United States Patent 7,399,865 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,399,865 B2, titled "Protein Tyrosine Kinase Enzyme Inhibitors," is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment. This patent, issued on July 15, 2008, to inventors Allan Wissner, Sridhar Krishna Rabindran, and Hwei-Ru Tsou, has been the subject of various legal and regulatory activities. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignees
The patent was originally assigned to Wyeth LLC, which later assigned its rights to Puma Biotechnology, Inc.[1].
Issue and Expiration Dates
The patent was issued on July 15, 2008, and is set to expire on December 29, 2025, considering the patent term adjustment of 475 days[1].
Claims and Scope
Claim Structure
The patent includes multiple claims, with Claims 2 and 7 being particularly relevant as they read on the approved product, Nerlynx™ (neratinib).
- Claim 2: Describes a specific compound, "(E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide or a pharmaceutically acceptable salt thereof."[1][4].
Scope of Invention
The patent covers protein tyrosine kinase enzyme inhibitors, which are crucial in treating various cancers by inhibiting specific enzymes involved in tumor growth. The scope includes the compounds themselves, methods of using these compounds, and methods of manufacturing them[1][4].
Regulatory and Legal Context
FDA Approval and IND
The patent is associated with the FDA-approved drug Nerlynx™ (neratinib), which was approved for the treatment of certain types of breast cancer. The FDA approval process involved an Investigational New Drug (IND) submission, and the patent claims the approved product and its methods of use[1].
Patent Term Extension
An application for a patent term extension under 35 U.S.C. § 156 was submitted, which included various exhibits such as the chronology of IND sponsorship, FDA approval letters, and maintenance fee payments[1].
Litigation and Settlements
Patents like U.S. 7,399,865 B2 are often involved in litigation, particularly in the context of generic drug approvals under the Hatch-Waxman Act.
Generic Challenges
Generic manufacturers often file Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, challenging the validity or enforceability of the original patent. However, specific details on litigation involving U.S. 7,399,865 B2 are not provided in the sources, but it is common for such patents to be defended vigorously by the patent holders[2].
Patent Quality and Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that narrower claims, as measured by independent claim length and count, are associated with a higher probability of grant and a shorter examination process. This is relevant as the claims in U.S. 7,399,865 B2 are specific and detailed, indicating a narrower scope which could have facilitated the patent's approval[3].
Industry Impact
Innovation and Licensing
The patent landscape around protein tyrosine kinase inhibitors is complex, with multiple patents covering various aspects of these compounds. This complexity can lead to increased licensing and litigation costs, potentially affecting innovation in the field. However, patents like U.S. 7,399,865 B2 also provide incentives for research and development by protecting intellectual property[3].
Statutory Disclaimer and Maintenance Fees
A statutory disclaimer was filed for this patent, disclaiming certain claims (1, 3, 4, 5, 6, 8, 9, and 10) under 37 CFR 1.321(a). Additionally, maintenance fees for the 3.5 and 7.5-year periods were paid, ensuring the patent remains in force until its expiration date[1].
Key Takeaways
- Patent Scope: The patent covers specific protein tyrosine kinase enzyme inhibitors, including the approved drug Nerlynx™.
- Claims: Claims 2 and 7 are critical as they read on the approved product.
- Regulatory Context: Associated with FDA approval and IND submissions.
- Litigation: Potentially involved in ANDA litigation, though specific details are not provided.
- Patent Quality Metrics: Narrower claims facilitate approval and shorter examination processes.
- Industry Impact: Balances innovation incentives with licensing and litigation costs.
FAQs
What is the main subject of U.S. Patent 7,399,865 B2?
The main subject is protein tyrosine kinase enzyme inhibitors, specifically compounds used in cancer treatment.
Who are the inventors of this patent?
The inventors are Allan Wissner, Sridhar Krishna Rabindran, and Hwei-Ru Tsou.
What is the approved product associated with this patent?
The approved product is Nerlynx™ (neratinib), used in the treatment of certain types of breast cancer.
What is the significance of the patent term extension application?
The application seeks to extend the patent term under 35 U.S.C. § 156, which can provide additional time for the patent holder to benefit from their invention.
How do narrower claims affect the patent approval process?
Narrower claims are associated with a higher probability of grant and a shorter examination process, as they are more specific and less likely to be challenged.
Cited Sources
- Document code: WFEE GARIAS United States Patent and Trademark Office Sales Receipt - [PDF]
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Patent Claims and Patent Scope - Hoover Institution - [PDF]
- US7399865B2 - Protein tyrosine kinase enzyme inhibitors - Google Patents
- II US FOOD & DRUG - accessdata.fda.gov - [PDF]
