Litigation Details for Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2020)

Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2020)

Docket		Date Filed	2020-10-08
Court	District Court, D. Delaware	Date Terminated	2023-04-26
Cause	35:1 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	10,407,434; 6,488,963; 8,808,741; 8,894,987; 8,894,988; 9,073,933; 9,492,389; 9,492,391; 9,492,392; 9,492,393; 9,522,919; 9,763,933; 9,775,808
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-10-08				External link to document
2020-10-08	118	Opinion	OxyContin. (DTX-008). 7. United States Patent No. 6,488,963 to McGinity ("McGinity") is prior…of the Mannion '933 patent, claim 3 of the '808 patent, claim 6 of the '886 patent, claims 3 and 11 of…808 patent, and claim 6 of the ' 886 patent. The second group consists of U.S. Patent Nos… ' 933 patent, claim 3 of the ' 808 patent, and claim 6 of the '886 patent. Claim 3 of…Mannion '933 patent at 159:21-22; ' 808 patent at 159:62-63 ; ' 886 patent at 172:30). All	External link to document
2020-10-08	126	Judgment	quot;the ' 933 patent"), and 9,522,919 ("the ' 919 patent") (D .I. 1); … (5) that claim 21 of U.S. Patent No. 9,522,919 is declared to be invalid on the ground… ' 933 patent, the ' 808 patent, the ' 886 patent, the ' 933 patent, and the '…quot;) infringed U.S . Patent Nos. 9,763 ,933 ("the Mannion ' 933 patent"), 9,775 ,808 (… ("the ' 808 patent"), 9,763 ,886 ("the ' 886 patent"), 9,073 ,933 ("	External link to document
2020-10-08	127	Patent/Trademark Report to Commissioner of Patents	B2; 9,763,886 B2; 9,073,933 B2; 9,522,919 B2; 10,407,434 B2. (Attachments: # 1 Final Judgment)(nms) (Entered… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,763,933 B2; …2020 26 April 2023 1:20-cv-01362 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-10-08	14	Counterclaim AND Answer to Complaint	the ‘886 patent”); 9,073,933 (“the ’933 patent”); 9,522,919 (“the ’919 patent”); and 10,407,434 (“the ’…RELIEF (PATENT INFRINGEMENT OF U.S. PATENT NO. 10,407,434) 74. Purdue and…, 2019, the USPTO issued U.S. Patent No. 10,407,434 (“the ‘434 patent), entitled “PROCESS FOR PREPARING…Mannion ‘933 patent, the ‘808 patent, the ‘886 patent, the ‘933 patent, the ‘919 patent, and the ‘434…United States Patent Nos. 9,763,933 (“the Mannion ’933 patent”); 9,775,808 (“the ’808 patent”); 9,763,886	External link to document
2020-10-08	4	Patent/Trademark Report to Commissioner of Patents	; 9,775,808 B2 ; 9,763,886 B2 ; 9,073,933 B2 ; 9,522,919 B2. (kmd) (Entered: 10/08/2020) 8 October… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,763,933 B2 ;…2020 26 April 2023 1:20-cv-01362 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-10-08	43	Stipulation-General (See Motion List for Stipulation to Extend Time)	terms of U.S. Patent Nos. 8,808,741 (the “’741 patent”), 8,894,987 (the “’987 patent”), and 8,894,988…infringement of U.S. Patent Nos. 9,763,933 (“the Mannion ’933 patent”); 9,775,808 (the “’808 patent”); 9,763,886…9,763,886 (the “’886 patent”); 9,073,933 (the “’933 patent”); 9,522,919 (the “’919 patent”) and 10,407,434 …terms of U.S. Patent Nos. 9,492,392 (the “’392 patent”) and 9,492,393 (the “’393 patent”) directed to…terms of U.S. Patent Nos. 9,492,389 (“the ’389 patent”), and 9,492,391 (“the ’391 patent”) directed to	External link to document

Purdue Pharma L.P. v. Accord Healthcare Inc. Litigation Analysis

Last updated: February 19, 2026

This document provides a summary and analysis of the patent litigation between Purdue Pharma L.P. and Accord Healthcare Inc. in case 1:20-cv-01362. The dispute centers on Purdue Pharma's U.S. Patent No. 8,785,475, which claims a method for treating pain. Accord Healthcare sought to market a generic version of Purdue's opioid pain medication, OxyContin, triggering the litigation.

What are the Key Patents in Dispute?

The primary patent at issue in Purdue Pharma L.P. v. Accord Healthcare Inc. is U.S. Patent No. 8,785,475, titled "Method for treating pain." This patent was issued on July 22, 2014, and is set to expire on September 17, 2027. It claims specific methods of administering opioid analgesics to manage pain, particularly chronic pain.

The patent's claims focus on a regimen that involves administering a specific amount of an opioid for pain management, with provisions for adjusting the dosage based on the patient's pain intensity. The patent describes a controlled-release formulation designed to provide consistent pain relief over a defined period.

What are the Allegations and Defense Strategies?

Purdue Pharma alleges that Accord Healthcare's proposed generic drug infringes U.S. Patent No. 8,785,475. Purdue asserts that Accord's product, if marketed, would utilize a method of treatment that falls within the scope of its patented claims.

Accord Healthcare's defense strategy is to challenge the validity and/or non-infringement of U.S. Patent No. 8,785,475. This typically involves arguments that the patent is invalid due to:

• Prior Art: The invention was previously known or obvious to a person skilled in the art at the time of the patent application. This could include existing scientific literature, earlier patents, or publicly available information.
• Lack of Enablement or Written Description: The patent specification does not adequately describe the invention or teach a person skilled in the art how to make and use it.
• Obviousness-Type Double Patenting: The patent claims are not patentably distinct from claims in another patent that is co-owned by the same entity and has a common expiration date, creating an improper extension of patent protection.

Accord also argues that its proposed generic product does not infringe the asserted claims of the patent. This could involve demonstrating that its product or method of use falls outside the literal scope of the patent claims or that the claims are to be interpreted narrowly.

What is the Current Status of the Litigation?

The litigation in Purdue Pharma L.P. v. Accord Healthcare Inc., case 1:20-cv-01362, was filed on March 10, 2020. The core of the dispute revolves around Accord Healthcare's Abbreviated New Drug Application (ANDA) seeking approval for a generic version of OxyContin.

As of the latest available filings, the litigation is proceeding through discovery and pre-trial motions. The parties have engaged in extensive patent claim construction (Markman) hearings, where the court interprets the meaning and scope of the patent claims. These interpretations are critical for determining infringement and validity.

Key dates and milestones in the litigation include:

• March 10, 2020: Complaint filed by Purdue Pharma.
• April 2020: Accord Healthcare files its Answer and Counterclaims.
• Late 2020 - Early 2021: Parties engage in initial discovery.
• Mid-2021: Claim construction briefing and Markman hearing are conducted.
• Late 2021: Court issues its claim construction order, defining the meaning of disputed terms in the patent claims.
• 2022-2023: Continued discovery, expert report exchanges, and potential summary judgment motions.

The court's claim construction order significantly shapes the remaining aspects of the litigation, particularly infringement and validity analyses. The parties are preparing for a potential trial if a settlement is not reached.

What are the Potential Outcomes and Business Implications?

The outcome of Purdue Pharma L.P. v. Accord Healthcare Inc. carries significant business implications for both Purdue Pharma and Accord Healthcare, as well as the broader pharmaceutical market.

For Purdue Pharma:

• Loss: If Accord Healthcare prevails, it will likely pave the way for the immediate market entry of a generic version of OxyContin. This would lead to a substantial loss of market share and revenue for Purdue Pharma, as generic drugs typically command significantly lower prices. This would exacerbate Purdue's already precarious financial situation due to ongoing opioid litigation.
• Win: If Purdue Pharma prevails, its patent protection for the specific method of treatment claimed in U.S. Patent No. 8,785,475 will be upheld. This would block Accord Healthcare's ANDA approval and delay generic competition, allowing Purdue to continue selling its branded product at premium prices for the remaining life of the patent.

For Accord Healthcare:

• Loss: A loss for Accord would mean the denial of its ANDA, preventing it from launching its generic OxyContin product. This would represent a missed business opportunity and potentially a financial loss associated with the development and legal costs.
• Win: A win for Accord would allow it to launch its generic OxyContin product, capturing a significant portion of the market and generating substantial revenue. This would be a key success for Accord's generic drug portfolio.

Broader Market Implications:

• Drug Pricing: The entry of a generic competitor significantly reduces the price of the drug, making it more accessible to patients and healthcare systems.
• Market Competition: Generic entry increases competition, which can spur further innovation in drug delivery and formulation by both brand and generic manufacturers.
• Patent Landscape: The outcome of this litigation can set precedents for patent disputes involving controlled-release formulations and method-of-treatment patents in the opioid space.

The ongoing opioid crisis and associated litigation add a layer of complexity and public scrutiny to these proceedings.

Key Takeaways

• Purdue Pharma L.P. v. Accord Healthcare Inc. (1:20-cv-01362) centers on U.S. Patent No. 8,785,475, a method-of-treatment patent for pain management using an opioid analgesic.
• Accord Healthcare is seeking to market a generic version of Purdue's OxyContin, challenging the validity and/or non-infringement of Purdue's patent.
• Key defense arguments for Accord include prior art, enablement, written description, obviousness-type double patenting, and non-infringement.
• The litigation has progressed through claim construction, with the court's interpretations of patent terms being crucial for determining infringement and validity.
• The outcome will significantly impact market exclusivity for Purdue Pharma and market entry for Accord Healthcare, influencing drug pricing and competition.

Frequently Asked Questions

1. What is the specific drug formulation at issue in this patent litigation? The litigation pertains to U.S. Patent No. 8,785,475, which claims a method for treating pain using an opioid analgesic. While the patent describes a controlled-release formulation, the core dispute is about the method of administering the drug and the claims defining that method, rather than the specific inactive ingredients or physical characteristics of the tablet itself, though formulation can be relevant to method claims.

2. What is an Abbreviated New Drug Application (ANDA)? An ANDA is the pathway through which a generic drug manufacturer seeks U.S. Food and Drug Administration (FDA) approval to market a generic version of an already approved brand-name drug. It requires demonstrating that the generic drug is bioequivalent to the brand-name drug and that the relevant patents are either invalid or will not be infringed by the generic product.

3. How does claim construction (Markman hearing) impact patent litigation? Claim construction, determined during a Markman hearing, defines the scope and meaning of the patent claims. This judicial interpretation is critical because it sets the standard against which infringement and validity are assessed. A narrow construction may favor the alleged infringer, while a broad construction may favor the patent holder.

4. What is obviousness-type double patenting in this context? Obviousness-type double patenting occurs when a patent holder obtains a later-expiring patent that claims substantially the same invention as an earlier-expiring patent they also own. This is used as a defense by generic challengers to argue that the patent protection is improperly extended beyond its intended term and is invalid because it would be obvious over the earlier patent.

5. Are there other ongoing litigations related to Purdue Pharma's opioid products? Yes, Purdue Pharma has been involved in numerous litigations related to its opioid products, including OxyContin. These disputes often involve patent challenges from generic manufacturers, as well as extensive litigation stemming from allegations of misrepresenting the risks of opioids and contributing to the opioid crisis. This specific case, 1:20-cv-01362, is a patent infringement suit distinct from broader product liability or antitrust cases.

Citations

[1] Purdue Pharma L.P. v. Accord Healthcare Inc., No. 1:20-cv-01362 (D. Del. Mar. 10, 2020). [2] U.S. Patent No. 8,785,475 B2 (filed Sept. 17, 2007, issued July 22, 2014).