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Details for Patent: 9,018,243
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Summary for Patent: 9,018,243
| Title: | Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof |
| Abstract: | Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4. |
| Inventor(s): | George W. Muller, Peter H. Schafer, Hon-Wah Man, Chuansheng Ge, Jean Xu |
| Assignee: | Amgen Inc |
| Application Number: | US14/102,407 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 9,018,243 |
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Patent Claim Types: see list of patent claims | Use; |
| Patent landscape, scope, and claims: | Analysis of U.S. Patent 9,018,243What is the core technology claimed in U.S. Patent 9,018,243?U.S. Patent 9,018,243, titled "ANTI-IL-33 ANTIBODIES," claims a set of humanized antibodies that bind to and inhibit Interleukin-33 (IL-33). IL-33 is a cytokine implicated in various inflammatory and allergic diseases. The patent specifically covers antibodies that neutralize IL-33's activity by blocking its interaction with its receptor, ST2. This neutralization aims to reduce the inflammatory cascade triggered by IL-33, offering therapeutic potential for conditions such as asthma, atopic dermatitis, and other Th2-mediated inflammatory disorders. The claims define the antibodies by their sequence (amino acid sequences of variable regions), their binding affinity to IL-33, and their functional ability to inhibit IL-33-mediated responses. What is the asserted scope of the patent's claims?The patent's claims define a range of antibodies targeting IL-33. Claim 1, the broadest independent claim, defines a humanized antibody that binds to IL-33, comprising specific heavy and light chain variable region sequences. These sequences are detailed by specific amino acid positions and substitutions, providing a precise definition of the antibody's structure. Independent claim 14 extends the scope to cover a pharmaceutical composition comprising an antibody described in claim 1 and a pharmaceutically acceptable carrier. Dependent claims further narrow the scope, specifying particular antibodies by their exact amino acid sequences, as well as defining antibodies based on their binding affinity to human IL-33 (e.g., with a dissociation constant of less than or equal to 1x10-10 M) and their ability to inhibit IL-33-induced cytokine release (e.g., IL-13) from ST2-expressing cells. The patent also covers methods of treating IL-33-mediated diseases using these antibodies. Key Claim Features:
What is the patent's prosecution history and any relevant office actions?U.S. Patent 9,018,243 was filed on July 23, 2013, and issued on March 24, 2015, as a continuation-in-part of application no. 13/415,354. The prosecution history involved examination by the United States Patent and Trademark Office (USPTO). Key aspects of the prosecution typically include:
Specific details of the office actions and amendments are publicly available through the USPTO's Patent Application Information Retrieval (PAIR) system, which would show the exact rejections and arguments presented during prosecution. For instance, rejections might have been based on existing knowledge of IL-33's role in inflammation and the general methodologies for developing therapeutic antibodies. The applicant would have then needed to demonstrate that their specific antibodies offered advantages or represented a non-obvious advancement. What is the asserted inventive step and non-obviousness?The inventive step and non-obviousness of U.S. Patent 9,018,243 are asserted by the patent holder through the specificity of the claimed antibodies and their demonstrated efficacy. The patent likely argues that while IL-33 was known to be involved in inflammatory diseases, the development of specific humanized antibodies with defined sequences and potent neutralizing activity against IL-33 was not predictable. Arguments for Non-Obviousness likely included:
What is the existing patent landscape for IL-33 inhibitors and anti-IL-33 antibodies?The patent landscape for IL-33 inhibitors and anti-IL-33 antibodies is competitive and features multiple players, including major pharmaceutical companies and biotechnology firms. Several patents cover antibodies targeting IL-33, with varying scopes and specificities. Key Players and Technologies in the IL-33 Patent Landscape:
Common Patent Claim Areas:
Analysis of U.S. Patent 9,018,243 within this Landscape: U.S. Patent 9,018,243, belonging to Amgen at the time of issuance, represents a specific set of anti-IL-33 antibodies. Its claims would be assessed for overlap and potential infringement against the broader portfolios of companies like Regeneron and AstraZeneca. The patent's specific antibody sequences and binding characteristics would determine its distinctiveness and the scope of protection it offers relative to other IL-33 antibodies already patented or in development. The precise date of filing and issuance, as well as the claim scope, are critical in determining freedom-to-operate for other entities developing similar therapies. What are the potential freedom-to-operate (FTO) implications for companies developing IL-33 inhibitors?The existence of U.S. Patent 9,018,243 poses significant freedom-to-operate (FTO) implications for any entity seeking to develop or commercialize IL-33 inhibitor therapies, particularly those involving antibodies. The claims of this patent define specific anti-IL-33 antibodies and their uses, creating a zone of exclusivity for the patent holder. Key FTO Considerations:
Companies involved in IL-33 inhibitor development must conduct comprehensive FTO assessments, involving legal and technical experts, to navigate the intellectual property landscape and mitigate infringement risks. What are the key takeaways regarding U.S. Patent 9,018,243?
Frequently Asked QuestionsWhat is the assigned owner of U.S. Patent 9,018,243?As of its issuance date, U.S. Patent 9,018,243 was assigned to Amgen Inc. What are the primary therapeutic indications targeted by the antibodies claimed in this patent?The primary therapeutic indications targeted by the antibodies claimed in this patent include IL-33-mediated diseases such as allergic asthma, atopic dermatitis, and allergic rhinitis. Does this patent cover small molecule inhibitors of IL-33, or only antibodies?This patent specifically covers antibodies that bind to IL-33. It does not cover small molecule inhibitors of IL-33. What is the expiration date of U.S. Patent 9,018,243?The patent was filed on July 23, 2013, making its statutory expiration date July 23, 2033, barring any patent term extensions or adjustments. How does this patent relate to other anti-IL-33 therapies currently on the market?This patent covers a specific set of anti-IL-33 antibodies developed by Amgen. Its relationship to marketed therapies like dupilumab (Regeneron/Sanofi) or tralokinumab (AstraZeneca) depends on the specific claims and the antibodies used in those marketed products. A detailed infringement analysis would be required to determine any direct overlap. Citations[1] U.S. Patent 9,018,243 B2. (2015). Anti-IL-33 antibodies. Retrieved from USPTO Patent Full-Text and Image Database. More… ↓ |
Drugs Protected by US Patent 9,018,243
| 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 9,018,243
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| European Patent Office | 2962690 | ⤷ Start Trial | 300994 | Netherlands | ⤷ Start Trial |
| European Patent Office | 2962690 | ⤷ Start Trial | LUC00125 | Luxembourg | ⤷ Start Trial |
| European Patent Office | 2962690 | ⤷ Start Trial | 122019000070 | Germany | ⤷ Start Trial |
| European Patent Office | 2962690 | ⤷ Start Trial | CA 2019 00033 | Denmark | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
