United States Patent 6,080,428: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,080,428, hereafter referred to as the '428 patent, is a significant patent in the pharmaceutical industry, particularly in the treatment of hyperlipidemia. This patent, owned by Abbott Laboratories, covers compositions and methods related to nicotinic acid (niacin) extended-release formulations, often used in conjunction with other drugs like simvastatin.
Background and History
The '428 patent was filed in 1995 as a continuation-in-part application of an initial application submitted in 1993 (08/124,392), which was later abandoned. The patent was granted in June 2000[2].
Claims and Scope
The '428 patent includes multiple claims that define the scope of the invention. Here are some key aspects:
Composition Claims
The patent claims cover specific compositions of nicotinic acid in extended-release formulations. These compositions are designed to treat hyperlipidemia by managing cholesterol levels and reducing the risk of cardiovascular diseases[4].
Method Claims
In addition to composition claims, the patent also includes method claims related to the administration and dosing of these formulations. These methods are crucial for ensuring the efficacy and safety of the treatment[2].
Key Claim Elements
- The patent specifies the use of an internal hydrophobic component, which is distinct from other similar patents.
- The dosing and time of administration are critical elements, highlighting the importance of controlled release to achieve therapeutic effects[2].
Patent Family and Continuations
The '428 patent is part of a larger family of patents related to the same invention. Other patents in this family include:
- U.S. Patent No. 6,129,930 ('930 patent), a continuation-in-part of the '428 patent.
- U.S. Patent No. 6,406,715 ('715 patent), U.S. Patent No. 6,818,229 ('229 patent), U.S. Patent No. 6,676,967 ('967 patent), and U.S. Patent No. 6,746,691 ('691 patent), all of which are continuations-in-part from the '930 patent.
- U.S. Patent No. 7,011,848 ('848 patent), a continuation from the '930 patent[2].
Patent Infringement and Litigation
The '428 patent has been at the center of several patent infringement lawsuits. For instance, Abbott Laboratories has sued companies like Teva Pharmaceuticals and Lupin Limited for allegedly infringing on this and other related patents by manufacturing and selling generic versions of niacin extended-release/simvastatin tablets[1][2].
Teva Pharmaceuticals Case
In one notable case, Abbott alleged that Teva's submission of an Abbreviated New Drug Application (ANDA) for generic niacin extended-release/simvastatin tablets constituted an act of infringement. Abbott sought an injunction to prevent Teva from making, using, offering to sell, or selling these generic tablets until the expiration of the '428 patent and other related patents[1].
Lupin Limited Case
Similarly, in a case against Lupin Limited, Abbott argued that Lupin's proposed construction of certain claim terms was incorrect and that the prosecution history of the '428 patent supported Abbott's interpretation. This case highlights the complexities and disputes that can arise in claim construction and patent infringement litigation[2].
Claim Construction and Prosecution History
The interpretation of claim terms is crucial in patent litigation. The prosecution history of the '428 patent, including office actions and communications, plays a significant role in determining the proper construction of disputed claim terms. For example, the argument over the term "oral solid dosage form" involved detailed analysis of the patent's file history and the inventor's arguments during the patent application process[2].
Economic and Strategic Impact
The '428 patent and its related family of patents have significant economic and strategic implications for pharmaceutical companies. These patents protect valuable intellectual property related to the treatment of hyperlipidemia, a common condition affecting millions of people worldwide. The ability to enforce these patents can provide a competitive advantage and protect market share against generic competitors.
Statistical and Data Analysis
The USPTO's Patent Claims Research Dataset provides insights into the scope and complexity of patent claims, including those of the '428 patent. This dataset can help in analyzing the dependency relationships between claims and the overall scope of the patent, which is crucial for understanding the patent's strength and potential vulnerabilities[3].
Inventorship and Patent Ownership
Correctly identifying the inventors of a patent is essential for its validity and enforceability. The '428 patent lists David J. Bova as the inventor, and ensuring that the true and only inventors are listed is critical to avoid legal challenges in the future[4][5].
Conclusion
The United States Patent 6,080,428 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of hyperlipidemia. Its claims and scope are carefully defined to protect specific compositions and methods of administration. The patent's history, litigation, and economic impact highlight its significance and the complexities involved in patent law.
Key Takeaways
- Patent Scope: The '428 patent covers specific compositions and methods related to nicotinic acid extended-release formulations.
- Patent Family: It is part of a larger family of patents related to hyperlipidemia treatments.
- Litigation: The patent has been involved in several infringement lawsuits against generic drug manufacturers.
- Claim Construction: The interpretation of claim terms is critical and often disputed in litigation.
- Economic Impact: The patent has significant economic implications for pharmaceutical companies.
- Inventorship: Correct identification of inventors is crucial for the patent's validity.
FAQs
Q: What is the main subject matter of the '428 patent?
A: The '428 patent covers compositions and methods for treating hyperlipidemia using nicotinic acid extended-release formulations.
Q: Who is the inventor listed on the '428 patent?
A: David J. Bova is listed as the inventor.
Q: What other patents are part of the same family as the '428 patent?
A: Other patents include U.S. Patent No. 6,129,930, U.S. Patent No. 6,406,715, U.S. Patent No. 6,818,229, U.S. Patent No. 6,676,967, U.S. Patent No. 6,746,691, and U.S. Patent No. 7,011,848.
Q: What are some of the key claim elements of the '428 patent?
A: Key elements include the use of an internal hydrophobic component and specific dosing and administration methods.
Q: Why is claim construction important in patent litigation?
A: Claim construction is crucial because it determines the scope of the patent and can significantly impact the outcome of infringement lawsuits.
Cited Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ABBOTT LABORATORIES and ABBOTT RESPIRATORY LLC, Plaintiffs, v. TEVA PHARMACEUTICAL INDUSTRIES, LTD. and TEVA PHARMACEUTICALS USA, INC., Defendants. [PDF]
- Case 1:09-cv-00152-JJF-LPS Document 95 Filed 06/18/10 Page 1 [PDF]
- Patent Claims Research Dataset - USPTO
- Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
- Determining Inventorship for US Patent Applications [PDF]
