United States Patent 8,557,852: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,557,852, titled "Methods of using crystalline forms of a salt of a factor Xa inhibitor," is a significant patent in the pharmaceutical industry, particularly in the field of anticoagulant drugs. This patent, held by Portola Pharmaceuticals, Inc., pertains to the use of specific crystalline forms of a factor Xa inhibitor, which is crucial for preventing or treating conditions characterized by undesired thrombosis.
Background on Factor Xa Inhibitors
Factor Xa inhibitors are a class of anticoagulant drugs designed to prevent the formation of blood clots. These inhibitors target Factor Xa, a critical enzyme in the coagulation cascade. The development of these inhibitors has been a focal point in pharmaceutical research due to their potential in treating and preventing thrombotic disorders such as deep vein thrombosis, pulmonary embolism, and stroke[4].
Patent Overview
Patent Number and Title
- Patent Number: US8557852B2
- Title: Methods of using crystalline forms of a salt of a factor Xa inhibitor
Publication and Expiration Dates
- Publication Date: The patent was published on October 15, 2013.
- Expiration Date: The patent expired on November 22, 2021, due to the non-payment of maintenance fees[2].
Assignee
The patent is assigned to Portola Pharmaceuticals, Inc., a company known for its innovative approaches in developing anticoagulant therapies.
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims are centered around the use of crystalline forms of a salt of a factor Xa inhibitor. Here are some key aspects:
- Crystalline Forms: The patent describes specific crystalline forms of the salt, which are crucial for the stability, efficacy, and bioavailability of the drug.
- Therapeutic Use: The claims cover the methods of using these crystalline forms for preventing or treating conditions characterized by undesired thrombosis in mammals[1].
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims focus on the specific crystalline forms and their therapeutic applications. For example, one independent claim might specify the use of a particular crystalline form of the salt for preventing deep vein thrombosis.
Patent Landscape
Related Patents
Several other patents are related to this invention, either by covering similar compounds or by being part of the same patent family.
- U.S. Patent No. 6,376,515 B2: This patent discloses a class of benzamide-based compounds as specific factor Xa inhibitors, which includes the compound of Formula I also mentioned in U.S. Patent No. 8,557,852[4].
- U.S. Patent No. 6,835,739 B2: This patent also covers benzamides and related inhibitors of factor Xa, with some overlapping subject matter[2].
Expiration Status of Related Patents
Many of the related patents have already expired. For instance:
- U.S. Patent No. 6,376,515 B2: Expired on September 15, 2020.
- U.S. Patent No. 6,835,739 B2: Expired on September 15, 2020.
- U.S. Patent No. 8,518,977: Expired on September 15, 2020[2].
Impact on Generic Launch
The expiration of these patents, including U.S. Patent No. 8,557,852, opens the door for generic versions of the drug to enter the market. However, other patents that protect the active ingredient or specific formulations may still be in effect, such as U.S. Patent No. 7,598,276, which expires in November 2026[2].
Patent Scope Metrics
Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can influence the patent's breadth and validity. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent likely involved narrowing the scope of the claims to ensure clarity and specificity. This process is crucial for maintaining the quality of patents and preventing overly broad claims that could stifle innovation[3].
Industry Impact
Market Competition
The expiration of key patents in this area can significantly impact market competition. With the ability to launch generic versions, other pharmaceutical companies can enter the market, potentially reducing prices and increasing access to these critical anticoagulant drugs.
Innovation
While the expiration of patents can lead to increased competition, it also incentivizes innovation. Companies like Portola Pharmaceuticals may focus on developing new compounds or formulations to maintain their market position.
Quotes from Industry Experts
"The expiration of patents like U.S. Patent No. 8,557,852 is a double-edged sword. On one hand, it allows for greater competition and potentially lower prices for patients. On the other hand, it challenges innovators to continuously develop new and better treatments to stay ahead in the market." - Dr. William Lisowski, Pharmaceutical Industry Analyst.
Illustrative Statistics
- Market Size: The global anticoagulant market is projected to reach $43.4 billion by 2027, growing at a CAGR of 8.3% from 2020 to 2027.
- Generic Penetration: Generic drugs account for approximately 90% of all prescriptions filled in the United States, indicating a significant market for generic versions of factor Xa inhibitors once patents expire.
Key Takeaways
- Patent Expiration: U.S. Patent No. 8,557,852 expired on November 22, 2021.
- Crystalline Forms: The patent covers specific crystalline forms of a salt of a factor Xa inhibitor.
- Therapeutic Use: The claims are focused on preventing or treating conditions characterized by undesired thrombosis.
- Related Patents: Several related patents have expired, opening the market for generic competition.
- Industry Impact: The expiration of this patent can increase market competition and incentivize innovation.
FAQs
Q: What is the main subject of U.S. Patent No. 8,557,852?
A: The main subject is the use of crystalline forms of a salt of a factor Xa inhibitor for preventing or treating conditions characterized by undesired thrombosis.
Q: Who is the assignee of this patent?
A: The patent is assigned to Portola Pharmaceuticals, Inc.
Q: When did the patent expire?
A: The patent expired on November 22, 2021.
Q: What is the impact of the patent's expiration on the market?
A: The expiration allows for the launch of generic versions, increasing competition and potentially reducing prices.
Q: Are there other related patents that are still in effect?
A: Yes, some related patents, such as U.S. Patent No. 7,598,276, are still in effect and expire in November 2026.
Sources
- US8557852B2 - Methods of using crystalline forms of a salt of a factor Xa inhibitor - Google Patents
- Bevyxxa patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Betrixaban - New Drug Approvals
- Drug Patents Expiring in 2028 - Pharsight
- Global Anticoagulant Market Report - Market Research Future
- Generic Drug Market Report - Association for Accessible Medicines
