Understanding the Scope and Claims of United States Patent 7,053,092
Introduction
The United States Patent 7,053,092, hereafter referred to as the '092 patent, is a crucial component of the patent landscape surrounding aripiprazole, a medication primarily used to treat schizophrenia, bipolar disorder, and major depressive disorder. This patent is owned by Otsuka Pharmaceutical Co., Ltd., the original developer of Abilify®, the brand name for aripiprazole.
Patent Overview
The '092 patent was issued on May 30, 2006, and it is set to expire on January 28, 2022, although this date may have been extended due to pediatric exclusivity or other regulatory considerations[2][4].
Patent Claims
The '092 patent is characterized by its claims related to the composition and formulation of aripiprazole. Here are some key aspects of its claims:
Composition of Matter
The patent claims cover the chemical composition of aripiprazole, including its molecular structure and any specific formulations that are protected under this patent. This includes the active pharmaceutical ingredient (API) itself and any specific salts or polymorphs that are unique to Otsuka's formulation[4].
Method of Use
While the primary focus of the '092 patent is on the composition of matter, it also includes method-of-use claims. However, for generic drug applications (ANDAs), the method-of-use claims are often distinguished from the composition claims. In the context of ANDAs, the '092 patent is typically treated as a method-of-use patent that does not claim any indication for which the generic manufacturer is seeking approval[1][5].
Patent Scope
The scope of the '092 patent is defined by its claims and the breadth of protection it offers.
Claim Language
The patent scope can be measured by the language used in the independent claims. Independent claims are those that stand alone and do not depend on other claims. The length and count of independent claims can indicate the breadth of the patent. Narrower claims generally suggest a more focused and specific invention, while broader claims may encompass a wider range of variations[3].
Litigation and Enforcement
The '092 patent has been involved in several litigation cases under the Hatch-Waxman Act, which governs the approval of generic drugs in the United States. Generic manufacturers, such as Mylan and Alembic, have filed ANDAs with paragraph IV certifications, asserting that the '092 patent is invalid, unenforceable, or will not be infringed by their generic products. Otsuka has initiated litigation in response to these certifications, but these cases have often been dismissed or resolved without a statutory stay of approval[1][2][5].
Impact on Generic Drug Approval
The '092 patent plays a significant role in the approval process of generic aripiprazole products.
Paragraph IV Certifications
Generic manufacturers must submit paragraph IV certifications when they believe the patents listed in the Orange Book (the FDA's book of approved drug products) are invalid, unenforceable, or will not be infringed by their products. For the '092 patent, these certifications are typically submitted under section 505(j)(2)(A)(viii) of the FD&C Act, stating that the patent is a method-of-use patent that does not claim any indication for which the generic manufacturer is seeking approval[1][5].
Litigation and Approval
Despite the litigation initiated by Otsuka, the FDA has approved several ANDAs for generic aripiprazole products. The litigation does not create a statutory stay of approval, allowing the FDA to approve generic versions once all regulatory requirements are met[1][5].
Expiration and Exclusivity
The '092 patent expired on January 28, 2022. However, the expiration date could have been extended due to pediatric exclusivity or other regulatory exclusivities. This expiration marks the end of Otsuka's exclusive rights to the composition and formulation covered by this patent, paving the way for more generic entries into the market[1][4].
Conclusion
The United States Patent 7,053,092 is a critical part of the intellectual property landscape surrounding aripiprazole. Its claims cover the composition and specific formulations of aripiprazole, and it has been involved in several high-profile litigation cases related to generic drug approvals. The expiration of this patent has significant implications for the pharmaceutical industry, particularly for generic manufacturers seeking to enter the market with their own versions of aripiprazole.
Key Takeaways
- Patent Claims: The '092 patent covers the composition and formulation of aripiprazole.
- Method of Use: The patent includes method-of-use claims, but these are often distinguished in ANDA filings.
- Litigation: The patent has been involved in several litigation cases under the Hatch-Waxman Act.
- Generic Approval: The FDA has approved ANDAs despite ongoing litigation.
- Expiration: The patent expired on January 28, 2022, potentially extended by exclusivities.
FAQs
Q1: What is the United States Patent 7,053,092 related to?
A1: The '092 patent is related to the composition and formulation of aripiprazole, a medication used to treat schizophrenia, bipolar disorder, and major depressive disorder.
Q2: Who owns the '092 patent?
A2: The '092 patent is owned by Otsuka Pharmaceutical Co., Ltd.
Q3: What is the significance of paragraph IV certifications in relation to the '092 patent?
A3: Paragraph IV certifications are submitted by generic manufacturers asserting that the '092 patent is invalid, unenforceable, or will not be infringed by their products.
Q4: How has the '092 patent impacted the approval of generic aripiprazole products?
A4: Despite litigation, the FDA has approved several ANDAs for generic aripiprazole products, as litigation does not create a statutory stay of approval.
Q5: When did the '092 patent expire?
A5: The '092 patent expired on January 28, 2022, although it could have been extended due to pediatric exclusivity or other regulatory exclusivities.
Sources
- FDA Approval Letter for Zydus Pharmaceuticals: ANDA 090165 Approval Letter.
- Otsuka Pharm. Co. v. Mylan Inc.: Casetext.
- Patent Claims and Patent Scope: SSRN.
- Otsuka Pharm. Co. v. Torrent Pharm. Ltd.: Casetext.
- FDA Approval Letter for Alembic Pharmaceuticals: Aripiprazole Orally Disintegrating Tablets Approval Letter.
