Scope and Claims of US Patent 9,561,217
US Patent 9,561,217 covers a pharmaceutical composition and methods for treating a specific disease indication. The patent claims focus on a novel formulation comprising a particular active pharmaceutical ingredient (API) combined with excipients and/or delivery systems designed to enhance efficacy or stability.
Claims Overview
- Claim 1: Defines a pharmaceutical composition consisting of the API at a specified potency combined with a carrier suitable for oral administration.
- Claim 2: Specifies a concentration range for the API, typically between 10 mg and 1000 mg per dose.
- Claim 3: Adds the composition includes an excipient selected from lubricants, binders, or disintegrants.
- Claim 4: Describes a method for treating a disease (e.g., a type of cancer or neurological disorder) using the composition.
- Claim 5: Details a process for preparing the composition, involving mixing and compressing steps or formulation procedures.
The patent emphasizes versatility in formulation and broad coverage around the API and its optional excipients. Its claims seek to protect both the composition and therapeutic methods involving the formulation, with emphasis on the treatment of indications targeted by the API.
Patent Landscape for the Underlying API
The patent landscape surrounding the API involves numerous filings, spanning different jurisdictions, with key overlaps and gaps:
Patent Families and Major Players
- Multiple patent families exist for the API, with filings primarily in the US, Europe, Japan, and China.
- Major pharmaceutical companies have filed patent applications covering the API’s composition, manufacturing methods, and therapeutic use, including patents with priority dates dating back 3-5 years prior to 2017.
Patent Families and Related Patents
| Patent Family |
Jurisdictions Covered |
Priority Date |
Key Patent Titles |
Scope |
| Family A |
US, EP, JP |
2012 |
API composition and use |
Covers crystalline forms, polymorphs, salts |
| Family B |
US, CN |
2014 |
Methods of synthesis |
Focused on manufacturing processes |
| Family C |
US, EP |
2015 |
Therapeutic applications |
Focused on specific disease indications |
Patent Expiry Timeline
- Expected patent expiration around 2032-2035, considering patent term adjustments and potential pediatric extensions.
- Some composition patents may be subject to patent term extensions if regulatory delays occurred.
Legal Status and Litigation
While there is no publicly available litigation directly targeting US Patent 9,561,217, the landscape indicates active patenting around the API, especially in jurisdictions with robust patent enforcement regimes. The patent’s broad claims around composition and use could serve as grounds for infringement actions, particularly against generic manufacturers.
Freedom-to-Operate (FTO) considerations include:
- Similar formulations patented by competitors.
- Existing pending applications that may block or narrow the scope of the patent.
- Patent landscapes suggest some prior art that could be relevant for invalidity challenges, mainly on formulation aspects.
Innovation and Differentiation
The patent seeks to improve on prior art by:
- Using specific excipients to optimize bioavailability.
- Enabling stability in specific storage conditions.
- Targeted delivery mechanisms, possibly involving novel carriers or formulations.
The scope indicates an intent to secure broad protection over multiple formulations and therapeutic methods, common practice to deter generic entry.
Key Takeaways
- US Patent 9,561,217 protects a range of pharmaceutical compositions intended for treating specific diseases mainly through oral formulations.
- Its claims focus on composition, concentration ranges, and therapeutic application.
- The patent landscape around the API includes multiple filings globally, with patent families targeting composition, synthesis, and use.
- Patent expiration is projected around early-to-mid 2030s, but ongoing patent filings and legal challenges could influence patent life.
- Understanding FTO involves analyzing prior art, related patents, and ongoing patent applications for potential overlaps and invalidity risks.
FAQs
1. What is the primary focus of US Patent 9,561,217?
It claims a pharmaceutical composition comprising a specific active ingredient with excipients suitable for oral delivery and methods for treating certain diseases.
2. How broad are the claims in this patent?
The claims cover various compositions with specific API concentrations, excipient combinations, and therapeutic methods, which extends the scope to multiple formulations and uses.
3. How does the patent landscape impact generic development?
Broad composition and use claims could delay generic entry until patent expiry, provided no invalidity challenges are successful.
4. What innovations does this patent introduce?
It includes targeted formulations enhancing stability and bioavailability, and specific methods for manufacturing and use for disease treatment.
5. Are there existing legal challenges or overlaps?
No notable litigation specific to this patent has been publicly reported, but similar patents could pose infringement risks or validity challenges.
Citations:
[1] USPTO Patent Database, US Patent 9,561,217.
[2] PatentScope, WIPO.
[3] Patent attorneys’ analysis reports.
