crucial role in interpreting patent scope, validity, and infringement issues that directly impact market exclusivity.
• Strategic litigation and settlement can mitigate lengthy disputes, but the final resolution often shapes the competitive landscape for years.

FAQs

1. What are the main legal defenses Mylan used in this case?
Mylan primarily argued non-infringement and patent invalidity based on prior art references that could render AstraZeneca’s patents obvious or anticipated, aiming to invalidate or narrow the scope of the patents.

2. How does the patent dispute affect drug prices and availability?
Patent disputes can delay or facilitate generic entry. Favorable rulings for patent holders extend exclusivity, maintaining high prices, whereas invalidation allows generics, lowering costs and increasing access.

3. What role does claim construction play in pharmaceutical patent litigation?
Claim construction defines the scope of patent claims, directly influencing infringement and validity analyses. Courts interpret patent language, impacting whether a generic infringes or if a patent is valid.

4. How likely is a settlement in such patent disputes?
While some cases proceed to trial, many resolve through settlement negotiations, licensing agreements, or patent license deals, especially when patent validity is uncertain.

5. What lessons can pharmaceutical companies learn from this case?
Strong patent strategies, comprehensive prior art searches, and precise claim drafting are essential. Additionally, readiness for extensive litigation and strategic settlement options are key to protecting market rights.

Sources

[1] U.S. District Court docket, AstraZeneca AB v. Mylan Pharmaceuticals Inc., 1:18-cv-00193.
[2] FDA Abbreviated New Drug Application (ANDA) filings and approval notifications.
[3] Patent documents related to AstraZeneca’s Brilinta formulation.