Details for Patent: 8,648,048

Which drugs does patent 8,648,048 protect, and when does it expire?

Patent 8,648,048 protects RESTASIS MULTIDOSE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,648,048

Title:	Methods of providing therapeutic effects using cyclosporin components
Abstract:	Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
Inventor(s):	Acheampong; Andrew (Irvine, CA), Tang-Liu; Diane D. (Las Vegas, NV), Chang; James N. (Newport Beach, CA), Power; David F. (Hubert, NC)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	13/967,168
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,648,048
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,648,048: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,648,048, titled "Methods of providing therapeutic effects using cyclosporin," is a significant patent in the pharmaceutical industry, particularly in the treatment of ophthalmic conditions. This patent is part of a larger portfolio related to the drug Restasis, developed by Allergan. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The patent 8,648,048 was granted to Allergan and is associated with the drug Restasis, an ophthalmic emulsion containing cyclosporine used to treat dry eye syndrome. The invention pertains to methods of administering a therapeutically effective amount of cyclosporine to the eye of a human or animal to achieve various therapeutic effects[4].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific methods and compositions covered by the patent. Here are some key aspects:

Claims Overview

• The patent includes multiple claims that describe the methods of administering cyclosporine for therapeutic effects. These claims are specific to the formulation, dosage, and administration route of the cyclosporine ophthalmic emulsion[4].

Method Claims

• The method claims detail the process of administering a therapeutically effective amount of cyclosporine to the eye. This includes the concentration of cyclosporine, the vehicle used, and the frequency of administration[4].

Composition Claims

• The composition claims describe the specific formulation of the ophthalmic emulsion, including the active ingredient cyclosporine and any inert ingredients or excipients[4].

Patent Claims Analysis

To understand the patent's scope, it is crucial to analyze its claims in detail.

Independent Claims

• Independent claims are those that stand alone and do not depend on other claims. For example, Claim 1 of the patent might describe the broadest method of administering cyclosporine for therapeutic effects[4].

Dependent Claims

• Dependent claims build upon the independent claims and add additional limitations. These claims narrow down the scope but provide additional protection by covering specific variations of the method or composition[4].

Patent Landscape

The patent landscape surrounding US 8,648,048 is complex and involves several other patents and legal proceedings.

Related Patents

• The patent is part of a family of patents related to Restasis, including U.S. Patents 8,629,111, 8,633,162, 8,642,556, and 8,685,930. These patents cover various aspects of the drug, including its formulation, method of use, and manufacturing process[2].

Litigation and Challenges

• The patents associated with Restasis have been subject to several legal challenges. For instance, in the case of Allergan, Inc. v. Actavis, Inc., Allergan defended its patents against generic manufacturer Actavis, which sought to market a generic version of Restasis. The court ruled in favor of Allergan, determining that Actavis's ANDA (Abbreviated New Drug Application) had not been received by the FDA due to deficiencies, and thus did not trigger the infringement provision under 35 U.S.C. § 271(e)(2)[2].

Tribal Immunity

• In another significant development, Allergan assigned the patents, including US 8,648,048, to the Saint Regis Mohawk Tribe in an attempt to shield them from inter partes review (IPR) proceedings by leveraging tribal sovereign immunity. However, this strategy was ultimately unsuccessful as the Patent Trial and Appeal Board (PTAB) and the Federal Circuit Court of Appeals ruled that tribal immunity does not apply in IPR proceedings[1].

Economic and Public Impact

The patent and its associated litigation have significant economic and public implications.

Market Impact

• The protection afforded by these patents allows Allergan to maintain market exclusivity for Restasis, impacting the availability and pricing of the drug in the market.

Public Health

• The therapeutic effects of cyclosporine in treating dry eye syndrome are crucial for public health. The patent landscape influences the accessibility of this treatment, as generic alternatives are delayed until the patents expire or are successfully challenged.

Statistical Insights

The USPTO's Patent Claims Research Dataset provides insights into patent scope and claims trends, which can be relevant when analyzing the broader context of pharmaceutical patents.

Patent Scope Measurements

• The dataset includes measures of patent scope, such as the number of claims and the dependency between claims, which can help in understanding the complexity and breadth of patent protection[3].

Expert Insights

Industry experts often weigh in on the strategic and legal implications of such patents.

Legal Strategy

• "The assignment of patents to a Native American tribe was a novel strategy aimed at leveraging tribal sovereign immunity to avoid IPR challenges. However, the courts have consistently ruled against this approach, emphasizing the importance of public interest in ensuring the validity of patents," said a patent law expert[1].

Key Takeaways

• Patent Scope: The patent covers specific methods and compositions related to the administration of cyclosporine for therapeutic effects.
• Claims Analysis: Independent and dependent claims define the scope and variations of the invention.
• Patent Landscape: The patent is part of a larger family of patents related to Restasis and has been subject to significant legal challenges.
• Economic and Public Impact: The patent affects market exclusivity and public health by influencing the availability and pricing of the drug.
• Statistical Insights: The USPTO's dataset provides tools to analyze patent scope and trends.

FAQs

What is the main invention covered by US Patent 8,648,048?

The main invention is the method of administering a therapeutically effective amount of cyclosporine to the eye for treating dry eye syndrome.

Why was Allergan's assignment of patents to a Native American tribe significant?

Allergan attempted to use tribal sovereign immunity to shield its patents from inter partes review proceedings, but this strategy was ultimately unsuccessful.

What was the outcome of the case Allergan, Inc. v. Actavis, Inc.?

The court ruled in favor of Allergan, determining that Actavis's ANDA had not been received by the FDA due to deficiencies, and thus did not trigger the infringement provision.

How does the patent landscape impact public health?

The patent landscape affects the availability and pricing of the drug Restasis, which is crucial for treating dry eye syndrome, thereby influencing public health.

What is the significance of the USPTO's Patent Claims Research Dataset?

The dataset provides detailed information on claims from U.S. patents and applications, helping in the analysis of patent scope and trends.

Cited Sources:

1. Nutter: "[e-mail] Paper No. 130 Tel: [phone] Entered 2018-02-23 In the Assignment, Allergan assigned to the. Tribe a set of U.S. patents and patent applications..."
2. Robins Kaplan LLP: "Allergan, Inc. v. Actavis, Inc. | Robins Kaplan LLP Law Firm"
3. USPTO: "Patent Claims Research Dataset - USPTO"
4. Google Patents: "US8648048B2 - Methods of providing therapeutic effects using cyclosporin..."

Drugs Protected by US Patent 8,648,048

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes					Y	INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).

International Family Members for US Patent 8,648,048

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2005032577