United States Patent 9,694,078: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,694,078, hereafter referred to as the '078 patent, is associated with the drug Tygacil, which is a brand name for the antibiotic tigecycline. This patent is part of a complex landscape of intellectual property rights surrounding Tygacil, and understanding its scope and claims is crucial for navigating the pharmaceutical industry.
Background on Tygacil
Tygacil, or tigecycline, is a glycylcycline antibiotic that inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking the entry of amino-acyl tRNA molecules. This mechanism makes it effective against a wide range of bacterial infections[1].
Patent Overview
The '078 patent is one of several patents protecting Tygacil. Here are some key details:
Patent Number and Issue Date
- The patent number is US9694078.
- The patent issue date is July 4, 2017[2].
Patent Owner
- The patent is owned by Wyeth LLC, which is now part of Pfizer Inc.[2].
Claims
The '078 patent includes various claims related to the composition, method of use, and manufacturing process of tigecycline. Here are some general categories of claims:
Composition Claims
- These claims pertain to the chemical structure and formulation of tigecycline, including its salts and derivatives[2].
Method of Use Claims
- These claims cover the therapeutic uses of tigecycline, such as treating bacterial infections and specific disease conditions[2].
Manufacturing Process Claims
- These claims detail the methods and processes for synthesizing and purifying tigecycline[2].
Patent Landscape Analysis
Patent Exclusivities
The '078 patent is part of a broader set of patents and exclusivities that protect Tygacil. These exclusivities are critical in delaying the generic launch of the drug:
- New Molecular Entity Exclusivity: Tygacil was granted exclusivity as a new molecular entity, which typically lasts for five years from the date of FDA approval[4].
- Patent Exclusivities: The '078 patent, along with other related patents, provides additional exclusivity periods. These patents have various expiration dates, with some extending into the late 2020s and early 2030s[2].
Litigation History
The '078 patent has been involved in several legal proceedings:
- Patent Challenges: Companies like Apotex Inc. have challenged the validity of related patents, such as US7879828, through inter partes review (IPR) and other legal mechanisms. However, many of these challenges have been terminated or denied[2].
- Litigation Status: The '078 patent itself has not been subject to significant litigation, but its validity and enforceability are tied to the broader litigation landscape surrounding Tygacil's patent portfolio[2].
Expected Expiry Dates
The '078 patent is expected to expire on March 13, 2026. However, the overall patent landscape for Tygacil includes patents with expiration dates extending beyond this period, such as US10588975, which is expected to expire on March 13, 2026, and others that extend into the early 2030s[2].
Impact on Generic Launch
The combination of patent exclusivities and the litigation history significantly impacts the timing of generic versions of Tygacil:
- Generic Delay: The presence of multiple patents with staggered expiration dates and ongoing exclusivities delays the entry of generic competitors into the market[2][4].
- Market Competition: The absence of generic versions allows the original manufacturer to maintain market exclusivity, influencing pricing and market dynamics[4].
Strategic Insights
Patent Landscape Analysis
Conducting a thorough patent landscape analysis, as described in patent mapping, is essential for understanding the competitive landscape and identifying potential risks and opportunities. This analysis includes:
- Legal Status: Tracking the status of patents (alive, pending, lapsed, revoked, or expired) to anticipate future market changes[3].
- Expected Expiry Dates: Identifying the dates when patents are expected to expire to plan for generic launches or other strategic moves[3].
Business and Technical Insights
Patent landscape analysis provides valuable insights into:
- Market Trends: Identifying trends in patent filings and litigation can help predict market developments, such as mergers and acquisitions or licensing agreements[3].
- Competitor Activity: Analyzing competitors' patent portfolios can reveal their strategic directions and potential areas of innovation[3].
Key Takeaways
- Patent Protection: The '078 patent is part of a robust patent portfolio protecting Tygacil, with multiple patents and exclusivities extending into the late 2020s and early 2030s.
- Litigation Impact: The litigation history and ongoing challenges to related patents can influence the validity and enforceability of the '078 patent.
- Generic Launch: The combination of patent exclusivities and litigation delays the entry of generic versions of Tygacil into the market.
- Strategic Planning: Conducting a patent landscape analysis is crucial for understanding the competitive landscape and making informed business decisions.
FAQs
What is the primary mechanism of action of tigecycline?
Tigecycline inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking the entry of amino-acyl tRNA molecules[1].
When is the '078 patent expected to expire?
The '078 patent is expected to expire on March 13, 2026[2].
What are the implications of patent exclusivities on generic drug launches?
Patent exclusivities delay the entry of generic competitors into the market, allowing the original manufacturer to maintain market exclusivity and influence pricing and market dynamics[2][4].
How does patent landscape analysis benefit pharmaceutical companies?
Patent landscape analysis provides insights into market trends, competitor activity, and potential risks and opportunities, helping companies make informed strategic decisions[3].
What are some common types of claims in pharmaceutical patents?
Common types include composition claims, method of use claims, and manufacturing process claims[2].
