Introduction
The litigation between Endo Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc. is a significant case in the realm of patent law, particularly involving pharmaceuticals. This dispute revolves around the validity and infringement of Endo’s patents related to its opioid product, Opana® ER (oxymorphone hydrochloride).
Background of the Case
Endo Pharmaceuticals Inc. and Mallinckrodt LLC filed patent infringement suits against several defendants, including Teva Pharmaceuticals USA, Inc. and Actavis Pharma, Inc., who had submitted Abbreviated New Drug Applications (ANDAs) to market generic versions of Opana® ER. The case was consolidated and heard in various permutations at different courts, ultimately reaching the Court of Appeals for the Federal Circuit[1][3][5].
The Patent in Question: U.S. Patent 8,808,737
The central patent at issue is U.S. Patent 8,808,737 (’737 patent), which pertains to a method of treating pain in renally impaired patients. The method involves performing a kidney function test and then administering an altered dosage of the drug based on the test results. The patent claims specify reducing the dosage to a certain Area Under the Curve (AUC) level[1][3].
District Court Ruling and Appeal
Initially, the district court partially dismissed the case, finding that the ’737 patent claims were invalid for lack of patent-eligible subject matter under 35 U.S.C. § 101. Endo appealed this decision to the Federal Circuit, arguing that the district court erred both in substance and process. Endo contended that the claims were patent-eligible as they directed a specific method of treatment and that factual disputes precluded dismissal based solely on the pleadings[1].
Federal Circuit Ruling
The Federal Circuit reversed the district court’s holding, stating that the claims of the ’737 patent were not directed to a natural law and thus were patent-eligible. The court distinguished the ’737 claims from those in the Mayo case, noting that the ’737 claims set out specific treatment steps based on test results, unlike the Mayo claims which merely indicated a need to adjust dosage without specifying how. The court also rejected Actavis’s argument that the ’737 claims were distinguishable from the Vanda claims, finding that the lack of specific details on obtaining and assaying biological samples was not a significant difference[3].
Infringement and Invalidity Claims
In addition to the patent eligibility issue, the case involved claims of infringement and invalidity of other patents related to Opana® ER, specifically the ’122 and ’216 patents. The district court found that the generic drug manufacturers failed to show that these patents were invalid for obviousness, lack of written description, or indefiniteness. The court also determined that Endo had carried its burden to show infringement of all but two of the asserted claims and issued a permanent injunction against Actavis’s manufacture and sale of its generic version of Opana® ER[5].
Permanent Injunction
Actavis challenged the permanent injunction, arguing that the district court abused its discretion. However, the court found that Endo had demonstrated irreparable harm, as evidenced by past harms such as loss of market share, reduction in sales force and promotional expenses, and changes in research and development strategies. The court also considered the balance of hardships and the public interest, ultimately concluding that the permanent injunction was justified[5].
Additional Context: Opioid Litigation and Settlements
It is worth noting that Teva Pharmaceuticals has been involved in broader opioid-related litigation. In a separate case, Teva agreed to pay up to $4.2 billion nationwide to settle opioid claims, including a settlement in New York that resolved administrative charges related to insurance fraud and fraudulent misrepresentations about the safety and efficacy of its opioid drugs[2].
Key Takeaways
- Patent Eligibility: The Federal Circuit ruled that the ’737 patent claims were patent-eligible under 35 U.S.C. § 101, distinguishing them from other cases like Mayo.
- Infringement: The district court found that the generic drug manufacturers infringed on Endo’s patents, leading to a permanent injunction.
- Irreparable Harm: Endo demonstrated irreparable harm due to the introduction of generic versions, justifying the permanent injunction.
- Broader Implications: The case highlights the complexities and challenges in pharmaceutical patent litigation, especially in the context of opioid products.
FAQs
Q: What was the main issue in the Endo v. Teva case?
A: The main issue was whether the claims of U.S. Patent 8,808,737 were patent-eligible under 35 U.S.C. § 101 and whether the generic versions of Opana® ER infringed on Endo’s patents.
Q: How did the Federal Circuit rule on the patent eligibility of the ’737 patent?
A: The Federal Circuit ruled that the claims of the ’737 patent were patent-eligible, distinguishing them from other cases like Mayo.
Q: What was the outcome regarding the infringement claims?
A: The district court found that the generic drug manufacturers infringed on Endo’s patents, leading to a permanent injunction against Actavis.
Q: Why was a permanent injunction issued against Actavis?
A: The permanent injunction was issued because Endo demonstrated irreparable harm due to the introduction of generic versions, and the court considered the balance of hardships and the public interest.
Q: Is this case related to other opioid litigation involving Teva?
A: Yes, Teva has been involved in broader opioid-related litigation, including a settlement in New York related to insurance fraud and fraudulent misrepresentations about its opioid drugs.
Cited Sources
- Banner Witcoff, "IP Alert: Endo v. Teva: Courts Continue to Invalidate Patent Claims Without Construing Them," December 21, 2018.
- New York State Office of the Attorney General, "Attorney General James Secures $523 Million from Top Opioid Manufacturer Teva," November 3, 2022.
- Robins Kaplan LLP, "Endo Pharms. Inc. v. Teva Pharms. USA, Inc.," March 28, 2019.
- United States Court of Appeals for the Federal Circuit, "ENDO PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC. [ORDER]," June 29, 2018.
- FindLaw, "ENDO PHARMACEUTICALS INC v. TEVA PHARMACEUTICALS USA, INC."
