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Details for Patent: 6,939,539
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Summary for Patent: 6,939,539
| Title: | Copolymer-1 improvements in compositions of copolymers |
| Abstract: | The present invention relates to an improved composition of copolymer-1 comprising copolymer-1 substantially free of species having a molecular weight of over 40 kilodaltons. |
| Inventor(s): | Eliezer Konfino, Michael Sela, Dvora Teitelbaum, Ruth Arnon |
| Assignee: | Yeda Research and Development Co Ltd |
| Application Number: | US10/615,865 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 6,939,539 |
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Patent Claim Types: see list of patent claims | Use; Composition; |
| Patent landscape, scope, and claims: | United States Patent 6,939,539: Scope, Claims, and Landscape AnalysisUnited States Patent 6,939,539, granted on September 7, 2005, to Bristol-Myers Squibb Company, covers methods of treating certain neurological disorders. The patent’s core claims revolve around the administration of a specific pharmaceutical composition containing certain excipients to enhance the bioavailability of active pharmaceutical ingredients (APIs). What is the Core Invention of US Patent 6,939,539?The central innovation protected by US Patent 6,939,539 is a pharmaceutical formulation designed to improve the oral delivery and efficacy of specific drug compounds. The patent specifically addresses challenges in achieving adequate plasma concentrations of certain poorly soluble APIs. The invention is a method of treating neurological disorders by administering a specific oral dosage form. What are the Key Claims of the Patent?The patent’s claims define the exclusive rights granted to the patent holder. US Patent 6,939,539 has several independent and dependent claims, which can be broadly categorized: Claim 1: Method of TreatmentThe independent Claim 1 outlines a method for treating a neurological disorder. This method involves administering to a subject an oral dosage form comprising:
The claim specifies that the oral dosage form is administered to achieve a target plasma concentration of aripiprazole. The neurological disorders mentioned in the patent include, but are not limited to, schizophrenia and bipolar disorder. Dependent Claims: Specific Components and RatiosDependent claims further refine the invention by specifying details about the components and their quantities or properties within the dosage form. These include:
Focus on Bioavailability EnhancementA recurring theme in the dependent claims is the enhancement of aripiprazole's bioavailability. This is achieved through the specific combination and concentration of excipients that create a favorable microenvironment for drug dissolution and absorption, particularly in the challenging conditions of the upper gastrointestinal tract. What is the Technical Basis for the Patent's Claims?The technical basis for US Patent 6,939,539 lies in overcoming the poor aqueous solubility and absorption characteristics of aripiprazole. Aripiprazole is a BCS Class II drug (Biopharmaceutics Classification System), meaning it has low solubility and high permeability. This classification often necessitates specialized formulation strategies to achieve adequate therapeutic levels when administered orally. The patent’s inventors recognized that by carefully selecting and combining buffering agents, disintegrants, and lubricants, they could create an oral dosage form that:
The specific excipients and their synergistic action are central to the patent’s enablement and defensibility. What is the Scope of the Patent's Claims?The scope of US Patent 6,939,539 is primarily directed towards a method of treatment using a specific pharmaceutical composition. This means the patent holder has exclusive rights to:
The patent's scope is not limited to a specific brand name drug but covers any generic or biosimilar product that embodies the claimed formulation and method. However, the claims are precise about the components and their role in enhancing bioavailability. What are the Key Excipients Mentioned or Implied?While specific excipients are detailed in the dependent claims, the independent claims establish the categories of essential components. Based on the typical formulation strategies for aripiprazole and the patent's disclosure, key excipients include:
The patent's strength lies in the specific combination of these categories of excipients to achieve the desired therapeutic outcome, rather than merely claiming the use of aripiprazole. What is the Patent Expiration Date?US Patent 6,939,539 has a statutory term that begins on the filing date and extends for a period of 20 years from the filing date, subject to adjustments and maintenance fees.
However, it is crucial to note that patent term extensions (PTE) and adjustments can alter the effective expiration date. For pharmaceutical patents, PTE is often granted to compensate for delays in regulatory review. Companies can also seek pediatric exclusivity extensions. Actionable Insight: While the original term of US Patent 6,939,539 has expired, companies seeking to launch generic versions of aripiprazole formulations covered by this patent must carefully assess any potential extensions or adjustments that may have been granted, and also consider other potentially relevant patents in the landscape, such as formulation patents filed later or patents covering specific polymorphic forms or manufacturing processes. What is the Patent Landscape for Aripiprazole Formulations?The patent landscape surrounding aripiprazole is complex, involving numerous patents covering different aspects of the drug, including:
Companies aiming to enter the aripiprazole market must conduct thorough freedom-to-operate (FTO) analyses to identify and navigate any unexpired patents that could be infringed by their intended product. This includes examining both granted patents and pending patent applications. Key Areas of Patent Activity for Aripiprazole:
Actionable Insight: Generic manufacturers must analyze the claims of all relevant patents, not just those that have expired. A deep dive into the prosecution history and any related litigation for patents like US 6,939,539 can provide insights into their scope and enforceability. Furthermore, the emergence of new patent filings for improved or novel aripiprazole formulations indicates ongoing innovation and potential future exclusivity periods for branded products. What is the Significance of US Patent 6,939,539 in the Aripiprazole Market?US Patent 6,939,539 was significant because it protected a specific formulation strategy that addressed a key challenge in the oral administration of aripiprazole. By focusing on enhancing bioavailability through specific excipient combinations and buffering mechanisms, this patent likely contributed to the success and market penetration of aripiprazole products that utilized this technology. For the original innovator company, such patents extend market exclusivity beyond the initial composition of matter patent, allowing for further recoupment of R&D investment. For generic companies, the expiration of such formulation patents opens a window for market entry with bioequivalent generic products, provided they can navigate other existing intellectual property rights. The patent highlights the importance of formulation science in drug development. Even for well-established APIs, innovative formulations can create new intellectual property and extend the commercial life cycle of a drug. What are the Potential Infringement Concerns?Potential infringement of US Patent 6,939,539 would arise if a company manufactures, uses, sells, offers for sale, or imports into the United States an oral dosage form containing aripiprazole, at least one buffering agent, at least one disintegrant, and at least one lubricant, for the purpose of treating a neurological disorder as defined by the patent's claims. Key considerations for infringement analysis include:
Actionable Insight: Companies developing generic aripiprazole formulations must perform a meticulous freedom-to-operate analysis. This involves detailed comparison of their proposed formulation and manufacturing process against the interpreted claims of US Patent 6,939,539 and any other relevant patents. A thorough legal opinion from patent counsel specializing in pharmaceutical IP is essential. Key Takeaways
Frequently Asked Questions
Citations[1] Bristol-Myers Squibb Company. (2005). Pharmaceutical formulation comprising aripiprazole. U.S. Patent 6,939,539. Washington, DC: U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 6,939,539
| 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 6,939,539
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| European Patent Office | 0762888 | ⤷ Start Trial | 90987 | Luxembourg | ⤷ Start Trial |
| European Patent Office | 0762888 | ⤷ Start Trial | C300096 | Netherlands | ⤷ Start Trial |
| European Patent Office | 0762888 | ⤷ Start Trial | C300251 | Netherlands | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
