United States Patent 9,060,976: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,060,976, titled "PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT," is a significant patent owned by Purdue Pharma L.P. This patent is crucial in the context of pharmaceutical formulations, particularly those designed to prevent or deter the abuse of opioid drugs. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
The patent was issued on June 23, 2015, and names Curtis Wright, Benjamin Oshlack, and Christopher Breder as the inventors. It is part of a family of patents related to opioid formulations, specifically OxyContin®, which is covered under approved NDA No. 022272[1][4].
Scope of the Patent
The patent describes a pharmaceutical formulation containing a gelling agent, designed to prevent the abuse of opioid drugs. The formulation includes a core matrix composed of oxycodone or a pharmaceutically acceptable salt thereof, along with a gelling agent such as polyethylene oxide (PEO) and polyethylene glycol (PEG). The core matrix is heated to melt at least a portion of the PEO, and PEG is applied onto the core matrix. This process creates a formulation that is resistant to tampering and abuse, such as crushing or dissolving in water to extract the opioid[1][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Key claims include:
- Claim 1: Describes the pharmaceutical formulation with a core matrix containing oxycodone and a gelling agent.
- Claim 2: Specifies the molecular weight range of the PEO used in the formulation.
- Claim 3: Details the method of applying PEG onto the core matrix.
- Claim 4: Describes the heating process to melt at least a portion of the PEO[1][4].
Patent Landscape and Litigation
The patent landscape surrounding U.S. Patent 9,060,976 is complex and has been the subject of several legal disputes.
Litigation with Ascent Pharmaceuticals
Purdue Pharma L.P. has been involved in patent infringement litigation with Ascent Pharmaceuticals regarding this patent. Ascent Pharmaceuticals had submitted an Abbreviated New Drug Application (ANDA) to the FDA, which Purdue alleged would infringe on several of its patents, including the '976 patent. The litigation centered on whether Ascent's ANDA product would infringe on the claims of the '976 patent[1].
Claim Construction and Interpretation
In the District of Delaware, the court has considered the claim construction of multiple terms in the '976 patent. The court's decision involved analyzing the literal language of the claim, the patent specification, and the prosecution history to determine the scope of the claims[2].
Post-Grant Review and Inter Partes Review
The '976 patent has been subject to post-grant review and inter partes review (IPR) proceedings. In one such proceeding, the Patent Trial and Appeal Board (PTAB) determined that claim 1 of the '976 patent was unpatentable for obviousness. This decision was affirmed by the Federal Circuit[5].
Impact on Patent Quality and Innovation
The debates over patent quality and scope are relevant to this patent. Critics argue that overly broad and unclear patent claims can impede innovation by increasing licensing and litigation costs. The '976 patent, along with other patents in the same family, has faced scrutiny for its claim scope and clarity. The Federal Trade Commission (FTC) and various studies have highlighted concerns about the breadth and clarity of such patents, particularly in the pharmaceutical sector[3].
Real-World Implications
The '976 patent has significant real-world implications, particularly in the context of opioid abuse prevention. The formulation described in the patent is designed to deter tampering and abuse, which is a critical issue given the opioid epidemic. However, the ongoing litigation and challenges to the patent's validity highlight the complexities and challenges in bringing such formulations to market[1][4].
Key Takeaways
- Patent Scope: The '976 patent covers a specific pharmaceutical formulation designed to prevent opioid abuse.
- Litigation: The patent has been involved in several legal disputes, including infringement litigation and post-grant review proceedings.
- Claim Construction: The court's interpretation of the claims is crucial in determining the scope of the patent.
- Impact on Innovation: The patent's breadth and clarity have been questioned, with implications for innovation in the pharmaceutical sector.
- Real-World Implications: The patent is significant in the context of opioid abuse prevention but faces challenges in its validity and enforcement.
FAQs
What is the main invention described in U.S. Patent 9,060,976?
The main invention is a pharmaceutical formulation containing a gelling agent designed to prevent the abuse of opioid drugs.
Who are the inventors of the patent?
The inventors are Curtis Wright, Benjamin Oshlack, and Christopher Breder.
What is the significance of the gelling agent in the formulation?
The gelling agent, such as PEO and PEG, makes the formulation resistant to tampering and abuse by preventing it from being easily crushed or dissolved.
Has the patent been subject to any legal challenges?
Yes, the patent has been involved in several legal disputes, including infringement litigation and post-grant review proceedings.
What are the implications of the patent's validity challenges for innovation?
The challenges to the patent's validity highlight concerns about patent quality and scope, which can impact innovation by increasing licensing and litigation costs.
Cited Sources:
- Pharmacompass: "OxyContin (Oxycodone Hydrochloride) - Purdue Pharma v. Ascent Pharmaceuticals" [PDF].
- District of Delaware: "17-392.pdf - District of Delaware" [PDF].
- Hoover Institution: "Patent Claims and Patent Scope" [PDF].
- United States Patent and Trademark Office: "United States Patent 9,060,976 B2".
- Casetext: "Purdue Pharma L.P. - PGR2018-00048".
