Understanding the Scope and Claims of United States Patent 11,642,317
United States Patent 11,642,317, titled "Nanocrystals, compositions, and methods that aid particle transport in mucus," is a significant patent in the pharmaceutical sector, particularly protecting drugs like EYSUVIS and INVELTYS. Here’s a detailed analysis of its scope, claims, and the broader patent landscape.
Patent Overview
Patent Title and Description
The patent, numbered US11642317B2, focuses on nanocrystals, compositions, and methods designed to facilitate particle transport in mucus. This technology is crucial for ophthalmic and other applications where drug delivery through mucus membranes is necessary[4].
Patent Claims
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific details or limitations. For example, the patent claims cover various compositions and methods involving nanocrystals that enhance particle transport in mucus, which is vital for effective drug delivery[4].
Claim Language and Scope
The scope of the patent claims can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Generally, narrower claims with shorter lengths and fewer counts are associated with a higher probability of grant and a shorter examination process[3].
Protected Drugs
EYSUVIS and INVELTYS
This patent protects two specific drugs: EYSUVIS and INVELTYS. EYSUVIS is used for the treatment of dry eye disease, while INVELTYS is an ophthalmic solution for the treatment of postoperative inflammation and pain following cataract surgery[2].
Patent Expiration and Exclusivities
Patent Expiration Date
The patent is set to expire in May 2033, assuming no extensions or amendments that could alter its lifespan. This expiration date is critical for generic drug manufacturers planning to enter the market[1].
Exclusivities
While the patent itself remains active until 2033, any exclusivities associated with the drugs protected by this patent have already expired. For instance, INVELTYS had a "New Product" exclusivity that expired in August 2021[1].
Legal Activities and Patent Maintenance
Recent Legal Activities
The patent has undergone several recent legal activities, including the payment of maintenance fees and changes in correspondence addresses. These activities are crucial as they can impact the patent's lifespan and the timing of generic drug launches[1].
Maintenance Fees
The payment of maintenance fees is essential to keep the patent active. For example, the 8th-year maintenance fee for one of the related patents (US9532955) was paid in June 2024, ensuring the patent remains in force[1].
Broader Patent Landscape
Family Patents
The patent is part of a larger family of patents that protect various aspects of the drug, including dosage forms, modes of administration, and specific compositions. Understanding this broader landscape is vital for strategizing market entry and identifying potential weaknesses in patent protection across different regions[1].
International Protection
While the focus here is on US patents, it is important to note that these drugs are protected by patents in multiple countries. Analyzing the global patent landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry[1].
Impact on Generic Launch
Generic Launch Date
The estimated generic launch date for drugs protected by this patent is May 2033, based on the current patent expiration dates. However, this date can be influenced by legal activities such as patent term extensions, amendments, or the abandonment of patents[1].
Strategic Considerations
For generic manufacturers, tracking the legal activities and patent landscape is crucial. Identifying potential gaps or weaknesses in the patent protection can provide strategic advantages in planning market entry and avoiding litigation[1].
Key Takeaways
- Patent Scope: The patent covers nanocrystals, compositions, and methods aiding particle transport in mucus, crucial for ophthalmic drugs.
- Protected Drugs: EYSUVIS and INVELTYS are the primary drugs protected by this patent.
- Patent Expiration: The patent is set to expire in May 2033.
- Exclusivities: Exclusivities associated with these drugs have already expired.
- Legal Activities: Ongoing legal activities, such as maintenance fee payments and address changes, are critical for the patent's lifespan.
- Broader Landscape: Understanding the global patent landscape is essential for market strategy and generic entry.
FAQs
1. What is the primary focus of United States Patent 11,642,317?
The primary focus of this patent is on nanocrystals, compositions, and methods that aid particle transport in mucus, particularly for ophthalmic applications.
2. Which drugs are protected by this patent?
The drugs protected by this patent are EYSUVIS and INVELTYS.
3. When is the patent set to expire?
The patent is set to expire in May 2033, assuming no extensions or amendments.
4. Have any exclusivities associated with these drugs expired?
Yes, the exclusivities associated with these drugs, such as the "New Product" exclusivity for INVELTYS, have already expired.
5. Why is tracking legal activities on the patent important?
Tracking legal activities is crucial as it can impact the patent's lifespan and the timing of generic drug launches, providing strategic advantages for market entry.
Cited Sources:
- Pharsight: Inveltys patent expiration - Pharsight
- Drug Patent Watch: Drugs Protected by US Patent 11642317
- SSRN: Patent Claims and Patent Scope
- Google Patents: US11642317B2 - Nanocrystals, compositions, and methods that aid particle transport in mucus
