United States Patent 6,913,768: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,913,768, hereafter referred to as the '768 patent, is a significant patent in the pharmaceutical industry, particularly related to the sustained release delivery of amphetamine salts. This patent has been at the center of several legal battles and is crucial for understanding patent strategies, especially in the context of pharmaceutical formulations.
Background of the Patent
The '768 patent, titled "Sustained release delivery of amphetamine salts," is associated with Shire LLC and its affiliates. It pertains to formulations and methods for the sustained release of amphetamine salts, which are commonly used in medications such as Adderall XR® for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)[2][4].
Scope and Claims of the Patent
The '768 patent encompasses claims related to specific formulations and delivery mechanisms of amphetamine salts. Here are some key aspects of its scope:
Formulation and Delivery
- The patent describes formulations that ensure the sustained release of amphetamine salts, which is critical for maintaining therapeutic levels of the drug over an extended period. This is achieved through specific combinations of active and inactive ingredients[2][5].
Claims and Specifications
- The claims of the '768 patent are detailed and specify the components and methods involved in the sustained release formulations. These claims are essential for defining the boundaries of the patent owner’s rights and for determining infringement[3].
Related Patents and Family
- The '768 patent is often discussed in conjunction with other related patents, such as the '096 and '148 patents, which also pertain to components of pharmaceutical formulations suitable for oral administration and delivery of amphetamine salts. The inventors listed for the '768 patent are also inventors for these related patents, highlighting their interconnected nature[1].
Patent Landscape and Litigation
The '768 patent has been involved in several high-profile litigation cases, which provide insights into its significance and the challenges faced in the pharmaceutical patent landscape.
Shire LLC v. Corepharma, LLC
- In this case, the court ruled that the '768 patent is sufficiently related to the '096 and '148 patents, allowing Shire to review Amerigen's Abbreviated New Drug Application (ANDA) to determine if the '768 patent was infringed. This decision underscores the interconnectedness of these patents and their relevance to the same therapeutic area[1].
Shire Development LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.
- This case involves a complaint for patent infringement where Shire alleged that Teva’s actions would infringe the '768 patent, among others. The complaint highlights the importance of these patents in protecting Shire’s intellectual property and the commercial viability of their products[2].
FDA and Regulatory Aspects
The '768 patent is listed in the FDA's Orange Book, which is a publication that lists approved drug products with therapeutic equivalence evaluations. This listing is crucial for generic drug manufacturers, as it affects their ability to market generic versions of the drug without infringing on the listed patents.
Orange Book Listing
- The '768 patent is listed in the Orange Book with an expiration date of May 24, 2023. This listing indicates that any generic version of the drug must address the validity or infringement of this patent before receiving FDA approval[4].
Challenges in Pharmaceutical Patent Protection
The pharmaceutical industry faces unique challenges in patent protection, particularly with genus claims and the enablement requirements under 35 U.S.C. § 112(a).
Genus Claims and Enablement
- Genus claims, which cover a broad class of compounds, are common in pharmaceutical patents. However, recent jurisprudence has made it challenging to obtain and maintain such claims due to stringent written description and enablement requirements. This has significant implications for innovators who must balance broad claims with the risk of invalidation[3].
Impact on Innovators
- Innovators in the pharmaceutical industry are caught between claiming too broadly and risking invalidation, or claiming too narrowly and allowing competitors to design around the claims. This dilemma is particularly acute in the context of genus claims, where the scope of the claim must be carefully defined to ensure validity and enforceability[3].
Key Takeaways
- Patent Interconnectedness: The '768 patent is closely related to other patents in the same therapeutic area, such as the '096 and '148 patents, which affects litigation and infringement analysis.
- Litigation Significance: The patent has been central in several litigation cases, highlighting its importance in protecting intellectual property in the pharmaceutical industry.
- Regulatory Impact: Listing in the FDA's Orange Book is crucial for generic drug manufacturers and affects the commercialization strategies of pharmaceutical companies.
- Challenges in Patent Protection: The pharmaceutical industry faces significant challenges in maintaining broad patent claims due to stringent legal requirements, which can impact innovation and competition.
FAQs
Q: What is the primary subject matter of the '768 patent?
A: The '768 patent pertains to the sustained release delivery of amphetamine salts, commonly used in medications for ADHD.
Q: Why is the '768 patent significant in litigation cases?
A: The patent is significant because it is often involved in cases related to generic drug approvals and infringement disputes, particularly concerning Adderall XR®.
Q: How does the '768 patent relate to other patents in the same therapeutic area?
A: The '768 patent is closely related to other patents such as the '096 and '148 patents, which are also involved in the formulation and delivery of amphetamine salts.
Q: What are the challenges faced by pharmaceutical companies in maintaining broad patent claims?
A: Pharmaceutical companies face challenges in maintaining broad patent claims due to stringent written description and enablement requirements under 35 U.S.C. § 112(a), which can lead to invalidation if not properly addressed.
Q: Why is the listing in the FDA's Orange Book important for the '768 patent?
A: The listing in the Orange Book is important because it affects the ability of generic drug manufacturers to market their products without infringing on the listed patents.
Sources
- Shire LLC v. Corepharma, LLC, Civil No. 14-5694 (RMB/JS) - Casetext.
- Case 1:17-cv-01696-RGA Document 1 Filed 11/22/17 - Insight.RPXCorp.
- Eviscerating Patent Scope - DigitalCommons@NYLS.
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) - FDA.
