United States Patent 9,561,229: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,561,229, owned by Heron Therapeutics, Inc., is a pivotal patent in the pharmaceutical industry, particularly in the realm of emulsion formulations for intravenous or parenteral administration of aprepitant. Aprepitant is a compound used to treat and prevent nausea and vomiting associated with emetogenic cancer chemotherapy. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Invention
The '229 patent, filed as part of a series of patents related to aprepitant formulations, addresses the need for a more effective and stable method of administering aprepitant. Traditionally, aprepitant was administered orally, which is undesirable for patients suffering from vomiting. The inventors sought to formulate aprepitant as a liquid suitable for parenteral or intravenous administration, overcoming the limitations of oral administration[4].
Patent Claims
Composition Claims
The '229 patent includes both composition and method claims. The composition claims (Claims 1-11) are directed to an aprepitant emulsion. These claims specify the components and characteristics of the emulsion, such as the presence of aprepitant, a stabilizer, and an emulsifier. Notably, these claims do not include the "physically stable" limitation found in some of the other related patents, such as the '794 patent[4].
Method Claims
The method claims (Claims 12-21) are directed to the procedure for administering the aprepitant emulsion. These claims outline the steps and conditions under which the emulsion is administered to ensure its efficacy and stability.
Claim Construction
"Physically Stable"
In the context of related patents, the term "physically stable" has been a subject of contention. For the '794 patent, which includes this term, the court has defined "physically stable" to mean that the emulsion meets the criteria under USP<729> for mean droplet size not exceeding 500 nm and PFAT5 (percent fat above 5 microns) not exceeding 0.05%, with no visible crystals when stored at specified temperatures[1].
Other Key Terms
- Aprepitant: The pharmaceutical compound central to the invention.
- Emulsifier and Stabilizer: Components essential for maintaining the stability and efficacy of the emulsion.
- Parenteral or Intravenous Administration: The method of administration that the invention aims to facilitate.
Patent Scope and Breadth
The scope of the '229 patent is defined by its claims and the specifications provided in the patent document. The patent scope is critical in determining the extent of protection and the potential for infringement.
- Independent Claim Length and Count: Research suggests that narrower claims, as measured by independent claim length and count, are associated with a higher probability of grant and a shorter examination process. This metric can be used to assess the breadth and clarity of the patent claims[3].
Patent Landscape
Related Patents
Heron Therapeutics, Inc. holds a series of patents related to aprepitant emulsions, including U.S. Patent Nos. 9,808,465, 9,974,793, 9,974,794, 10,500,208, and 10,953,018. These patents collectively protect various aspects of the emulsion formulations, including composition, method of administration, and stability criteria[2][4].
Expiry Dates and Generic Launch
The '229 patent, along with other related patents, is set to expire in September 2035. This expiry date is subject to change based on legal activities such as term extensions or amendments to the claims. Understanding the patent expiry dates is crucial for strategizing market entry and potential generic launches[5].
Litigation and Infringement
The '229 patent has been involved in several Hatch-Waxman Act patent cases, including disputes with Fresenius Kabi USA, LLC, and Slayback Pharma LLC. These cases highlight the importance of claim construction and the need to establish infringement under the traditional elements of direct, induced, and/or contributory infringement[2][4].
Indefiniteness and Validity
The validity of the '229 patent, like any patent, hinges on its claims being definite and clear. The court has emphasized that a patent is invalid for indefiniteness if its claims fail to inform those skilled in the art about the scope of the invention with reasonable certainty[4].
Key Takeaways
- Invention Focus: The '229 patent focuses on emulsion formulations for intravenous or parenteral administration of aprepitant.
- Claims: Includes both composition and method claims, with specific criteria for the emulsion's stability and administration.
- Scope and Breadth: Defined by claim language and specifications, with narrower claims generally associated with higher grant probabilities.
- Related Patents: Part of a series of patents protecting various aspects of aprepitant emulsions.
- Expiry Dates: Set to expire in September 2035, subject to legal activities.
- Litigation: Involved in several Hatch-Waxman Act cases, emphasizing the importance of claim construction and infringement analysis.
FAQs
What is the primary focus of the '229 patent?
The primary focus of the '229 patent is on emulsion formulations for the intravenous or parenteral administration of aprepitant, a compound used to treat and prevent nausea and vomiting associated with emetogenic cancer chemotherapy.
What are the key components of the emulsion as described in the '229 patent?
The emulsion includes aprepitant, a stabilizer, and an emulsifier, which are essential for maintaining the stability and efficacy of the formulation.
How is "physically stable" defined in related patents?
In related patents, "physically stable" is defined as meeting the criteria under USP<729> for mean droplet size not exceeding 500 nm and PFAT5 not exceeding 0.05%, with no visible crystals when stored at specified temperatures.
What is the expiry date of the '229 patent?
The '229 patent is set to expire in September 2035, subject to any changes based on legal activities such as term extensions or amendments to the claims.
What are the implications of the '229 patent in litigation?
The '229 patent has been involved in several Hatch-Waxman Act cases, highlighting the importance of claim construction and establishing infringement under traditional elements of direct, induced, and/or contributory infringement.
Sources
- Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC, United States District Court for the District of Delaware, Civil Action No. 22-985-WCB.
- Heron Therapeutics, Inc. v. Slayback Pharma LLC, Casetext.
- Patent Claims and Patent Scope, SSRN.
- Heron Therapeutics, Inc. v. Fresenius Kabi U.S., LLC, Casetext.
- Cinvanti patent expiration, Pharsight.
