Details for Patent: 8,071,648

Which drugs does patent 8,071,648 protect, and when does it expire?

Patent 8,071,648 protects NEVANAC and is included in one NDA.

This patent has twenty-seven patent family members in twenty-three countries.

Summary for Patent: 8,071,648

Title:	Topical nepafenac formulations
Abstract:	Topical suspension compositions of nepafenac are disclosed. The compositions are especially suitable for topical ophthalmic administration.
Inventor(s):	Wong; Warren (Fort Worth, TX)
Assignee:	Novartis AG (Basel, CH)
Application Number:	12/888,631
Patent Claim Types: see list of patent claims	Composition;

Understanding the Scope and Claims of United States Patent 8,071,648

Introduction

Patents are crucial for protecting intellectual property and fostering innovation. The United States Patent 8,071,648, issued to Novartis AG, is a significant example of a patent in the pharmaceutical sector. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.

Patent Overview

United States Patent 8,071,648 was issued on December 4, 2012, to Novartis AG. This patent pertains to topical suspension compositions of nepafenac, particularly suited for topical ophthalmic administration[5].

Inventors and Assignees

The inventors listed on this patent include individuals associated with Novartis AG. The assignee is Novartis AG, indicating that the company holds the rights to this invention[5].

Patent Claims

The claims section of a patent is critical as it defines the scope of the invention. Here are some key aspects of the claims in Patent 8,071,648:

Independent Claims

Independent claims are those that stand alone and do not depend on other claims. For this patent, the independent claims typically describe the composition and method of preparation of the topical nepafenac suspension. For example, Claim 1 might describe the composition as:

• "A topical ophthalmic suspension composition comprising nepafenac and a solvent selected from the group consisting of diethyl ether, etc."[2].

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims might specify particular concentrations of nepafenac, additional ingredients, or specific methods of preparation.

Scope of the Patent

The scope of a patent is determined by the language of the claims. Here are some key points regarding the scope of Patent 8,071,648:

Claim Language and Scope

The scope is defined by the independent and dependent claims. The use of specific language, such as "topical ophthalmic suspension composition," narrows the scope to a particular application, preventing others from making, using, or selling similar compositions without permission[3].

Patent Scope Metrics

Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims in terms of both claim length and claim count[3].

Patent Examination Process

The patent examination process is crucial in determining the validity and scope of a patent. Here’s how it applies to Patent 8,071,648:

Assignment to Examiners

The USPTO assigns patent applications to examiners based on the technology field. For pharmaceutical patents, examiners specialize in relevant areas such as ophthalmic formulations. The assignment to an examiner with varying leniency can significantly impact the outcome of the patent application[1][4].

Legal Thresholds

Examiners assess whether the claims meet the legal thresholds of novelty, usefulness, and non-obviousness. The process involves multiple stages, including first-action dates and final-decision dates, which can influence the final scope of the patent[1][4].

Patent Landscape

The patent landscape surrounding Patent 8,071,648 includes other related patents and the broader context of pharmaceutical patents.

Related Patents

Other patents related to nepafenac formulations include:

• Patent 7,834,059: Also related to nepafenac formulations, with an expiration date of January 31, 2027.
• Patent 8,324,281: Issued for topical suspension compositions of nepafenac, with an expiration date of December 2, 2025[5].

Generic Availability

As of the current date, there is no generic version of Nevanac (nepafenac) available in the United States, indicating that the patent protection is still in effect[5].

Economic and Strategic Impact

Patents like 8,071,648 have significant economic and strategic implications for companies like Novartis AG.

Value of Patents to Startups

Research indicates that patents can significantly impact the growth and funding of startups. Patents can be used as collateral to raise debt, attract venture funding, and even influence the decision to go public through an IPO[1].

Licensing and Litigation

The breadth and clarity of patent claims can affect licensing and litigation costs. Broader or unclear claims can lead to increased costs and potentially diminish innovation incentives[3].

Key Takeaways

• Patent Claims: The claims in Patent 8,071,648 define the scope of the invention, focusing on topical ophthalmic suspension compositions of nepafenac.
• Scope and Examination: The scope is narrowed by the examination process, ensuring the patent meets legal thresholds of novelty, usefulness, and non-obviousness.
• Related Patents: Other patents related to nepafenac formulations are part of the broader patent landscape.
• Economic Impact: Patents can significantly influence the economic and strategic decisions of companies, including funding and licensing.

FAQs

1. What is the main subject of United States Patent 8,071,648?

   • The main subject is topical suspension compositions of nepafenac for ophthalmic use.

2. Who are the inventors and assignees of this patent?

   • The inventors are associated with Novartis AG, and the assignee is Novartis AG.

3. How does the patent examination process affect the scope of a patent?

   • The examination process can narrow the scope of patent claims in terms of claim length and count, ensuring the patent meets legal thresholds.

4. Are there any generic versions of Nevanac available?

   • As of the current date, there are no generic versions of Nevanac available in the United States.

5. What is the economic impact of patents like 8,071,648 on companies?

   • Patents can be used as collateral, attract venture funding, and influence IPO decisions, significantly impacting a company's growth and strategy.

Sources

1. NBER Working Paper Series: What is a Patent Worth?
2. United States Patent: Process for the Preparation of Nepafenac
3. Hoover Institution: Patent Claims and Patent Scope
4. NBER Working Paper Series: What is a Patent Worth? (Revisions)
5. Drugs.com: Generic Nevanac Availability

Drugs Protected by US Patent 8,071,648

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes			Y

International Family Members for US Patent 8,071,648

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	052252
Austria	E476200
Australia	2005311738
Brazil	PI0518904