Understanding the Scope and Claims of United States Patent 9,107,827
Introduction
United States Patent 9,107,827, hereafter referred to as the '827 Patent, is a significant intellectual property asset in the pharmaceutical industry. This patent is involved in several legal and commercial activities, particularly in the context of generic drug approvals and patent infringement disputes. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.
Patent Overview
The '827 Patent is part of a series of patents related to the drug Megace® ES (megestrol acetate), a medication used for the treatment of anorexia, cachexia, and unexplained weight loss in patients with AIDS. The patent is held by Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited[2].
Claims of the '827 Patent
The claims of a patent define the scope of protection granted to the patentee. For the '827 Patent, the claims are centered around specific formulations and methods related to megestrol acetate.
Independent Claims
Independent claims are the broadest claims in a patent and define the core invention. In the '827 Patent, these claims likely cover the unique formulation of megestrol acetate, including its composition, dosage form, and method of administration. For instance, an independent claim might read: "A method of treating anorexia, cachexia, or unexplained weight loss in a patient, comprising administering a suspension of megestrol acetate in a specific concentration and dosage regimen"[5].
Dependent Claims
Dependent claims are narrower and build upon the independent claims. They serve as fallback positions in case the independent claims are invalidated. These claims might specify particular aspects of the formulation, such as the type of excipients used, the pH range of the suspension, or specific manufacturing processes.
Scope of the '827 Patent
The scope of a patent is determined by its broadest claims, which define what is protected and what would constitute infringement.
Breadth of Protection
The breadth of protection offered by the '827 Patent can be measured by the length and specificity of its claims. Generally, longer claims with more specific conditions are narrower and harder to design around. For example, a claim that specifies a "method of treating anorexia using a suspension of megestrol acetate with a specific concentration of 40 mg/mL" is narrower than a claim that simply states "a method of treating anorexia using megestrol acetate"[3].
Patent Scope Measurement
Research suggests that the number of words in the first independent claim is a reliable measure of patent scope. More words typically indicate a narrower scope because each condition must be met for infringement to occur. The '827 Patent's scope would thus be evaluated based on the complexity and specificity of its independent claims[3].
Patent Landscape
The '827 Patent operates within a complex patent landscape, particularly in the pharmaceutical sector.
Competitor Activity
Generic drug manufacturers often challenge the validity and scope of patents like the '827 Patent to gain market entry. For instance, Breckenridge Pharmaceutical, Inc. filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, alleging that the '827 Patent is invalid, unenforceable, or not infringed by their proposed generic product[2].
Litigation
The '827 Patent has been involved in several litigation cases. Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited have sued Breckenridge Pharmaceutical, Inc. for patent infringement, seeking declarations of invalidity, non-infringement, and collateral estoppel. These legal battles highlight the importance of the '827 Patent in protecting the intellectual property rights of the original drug manufacturers[2].
Impact on Market Competition
The '827 Patent significantly influences market competition in the pharmaceutical industry.
Barrier to Entry
The patent acts as a barrier to entry for generic manufacturers, allowing the original patent holders to maintain market exclusivity until the patent expires. This exclusivity can result in higher prices for the drug, as generic alternatives are not available.
Innovation Incentives
On the other hand, the '827 Patent provides incentives for innovation by protecting the investment made in developing the drug. This protection encourages further research and development in the pharmaceutical sector.
Expert Insights
Patent attorneys and experts emphasize the importance of broad patents in offering comprehensive protection against infringers. Thomas Kulaga notes, "Broad patents typically offer more protection against infringers than a narrow patent" because they are "oftentimes very hard to design around"[3].
Statistical Context
The economic impact of patents like the '827 Patent can be substantial. For example, Megace® ES generated sales of $81 million based on industry sales data, highlighting the commercial significance of protecting such intellectual property[2].
Key Takeaways
- Claims and Scope: The '827 Patent's claims define its scope, with independent claims providing the broadest protection and dependent claims serving as narrower fallback positions.
- Patent Landscape: The patent is part of a complex landscape involving generic drug challenges and litigation.
- Market Impact: The patent acts as a barrier to entry for generics, maintaining market exclusivity and higher prices, while also incentivizing innovation.
- Expert Insights: Broad patents offer more comprehensive protection, making them harder to design around.
- Economic Significance: The patent protects a commercially significant drug, with substantial sales revenue.
FAQs
-
What is the '827 Patent related to?
The '827 Patent is related to the drug Megace® ES (megestrol acetate), used for treating anorexia, cachexia, and unexplained weight loss in patients with AIDS.
-
Who holds the '827 Patent?
The '827 Patent is held by Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited.
-
What is the significance of independent claims in the '827 Patent?
Independent claims define the broadest scope of protection and are crucial in determining what constitutes infringement.
-
How does the '827 Patent affect generic drug manufacturers?
The patent acts as a barrier to entry for generic manufacturers, requiring them to either challenge the patent's validity or wait for its expiration.
-
What is the economic impact of the '827 Patent?
The patent protects a drug that generated $81 million in sales, highlighting its commercial significance and the importance of maintaining market exclusivity.
Sources
- Par Pharmaceutical, Inc. v. Breckenridge Pharmaceutical, Inc. - RPX Insight
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - RPX Insight
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law Review
- Agreement and Plan of Merger - Justia
- Par v. TWI - Patent Docs
