United States Patent 10,166,190: A Detailed Analysis of Scope and Claims in the Patent Landscape
Introduction
The United States Patent 10,166,190, titled "Tacrolimus for Improved Treatment of Transplant Patients," is a significant patent in the pharmaceutical industry, particularly in the field of immunosuppressive therapy. This patent is part of a broader landscape involving the use of tacrolimus, a calcineurin inhibitor, in preventing organ transplant rejection and treating various conditions.
Background on Tacrolimus
Tacrolimus is a widely used immunosuppressive drug, known by its brand name Prograf, among others. It is crucial for preventing organ rejection in transplant patients and is also used to treat moderate to severe atopic dermatitis[4].
Patent Overview
The patent 10,166,190 is associated with extended-release formulations of tacrolimus, which are designed to improve the treatment outcomes for transplant patients. Here are some key aspects of the patent:
Dosage Forms and Release Mechanisms
The patent describes various oral dosage forms of tacrolimus, including extended-release (ER) formulations. These formulations are designed to provide a controlled release of the active substance over a prolonged period, typically 24 hours, to maintain therapeutic drug levels and reduce the frequency of dosing[1].
Active Substance and Excipients
The patent details the composition of the oral dosage forms, which include tacrolimus as the active substance and various excipients such as polyethylene glycol, hydroxypropyl cellulose, and poloxamer. These excipients help in achieving the desired release profile and stability of the formulation[1].
Method of Preparation
The patent outlines the methods for preparing these extended-release formulations, including the use of specific polymers and vehicles to ensure the controlled release of tacrolimus. The methods involve various steps such as mixing, granulation, and compression to form the final dosage form[1].
Claims and Scope
The claims of the patent are critical in defining the scope of protection granted to the inventor. Here are some key claims and their implications:
Claim Scope
The patent includes claims related to the specific formulations, methods of preparation, and the use of these formulations in treating transplant patients. The claims are broad enough to cover various aspects of the extended-release formulations but narrow enough to be specific and non-obvious over the prior art[1].
Genus Claims
In the context of pharmaceutical patents, genus claims are often used to capture a class of compounds or formulations rather than specific embodiments. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain broad genus claims due to stringent requirements under 35 U.S.C. § 112(a) regarding written description and enablement[3].
Enablement and Written Description
The patent must satisfy the enablement and written description requirements, meaning the specification must provide enough detail to enable a person skilled in the art to make and use the invention. The patent 10,166,190 includes detailed descriptions of the formulations, methods of preparation, and dissolution tests to ensure compliance with these requirements[1].
Patent Landscape and Litigation
The patent landscape surrounding tacrolimus extended-release formulations is complex and involves various litigation and settlement agreements.
Litigation and Settlements
The patent 10,166,190 has been involved in litigation, particularly in cases related to Abbreviated New Drug Applications (ANDAs) filed by generic manufacturers. For example, Veloxis Pharmaceuticals, Inc. v. Accord Healthcare, Inc. involved disputes over the infringement of patents related to Envarsus XR (tacrolimus extended-release tablets), including the patent 10,166,190. The settlement agreements often involve the dismissal of claims and counterclaims, with the generic manufacturer being enjoined from infringing the patents until their expiration[2].
Competitive Landscape
The market for immunosuppressive drugs, including tacrolimus, is highly competitive. The patent protection provided by patents like 10,166,190 is crucial for innovators to recoup their significant investment in drug development. However, the rigid application of patent disclosure laws can make it difficult for innovators to secure broad patent protection, allowing competitors to design around narrow claims[3].
Impact on Pharmaceutical Industry
The patent 10,166,190 and similar patents have a significant impact on the pharmaceutical industry in several ways:
Innovation and Investment
Patents like 10,166,190 encourage innovation by providing a period of exclusivity that allows companies to recover their investment in research and development. However, the current jurisprudence on genus claims can deter investment in pharmaceutical research due to the uncertainty and challenges in securing meaningful patent protection[3].
Market Competition
The patent landscape influences market competition by determining which products can be marketed and when generic versions can enter the market. The settlements and litigation related to these patents often delay the entry of generic competitors, affecting the pricing and availability of these critical drugs[2].
Key Takeaways
- Extended-Release Formulations: The patent 10,166,190 focuses on extended-release formulations of tacrolimus, designed to improve treatment outcomes for transplant patients.
- Claims and Scope: The patent includes specific claims related to formulations, methods of preparation, and use, which must comply with enablement and written description requirements.
- Patent Landscape: The patent is part of a complex landscape involving litigation and settlement agreements, particularly with generic manufacturers.
- Impact on Industry: The patent affects innovation, investment, and market competition in the pharmaceutical industry, highlighting the importance of robust and predictable patent protection.
FAQs
What is the primary use of the drug described in United States Patent 10,166,190?
The primary use of the drug described in this patent is to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
What type of formulations are described in the patent?
The patent describes extended-release oral dosage forms of tacrolimus.
What are the key components of the extended-release formulations?
The formulations include tacrolimus as the active substance and various excipients such as polyethylene glycol, hydroxypropyl cellulose, and poloxamer.
How does the patent landscape affect the pharmaceutical industry?
The patent landscape influences innovation, investment, and market competition by determining the exclusivity period for new drugs and delaying the entry of generic competitors.
What are the challenges in securing broad patent protection for pharmaceuticals?
The challenges include stringent requirements under 35 U.S.C. § 112(a) regarding written description and enablement, making it difficult to secure broad genus claims.
How do litigation and settlement agreements impact the availability of generic drugs?
Litigation and settlement agreements can delay the entry of generic competitors into the market, affecting the pricing and availability of critical drugs.
Sources
- US8685998B2 - Tacrolimus for improved treatment of transplant patients - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Tacrolimus: Uses, Interactions, Mechanism of Action - DrugBank
