United States Patent 8,828,427: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 8,828,427, assigned to Celgene Corporation, is a formulation patent that covers specific formulations of the drug pomalidomide, which is marketed under the brand name Pomalyst®. This patent is part of a broader patent landscape that protects Celgene's intellectual property related to pomalidomide.
Patent Background
- Inventors and Assignee: The patent was invented by Anthony Tutino and Michael T. Kelly, and it is assigned to Celgene Corporation, headquartered in Summit, New Jersey[4].
- Date of Patent: The patent was granted on September 9, 2014[4].
Claims and Scope
Claim Structure
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Independent Claims: These claims are crucial as they define the broadest scope of the invention. For example, Claim 1 of the '427 patent describes a pharmaceutical formulation comprising pomalidomide and a lubricant, such as Sodium Stearyl fumarate, mixed with the pre-blend at the end of the process[4].
- Dependent Claims: These claims narrow down the scope by adding additional limitations to the independent claims. They often specify particular aspects of the formulation, such as the amount of active ingredient, excipients, and manufacturing processes.
Key Claim Terms
- Pomalidomide: The active ingredient, a 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione compound.
- Lubricant: Specifically mentioned is Sodium Stearyl fumarate, which is mixed with the pre-blend to complete the pharmaceutical formulation.
- Formulation: The patent covers various aspects of the formulation, including the composition and the process of preparing the pharmaceutical product[4].
Patent Landscape
Related Patents
The '427 patent is part of a family of patents that protect different aspects of pomalidomide formulations and methods of treatment. Other related patents include:
- U.S. Patent No. 8,198,262: A method of treatment patent that covers the use of pomalidomide for treating certain diseases[5].
- U.S. Patent No. 8,673,939: Another formulation patent that is closely related to the '427 patent and covers similar aspects of pomalidomide formulations[5].
- U.S. Patent No. 8,735,428: Also a method of treatment patent that is part of the same patent family[5].
Litigation and Enforcement
The '427 patent has been involved in several patent infringement actions under the Hatch-Waxman Act. For instance:
- Celgene Corp. v. Hetero Labs Ltd.: Celgene alleged that the defendants' submissions of their Abbreviated New Drug Applications (ANDAs) to the FDA constituted infringements of the claims of the '427 patent and other related patents[1][5].
Claim Construction and Interpretation
Court Rulings
In patent litigation, the construction of claims is a critical issue. Courts rely heavily on the written description and the specification of the patent to determine the meaning of the claims.
- Markman Decision: In the context of the Celgene Corp. v. Hetero Labs Ltd. case, the court had to interpret several disputed terms from the patents, including those from the '427 patent. The court emphasized that the specification informs the proper construction of the claims but noted that limitations from the specification should not be read into the claims[1].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research has shown that the scope of a patent can be measured using metrics such as independent claim length and count. Narrower claims, as seen in the '427 patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation and Litigation
Patent Quality and Scope
The breadth and clarity of patent claims, such as those in the '427 patent, are significant concerns for patent quality. Broader and less clear claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation[3].
Examples and Statistics
- Litigation Costs: The litigation involving the '427 patent and other related patents has highlighted the significant costs associated with patent disputes. For instance, the Celgene Corp. v. Hetero Labs Ltd. case involved multiple patents and extensive legal proceedings[1][5].
- Patent Maintenance: The maintenance of patents like the '427 patent involves ongoing costs and efforts to ensure the patent remains valid and enforceable. Statistics show that narrower claims at publication are associated with a higher probability of grant and shorter examination processes[3].
Quotes from Industry Experts
- On Patent Scope: "Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity"[3].
Highlight and Citation
"Patent claim scope and claim clarity have been identified as significant concerns for patent quality. Even the basic approach to determining claim meaning has been called into question."
- Hoover Institution, "Patent Claims and Patent Scope"[3].
Key Takeaways
- Specific Formulation: The '427 patent covers a specific formulation of pomalidomide, including the use of a lubricant like Sodium Stearyl fumarate.
- Related Patents: The patent is part of a broader family of patents protecting pomalidomide formulations and methods of treatment.
- Litigation: The patent has been involved in significant litigation under the Hatch-Waxman Act.
- Claim Construction: Courts rely on the specification to interpret claim terms but avoid reading limitations from the specification into the claims.
- Impact on Innovation: The clarity and breadth of patent claims can affect innovation and litigation costs.
FAQs
Q: What is the main subject of the United States Patent 8,828,427?
A: The main subject is a pharmaceutical formulation of pomalidomide, specifically the composition and process of preparing the formulation.
Q: Who are the inventors of the '427 patent?
A: The inventors are Anthony Tutino and Michael T. Kelly.
Q: What is the significance of the '427 patent in the context of Celgene's intellectual property?
A: The '427 patent is part of a family of patents that protect Celgene's intellectual property related to pomalidomide formulations and methods of treatment.
Q: How has the '427 patent been involved in litigation?
A: The patent has been involved in Hatch-Waxman Act infringement actions, such as the Celgene Corp. v. Hetero Labs Ltd. case.
Q: What metrics are used to measure the scope of a patent like the '427 patent?
A: Metrics such as independent claim length and count are used to measure patent scope, with narrower claims often associated with a higher probability of grant and shorter examination processes.
Sources
- Celgene Corp. v. Hetero Labs Ltd. - Casetext
- Case 2:20-cv-02593-ES-MAH Document 1 Filed 03/10 - RPX Insight
- Patent Claims and Patent Scope - Hoover Institution
- United States Patent 8,828,427 - Google Patents
- Celgene Corp. v. Hetero Labs Ltd. - Robins Kaplan LLP - JDSupra
