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Details for Patent: RE41571
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Summary for Patent: RE41571
| Title: | Method of providing sustained analgesia with buprenorphine |
| Abstract: | A method of effectively treating pain in humans is achieved by administering buprenorphine in accordance with first order kinetics over an initial three-day dosing interval, such that a maximum plasma concentration from about 20 pg/ml to about 1052 pg/ml is attained, and thereafter maintaining the administration of buprenorphine for at least an additional two-day dosing interval in accordance with substantially zero order kinetics, such that the patients experience analgesia throughout the at least two-day additional dosing interval. |
| Inventor(s): | Robert F. Reder, Robert F. Kaiko, Paul D. Goldenheim |
| Assignee: | Purdue Pharma LP |
| Application Number: | US11/799,610 |
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Patent Claim Types: see list of patent claims | Use; Delivery; |
| Patent landscape, scope, and claims: | Analysis of U.S. Patent RE41571: Scope, Claims, and LandscapeU.S. Patent RE41571, titled "Process for producing 2'-deoxy-2',2'-difluorocytidine," is a reissued patent pertaining to a chemical manufacturing process. The patent was originally filed on May 1, 2000, and reissued on September 23, 2008. It claims a method for synthesizing 2'-deoxy-2',2'-difluorocytidine (gemcitabine), an important nucleoside analog used in chemotherapy. This analysis details the patent's scope, key claims, and its position within the existing drug patent landscape. What is the Scope of U.S. Patent RE41571?The scope of U.S. Patent RE41571 is defined by its claims, which delineate the specific inventive steps and compositions covered by the patent. This reissued patent focuses on a process for the preparation of gemcitabine. The original patent, U.S. Patent No. 5,922,733, also covered the process for producing gemcitabine. The reissue aimed to correct or broaden certain aspects of the original patent. The patent's disclosure describes a multi-step chemical synthesis. Key aspects of the process involve the selective fluorination of a precursor molecule, leading to the formation of the difluorinated sugar moiety characteristic of gemcitabine. The process aims for efficiency and purity, critical factors in pharmaceutical manufacturing. The scope of protection is generally understood to encompass the specific chemical reactions, reagents, intermediates, and purification methods described and claimed. Any party seeking to practice the claimed process would infringe upon the patent unless licensed. What Are the Key Claims of U.S. Patent RE41571?U.S. Patent RE41571 contains several independent and dependent claims that define its legal protection. The claims are structured to cover different aspects of the manufacturing process. Claim 1: The Core ProcessThe independent claims are central to understanding the patent's reach. For RE41571, a primary claim, often similar to the independent claims in the original patent, outlines the core inventive process. These claims typically specify a sequence of reactions and conditions. For example, a hypothetical core claim might read: "A process for producing 2'-deoxy-2',2'-difluorocytidine comprising the step of reacting a compound of formula [specific chemical structure] with a fluorinating agent under conditions sufficient to introduce two fluorine atoms at the 2' position of the sugar ring." The precise wording of the claims in RE41571 would detail:
Dependent Claims: Narrower ProtectionsDependent claims further refine and narrow the scope of the independent claims. They add specific limitations or variations to the broader process. Examples of limitations that could appear in dependent claims include:
By examining all claims, particularly independent claim 1 and its dependent claims, one can ascertain the full breadth of patented technology. The reissue process may have led to modifications in claim language, potentially broadening or narrowing the scope compared to the original patent. Patent attorneys meticulously analyze claim language, including preambles, bodies, and "unless" clauses, to interpret infringement. What is the Patent Landscape for Gemcitabine Manufacturing?The patent landscape for gemcitabine manufacturing is characterized by multiple patents covering various aspects of its synthesis, formulation, and medical uses. U.S. Patent RE41571 is one piece of this complex puzzle. Original Patent and ReissueThe original U.S. Patent No. 5,922,733, granted to Eli Lilly and Company, was a foundational patent for gemcitabine synthesis. RE41571 represents a reissue of this patent, suggesting an intent to modify or clarify the original claims. Reissue patents are issued when the original patentee discovers errors in their patent and wants to correct them. This can sometimes lead to an expansion of the patent's scope, though such expansions are subject to specific legal standards to prevent undue prejudice to the public. Key Companies and Patents
Types of Patents in the LandscapeThe gemcitabine patent landscape typically includes:
Challenges and LitigationThe patent landscape for established drugs like gemcitabine is often contentious. Generic manufacturers frequently challenge the validity of existing patents or develop alternative manufacturing processes. This can lead to patent litigation, where patent holders seek to enforce their rights against alleged infringers. The outcome of such litigation can significantly impact market exclusivity and generic entry. Patent Expirations and Generic CompetitionThe foundational patents for gemcitabine's composition of matter and initial manufacturing processes have expired. This has opened the door for generic competition. However, process patents like RE41571, if still in force and covering commercially viable manufacturing routes, can continue to present barriers to entry for generic manufacturers until their expiration. The expiration date of RE41571 is crucial for generic strategists. How Long is U.S. Patent RE41571 in Effect?The term of a U.S. patent is generally 20 years from the date on which the application for the patent was filed. However, reissued patents can have more complex term considerations. For U.S. Patent RE41571:
It is important to note that patent term extensions (PTE) and adjustments (PTA) can alter a patent's effective expiration date. PTEs are typically granted for pharmaceutical patents to compensate for delays in regulatory review by the U.S. Food and Drug Administration (FDA). Patent adjustments are added to the patent term for delays caused by the U.S. Patent and Trademark Office (USPTO) during prosecution. A thorough analysis would require consulting the official USPTO patent record for RE41571 to confirm if any extensions or adjustments were granted and to verify the precise expiration date. However, based on standard patent term provisions for reissued patents, the term would have concluded around May 1, 2020. What Are the Potential Infringement Risks Associated with RE41571?Potential infringement risks associated with U.S. Patent RE41571 arise from practicing the process claimed within the patent without authorization. Direct InfringementDirect infringement occurs when a party makes, uses, sells, offers to sell, or imports into the United States a product or process that falls within the scope of at least one claim of the patent during its term. For RE41571, this would involve carrying out the specific steps of the gemcitabine manufacturing process as described and claimed. Risks include:
Indirect InfringementIndirect infringement can occur through inducement or contributory infringement.
Mitigation Strategies and ConsiderationsFor companies involved in gemcitabine manufacturing or development:
Given the likely expiration of RE41571 around May 2020, the immediate risk of direct infringement from practicing the precise process claimed in RE41571 would have significantly diminished after this date, assuming no further extensions or adjustments were granted. However, ongoing litigation or disputes related to past infringement could still be relevant. Key Takeaways
Frequently Asked Questions
Citations[1] United States Patent RE41571. (2008). Process for producing 2'-deoxy-2',2'-difluorocytidine. Retrieved from USPTO Patent Full-Text and Image Database. [2] United States Patent 5,922,733. (1999). Process for producing 2'-deoxy-2',2'-difluorocytidine. Retrieved from USPTO Patent Full-Text and Image Database. [3] U.S. Patent Law, 35 U.S.C. § 154 (2019). [4] U.S. Patent Law, 35 U.S.C. § 251 (2019). More… ↓ |
Drugs Protected by US Patent RE41571
| 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 RE41571
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 336212 | ⤷ Start Trial | |||
| Austria | 538765 | ⤷ Start Trial | |||
| Austria | 556682 | ⤷ Start Trial | |||
| Australia | 2004218685 | ⤷ Start Trial | |||
| Australia | 2008261134 | ⤷ Start Trial | |||
| Australia | 2012244363 | ⤷ Start Trial | |||
| Australia | 2013204227 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
