|
Patent landscape, scope, and claims: |
United States Drug Patent 8,993,761: Analysis of Scope, Claims, and Landscape
Patent 8,993,761, issued on March 24, 2015, to Allergan, Inc., pertains to pharmaceutical formulations and methods of treating ocular conditions. The patent claims specific compositions and uses related to the management of dry eye disease.
What Are the Key Claims of Patent 8,993,761?
The patent’s claims define the legal boundaries of the invention, specifying what is protected. The core claims of U.S. Patent 8,993,761 are directed towards:
- Claim 1: A method for treating dry eye disease in a subject. This method involves administering a therapeutically effective amount of a composition. The composition comprises a specific concentration range of certain active ingredients and excipients. The active ingredient is a lidocaine derivative, specifically 2-[2-(diethylamino)-6-methylphenyl]amino]-2-oxoethyl}carbamic acid ester. The composition is characterized by its low viscosity and high pH, details of which are further specified in dependent claims.
- Claim 14: A pharmaceutical composition for treating dry eye disease. This claim details a specific formulation comprising the aforementioned lidocaine derivative, along with a buffering system to maintain a specific pH range, and a viscosity modifier.
- Dependent Claims: Numerous dependent claims further refine the scope, specifying:
- Exact concentration ranges for the active ingredient (e.g., between 0.01% and 1.0% by weight).
- Specific buffering agents and their concentrations to achieve a pH between 7.5 and 9.5.
- Particular viscosity modifiers and their acceptable viscosity ranges (e.g., between 1 cP and 50 cP).
- The exclusion of certain other active ingredients, such as artificial tears or conventional anti-inflammatory agents, from the formulation.
- Methods of manufacturing the composition.
The patent’s claims are designed to protect a specific therapeutic approach to dry eye, focusing on a novel formulation characterized by its pH and viscosity, utilizing a specific anesthetic derivative for symptom relief.
What Is the Therapeutic Application Protected by Patent 8,993,761?
The primary therapeutic application protected by U.S. Patent 8,993,761 is the treatment of dry eye disease. Dry eye disease is a multifactorial condition characterized by insufficient tear production or excessive tear evaporation, leading to discomfort, visual disturbance, and potential damage to the ocular surface.
The patent focuses on alleviating the symptoms associated with dry eye, particularly the stinging, burning, and irritation. The active ingredient claimed, a lidocaine derivative, acts as a topical anesthetic. The novelty lies not solely in the active ingredient but in the formulation of this ingredient into an ophthalmic preparation. The specific high pH (alkaline) and low viscosity of the formulation are presented as key attributes for improved efficacy and patient tolerability in managing dry eye symptoms. This formulation is intended to provide rapid and transient symptomatic relief.
Who Are the Key Entities Involved in Patent 8,993,761?
The primary entities associated with U.S. Patent 8,993,761 are:
- Assignee: Allergan, Inc. (now part of AbbVie Inc.). Allergan, Inc. is the legal owner of the patent.
- Inventors: The patent lists specific individuals as the inventors. The named inventors include Daniel S. Preston, Eric D. Donnenfeld, Steven S. Chang, and J. Michael Bohnen.
- Applicant: Allergan, Inc. was the applicant for the patent.
- U.S. Patent and Trademark Office (USPTO): The issuing authority for the patent.
The assignee, Allergan, Inc., is a pharmaceutical company with a significant portfolio in ophthalmology. The inventors are individuals recognized for their contributions to the development of the patented technology.
What Is the Patent Landscape Surrounding Patent 8,993,761?
The patent landscape for U.S. Patent 8,993,761 is shaped by existing treatments for dry eye disease and the development of new therapeutic modalities.
Existing Dry Eye Treatments:
Prior art and existing market products for dry eye disease include:
- Artificial Tears: Over-the-counter lubricating eye drops and ointments (e.g., Systane, Refresh, TheraTears). These aim to supplement natural tears and provide lubrication.
- Anti-inflammatory Agents: Prescription eye drops such as cyclosporine (Restasis, Cequa) and lifitegrast (Xiidra) target the underlying inflammation associated with dry eye.
- Punctal Plugs: Devices inserted into tear ducts to reduce tear drainage.
- Lifestyle and Environmental Modifications: Advice on reducing screen time, using humidifiers, and avoiding irritants.
Patented Technologies in Ophthalmology:
The broader patent landscape in ophthalmology is extensive, covering:
- Novel Drug Delivery Systems: Devices and formulations for sustained or targeted delivery of ocular medications.
- New Chemical Entities (NCEs): Discovery and patenting of entirely new molecules with therapeutic potential.
- Formulation Technologies: Innovations in excipients, viscosity modifiers, pH adjusters, and preservatives to improve drug stability, efficacy, and patient experience.
- Methods of Treatment: Patents claiming specific protocols or regimens for treating ophthalmic diseases.
Competitive Filings and Expiry:
The patent for the specific formulation described in 8,993,761 is subject to potential challenges and the expiration of its term.
- Patent Term: U.S. Patent 8,993,761 has a term that generally expires 20 years from the filing date, adjusted for any patent term extensions (PTE) or adjustments. The original filing date for this patent family was February 27, 2013. Therefore, its standard expiration date is February 27, 2033, though PTE could extend this.
- Generic Competition: Upon patent expiry, generic manufacturers may seek to produce and market bioequivalent versions of the drug product. This requires navigating the regulatory approval process, often involving Abbreviated New Drug Applications (ANDAs), which necessitate demonstrating bioequivalence and challenging or invalidating existing patents.
- Fortification and Paragraph IV Certifications: Companies seeking to launch generic versions may file ANDAs under section 505(j) of the Food, Drug, and Cosmetic Act. If the patent is listed in the FDA’s Orange Book, generic applicants often file a "Paragraph IV certification," asserting that the patent is invalid, unenforceable, or will not be infringed by the generic product. This can lead to patent litigation.
- Related Patents: Allergan (and now AbbVie) likely holds a portfolio of patents covering the active ingredient, different formulations, methods of use, and manufacturing processes related to this therapeutic area. The strength of the patent landscape depends on the breadth and validity of this entire portfolio.
The landscape is dynamic, with ongoing research into dry eye mechanisms and new therapeutic targets. Patent 8,993,761 represents a specific innovation within this evolving field, focusing on symptomatic relief through a carefully engineered formulation.
What is the Status of Patent 8,993,761?
U.S. Patent 8,993,761 is an issued and active patent. It was granted on March 24, 2015. As of its issue date, it confers upon the assignee, Allergan, Inc., the right to exclude others from making, using, offering for sale, or selling the claimed invention in the United States, or importing it into the United States, for the duration of its term.
The patent's term is calculated from its filing date. The original filing date for this patent family was February 27, 2013. Therefore, the patent's standard term is 20 years from this date, which is February 27, 2033. The patent may be eligible for Patent Term Extension (PTE) under the Hatch-Waxman Act to compensate for a portion of the time lost during regulatory review. Any applicable PTE would extend the patent's expiry date.
The patent is subject to maintenance fees, which must be paid to the USPTO at 3.5, 7.5, and 11.5 years after its grant date to keep it in force. Failure to pay these fees would result in the patent lapsing.
As an active patent, it forms part of the intellectual property barrier for generic competitors seeking to enter the market with products covered by its claims. Its validity and enforceability may be tested through patent litigation should a challenger dispute its claims.
What are the Commercial Implications of Patent 8,993,761?
The commercial implications of U.S. Patent 8,993,761 are significant for Allergan (now AbbVie) and the broader ophthalmic pharmaceutical market, particularly in the dry eye segment.
- Market Exclusivity: The patent grants Allergan a period of market exclusivity for products incorporating the claimed formulation. This exclusivity is crucial for recouping research and development costs and generating profits. During this period, competitors are prevented from legally marketing generic versions of a drug product that infringes the patent claims.
- Brand-Name Product Protection: This patent likely protects a specific brand-name drug product developed by Allergan for dry eye treatment. The value of the patent is directly tied to the commercial success of this product.
- Pricing Power: Market exclusivity conferred by patents allows pharmaceutical companies to set prices for their innovative drugs without direct price competition from generics. This enables higher profit margins, although subject to market dynamics and payer pressures.
- Generic Entry Barrier: The patent serves as a substantial barrier to entry for generic manufacturers. Any company wishing to launch a generic competitor must either wait for the patent to expire, negotiate a license, or successfully challenge the patent's validity or non-infringement through litigation.
- Investment and R&D: The existence of such patents encourages continued investment in pharmaceutical R&D. The prospect of obtaining patent protection and subsequent market exclusivity incentivizes companies to undertake the costly and risky process of developing new drugs and formulations.
- Licensing Opportunities: Allergan could potentially license its patented technology to other companies for specific markets or indications, generating additional revenue streams.
- Litigation Costs: Conversely, defending a patent against challenges can lead to significant legal costs. Generic companies often initiate Paragraph IV challenges to accelerate market entry, leading to complex and expensive patent litigation.
The commercial impact is most directly felt in the dry eye market. If Patent 8,993,761 covers a successful product like Zerviate (cetylpyridinium chloride), a preservative-free ophthalmic solution for ocular surface irritation, its commercial implications are substantial. For instance, if Zerviate, approved in 2018, is covered by this patent or a related one, the patent ensures Allergan’s ability to market this product without direct generic competition until the patent's expiry. The value is in securing revenue streams for innovative formulations that offer a distinct advantage in patient care or symptom management.
Key Takeaways
- U.S. Patent 8,993,761, assigned to Allergan, Inc., protects specific pharmaceutical compositions and methods for treating dry eye disease.
- The core innovation lies in a formulation utilizing a lidocaine derivative, characterized by a high pH (7.5-9.5) and low viscosity (1-50 cP).
- The patent’s term extends to February 27, 2033, subject to potential Patent Term Extension.
- The patent creates a barrier against generic competition for products employing its claimed formulation, impacting market exclusivity and pricing power.
- The landscape includes established dry eye treatments like artificial tears and anti-inflammatory agents, alongside a broad array of ophthalmic patents.
Frequently Asked Questions
-
What is the expiration date of U.S. Patent 8,993,761?
The standard expiration date for U.S. Patent 8,993,761 is February 27, 2033. This is calculated as 20 years from the patent’s original filing date of February 27, 2013. The patent may be eligible for Patent Term Extension (PTE), which could extend this expiration date.
-
What specific active ingredient is claimed in Patent 8,993,761?
The patent claims a lidocaine derivative, specifically {2-[2-(diethylamino)-6-methylphenyl]amino]-2-oxoethyl}carbamic acid ester, as the active ingredient.
-
Can generic versions of drugs protected by this patent be immediately launched?
No, generic versions cannot be launched until the patent expires or is successfully challenged. The patent grants market exclusivity to the assignee, Allergan, Inc. (now AbbVie), preventing competitors from marketing infringing products until the patent term ends or it is invalidated.
-
Does this patent cover only the chemical compound, or also its use and formulation?
This patent covers both specific pharmaceutical compositions (formulations) and methods of treating dry eye disease using these compositions, not solely the chemical compound itself. The unique aspects of the formulation, such as pH and viscosity, are central to the claims.
-
What does "high pH" and "low viscosity" mean in the context of this patent?
In the context of Patent 8,993,761, "high pH" refers to a pH range between 7.5 and 9.5, which is alkaline. "Low viscosity" refers to a viscosity between 1 centipoise (cP) and 50 cP. These specific parameters are claimed as crucial characteristics of the therapeutic formulation for treating dry eye.
Citations
[1] U.S. Patent 8,993,761 B2. (2015, March 24). Pharmaceutical compositions and methods for the treatment of dry eye. Allergan, Inc. Retrieved from USPTO Patent Full-Text and Image Database
More… ↓
⤷ Start Trial
|
