United States Patent 8,617,595: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,617,595, hereafter referred to as the '595 Patent, is a significant intellectual property asset in the pharmaceutical industry, particularly related to the drug aliskiren. This patent is crucial for understanding the formulation, production, and protection of aliskiren-based medications.
Overview of the Patent
The '595 Patent, titled "Galenic formulations of organic compounds," was granted to cover specific compositions and formulations of aliskiren, a renin inhibitor used in the treatment of hypertension and other cardiovascular diseases. The patent describes solid oral dosage forms of aliskiren and its pharmaceutically acceptable salts, along with various formulation components[1][4][5].
Scope of the Patent
Therapeutic Use
The '595 Patent encompasses formulations of aliskiren, which is used to treat conditions such as hypertension, heart failure, and diabetic nephropathy. The patent's scope extends to various disease states where aliskiren's therapeutic benefits are applicable[1][4].
Formulation Components
The patent details the composition of solid oral dosage forms, including aliskiren or its salts, and other excipients like microcrystalline cellulose, hydroxypropyl methyl cellulose, and colloidal silicon dioxide. These components are crucial for the stability, bioavailability, and patient compliance of the drug[1].
Manufacturing Process
The patent describes methods for preparing these formulations, including granulation, mixing, and film coating. These processes ensure the uniformity and efficacy of the final product[1].
Claims of the Patent
Independent Claims
The '595 Patent includes several independent claims that define the scope of the invention. These claims specify the active ingredient (aliskiren or its salts), the dosage form (solid oral), and the presence of specific excipients. The claims also cover various aspects of the formulation, such as the amount of aliskiren, the type of coating, and the physical characteristics of the dosage form[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying additional details such as the ratio of aliskiren to other components, the type of coating agents, and the method of preparation. These claims provide a detailed description of the preferred embodiments of the invention[1].
Patent Landscape
Expiration Dates
The '595 Patent is listed in the FDA Orange Book and is set to expire on February 19, 2026. This expiration date is critical for generic manufacturers planning to enter the market with their own versions of aliskiren-based drugs[4][5].
Litigation and Settlements
The '595 Patent has been involved in significant litigation. Noden Pharma DAC filed a complaint against Anchen Pharmaceuticals and Par Pharmaceutical for patent infringement related to their ANDA submissions for generic versions of aliskiren. The litigation resulted in a settlement agreement that allowed Anchen to manufacture and commercialize a generic version of aliskiren under certain conditions, while acknowledging the validity and enforceability of the '595 Patent[4].
Related Patents
Other patents related to aliskiren formulations, such as U.S. Patent Nos. 8,618,172 and 9,023,893, also protect compositions comprising aliskiren and hydrochlorothiazide. These patents further extend the protection landscape for aliskiren-based products[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
The '595 Patent and related patents have significant implications for innovation and competition in the pharmaceutical industry. The protection afforded by these patents allows the patent holder to maintain market exclusivity, which can influence the development and marketing strategies of generic manufacturers[4].
Licensing and Litigation Costs
The patent landscape around aliskiren formulations highlights the importance of patent scope and the potential for litigation. The costs associated with licensing and litigation can be substantial and may deter some companies from entering the market, thereby affecting the overall availability of generic alternatives[3].
Metrics for Measuring Patent Scope
Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth of a patent. Narrower claims, as seen in the '595 Patent after the examination process, are associated with a higher probability of grant and a shorter examination process[3].
Conclusion
The '595 Patent is a critical component of the intellectual property portfolio related to aliskiren formulations. Understanding its scope, claims, and the surrounding patent landscape is essential for pharmaceutical companies, especially those considering the development of generic versions of aliskiren-based drugs.
Key Takeaways
- The '595 Patent covers solid oral dosage forms of aliskiren and its pharmaceutically acceptable salts.
- The patent includes detailed descriptions of formulation components and manufacturing processes.
- The patent is set to expire on February 19, 2026.
- Litigation and settlements have shaped the market entry of generic versions of aliskiren.
- Related patents extend the protection landscape for aliskiren-based products.
- The patent's scope and claims have significant implications for innovation and competition in the pharmaceutical industry.
FAQs
What is the main subject of the '595 Patent?
The '595 Patent primarily covers galenic formulations of aliskiren, a renin inhibitor used in treating hypertension and other cardiovascular diseases.
When is the '595 Patent set to expire?
The '595 Patent is set to expire on February 19, 2026.
What are the key components of the formulations described in the '595 Patent?
The formulations include aliskiren or its salts, along with excipients such as microcrystalline cellulose, hydroxypropyl methyl cellulose, and colloidal silicon dioxide.
Has the '595 Patent been involved in any significant litigation?
Yes, the '595 Patent was involved in litigation against Anchen Pharmaceuticals and Par Pharmaceutical, resulting in a settlement agreement that allowed for the manufacture and commercialization of a generic version of aliskiren under certain conditions.
How does the '595 Patent impact the pharmaceutical industry?
The patent affects innovation and competition by maintaining market exclusivity for the patent holder and influencing the development and marketing strategies of generic manufacturers.
What metrics can be used to measure the scope of a patent like the '595 Patent?
Metrics such as independent claim length and count can be used to measure the breadth of a patent, with narrower claims often associated with a higher probability of grant and a shorter examination process.
Sources
- US8617595B2 - Galenic formulations of organic compounds - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE ... - Insight.rpxcorp.com
- Patent Claims and Patent Scope - Hoover Institution
- PDL BioPharma, Inc. - PDL.com
- US Patent 8617595 | Expiration | Dates - PharmaCompass.com
