United States Patent 6,465,504: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,465,504, hereafter referred to as the '504 Patent, is a significant patent in the pharmaceutical industry, particularly in the context of iron chelation therapy. This patent, owned by Novartis Pharmaceuticals Corporation, has been at the center of several legal and regulatory discussions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Issuance
The '504 Patent was issued on October 15, 2002, and it pertains to the chemical entity known as deferasirox, an iron chelator used to treat iron overload in patients[1][2][5].
Claims and Scope
Claim Construction
The '504 Patent includes claims that define the invention of deferasirox and its use. The claims are crucial as they set the boundaries of the patentee's right to exclude others from making, using, or selling the invention. The patent claims specifically recite the chemical structure of deferasirox and its therapeutic applications[1].
Key Claim Terms
- Chemical Entity: The patent describes deferasirox as a compound that causes iron to be removed from the body. This is a critical aspect of the claims, as it defines the specific chemical entity and its function[1].
- Therapeutic Use: The claims include methods of treating diseases caused by an excess of metal in the human or animal body, specifically iron overload. This indicates the patent's scope extends to the therapeutic application of deferasirox[1].
Patent Specification and Intrinsic Evidence
The specification of the patent provides additional context and definitions that help in interpreting the claims. For instance, the specification may reveal special definitions given to claim terms that differ from their ordinary meanings. In the case of the '504 Patent, the specification supports the broad construction of terms like "diseases" and "disorders," which are used interchangeably[1].
Legal and Regulatory Context
Hatch-Waxman Act
The '504 Patent has been involved in several Hatch-Waxman actions, which are legal proceedings related to the approval of generic drugs. Under the Hatch-Waxman Act, generic drug manufacturers must identify all relevant patents listed in the Orange Book, a publication by the FDA that lists approved drug products with their corresponding patents. The Act allows for the filing of Abbreviated New Drug Applications (ANDAs) with either a paragraph IV certification (challenging the validity or non-infringement of the listed patent) or a section viii statement (seeking approval for a different method of use)[2][5].
Litigation and Infringement Claims
Novartis has filed several lawsuits against generic manufacturers, including Actavis, alleging infringement of the '504 Patent. These lawsuits often involve disputes over claim construction, patent validity, and the scope of protection afforded by the patent. For example, in Novartis Pharm. Corp. v. Actavis, Inc., the court had to determine whether Actavis's ANDA filing infringed the claims of the '504 Patent[1][2].
Patent Landscape and Exclusivity
Orange Book Listings
The '504 Patent is listed in the Orange Book, which is a critical factor in the regulatory approval process for generic drugs. The listing of this patent affects the ability of generic manufacturers to obtain FDA approval for their versions of deferasirox. Other patents, such as the '209 Patent, also listed for the drug Jadenu (a formulation of deferasirox), further complicate the landscape by extending exclusivity periods and affecting first-filer exclusivity for generic manufacturers[5].
Exclusivity and First-Filer Status
The '504 Patent's expiration on April 5, 2019, marked a significant event in the patent landscape. However, other patents like the '209 Patent, which expire later, continue to influence the market exclusivity for generic versions of deferasirox. The first-filer exclusivity under the Hatch-Waxman Act can be affected by judgments of non-infringement or validity challenges to these patents[5].
Impact on Innovation and Competition
Patent Scope and Quality
The debate over patent scope and quality is relevant here. Broader patents can sometimes lead to increased litigation and licensing costs, potentially diminishing innovation incentives. However, the '504 Patent's claims are specific and well-defined, which helps in maintaining clarity and validity. The examination process, as seen in other contexts, tends to narrow the scope of patent claims, ensuring that only valid and clear claims are granted[3].
Generic Competition
The expiration of the '504 Patent and the ongoing litigation surrounding other related patents have significant implications for generic competition. Generic manufacturers must navigate the complex patent landscape to ensure their products do not infringe valid claims, thereby facilitating competition and reducing drug costs[2][5].
Conclusion
The United States Patent 6,465,504 is a pivotal patent in the field of iron chelation therapy, with its claims and scope defining the boundaries of Novartis's exclusive rights to deferasirox. The patent's involvement in various legal and regulatory proceedings highlights the complex interplay between patent law, regulatory approvals, and market competition.
Key Takeaways
- Specific Claims: The '504 Patent includes specific claims defining deferasirox and its therapeutic use.
- Regulatory Impact: The patent is listed in the Orange Book and affects the approval process for generic versions of deferasirox.
- Litigation: The patent has been involved in several Hatch-Waxman actions and disputes over claim construction and infringement.
- Exclusivity: The patent's expiration and the presence of other related patents influence market exclusivity for generic manufacturers.
- Innovation and Competition: The patent's scope and validity impact innovation incentives and generic competition.
FAQs
1. What is the main subject of the '504 Patent?
The '504 Patent pertains to the chemical entity deferasirox, an iron chelator used to treat iron overload.
2. When was the '504 Patent issued?
The '504 Patent was issued on October 15, 2002.
3. What is the significance of the Orange Book listing for the '504 Patent?
The listing in the Orange Book affects the regulatory approval process for generic versions of deferasirox, requiring generic manufacturers to address the patent in their ANDA filings.
4. How does the '504 Patent impact generic competition?
The patent's claims and its listing in the Orange Book influence the ability of generic manufacturers to enter the market, with the patent's expiration facilitating increased competition.
5. What are the implications of the '504 Patent's expiration?
The expiration of the '504 Patent on April 5, 2019, marked a significant event, allowing for greater generic competition, but other related patents continue to affect market exclusivity.
Cited Sources
- Novartis Pharm. Corp. v. Actavis, Inc. - Casetext
- Novartis Pharms. Corp. v. Actavis, Inc., Civil Action No. 12-366-RGA-CJB - Casetext
- Patent Claims and Patent Scope - SSRN
- US6465504B1 - Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators - Google Patents
- Piramal Healthcare UK Ltd. v. Novartis Pharm. Corp. - Casetext
