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Last Updated: April 1, 2026

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
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent RE41571: Scope, Claims, and Landscape

U.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 Process

The 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:

  • The specific starting materials or precursors used.
  • The nature of the fluorinating agent employed (e.g., specific chemical compounds known for fluorination).
  • The reaction conditions, including temperature, pressure, solvents, and catalysts.
  • The formation of specific intermediates.
  • Purification methods to isolate the final product.

Dependent Claims: Narrower Protections

Dependent 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:

  • The use of a particular fluorinating agent from a class of agents.
  • The employment of a specific solvent system.
  • A defined temperature range for a particular reaction step.
  • A particular method for isolating or purifying an intermediate or the final gemcitabine.

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 Reissue

The 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

  • Eli Lilly and Company: As the original assignee of the patent family covering gemcitabine synthesis, Lilly holds significant intellectual property rights. Beyond RE41571, Lilly likely holds other patents related to gemcitabine's production and therapeutic applications.
  • Generic Manufacturers: Once primary patents expire or are successfully challenged, generic manufacturers seek to enter the market. Their ability to do so depends on navigating the patent landscape, potentially developing non-infringing processes or waiting for patent expiry. Companies like Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries have been involved in the gemcitabine market, often through generic versions. Their R&D efforts focus on alternative synthetic routes that do not infringe existing patents or on challenging the validity of those patents.
  • Other Research Institutions and Companies: Academic institutions and other pharmaceutical companies may also hold patents related to novel synthetic pathways, improved yields, specific polymorphs, or enantiomerically pure forms of gemcitabine or its precursors.

Types of Patents in the Landscape

The gemcitabine patent landscape typically includes:

  • Process Patents: Like RE41571, these cover methods of manufacturing the active pharmaceutical ingredient (API).
  • Composition of Matter Patents: These cover the chemical compound itself. These are typically the strongest and longest-lasting patents. For gemcitabine, the initial composition of matter patent has long since expired.
  • Formulation Patents: These cover specific drug delivery systems, dosage forms (e.g., solutions, lyophilized powders), and excipients.
  • Method of Use Patents: These cover the use of gemcitabine for treating specific diseases or conditions, often specifying dosages and treatment regimens.
  • Polymorph Patents: These cover specific crystalline forms of the API, which can affect stability, solubility, and bioavailability.

Challenges and Litigation

The 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 Competition

The 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:

  • Original Filing Date: May 1, 2000 (for the original U.S. Patent No. 5,922,733).
  • Original Patent Term: Based on the original filing date, the original patent would have been expected to expire 20 years later, around May 1, 2020.
  • Reissue Date: September 23, 2008.
  • Term of Reissued Patent: According to U.S. patent law, a reissued patent generally has the same term as the original patent would have had if no reissue had been made. This means the term of RE41571 is tied to the original filing date of May 1, 2000. The effective expiration date would therefore be approximately May 1, 2020.

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 Infringement

Direct 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:

  • Manufacturing Gemcitabine: Companies producing gemcitabine API using the patented process.
  • Importing Gemcitabine: Importing gemcitabine into the U.S. that was manufactured using the patented process abroad.
  • Selling Gemcitabine: Selling gemcitabine in the U.S. where the manufacturing process infringes the patent.

Indirect Infringement

Indirect infringement can occur through inducement or contributory infringement.

  • Induced Infringement: This happens when a party actively encourages or aids another party to directly infringe the patent. For example, providing detailed instructions and necessary reagents for a specific, patented synthesis route to a third party.
  • Contributory Infringement: This occurs when a party sells a component that is material to the patented process and knows that the component is specially made for use in an infringing process and is not a staple article of commerce suitable for substantial non-infringing use.

Mitigation Strategies and Considerations

For companies involved in gemcitabine manufacturing or development:

  1. Freedom-to-Operate (FTO) Analysis: Conducting a comprehensive FTO analysis is critical. This involves searching and analyzing relevant patents (including RE41571 and any related patents) to determine if a proposed commercial activity (e.g., manufacturing a specific synthetic route) would infringe existing intellectual property rights.
  2. Designing Around Patents: Developing alternative synthetic routes that avoid the specific steps, reagents, or conditions claimed in RE41571. This requires innovative R&D and careful claim construction to ensure the alternative process does not fall within the scope of the patent.
  3. Licensing: Negotiating a license with the patent holder (Eli Lilly and Company, or its successors) to use the patented process. This involves royalty payments and adherence to license terms.
  4. Patent Validity Challenges: If a company believes RE41571 or its claims are invalid, they may seek to challenge its validity through USPTO proceedings (e.g., inter partes review) or in court.
  5. Monitoring Patent Expiration: Carefully tracking the expiration dates of all relevant patents, including RE41571, is essential for planning market entry or product launches.

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

  • U.S. Patent RE41571 covers a process for manufacturing 2'-deoxy-2',2'-difluorocytidine (gemcitabine).
  • The patent is a reissue of U.S. Patent No. 5,922,733, originally assigned to Eli Lilly and Company.
  • The patent's claims define the specific steps, reagents, and conditions involved in the gemcitabine synthesis process.
  • The effective term of RE41571, tied to its original filing date of May 1, 2000, likely expired around May 1, 2020, subject to any granted patent term extensions or adjustments.
  • Potential infringement risks for companies practicing the claimed process were highest during the patent's active term.
  • Mitigation strategies include freedom-to-operate analysis, designing around patented processes, licensing, and challenging patent validity.
  • The gemcitabine patent landscape is complex, involving multiple patents covering synthesis, formulation, and use, and has seen significant activity from generic manufacturers.

Frequently Asked Questions

  1. What specific chemical transformations are protected by U.S. Patent RE41571? The patent protects a process for producing gemcitabine, focusing on the introduction of two fluorine atoms at the 2' position of the sugar ring of a cytidine precursor through specific chemical reactions and conditions.

  2. Can a generic company use the manufacturing process described in U.S. Patent RE41571 today? Given that the patent's likely expiration date was around May 1, 2020, a generic company would generally be free to use the process claimed in RE41571 now, provided no other valid patents or regulatory restrictions apply to that specific manufacturing method.

  3. What is the difference between the original patent and a reissued patent like RE41571? A reissued patent (RE) is granted when the patent holder discovers an error in the original patent and seeks to correct or broaden its scope. The claims of a reissued patent can be different from the original, potentially offering a wider or narrower scope of protection.

  4. Does U.S. Patent RE41571 cover the gemcitabine drug itself, or only its manufacturing method? U.S. Patent RE41571 specifically covers the process for producing gemcitabine, not the gemcitabine molecule itself. The composition of matter patent for gemcitabine would have been a separate, earlier patent.

  5. What actions constitute infringement of a process patent like RE41571? Infringement occurs if someone makes, uses, sells, offers to sell, or imports into the U.S. the patented process without authorization during the patent's term. This includes performing the specific series of chemical steps claimed in the patent to create gemcitabine.

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).

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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

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