Understanding the Scope and Claims of United States Patent 9,808,587
Introduction
United States Patent 9,808,587, hereafter referred to as the '587 patent, is one of the patents at the center of a recent legal dispute involving Teva Pharmaceuticals and Amneal Pharmaceuticals. This patent, along with four others, was listed in the FDA's Orange Book for Teva's ProAir® HFA Inhalation Aerosol product. Here, we will delve into the details of the '587 patent, its claims, and the broader patent landscape surrounding it.
Background of the Patent
The '587 patent is part of a group of patents related to inhaler devices, specifically metered dose inhalers (MDIs). These patents were listed by Teva in the Orange Book, a publication by the FDA that lists patents associated with approved drug products.
Claims of the '587 Patent
The '587 patent claims an inhaler for metered dose inhalation, detailing specific components and their interactions. Here are some key aspects of the claims:
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Inhaler Components: The patent describes an inhaler with a main body, a canister housing, a medicament canister, and a dose counter. The canister housing has an inner wall with a support formation, and the dose counter includes an actuation member located within the canister housing[4].
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Functional Aspects: The claims specify how the medicament canister is moveable relative to the canister housing and how the dose counter operates through the movement of the medicament canister. The patent also details the longitudinal axis of the canister housing and its alignment with various components[4].
Eligibility for Listing in the Orange Book
For a patent to be listed in the Orange Book, it must meet specific criteria under the Hatch-Waxman Act:
- Drug Substance Patents: Patents that claim the active ingredient of the drug.
- Drug Product Patents: Patents that claim the formulation or composition of the drug.
- Method of Use Patents: Patents that claim a method of using the drug for which approval is sought or has been granted[2][5].
The '587 patent was listed as a drug product patent, claiming the specific design and functionality of the inhaler device.
Legal Dispute and Court Ruling
Teva listed the '587 patent, along with four other patents, in the Orange Book for its ProAir® HFA product. Amneal, which filed an Abbreviated New Drug Application (ANDA) for a generic version of ProAir® HFA, challenged the listing of these patents. Amneal argued that the patents were improperly listed and sought their delisting from the Orange Book.
The US District Court for the District of New Jersey ruled in favor of Amneal, ordering Teva to delist the '587 patent and the other four patents from the Orange Book. The court determined that these patents did not meet the criteria for listing under the Hatch-Waxman Act, as they did not claim the drug substance, drug product, or a method of use in a manner that aligned with the statutory requirements[2][5].
Implications of the Court Ruling
The delisting of the '587 patent and other related patents has significant implications:
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Generic Competition: The removal of these patents from the Orange Book paves the way for generic competitors like Amneal to bring their products to market sooner, as it eliminates the 30-month stay that would have been triggered by the listing of these patents[2][5].
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Antitrust Considerations: The Federal Trade Commission (FTC) supported the delisting, highlighting concerns about the potential for antitrust violations through the improper listing of patents. This underscores the importance of ensuring that patent listings do not unfairly delay generic competition[2][5].
Patent Scope and Quality
The debate over patent scope and quality is relevant here. Patents with broader claims can sometimes be seen as overly broad or of questionable validity, which can lead to increased litigation costs and diminished incentives for innovation. Metrics such as independent claim length and independent claim count can help measure patent scope and quality. However, in the case of the '587 patent, the issue was not about the breadth of the claims but rather their relevance to the drug product as defined by the Hatch-Waxman Act[3].
Regulatory Environment
The regulatory environment, particularly under the Hatch-Waxman Act and the BPCIA (Biologics Price Competition and Innovation Act), plays a crucial role in how patents are asserted and litigated in the pharmaceutical sector. For instance, revisions to § 271(e) of the patent infringement statute impose limits on the number of patents that can be asserted in infringement actions against biosimilars and generics, aiming to prevent "patent thickets" that could hinder competition[1].
Conclusion
The '587 patent, along with other related patents, highlights the complex interplay between patent law, regulatory requirements, and competition in the pharmaceutical industry. The delisting of these patents from the Orange Book underscores the importance of ensuring that patent listings are accurate and do not unfairly delay the entry of generic competitors.
Key Takeaways
- Patent Claims: The '587 patent claims specific components and functionalities of an inhaler device.
- Orange Book Listing: The patent was listed as a drug product patent but was found to be improperly listed by the court.
- Legal Implications: The delisting allows for earlier generic competition and addresses antitrust concerns.
- Regulatory Context: The case is set against the backdrop of regulations aimed at balancing patent protection and competition in the pharmaceutical sector.
- Patent Scope and Quality: The debate on patent scope and quality is relevant but was not the primary issue in this case.
FAQs
Q: What is the '587 patent related to?
A: The '587 patent is related to an inhaler device, specifically a metered dose inhaler (MDI), for Teva's ProAir® HFA Inhalation Aerosol product.
Q: Why was the '587 patent delisted from the Orange Book?
A: The patent was delisted because the court determined it did not meet the criteria for listing under the Hatch-Waxman Act, as it did not claim the drug substance, drug product, or a method of use in a manner that aligned with the statutory requirements.
Q: What are the implications of delisting the '587 patent?
A: The delisting allows generic competitors to bring their products to market sooner and addresses antitrust concerns about the potential for delaying generic competition.
Q: How does the regulatory environment impact patent listings in the pharmaceutical sector?
A: Regulations under the Hatch-Waxman Act and BPCIA impose specific criteria for listing patents in the Orange Book and limit the number of patents that can be asserted in infringement actions to prevent "patent thickets."
Q: What metrics can be used to measure patent scope and quality?
A: Metrics such as independent claim length and independent claim count can help measure patent scope and quality, although these were not the primary issues in the '587 patent case.
Sources
- Analyses of Section 271 - Infringement of patent, 35 U.S.C. § 271. Casetext.
- Teva ordered to delist inhaler patents from FDA Orange Book. DLA Piper.
- Patent Claims and Patent Scope. SSRN.
- Teva-Opening-Brief.pdf. Patently-O.
- New Jersey District Court Orders Delisting Of Teva Inhaler Patents. Lit-IP.
