United States Patent 10,695,512: A Detailed Analysis
Introduction
The United States Patent 10,695,512 is one of the patents involved in a significant patent infringement case, particularly in the pharmaceutical industry. This patent, along with several others, is central to the dispute between Teva Branded Pharm. Products R&D, Inc. and Deva Holding A.S. regarding the generic version of ProAir® HFA (albuterol sulfate). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Description
The patent in question, U.S. Patent No. 10,695,512, is part of a series of patents related to inhaler devices and their components. Specifically, it pertains to innovations in the design and functionality of inhalers, such as dose counters and other mechanical improvements.
Inventors and Assignees
The patent is assigned to Teva Branded Pharm. Products R&D, Inc., a company known for its research and development in pharmaceutical products. The inventors listed on the patent are individuals who have contributed to the development of the specific technology described in the patent.
Claims and Scope
Independent and Dependent Claims
The patent includes a set of independent and dependent claims that define the scope of the invention. Independent claims typically describe the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details or limitations.
Claim Examples
For instance, Claim 1 might describe a general inhaler device with a dose counter, while Claim 2 might specify a particular mechanism for the dose counter. These claims are crucial in determining what constitutes infringement and what does not[5].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to inhaler devices and respiratory medications. Other patents in this family include U.S. Patents Nos. 8,132,712, 9,463,289, 9,808,587, 10,022,509, 10,022,510, 10,086,156, 10,561,808, and 11,395,889. These patents collectively cover various aspects of inhaler technology and the formulation of albuterol sulfate[5].
Hatch-Waxman Act and FDA Approval
The patent is also subject to the provisions of the Hatch-Waxman Act, which governs the approval process for generic drugs. Under this act, generic manufacturers like Deva Holding A.S. must file an Abbreviated New Drug Application (ANDA) with the FDA, which can trigger patent infringement litigation if the brand-name manufacturer lists the relevant patents in the FDA’s Orange Book[2][5].
Infringement Litigation
Teva v. Deva Holding A.S.
The patent is at the center of the lawsuit Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.. Teva alleges that Deva’s ANDA filing for a generic version of ProAir® HFA infringes on the patents listed, including U.S. Patent No. 10,695,512. Deva has moved to dismiss the complaint, arguing that the patents do not claim the drug itself and therefore do not support an act of infringement under 35 U.S.C. § 271(e)[5].
Jurisdiction and Declaratory Judgment
The court has denied Deva’s motion to dismiss in part, finding sufficient allegations to demonstrate an actual controversy subject to judicial resolution. The decision on the declaratory judgment aspect has been reserved pending the outcome of a related appeal in Teva v. Amneal[5].
Safe Harbor Provision
35 U.S.C. § 271(e)(1)
The Safe Harbor Provision under 35 U.S.C. § 271(e)(1), introduced as part of the Hatch-Waxman Act, is relevant to this case. This provision exempts certain activities from patent infringement liability if they are "solely for uses reasonably related" to obtaining FDA approval. However, this provision does not apply directly to the infringement allegations in this case, as the dispute revolves around the commercialization of the generic product rather than the testing and development phase[1].
Regulatory and Legislative Context
Affordable Prescriptions for Patients Act of 2023
Recent legislative efforts, such as the Affordable Prescriptions for Patients Act of 2023, aim to limit the number of patents that can be asserted in biosimilar and generic drug litigation. This bill proposes to cap the number of patents at 20, with specific mechanisms to exceed this cap under certain conditions. While this legislation does not directly impact the current case, it reflects broader efforts to address "patent thickets" and promote competition in the pharmaceutical industry[1].
Expert Insights and Statistics
Impact on Competition
Industry experts argue that the practice of asserting multiple patents, known as "patent thickets," can significantly hinder competition and drive up drug prices. The proposed legislation aims to mitigate this issue, but its impact remains a subject of debate among innovator and follow-on biologic manufacturers[1].
Patent Scope and Claims Data
Research datasets, such as the Patent Claims Research Dataset by the USPTO, provide insights into patent scope and claims. These datasets can help analyze the complexity and breadth of patent claims, which is crucial in understanding the patent landscape and potential infringement issues[3].
Key Takeaways
- Patent Scope: U.S. Patent No. 10,695,512 is part of a series of patents related to inhaler devices and components.
- Infringement Litigation: The patent is central to the dispute between Teva and Deva over the generic version of ProAir® HFA.
- Hatch-Waxman Act: The case is governed by the provisions of the Hatch-Waxman Act, particularly regarding ANDA filings and patent listings in the FDA’s Orange Book.
- Legislative Context: Recent legislation aims to limit the number of patents asserted in biosimilar and generic drug litigation to promote competition.
- Expert Insights: The practice of asserting multiple patents can hinder competition and drive up drug prices.
Frequently Asked Questions (FAQs)
What is the main subject of U.S. Patent No. 10,695,512?
The main subject of U.S. Patent No. 10,695,512 is related to innovations in inhaler devices, specifically dose counters and other mechanical improvements.
Why is this patent involved in litigation?
This patent is involved in litigation because Deva Holding A.S. filed an ANDA for a generic version of ProAir® HFA, which Teva alleges infringes on the patents listed, including U.S. Patent No. 10,695,512.
What is the Safe Harbor Provision under 35 U.S.C. § 271(e)(1)?
The Safe Harbor Provision under 35 U.S.C. § 271(e)(1) exempts certain activities from patent infringement liability if they are "solely for uses reasonably related" to obtaining FDA approval.
How does the Affordable Prescriptions for Patients Act of 2023 impact patent litigation?
The Affordable Prescriptions for Patients Act of 2023 proposes to limit the number of patents that can be asserted in biosimilar and generic drug litigation to no more than 20, with mechanisms to exceed this cap under certain conditions.
What are "patent thickets," and how do they affect competition?
"Patent thickets" refer to the practice of asserting multiple patents to frustrate competitors. This practice can significantly hinder competition and drive up drug prices by creating barriers to market entry for generic and biosimilar manufacturers.
Cited Sources:
- Analyses of Section 271 - Infringement of patent, 35 U.S.C. § 271 - Casetext.
- Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - Robins Kaplan.
- Patent Claims Research Dataset - USPTO.
- US10695512B2 - Dose counter for inhaler having an anti-reverse mechanism - Patents Google.
- Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - Robins Kaplan.
