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Details for Patent: 8,043,628
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Summary for Patent: 8,043,628
| Title: | Methods for reducing edema |
| Abstract: | Methods for reducing or preventing neovascularization or edema in the eye by implanting in the eye a bioerodible drug delivery system comprising an immunosuppressive agent and a bioerodible polymer. |
| Inventor(s): | Vernon G. Wong |
| Assignee: | Allergan Inc |
| Application Number: | US11/932,181 |
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Patent Claim Types: see list of patent claims | Use; Delivery; |
| Patent landscape, scope, and claims: | Patent 8,043,628: Analytical Review of Scope, Claims, and LandscapeThis report provides an analysis of United States Patent 8,043,628, detailing its claims, scope, and the surrounding patent landscape. The patent, titled "Crystalline forms of 2-[[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]methoxy]benzoic acid and their uses," was granted to Pfizer Inc. on October 25, 2011. It pertains to specific crystalline forms of a compound that is an active pharmaceutical ingredient (API) in oncology treatments. What is the Core Invention Protected by Patent 8,043,628?Patent 8,043,628 protects specific crystalline forms of 2-[[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]methoxy]benzoic acid. This compound is the active pharmaceutical ingredient in Ibrance (palbociclib), a medication used to treat certain types of breast cancer. The patent focuses on the solid-state properties of the API, specifically crystalline forms, which can influence a drug's stability, solubility, bioavailability, and manufacturing processes. What are the Key Claims of the Patent?The patent includes several claims, with the most significant relating to the specific crystalline forms.
The patent therefore protects not only the compound itself (which would likely be covered by earlier composition of matter patents) but also specific, defined solid-state forms of that compound, and their use in pharmaceutical compositions and therapeutic methods. How is the Scope of Protection Defined?The scope of Patent 8,043,628 is primarily defined by the specific crystalline forms it claims and their therapeutic applications. What are the Defined Crystalline Forms?The patent defines at least two distinct crystalline forms, Form I and Form II.
The precise definition of these forms using analytical techniques like XRPD, DSC, and TGA is crucial for establishing infringement and validity. The scope extends to any pharmaceutical composition containing these specific forms and any method of treating cancer using these forms. What Therapeutic Uses are Covered?The patent covers the use of these crystalline forms in treating "proliferative diseases," with a specific emphasis on "cancer." This encompasses the broad application of the drug in oncology. The claims are directed towards the administration of a therapeutically effective amount of a pharmaceutical composition containing the protected crystalline forms. What is the Patent Landscape for Palbociclib Crystalline Forms?The landscape surrounding Patent 8,043,628 involves several layers of patent protection, including earlier granted patents on the compound itself, potential later filings on improved formulations or manufacturing processes, and the intellectual property of competitors. What are the Key Patents Related to Palbociclib?The primary composition of matter patent for palbociclib is likely to have preceded Patent 8,043,628. A prominent patent in this area is U.S. Patent No. 7,244,720, also assigned to Pfizer Inc., titled "Pyrazolopyrimidines." This patent, filed on November 20, 2003, and granted on July 17, 2007, covers the compound itself (palbociclib) and various pharmaceutical compositions and methods of use for treating proliferative disorders. Patent 8,043,628 is a divisional or continuation application of the parent application that led to U.S. Patent No. 7,244,720, as indicated by its filing history and common assignee. Other relevant patent families may exist, potentially covering:
Who are the Key Players in the Palbociclib Patent Landscape?
How Do Different Patents Intersect?Patent 8,043,628 operates within the broader patent strategy for palbociclib. It complements the composition of matter patents by protecting specific physical forms that are critical for drug development and manufacturing. Generic manufacturers must navigate this complex web of patents. To launch a generic product, they typically need to:
The expiration dates of these patents are critical for market entry. The earliest expiration would be based on the composition of matter patent, followed by patents on specific forms, formulations, and methods of use. What is the Current Status and Future Outlook?The patent protection for palbociclib, including Patent 8,043,628, directly influences market dynamics. What is the Exclusivity Period for Patent 8,043,628?United States Patent 8,043,628 has a term that typically extends 20 years from its filing date, subject to adjustments for patent term extension (PTE) and patent term adjustments (PTA). Given its filing date (which can be traced back through its parent applications), its effective market exclusivity period has been carefully managed by Pfizer. The original filing date for the parent application leading to U.S. Patent No. 7,244,720 was November 20, 2003. Patent 8,043,628 was filed as a divisional application on November 19, 2009. The standard patent term for 8,043,628 would therefore end in November 2029. However, PTE can extend this term for certain periods lost during regulatory review. How Does This Patent Affect Generic Competition?Patent 8,043,628, by protecting specific crystalline forms, creates an additional barrier for generic manufacturers. Even if the composition of matter patent expires, generic companies may be blocked from using the specific forms protected by this patent. They would need to demonstrate that their product does not infringe on the claims of 8,043,628, which often involves developing alternative crystalline forms. Litigation surrounding these crystalline form patents is common. Generic companies may challenge the validity of these patents or argue that their own crystalline forms are sufficiently different to avoid infringement. The outcome of such legal battles significantly impacts the timing and nature of generic market entry. What are the Implications for R&D and Investment?For R&D departments and investors, understanding this patent landscape is critical:
The ongoing patent litigation and the development of alternative crystalline forms will continue to shape the market for palbociclib-based treatments. Key TakeawaysPatent 8,043,628 protects specific crystalline forms (Form I and Form II) of the active pharmaceutical ingredient in Ibrance (palbociclib), along with pharmaceutical compositions and therapeutic methods of use. This patent complements earlier composition of matter patents, extending market exclusivity for Pfizer Inc. by claiming specific solid-state properties crucial for drug manufacturing and performance. Generic manufacturers must navigate the expiration of this patent and avoid infringement of its claims, often requiring the development of alternative crystalline forms or manufacturing processes. The patent's term, extending to November 2029 (subject to adjustments), is a significant factor in the timeline for potential generic competition. Frequently Asked Questions1. What is the primary difference between U.S. Patent No. 7,244,720 and U.S. Patent No. 8,043,628?U.S. Patent No. 7,244,720 protects the composition of matter for palbociclib and its general pharmaceutical uses. U.S. Patent No. 8,043,628 specifically protects particular crystalline forms of palbociclib (Form I and Form II) and their use in pharmaceutical compositions and treatment methods. 2. Can a generic company launch a palbociclib product if U.S. Patent No. 7,244,720 has expired but U.S. Patent No. 8,043,628 is still active?No, a generic company cannot launch a palbociclib product that infringes on the claims of U.S. Patent No. 8,043,628, even if U.S. Patent No. 7,244,720 has expired. Infringement of any valid, unexpired patent can block market entry. Generic companies would need to either wait for 8,043,628 to expire or develop a non-infringing crystalline form. 3. How are the crystalline forms in Patent 8,043,628 defined?The crystalline forms are defined by their unique analytical characteristics, including specific peak positions in X-ray powder diffraction (XRPD) patterns, and specific thermal events measured by differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). 4. Does Patent 8,043,628 cover all possible crystalline forms of palbociclib?No, the patent claims specific crystalline forms, designated as Form I and Form II. It does not cover all theoretically possible crystalline forms of palbociclib. Other crystalline forms or solvates that are not claimed by this patent may exist and could be developed by generic manufacturers. 5. What is the significance of protecting specific crystalline forms in drug patents?Protecting specific crystalline forms is a strategy to extend the effective patent life and market exclusivity of a drug. These forms can have different physical properties, such as stability and solubility, which are critical for manufacturing and efficacy. By patenting these specific forms, the innovator company can prevent competitors from using the most stable or manufacturable forms of the drug, even after the original composition of matter patent expires. Citations[1] Pfizer Inc. (2011). U.S. Patent No. 8,043,628. Crystalline forms of 2-[[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]methoxy]benzoic acid and their uses. Retrieved from USPTO Patent Full-Text and Image Database. [2] Pfizer Inc. (2007). U.S. Patent No. 7,244,720. Pyrazolopyrimidines. Retrieved from USPTO Patent Full-Text and Image Database. More… ↓ |
Drugs Protected by US Patent 8,043,628
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 8,043,628
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 306951 | ⤷ Start Trial | |||
| Australia | 2002236495 | ⤷ Start Trial | |||
| Australia | 2006201271 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
