United States Patent 5,617,906: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,617,906, hereafter referred to as the '906 Patent, is a significant intellectual property asset in the pharmaceutical industry. This patent is associated with the drug Suprane® (desflurane), a general inhalation anesthetic. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the '906 Patent
The '906 Patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This listing indicates that the patent claims are relevant to the Suprane® drug product and could be asserted against generic manufacturers seeking to market a similar product[4][5].
Scope of the '906 Patent
The '906 Patent specifically claims the finished dosage form of desflurane, which is used as a general inhalation anesthetic. The scope of the patent includes the formulation, packaging, and administration method of the drug. This is crucial because it defines the boundaries of what would constitute infringement if a generic manufacturer were to produce a similar product[4][5].
Claims of the '906 Patent
The claims of the '906 Patent are centered around the specific formulation and delivery mechanism of desflurane. Here are some key aspects of the claims:
- Product Patent: The patent is coded as a product patent, meaning it protects the finished dosage form of desflurane[5].
- Formulation: The claims include the specific formulation of desflurane, which is essential for its therapeutic efficacy.
- Packaging and Administration: The patent also covers the packaging and administration method of the drug, which is critical for its safe and effective use[4].
Patent Landscape and Orange Book Listing
The '906 Patent is listed in the Orange Book, which serves as a notice to potential ANDA (Abbreviated New Drug Application) applicants of the patents that may protect the pioneer drug product. This listing requires ANDA applicants to certify against the listed patents to avoid infringement claims[1][4].
Challenges in Certifying Against the '906 Patent
ANDA applicants must certify against every patent listed in the Orange Book, including the '906 Patent. However, if an ANDA applicant believes a patent is listed improperly, they can dispute its inclusion. This process involves informing the FDA of the grounds for disagreement, but the NDA holder has significant control over the patent listing, making it challenging to have a patent removed from the Orange Book[1].
Legal Implications
In cases where an ANDA applicant seeks to market a generic version of Suprane®, they must navigate the legal implications of the '906 Patent. The patent holder can seek a court order to delay the approval of the ANDA until the patent expires, which can be a significant barrier to market entry for generic manufacturers[4].
Patent Analytics and Claim Coverage
To understand the full scope of protection offered by the '906 Patent, patent analytics can be employed. This involves analyzing the claims and scope concepts of the patent to identify gaps or opportunities in the intellectual property landscape.
Claim Coverage Matrix
A Claim Coverage Matrix can help in categorizing patents by claims and scope concepts, making it easier to determine which patents and claims are actively protecting the intellectual property. This tool is particularly useful for large portfolios, as it helps in filtering, searching, and analyzing large numbers of patent claims[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].
Infringement and Litigation
The '906 Patent has been the subject of litigation, particularly in cases where generic manufacturers have sought to market similar products. For instance, Minrad's attempt to market a generic version of Suprane® led to a lawsuit where the patent holder sought to enjoin Minrad from commercially manufacturing, using, or selling the generic product until the patent expired[4].
Key Takeaways
- Scope and Claims: The '906 Patent protects the finished dosage form, formulation, packaging, and administration method of desflurane.
- Orange Book Listing: The patent is listed in the Orange Book, requiring ANDA applicants to certify against it.
- Legal Implications: The patent can delay the approval of generic versions of Suprane® until its expiration.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding the patent landscape and identifying gaps in claim coverage.
- Infringement and Litigation: The patent has been involved in litigation to protect its claims against generic manufacturers.
FAQs
What is the '906 Patent associated with?
The '906 Patent is associated with the drug Suprane® (desflurane), a general inhalation anesthetic.
Why is the '906 Patent listed in the Orange Book?
The '906 Patent is listed in the Orange Book to provide notice to potential ANDA applicants of the patents that may protect the pioneer drug product.
Can an ANDA applicant dispute the inclusion of the '906 Patent in the Orange Book?
Yes, an ANDA applicant can dispute the inclusion, but the process is challenging and often unsuccessful due to the control of the NDA holder over the patent listing.
How does the '906 Patent affect generic manufacturers?
The '906 Patent can delay the approval of generic versions of Suprane® until its expiration, providing a significant barrier to market entry for generic manufacturers.
What tools can be used to analyze the claims and scope of the '906 Patent?
Tools such as Claim Coverage Matrix and Claim Charts can be used to analyze the claims and scope concepts of the patent, helping to identify gaps or opportunities in the intellectual property landscape.
Sources
- FDA PERSPECTIVE OF ANDA CERTIFICATION PROCESS AND ORANGE BOOK LISTING - International Journal of Pharma And Chemical Research[1].
- Baxter Healthcare Corporation vs. Minrad - Patent Docs[2].
- Patent Analytics - Schwegman, Lundberg & Woessner[3].
- KING & SPALDING - Regulations.gov - Regulations.gov[4].
- JUN 7 2011 - Orange Book Blog - Orange Book Blog[5].