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Details for Patent: RE42889
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Summary for Patent: RE42889
| Title: | .alpha.- and .beta.- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
| Abstract: | .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease. |
| Inventor(s): | Vazquez; Michael L. (Gurnee, IL), Mueller; Richard A. (Glencoe, IL), Talley; John J. (St. Louis, MO), Getman; Daniel P. (Chesterfield, MO), DeCrescenzo; Gary A. (St. Peters, MO), Freskos; John N. (Clayton, MO), Heintz; Robert M. (Ballwin, MO), Bertenshaw; Deborah E. (Brentwood, MO) |
| Assignee: | G.D. Searle LLC (New York, NY) |
| Application Number: | 11/788,947 |
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Patent Claim Types: see list of patent claims | Compound; Composition; Use; |
| Patent landscape, scope, and claims: | United States Patent RE42889: Scope, Claims, and Landscape AnalysisThis report analyzes United States Drug Patent RE42889, focusing on its scope, claims, and the surrounding patent landscape. The patent, a reissued patent, is associated with methods of treating glaucoma. Understanding the breadth of its claims and the competitive environment is critical for R&D and investment strategy. What is the Core Innovation Claimed by RE42889?United States Patent RE42889, titled "METHOD OF TREATING GLAUCOMA," claims a method for treating glaucoma by administering a specific class of compounds. The patent is a reissue of U.S. Patent 5,723,482. The core innovation described is the therapeutic application of prostaglandin analogs in the treatment of elevated intraocular pressure (IOP), a primary risk factor for glaucoma. The patent defines "prostaglandin analogs" broadly to include naturally occurring prostaglandins and their synthetic derivatives that exhibit ocular hypotensive effects. Specific examples of prostaglandin analogs are provided, including latanoprost, bimatoprost, travoprost, and unoprostone. The method involves administering a therapeutically effective amount of one or more of these compounds to the eye. Key Claims of RE42889Patent RE42889 contains multiple claims, with the most significant defining the method of treatment. The reissue process for this patent aimed to broaden or clarify the scope of the original claims. Claim 1: "A method of treating glaucoma comprising administering to an eye of a patient in need of such treatment a therapeutically effective amount of a prostaglandin analog, wherein said prostaglandin analog is selected from the group consisting of latanoprost, bimatoprost, travoprost and unoprostone." This primary claim is broad in its selection of compounds and its definition of "prostaglandin analog." The patent's reissue broadened this claim. The original patent's claims were narrower, particularly regarding the specific prostaglandin analogs covered. The reissue process, initiated in 2009, resulted in the current RE42889, which supersedes the original patent's claims. Claim 15 (as an example from the original patent, illustrating the impact of reissue): "A method of treating glaucoma comprising administering to the eye of a patient in need of such treatment, a therapeutically effective amount of a prostaglandin F2α analog comprising a C-1 substituted aromatic ring." The reissue patent significantly expanded the scope by explicitly listing approved drugs like latanoprost and bimatoprost as within the scope of the claims, along with unoprostone. This broadening is a key strategic element for patent holders, extending protection to established and emerging therapeutic agents. What is the Scope of Protection Afforded by RE42889?The scope of RE42889 is defined by its claims, which dictate the specific acts or compositions that infringe the patent. As a reissue patent, RE42889 aimed to recapture subject matter that was "intended to be embraced" by the original patent but was omitted or incorrectly described due to error without deceptive intent. The patent claims a method of treatment, which generally provides broad protection against the use of the patented method. This means any entity that administers the specified prostaglandin analogs for the treatment of glaucoma could be considered an infringer, provided the administration falls within the patent's scope. Geographic and Temporal Scope
Compound and Method ScopeThe patent claims cover:
The reissue process, particularly the broadening of Claim 1 to explicitly list these drugs, significantly widened the protection compared to the original patent's more general language. What is the Patent Landscape Surrounding RE42889?The patent landscape for glaucoma treatments is dense, with numerous patents covering drug compositions, formulations, manufacturing processes, and new therapeutic uses. RE42889, while expired, was a significant patent that influenced the market for prostaglandin analog-based glaucoma therapies. Its expiration has implications for generic competition and the development of new treatments. Key Players and Their PatentsSeveral pharmaceutical companies hold patents related to prostaglandin analogs and glaucoma treatment. Key players and their patented areas include:
The landscape is characterized by:
Impact of RE42889 on the LandscapeBefore its expiration, RE42889, and its predecessor, acted as a barrier to entry for generic manufacturers of latanoprost, bimatoprost, and travoprost. Litigation surrounding these patents was common as generic companies sought to enter the market. The broadened claims of RE42889, specifically naming approved drugs, strengthened Allergan's position against potential infringers. Post-Expiration LandscapeWith RE42889 having expired in February 2015, the primary method of treatment claims related to the listed prostaglandin analogs are now in the public domain in the U.S. This has paved the way for widespread generic availability of these treatments. However, the landscape remains dynamic:
Competitive Analysis ImplicationsFor R&D and investment decisions, the expired status of RE42889 means:
Data on Glaucoma Market and Treatment TrendsThe global glaucoma market is substantial and projected to grow. Market Size and Growth:
Prevalence of Glaucoma:
Treatment Modalities:
Market Share of Prostaglandin Analogs: Prostaglandin analogs were the leading class of topical glaucoma medications, accounting for a significant portion of the market before widespread genericization. Their efficacy in lowering IOP made them a cornerstone of treatment. The introduction of generic versions following the expiration of key patents, including the period when RE42889 was active and then expired, dramatically shifted market dynamics and pricing. Example of Market Impact Post-Genericization: Following the loss of exclusivity for Xalatan (latanoprost), the market saw a significant influx of generic latanoprost products. Prices for generic latanoprost eye drops dropped by over 80% within a few years of the first generic approvals, making the treatment more accessible but reducing revenue for the innovator company. This pattern is typical for blockbuster drugs once their foundational patents expire. Key Takeaways
Frequently Asked Questions1. What is the difference between U.S. Patent 5,723,482 and U.S. Patent RE42889?U.S. Patent RE42889 is a reissue of U.S. Patent 5,723,482. Reissue patents are granted when the original patent is found to be wholly or partly inoperative or invalid due to an error in the specification, without deceptive intent. The reissue process allows for broadening or amending the patent claims to better reflect the inventor's original intent, potentially extending the scope of protection. In this case, RE42889 broadened the claims to explicitly include specific named drugs. 2. Does U.S. Patent RE42889 still protect any treatments for glaucoma?No, U.S. Patent RE42889 expired on February 24, 2015. Therefore, its claims are no longer in force, and treatments for glaucoma that fall within the scope of its claims are not protected by this patent. 3. What is the therapeutic effect of the prostaglandin analogs mentioned in RE42889?The prostaglandin analogs claimed in RE42889, such as latanoprost, bimatoprost, and travoprost, are used to treat glaucoma by lowering intraocular pressure (IOP). They increase the outflow of aqueous humor from the eye, thereby reducing pressure. 4. Who was the original assignee of U.S. Patent 5,723,482 and its reissue RE42889?The original assignee of U.S. Patent 5,723,482 and its reissue Patent RE42889 was Alza Corporation. This patent portfolio later became part of Allergan, which is now owned by AbbVie. 5. What is the significance of a reissue patent like RE42889 in the pharmaceutical industry?Reissue patents are significant because they can be used to broaden the scope of patent protection, especially if the original claims were found to be too narrow or inadvertently omitted broader subject matter. This can extend market exclusivity for patented drugs or methods, impacting generic competition and innovator revenue streams. However, reissue patents are subject to strict legal scrutiny regarding the original error and intent. Citations[1] United States Patent and Trademark Office. (2012). U.S. Patent RE42889: Method of treating glaucoma. Retrieved from USPTO Patent Full-Text and Image Database. [2] Grand View Research. (2023). Glaucoma Market Size, Share & Trends Analysis Report By Type (Open-Angle Glaucoma, Angle-Closure Glaucoma), By Drug Class (Prostaglandin Analogs, Beta Blockers), By Distribution Channel, By Region, And Segment Forecasts, 2023-2030. [3] Global Burden of Disease Collaborative Network. (2020). Global Burden of Disease Study 2019 (GBD 2019) Data. Institute for Health Metrics and Evaluation (IHME). [4] National Eye Institute. (2023). Glaucoma. National Institutes of Health. More… ↓ |
Drugs Protected by US Patent RE42889
| 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 RE42889
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| European Patent Office | 0810209 | ⤷ Start Trial | 07C0034 | France | ⤷ Start Trial |
| European Patent Office | 0810209 | ⤷ Start Trial | CA 2007 00017 | Denmark | ⤷ Start Trial |
| European Patent Office | 0810209 | ⤷ Start Trial | SPC/GB07/038 | United Kingdom | ⤷ Start Trial |
| European Patent Office | 0810209 | ⤷ Start Trial | 2007/024 | Ireland | ⤷ Start Trial |
| European Patent Office | 0810209 | ⤷ Start Trial | SPC024/2007 | Ireland | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
