United States Patent 8,551,957: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,551,957, titled "Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative," is a significant patent in the pharmaceutical industry. This patent, issued to protect a specific pharmaceutical composition, has implications for drug development, patent litigation, and generic competition.
Patent Overview
Publication and Authority
The patent was published under the number US8551957B2 and is governed by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Keywords
The patent involves a glucopyranosyl-substituted benzene derivative, which is a key component in the pharmaceutical composition. Prior art keywords include "inhibitor," "DPP" (dipeptidyl peptidase), "glucopyranosyl," and "substituted benzene"[4].
Legal Status
As of the current date, the patent is active and set to expire on October 14, 2029[2][5].
Scope of the Patent
Pharmaceutical Composition
The patent protects a pharmaceutical composition that includes a glucopyranosyl-substituted benzene derivative. This compound is often used in the treatment of various diseases, particularly those related to diabetes and metabolic disorders. The composition may also include other active ingredients and excipients to enhance its efficacy and stability[4].
Therapeutic Uses
The glucopyranosyl-substituted benzene derivative is typically used as a DPP-4 inhibitor, which plays a crucial role in managing blood sugar levels. This makes the patent relevant to the development of drugs for type 2 diabetes and other metabolic conditions[4].
Claims of the Patent
Main Claims
The patent includes several claims that define the scope of protection. These claims cover the specific chemical structure of the glucopyranosyl-substituted benzene derivative, the pharmaceutical composition itself, and the methods of using this composition for therapeutic purposes[4].
Dependent Claims
Dependent claims further specify the composition, including the types and amounts of other ingredients that can be included, as well as specific methods of administration and dosages. These claims help to narrow down the scope and ensure that the patent covers a well-defined and novel invention[4].
Patent Landscape
Expiration Dates and Generic Competition
The patent is set to expire on October 14, 2029, which means that generic versions of the drug can be developed and marketed after this date. However, until then, any generic manufacturer must either wait for the patent to expire or challenge the patent through litigation or other legal means[2][5].
Litigation and Patent Disputes
There have been instances of litigation initiated against generic manufacturers for infringement of this patent. For example, litigation was initiated against Alkem and Lupin for their ANDA (Abbreviated New Drug Application) filings, which included certifications challenging the validity or non-infringement of the '957 patent[2][5].
Patent Portfolio and Strategy
The '957 patent is part of a broader patent portfolio that includes other related patents with different expiration dates. This strategy helps to extend the exclusivity period for the drug and complicates the entry of generic competitors. For instance, other patents like the '449, '938, '927, and '637 patents, which expire at different times, further protect the drug's market exclusivity[2][5].
Impact on the Pharmaceutical Industry
Innovation and R&D
The protection offered by this patent encourages innovation and research in the pharmaceutical sector. Companies are incentivized to invest in R&D to develop new drugs and compositions, knowing that their inventions will be protected for a significant period[3].
Generic Competition
The expiration of this patent will open the door for generic competition, which can lead to lower drug prices and increased accessibility for patients. However, until the patent expires, the original patent holder maintains a monopoly on the market, which can impact the affordability and availability of the drug[2][5].
Challenges and Opportunities
Patent Litigation
The patent landscape is complex, and litigation is a common occurrence. Companies must navigate these legal challenges to bring their products to market. This can be both a challenge and an opportunity, as successful litigation can protect market share, while unsuccessful litigation can open the market to competitors[3].
Regulatory Compliance
Compliance with regulatory requirements, such as those set by the FDA, is crucial. Generic manufacturers must ensure their products meet the necessary standards and do not infringe on existing patents, which can be a significant challenge but also an opportunity to enter a lucrative market[2][5].
Key Takeaways
- Patent Protection: The '957 patent protects a specific pharmaceutical composition containing a glucopyranosyl-substituted benzene derivative.
- Expiration Date: The patent is set to expire on October 14, 2029.
- Litigation: There have been instances of litigation against generic manufacturers for patent infringement.
- Impact on Industry: The patent influences innovation, R&D, and generic competition in the pharmaceutical sector.
- Regulatory Compliance: Compliance with FDA regulations and patent laws is essential for market entry.
FAQs
What is the main subject of the United States Patent 8,551,957?
The main subject is a pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative, often used as a DPP-4 inhibitor.
When is the patent set to expire?
The patent is set to expire on October 14, 2029.
What are the implications of this patent for generic competition?
The patent prevents generic manufacturers from marketing their versions of the drug until it expires, after which generic competition can begin.
Have there been any litigation cases related to this patent?
Yes, there have been litigation cases initiated against generic manufacturers for infringement of this patent.
How does this patent impact innovation in the pharmaceutical industry?
The patent protection incentivizes companies to invest in R&D to develop new drugs and compositions, knowing their inventions will be protected.
Sources
- US8551957B2 - Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate - Google Patents.
- II US FOOD & DRUG - accessdata.fda.gov.
- The BioLoquitur Bulletin - Seyfarth Shaw LLP.
- US8551957B2 - Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate - Google Patents.
- Empagliflozin Tablets - accessdata.fda.gov.
