United States Patent 6,172,090: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,172,090, titled "Pharmaceutical composition," is a significant patent in the field of diabetes treatment, particularly involving the combination of pioglitazone and a biguanide like metformin. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
This patent, issued on January 9, 2001, to inventors Hitoshi Ikeda, Takashi Sohda, and Hiroyuki Odaka, and assigned to Takeda Chemical Industries, Ltd. (TCI), addresses the need for effective and safe antihyperglycemic treatments. The invention combines pioglitazone, a thiazolidinedione derivative, with a biguanide such as metformin to reduce the side effects associated with these drugs when administered separately[2].
Scope of the Patent
The patent covers a pharmaceutical dosage form that includes an antihyperglycemic drug, specifically a combination of pioglitazone or its salts and a biguanide like metformin. This combination is designed to mitigate the adverse effects of each drug when used alone, such as gastrointestinal side effects associated with metformin and fluid retention associated with pioglitazone[2].
Therapeutic Benefits
The combination therapy offers several therapeutic benefits, including improved glycemic control and reduced risk of cardiovascular complications, which are common in diabetic patients. This dual-action approach enhances the efficacy of the treatment while minimizing side effects[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Active Components
- The patent claims the use of pioglitazone or its salts in combination with a biguanide, such as metformin, as the active components[2].
Methods of Administration
- It claims methods for reducing the side effects of these active components by administering a therapeutically effective amount of the combination to diabetic patients[2].
Dosage Forms
- The patent covers various oral dosage forms, including tablets, capsules, and other formulations that ensure controlled release of the active ingredients[1][2].
Patent Landscape
The patent landscape surrounding US 6,172,090 is complex and involves multiple related patents and legal disputes.
Related Patents
- The patent is part of a family of patents held by Takeda, including US 6,211,205, US 6,271,243, and US 6,303,640, among others. These patents collectively cover various aspects of the combination therapy and its formulations[2][4].
Litigation and Infringement
- Takeda has been involved in several patent infringement lawsuits to protect its intellectual property. For instance, Takeda sued Alphapharm Pty, Ltd., and Genpharm, Inc., alleging infringement of the '090 patent, among others[2].
Exclusivity and Licensing
- Takeda Pharmaceuticals North America, Inc. (TPNA) holds an exclusive license to sell pioglitazone-containing drug products, including those covered by the '090 patent, under the trade name ACTOS®. This exclusivity has been a subject of litigation and regulatory scrutiny[2].
Expiration and Impact
The '090 patent expired on June 19, 2016, which marked the end of Takeda's exclusivity over the specific combination and methods claimed in the patent. This expiration has allowed generic versions of the drug to enter the market, increasing competition and potentially reducing costs for patients[2][4].
Regulatory Approvals
The FDA approved the use of pioglitazone-containing drug products, including those covered by this patent, under New Drug Application (NDA) No. 021073. This approval was crucial for the commercialization of ACTOS® and similar products[2].
Economic and Innovation Impact
The patent and its related family have had significant economic and innovation impacts. The combination therapy has improved treatment outcomes for diabetic patients, while the patent disputes and litigation have highlighted the complexities and costs associated with protecting intellectual property in the pharmaceutical industry[3].
Patent Scope and Quality
Studies on patent scope and quality, such as those by the Hoover Institution, suggest that patents like the '090 patent, which have undergone rigorous examination and litigation, tend to have narrower claims and higher validity. This narrows the scope of protection but ensures that the invention is novel and non-obvious, thereby encouraging innovation[3].
Key Takeaways
- Combination Therapy: The patent covers a combination of pioglitazone and a biguanide like metformin to reduce side effects and improve glycemic control.
- Scope and Claims: The patent includes claims for the active components, methods of administration, and various dosage forms.
- Patent Landscape: The patent is part of a larger family of patents held by Takeda, with significant litigation and regulatory history.
- Expiration and Impact: The patent expired in 2016, allowing generic versions to enter the market.
- Regulatory Approvals: FDA approval under NDA No. 021073 was crucial for commercialization.
- Economic and Innovation Impact: The patent has improved treatment outcomes and highlighted the complexities of intellectual property protection.
Frequently Asked Questions
Q: What is the main invention covered by US Patent 6,172,090?
A: The main invention is a pharmaceutical dosage form combining pioglitazone and a biguanide like metformin to reduce side effects and improve glycemic control.
Q: Who are the inventors and assignees of the patent?
A: The inventors are Hitoshi Ikeda, Takashi Sohda, and Hiroyuki Odaka, and the assignee is Takeda Chemical Industries, Ltd.
Q: What are the therapeutic benefits of the combination therapy?
A: The combination therapy offers improved glycemic control and reduced risk of cardiovascular complications.
Q: What is the current status of the patent?
A: The patent expired on June 19, 2016.
Q: How has the patent impacted the pharmaceutical industry?
A: It has improved treatment outcomes for diabetic patients and highlighted the complexities of intellectual property protection in the industry.
Cited Sources
- United States Patent and Trademark Office, "United States Patent US007.959.946B2," Google Patents.
- United States District Court District of Columbia, "UNITED STATES DISTRICT COURT DISTRICT OF COLUMBIA," Insight.RPXCorp.
- Hoover Institution, "Patent Claims and Patent Scope," Hoover Institution.
- U.S. Food and Drug Administration, "PIOGLITAZONE HYDROCHLORIDE Approval Letter," FDA.
