Litigation Details for AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

Docket		Date Filed	2016-08-04
Court	District Court, D. Delaware	Date Terminated	2017-09-28
Cause	35:271 Patent Infringement	Assigned To	Mitchell S. Goldberg
Jury Demand	None	Referred To
Parties	AMGEN INC.
Patents	8,231,876; 8,663,945; 8,715,664; 8,808,700; 8,883,156; 8,889,136; 8,895,009; 8,906,372; 8,906,373; 8,906,646; 8,911,964; 8,916,153; 8,926,975; 8,961,973; 8,961,974; 8,986,693; 8,999,337; 9,018,361; 9,061,005; 9,067,992; 9,073,988; 9,085,618; 9,085,620; 9,090,689; 9,090,867; 9,096,666; 9,102,723; 9,150,645; 9,187,559; 9,200,069; 9,200,070; 9,206,390; 9,234,032; 9,234,033; 9,255,143; 9,266,949; 9,273,132; 9,284,370; 9,284,371; 9,290,568; 9,315,574; 9,328,165; 9,334,319; 9,346,879; 9,359,434; 9,365,645
Attorneys	Amanda L. Major; Evan R. Chesler
Firms	Greenberg Traurig, the Nemours Building; Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Biologic Drugs cited in AbbVie Inc. v. Amgen Inc.

Details for AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-08-04				External link to document
2016-08-04	1		Composition 9,328,165 Purified Antibody Composition 8,231,876 Purified Antibody Composition 8,663,945 … U.S Patent No. 8,916,157; U.S Patent No. 8,961,973; U.S Patent No. 8,986,693; U.S Patent No. 9,096,666… U.S Patent No. 9,220,781; U.S Patent No. 9,272,041; U.S. Patent No. 9,359,434; and U.S. Patent No. 9,365,645…United States Patent and Trademark Office (“Patent Office”) has granted AbbVie numerous patents which are…of 6 patents each, and the patents-in-suit constitute the compilation of the two lists (2 patents were	External link to document
2016-08-04	3		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,663,945; 8,911,964; 8,916,157… 28 September 2017 1:16-cv-00666 830 Patent None District Court, D. Delaware	External link to document
2016-08-04	62		owner by assignment of U.S. Patent No. 8,663,945 (“the ’945 Patent”). AbbVie has alleged that … Non-Infringement and Invalidity of U.S. Patent No. 8,663,945 38. Amgen and AML… The ’945 Patent, the ’964 Patent, the ’157 Patent, the ’973 Patent, the ’693 Patent, the …the ’666 Patent, the ’781 Patent, the ’041 Patent, the ’434 Patent, and the ’645 Patent, and each of … the ’945 Patent, the ’964 Patent, the ’157 Patent, the ’973 Patent, the ’693 Patent, the ’666	External link to document

AbbVie Inc. v. Amgen Inc.: A Comprehensive Analysis of the Litigation

Background and Context

The litigation between AbbVie Inc. and Amgen Inc. revolves around the biosimilar version of AbbVie's blockbuster drug Humira (adalimumab), which is one of the best-selling drugs in the world. Humira generates significant revenue for AbbVie, accounting for almost two-thirds of the company's revenue[1].

The Patent Infringement Claim

In August 2016, AbbVie filed a patent infringement complaint against Amgen in response to Amgen's 351(k) biologics license application with the U.S. Food and Drug Administration (FDA) for a biosimilar version of Humira. AbbVie alleged that Amgen's biosimilar infringed on 10 of its patents and potentially 61 more, including those covering Humira's complex manufacturing process and its subcutaneous formulation[1][2].

Key Patents in Dispute

The patents in dispute included several critical ones, such as U.S. Patent No. 6090382, which protects a method of treatment for moderate to severe psoriatic arthritis. AbbVie argued that Amgen's biosimilar would benefit from the significant investment and research that went into developing Humira, including two decades of R&D and numerous industry recognitions[2].

Litigation Strategy and Tactics

AbbVie's litigation strategy was aggressive and multifaceted. The company not only sought to block the launch of Amgen's biosimilar but also aimed to capitalize on Amgen's previous defense strategies. AbbVie highlighted that Amgen had previously delayed the launch of a biosimilar to its own drug, Neupogen, by arguing that biosimilars "piggyback" on the innovators' efforts. This was seen as hypocritical given Amgen's current position with its Humira biosimilar[1].

Negotiation and Settlement Attempts

During the litigation, AbbVie and Amgen engaged in negotiations, but these were contentious. AbbVie alleged that Amgen did not negotiate in good faith, failing to provide counter-proposals until the last possible moment and agreeing to be sued on only six patents out of the many identified by AbbVie[2].

Settlement and Agreement

In September 2017, AbbVie and Amgen reached a global settlement that resolved all pending litigation. Under the terms of the agreement, AbbVie granted patent licenses to Amgen for the use and sale of its biosimilar, AMGEVITA/AMJEVITA, on a country-by-country basis. The settlement allowed Amgen to launch its biosimilar in Europe on October 16, 2018, and in the United States on January 31, 2023, under the name Amjevita[4][5].

Impact on the Market

The settlement had significant implications for the market. It allowed for the introduction of a biosimilar to Humira, potentially reducing costs for patients and increasing competition in the biologics market. However, it also ensured that AbbVie maintained some level of control over the timing and terms of the biosimilar's launch, protecting its revenue stream to some extent[4][5].

Legal and Regulatory Framework

The litigation was conducted within the framework of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which created an abbreviated licensure pathway for biosimilar drugs. This legislation allows for patent litigation to protect the intellectual property of innovator companies while also facilitating the entry of biosimilars into the market[2].

Industry Implications

The case highlights the complex and often contentious nature of biosimilar litigation. It underscores the importance of intellectual property protection in the biopharmaceutical industry and the strategic maneuvers companies employ to defend their market positions. The settlement also reflects the evolving landscape of biologics and biosimilars, where innovator companies must balance their desire to protect their investments with the need to allow for competition and cost reduction in the healthcare sector[1][4].

Other Legal Challenges

AbbVie has faced other legal challenges related to Humira, including a declaratory judgment action by Alvotech USA and Alvotech hf., which aimed to challenge AbbVie's patents and alleged monopolistic practices. These cases further illustrate the ongoing legal battles in the biosimilar space and the efforts of various companies to enter the market with biosimilar versions of blockbuster drugs[3].

Key Takeaways

• Patent Protection: The case emphasizes the critical role of patent protection in the biopharmaceutical industry.
• Biosimilar Litigation: It highlights the complexities and strategies involved in biosimilar litigation.
• Market Impact: The settlement allowed for the introduction of a biosimilar to Humira, potentially reducing costs and increasing competition.
• Regulatory Framework: The litigation was conducted under the BPCIA, which balances intellectual property protection with market competition.
• Industry Dynamics: The case reflects the ongoing legal and strategic battles in the biosimilar market.

FAQs

Q: What was the main issue in the litigation between AbbVie and Amgen? A: The main issue was AbbVie's claim that Amgen's biosimilar to Humira infringed on several of its patents.

Q: How many patents did AbbVie claim were infringed by Amgen's biosimilar? A: AbbVie claimed that Amgen's biosimilar infringed on 10 patents initially and potentially 61 more.

Q: What was the outcome of the litigation? A: The companies reached a global settlement allowing Amgen to launch its biosimilar in Europe in 2018 and in the U.S. in 2023.

Q: What are the implications of this settlement for the market? A: The settlement allows for the introduction of a biosimilar to Humira, potentially reducing costs and increasing competition.

Q: What legislation governs biosimilar litigation in the U.S.? A: The Biologics Price Competition and Innovation Act (BPCIA) of 2009 governs biosimilar litigation.

Cited Sources

1. FiercePharma: "Aiming to shield $14B in sales, AbbVie smacks Amgen with a patent suit over Humira biosim"
2. IPWatchdog: "Patent settlement between AbbVie and Amgen delays Humira generic to 2023"
3. Insight.RPXCorp: "UNITED STATES DISTRICT COURT EASTERN DISTRICT OF VIRGINIA ALEXANDRIA DIVISION"
4. PR Newswire: "Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA/AMJEVITA"
5. Center for Biosimilars: "AbbVie Reaches Settlement With Amgen Over Amgevita"