Understanding the Scope and Claims of United States Patent 11,007,179
Introduction
The United States Patent 11,007,179, hereafter referred to as the '179 patent, is part of a complex patent family involving various pharmaceutical formulations, particularly those related to the drug compound eluxadoline. This patent is crucial in the context of pharmaceutical innovation and intellectual property disputes. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background
The '179 patent is one of several patents held by Allergan, a pharmaceutical company, and is related to the treatment of irritable bowel syndrome with diarrhea (IBS-D) using eluxadoline, marketed as Viberzi. This patent is part of a larger family of patents that include other related formulations and compounds[5].
Patent Scope
The scope of the '179 patent is defined by its claims, which describe specific pharmaceutical formulations. Here are some key aspects:
Claim Structure
The '179 patent includes multiple claims, each detailing different aspects of the pharmaceutical formulation. For example, Claim 1 describes an abuse-deterrent, mono-phasic pharmaceutical tablet comprising specific ingredients and their quantities:
- About 75 mg of eluxadoline
- About 390 mg-450 mg silicified microcrystalline cellulose
- About 30 mg crospovidone
- About 60 mg mannitol
- About 4.5 mg magnesium stearate
- About 18 mg of a film coating
- The nominal weight of the tablet without the film coating is about 600 mg, and the total weight of the tablet is about 618 mg[5].
Abuse-Deterrent Formulation
A significant aspect of the '179 patent is its focus on abuse-deterrent formulations. This is critical in the pharmaceutical industry, as it addresses the issue of drug abuse and misuse. The formulation described in the patent is designed to prevent or deter abuse, which is a key innovation in the field.
Validity and Infringement Issues
The validity of the '179 patent has been a subject of litigation. Here are some key points:
Lack of Written Description
Sun Pharmaceutical, a generic drug manufacturer, has argued that the asserted claims of the '179 patent are invalid for lack of written description. This argument hinges on whether the patent specification adequately describes the invention to enable one skilled in the art to make and use it. The court has considered factors such as the quantity of experimentation necessary, the amount of direction or guidance presented, and the presence or absence of working examples to determine the validity of these claims[5].
Obviousness
If the court finds that the claims have sufficient written description, Sun has also argued that the claims are obvious. This involves assessing whether the claimed invention would have been obvious to a person of ordinary skill in the art at the time of the invention. The court considers various factors, including the state of the prior art and the predictability of the art[5].
Obviousness-Type Double Patenting (ODP)
Another challenge to the '179 patent and related patents (such as the '356 patent) is the issue of obviousness-type double patenting. This occurs when a later-issued patent claims the same invention as an earlier-issued patent, potentially extending the patent term. Sun has argued that the '356 patent, which has a later expiration date due to Patent Term Adjustment (PTA), is invalid for ODP over earlier-issued patents like the '011 and '709 patents[1][5].
Procedural History
The litigation involving the '179 patent has been extensive. Here are some key points:
District Court Decision
After a three-day bench trial, the district court found the asserted claims of the '179, '291, '792, and '516 patents invalid for lack of written description. Additionally, the court held that the asserted claim of the '356 patent was invalid for obviousness-type double patenting[2][5].
Federal Circuit’s Decision
Allergan appealed the district court's decision. The Federal Circuit has provided guidance on what claims can properly serve as references for obviousness-type double patenting, which is crucial in this case. The court's decision will have significant implications for the validity of the '179 patent and related patents[3].
Patent Family and Expiration Dates
The '179 patent is part of a larger patent family that includes several related patents. Here are some key patents and their expiration dates:
'011 and '079 Patents
These patents would expire on March 14, 2025, 20 years from the filing date of the '647 application to which priority is claimed[1].
'356 Patent
This patent, which includes claim 40 reciting the formula of eluxadoline, would expire on June 24, 2026, excluding any awarded Patent Term Extension (PTE)[1].
Impact on Pharmaceutical Innovation
The '179 patent and related litigation highlight several important issues in pharmaceutical innovation:
Patent Scope and Quality
The debate over patent scope and quality is ongoing. Patents with broader claims can lead to increased litigation and licensing costs, potentially diminishing innovation incentives. The '179 patent case illustrates the importance of measuring patent scope and ensuring that claims are clear and valid[4].
Intellectual Property Protection
The protection of intellectual property in the pharmaceutical sector is critical for innovation. Patents like the '179 patent provide a temporary monopoly, allowing companies to recoup their investment in research and development. However, the validity and scope of these patents must be carefully scrutinized to ensure they do not stifle competition or innovation[5].
Key Takeaways
- Patent Scope: The '179 patent describes specific abuse-deterrent pharmaceutical formulations, particularly for eluxadoline.
- Validity Issues: The patent faces challenges related to lack of written description and obviousness.
- Obviousness-Type Double Patenting: The '356 patent's validity is questioned due to ODP over earlier-issued patents.
- Patent Family: The '179 patent is part of a larger family with varying expiration dates.
- Impact on Innovation: The case highlights the importance of clear and valid patent claims in pharmaceutical innovation.
FAQs
Q: What is the main subject of the '179 patent?
A: The '179 patent primarily deals with abuse-deterrent, mono-phasic pharmaceutical tablets containing eluxadoline.
Q: Why is the '179 patent facing validity challenges?
A: The patent is facing challenges related to lack of written description and obviousness, as well as obviousness-type double patenting issues.
Q: What is the significance of the '356 patent in this context?
A: The '356 patent is significant because it has a later expiration date due to PTA and is at the center of the ODP dispute.
Q: How does the '179 patent impact pharmaceutical innovation?
A: The patent's validity and scope affect the balance between protecting intellectual property and fostering innovation in the pharmaceutical sector.
Q: What are the key factors considered in determining the validity of the '179 patent's claims?
A: Factors include the quantity of experimentation necessary, the amount of direction or guidance presented, and the presence or absence of working examples, among others.
Sources
- Duanemorris.com: First-Filed, First-Issued and Later-Expiring Patent in a Family...
- Robinskaplan.com: Allergan USA, Inc. v. MSN Labs. Private Ltd.
- Wsgr.com: Federal Circuit Provides Guidance on What Claims Can Properly Serve As Obviousness-Type Double Patenting References.
- SSRN.com: Patent Claims and Patent Scope.
- Casetext.com: Allergan U.S., Inc. v. MSN Labs. P vt. Ltd.
