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Patent landscape, scope, and claims: |
United States Patent 6,488,963: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,488,963, titled "Hot-melt extrudable pharmaceutical formulation," is a significant patent in the pharmaceutical industry, particularly in the realm of drug formulation and delivery. This patent, assigned to Purdue Pharma, among others, has been a focal point in several legal and technical discussions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, filed on September 26, 1999, and granted on December 17, 2002, pertains to pharmaceutical formulations that utilize hot-melt extrusion techniques. This method involves combining a therapeutic compound with a high molecular weight polyethylene oxide (PEO) to create a formulation that can be administered through various routes[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Claims Overview
- The patent claims cover a hot-melt extrudable mixture of a therapeutic compound and a high molecular weight PEO.
- The formulation may include additional components such as plasticizers and antioxidants.
- The method of preparation involves hot-melt extrusion, with specific conditions like temperature, pressure, and extruder settings being crucial for the process[4].
Therapeutic Compound and PEO
- The therapeutic compound can be any drug that can be formulated using this method.
- The PEO must have a high molecular weight, typically greater than 5,000,000, which is essential for the hot-melt extrusion process[4].
Administration Methods
- The formulated drug can be administered through various routes, including oral, nasal, buccal, rectal, ophthalmic, otic, urethral, vaginal, or sublingual[4].
Claims Analysis
The claims of the patent are detailed and specific, ensuring that the protection is narrow but robust.
Independent Claims
- Claim 1 is the broadest independent claim, describing the hot-melt extrudable pharmaceutical formulation comprising a therapeutic compound and a high molecular weight PEO.
- Subsequent claims narrow down the scope by specifying additional components, such as plasticizers and antioxidants, and the conditions for the hot-melt extrusion process[4].
Dependent Claims
- Dependent claims further specify the types of therapeutic compounds, the molecular weight of PEO, and the methods of administration.
- These claims ensure that the patent covers a range of applications while maintaining specificity[4].
Patent Landscape
The patent landscape surrounding US 6,488,963 is complex, with several related patents and legal challenges.
Related Patents
- Patents like the "Tamper Resistant" or "Abuse-Deterrent Patents" (e.g., U.S. Patent Nos. 9,763,933, 9,775,808, and 9,763,886) also pertain to formulations designed to prevent abuse, often using similar techniques[2].
- The "Low ABUK Patents" (e.g., U.S. Patent Nos. 9,073,933 and 9,522,919) focus on reducing the levels of certain impurities in oxycodone formulations, which can be related to the hot-melt extrusion process[2].
Legal Challenges
- The patent has been involved in several legal disputes, particularly regarding its validity and infringement.
- For instance, in the case against Accord Healthcare, the court found the claims of related patents invalid for obviousness, which could have implications for the validity of US 6,488,963[2].
Obviousness and Anticipation
The validity of the patent has been challenged on grounds of obviousness and anticipation.
Obviousness
- The court in the Accord Healthcare case applied the standard from KSR Int'l Co. v. Teleflex Inc., which requires that the differences between the claimed invention and the prior art must be such that the claimed invention as a whole would have been obvious to a person having ordinary skill in the art[2].
- The combination of prior art references, such as Bartholomaus and McGinity, with heating techniques taught in other prior art, has been argued to render the claims obvious[2].
Anticipation
- Anticipation requires that a single prior art reference discloses each and every limitation of the claimed invention. If a feature is necessarily present or inherent in the prior art, it can still anticipate the claim[1].
Industry Impact
The patent has significant implications for the pharmaceutical industry, particularly in the development of abuse-deterrent and extended-release formulations.
Abuse-Deterrent Formulations
- The hot-melt extrusion technique described in the patent is crucial for creating formulations that are resistant to tampering and abuse, a major concern with opioids like oxycodone[2].
Extended-Release Formulations
- The ability to formulate drugs using high molecular weight PEO allows for the creation of extended-release formulations, which can improve patient compliance and reduce the risk of overdose[4].
Expert Insights
Industry experts emphasize the importance of such patents in driving innovation in drug delivery systems.
"Patents like US 6,488,963 are vital for encouraging the development of new drug delivery technologies. They protect the significant investment in research and development required to bring these innovations to market," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Examples
- The use of hot-melt extrusion in pharmaceutical formulations has increased significantly since the patent was granted, reflecting its importance in the industry.
- For example, the number of patents filed using this technique has risen by over 50% in the last decade, indicating a growing interest in this method[3].
Key Takeaways
- Scope and Claims: The patent covers hot-melt extrudable pharmaceutical formulations using high molecular weight PEO and therapeutic compounds.
- Patent Landscape: The patent is part of a broader landscape involving related patents on abuse-deterrent and extended-release formulations.
- Legal Challenges: The patent's validity has been challenged on grounds of obviousness and anticipation.
- Industry Impact: The patent is crucial for the development of abuse-deterrent and extended-release formulations.
FAQs
What is the main subject of US Patent 6,488,963?
The main subject is a hot-melt extrudable pharmaceutical formulation comprising a therapeutic compound and a high molecular weight polyethylene oxide (PEO).
What are the key components of the formulation?
The key components include a therapeutic compound, high molecular weight PEO, and optionally, plasticizers and antioxidants.
How is the formulation prepared?
The formulation is prepared using hot-melt extrusion, with specific conditions such as temperature, pressure, and extruder settings.
What are the potential administration routes for the formulation?
The formulation can be administered through various routes, including oral, nasal, buccal, rectal, ophthalmic, otic, urethral, vaginal, or sublingual.
Has the patent been involved in any legal disputes?
Yes, the patent has been involved in legal disputes regarding its validity and infringement, particularly on grounds of obviousness.
Cited Sources
- PURDUE PHARMA L.P. v. EPIC PHARMA, LLC - United States Court of Appeals for the Federal Circuit[1].
- Purdue Pharma L.P. v. Accord Healthcare - United States District Court for the District of Delaware[2].
- Patent Claims and Patent Scope - Hoover Institution[3].
- US6488963B1 - Hot-melt extrudable pharmaceutical formulation - Google Patents[4].
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