United States Patent 9,504,655: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,504,655, titled "Capsule Dosage Form of Metoprolol Succinate," was granted to Sun Pharmaceutical Industries Limited on November 29, 2016. This patent is significant in the pharmaceutical industry, particularly in the development of extended-release formulations of metoprolol succinate, a widely used beta-blocker.
Background of the Invention
Metoprolol succinate is prescribed for the treatment of hypertension, angina pectoris, and stable, symptomatic heart failure. The existing extended-release dosage forms of metoprolol succinate have certain limitations, such as variable drug release profiles and potential side effects. The invention described in this patent aims to address these issues by providing a novel extended-release capsule dosage form[1].
Scope of the Patent
The patent covers an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units. These units consist of:
- Inert Cores: Water-soluble or water-swellable materials such as sugar, microcrystalline cellulose, cellulose, starch, or modified starch.
- Drug Layer: A layer of metoprolol succinate over the inert cores.
- Extended Release Layer: A layer of extended-release polymer coating the drug layer, ensuring a controlled release of the drug over a prolonged period[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: The extended-release capsule dosage form comprising coated discrete units.
- Claim 5: The coated discrete units with inert cores, a drug layer of metoprolol succinate, and an extended-release layer.
- Claim 6: The inert cores being water-soluble or water-swellable.
- Claim 7: The specific materials used for the inert cores, such as sugar, microcrystalline cellulose, etc.
- Claim 9: The extended-release layer comprising an extended-release polymer in a specified amount[1].
Patent Landscape: Related Patents and Technologies
The patent landscape for extended-release formulations of metoprolol succinate includes several related patents and technologies:
- Prior Art: Previous patents such as US 5,246,714 and US 6,156,342 have described different formulations and delivery systems for metoprolol succinate. However, the current patent offers a unique combination of inert cores and extended-release layers[1].
- Global Patent System: The Global Dossier service provided by the USPTO allows for the tracking of related patent applications across different IP offices, which can be useful in understanding the broader patent landscape for similar inventions[4].
Administrative Challenges and Validity
The validity of patents, including US 9,504,655, can be challenged through administrative procedures such as Inter Partes Review (IPR) and Post-Grant Review (PGR) before the Patent Trial and Appeal Board (PTAB). These procedures, established by the Leahy-Smith America Invents Act (AIA), provide a faster and less expensive alternative to judicial proceedings for challenging patent validity[2].
Impact on Pharmaceutical Industry
The invention described in this patent has significant implications for the pharmaceutical industry:
- Improved Drug Delivery: The extended-release formulation ensures a more consistent and controlled release of metoprolol succinate, potentially improving patient compliance and reducing side effects.
- Competitive Advantage: The unique formulation and delivery system can provide a competitive edge to Sun Pharmaceutical Industries Limited in the market for beta-blockers[1].
Metrics for Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics can help in assessing the breadth and clarity of the patent claims. For instance, narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Controversies and Debates
The PTAB and IPR processes have been controversial, with critics arguing that they are biased against patent holders and create uncertainty in patent rights. However, these processes are designed to improve patent quality and provide a more efficient system for challenging patents that should not have been issued[2].
Current Debates and Proposed Reforms
There are ongoing debates and proposed reforms regarding the PTAB and IPR processes, including issues related to standing, burdens of proof, discretionary institution of IPRs, claim construction, and the role of the USPTO Director in reviewing PTAB decisions. These reforms aim to balance the rights of patent holders with the need to ensure patent quality and reduce litigation costs[2].
Key Takeaways
- Novel Formulation: The patent describes a novel extended-release capsule dosage form of metoprolol succinate with coated discrete units.
- Administrative Challenges: The patent's validity can be challenged through PTAB and IPR processes.
- Industry Impact: The invention has significant implications for improving drug delivery and providing a competitive advantage in the pharmaceutical market.
- Patent Scope Metrics: Metrics like independent claim length and count can help assess the patent's scope and clarity.
Frequently Asked Questions (FAQs)
Q: What is the main invention described in US Patent 9,504,655?
A: The main invention is an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units.
Q: What are the components of the coated discrete units?
A: The components include inert cores, a drug layer of metoprolol succinate, and an extended-release layer.
Q: How can the validity of this patent be challenged?
A: The validity can be challenged through Inter Partes Review (IPR) and Post-Grant Review (PGR) before the Patent Trial and Appeal Board (PTAB).
Q: What are the potential benefits of this invention for patients?
A: The invention ensures a more consistent and controlled release of metoprolol succinate, potentially improving patient compliance and reducing side effects.
Q: How does the PTAB process compare to judicial proceedings in challenging patent validity?
A: PTAB processes are generally faster and less expensive, with a lower burden of proof to invalidate patents compared to judicial proceedings.
Cited Sources:
- United States Patent and Trademark Office. Capsule Dosage Form of Metoprolol Succinate. US Patent 9,504,655 B2, November 29, 2016.
- Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
- SSRN. Patent Claims and Patent Scope. September 29, 2016.
- United States Patent and Trademark Office. Search for patents. October 18, 2018.
