United States Patent 9,463,289: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,463,289, titled "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof," is a significant patent in the pharmaceutical industry, particularly in the context of inhaler technology. This patent, held by Teva, has been at the center of several legal disputes, including the recent case of Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The '289 Patent was issued on October 11, 2016, and it is a divisional of U.S. Patent Application Serial No. 13/110,532, which was filed on May 18, 2011. The patent claims the benefit of priority to U.S. Provisional Patent Application Serial Nos. 61/345,763 and 61/417,659, filed on May 18, 2010, and November 29, 2010, respectively[4].
Scope of the Patent
The '289 Patent pertains to innovations in dose counters for inhalers, specifically metered dose inhalers (MDIs). The scope of the patent includes the design and functionality of the inhaler and its components, such as the dose counter, canister housing, and medicament canister.
Key Components
- Main Body and Canister Housing: The patent describes an inhaler with a main body having a canister housing that accommodates a medicament canister. This housing is designed to mate with the canister fire stem of the medicament canister[4].
- Dose Counter: The dose counter is an integral part of the inhaler, with an actuation member located within the canister housing. This member operates by the movement of the medicament canister, ensuring accurate dose counting[4].
Claims of the Patent
The '289 Patent includes several claims, with the most critical being the independent claim 1 and its dependent claims.
Independent Claim 1
Claim 1 of the '289 Patent reads:
"An inhaler for metered dose inhalation, the inhaler comprising: a main body having a canister housing, a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister, wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall"[4].
Dependent Claims
The dependent claims (claims 2, 4, 6, and 7) further specify various aspects of the inhaler's design and functionality, including the configuration of the dose counter and the interaction between the canister housing and the medicament canister[4].
Patent Landscape and Legal Disputes
Listing in the Orange Book
The '289 Patent, along with four other patents, was listed in the FDA's Orange Book for Teva's ProAir® HFA Inhalation Aerosol product. However, Amneal challenged the propriety of this listing, arguing that these patents did not meet the requirements for inclusion in the Orange Book. The court ultimately ruled that the patents did not claim the drug or drug product for which the associated New Drug Application (NDA) was submitted but rather components of a metered inhaler drug delivery device[2][5].
Court Decisions
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist the '289 Patent and other related patents from the Orange Book. The court found that these patents did not satisfy the statutory requirements for listing, as they did not claim the drug or drug product but rather components of the inhaler device[2][5].
Appeal and Stay
Teva appealed this decision, arguing on legal and technical grounds regarding the definition of "drug product" and procedural errors. The Federal Circuit granted a stay on the order to delist the patents during the pendency of the appeal[1].
Impact on the Pharmaceutical Industry
Patent Protection and Innovation
The '289 Patent and similar patents are crucial for innovators in the pharmaceutical industry, as they provide protection for significant investments in research and development. However, the current legal landscape, particularly the strict application of patent disclosure laws (Section 112(a)), has made it challenging to obtain and maintain robust patent protection for pharmaceutical and biotechnology innovations[3].
Generic Competition
The delisting of the '289 Patent and other related patents from the Orange Book has significant implications for generic competition. Amneal's generic version of ProAir® HFA can now proceed without the 30-month stay that would have been triggered by the improper listing of these patents. This development aligns with the FTC's policy statement warning against the abuse of the Orange Book listing system to delay generic competition[5].
Key Takeaways
- Patent Scope: The '289 Patent focuses on innovations in dose counters and inhaler design.
- Claims: The patent includes detailed claims about the inhaler's components and their interactions.
- Legal Disputes: The patent was challenged for improper listing in the Orange Book, leading to a court order for delisting.
- Industry Impact: The decision affects patent protection strategies and generic competition in the pharmaceutical industry.
FAQs
Q: What is the main subject of the '289 Patent?
A: The '289 Patent pertains to dose counters for inhalers, specifically metered dose inhalers (MDIs), and their design and functionality.
Q: Why was the '289 Patent delisted from the Orange Book?
A: The court ruled that the patent did not claim the drug or drug product for which the associated NDA was submitted but rather components of the inhaler device.
Q: What are the implications of the delisting for generic competition?
A: The delisting allows generic versions of ProAir® HFA to proceed without the 30-month stay, promoting competition in the market.
Q: How does the current patent landscape affect pharmaceutical innovation?
A: The strict application of patent disclosure laws makes it challenging to obtain robust patent protection, impacting innovation and investment in the pharmaceutical and biotechnology industries.
Q: What role did the FTC play in the case involving the '289 Patent?
A: The FTC submitted an amicus brief urging the court to order the removal of the '289 Patent and other related patents from the Orange Book, arguing against the improper use of the Orange Book listing system to delay generic competition.
Sources
- Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief. JDSupra.
- Teva ordered to delist inhaler patents from FDA Orange Book. DLA Piper.
- Eviscerating Patent Scope. DigitalCommons@NYLS.
- Teva Branded Pharm. Prods. R&D v. Cipla Ltd. Casetext.
- New Jersey District Court Orders Delisting Of Teva Inhaler Patents. Lit-IP.
