Details for Patent: 10,869,870

Which drugs does patent 10,869,870 protect, and when does it expire?

Patent 10,869,870 protects OPZELURA and is included in one NDA.

Protection for OPZELURA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-nine patent family members in thirty-four countries.

Summary for Patent: 10,869,870

Title:	Topical formulation for a JAK inhibitor
Abstract:	This invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Inventor(s):	Parikh; Bhavnish (Avondale, PA), Shah; Bhavesh (San Antonio, TX), Yeleswaram; Krishnaswamy (Landenberg, PA)
Assignee:	Incyte Corporation (Wilmington, DE)
Application Number:	16/947,735
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 10,869,870: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 10,869,870, titled "Topical Formulation for a JAK Inhibitor," is a significant patent in the pharmaceutical industry, particularly in the context of Janus kinase (JAK) inhibitors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of JAK Inhibitors

JAK inhibitors are a class of drugs that target the Janus kinase enzymes, which play a crucial role in the signaling pathways of various cytokines. These inhibitors are used to treat a range of conditions, including autoimmune diseases and certain types of cancer. The patent in question pertains to a topical formulation of a JAK inhibitor, specifically ruxolitinib, which is marketed under the brand name Opzelura® by Incyte[2][5].

Patent Scope and Claims

Patent Title and Abstract

The patent is titled "Topical Formulation for a JAK Inhibitor" and describes a topical formulation containing ruxolitinib, which is designed for the treatment of skin conditions such as atopic dermatitis.

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically outline the composition of the topical formulation, the method of preparation, and the specific use cases for the formulation. For example:

• Claim 1 might describe the composition of the topical formulation, including the active ingredient ruxolitinib and various excipients.
• Claim 2 could detail the method of preparing the formulation.
• Claim 3 might specify the use of the formulation for treating atopic dermatitis[2][5].

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims help to narrow down the scope of the invention and can include specific concentrations of the active ingredient, particular excipients, or specific methods of application.

Obviousness Standard

The obviousness of the patent is a critical aspect, as it determines whether the invention would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time of the invention. The Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. rejected the exclusive use of the Teaching, Suggestion, or Motivation (TSM) test for determining obviousness. Instead, it emphasized that the combination of existing elements must yield predictable benefits and be within the knowledge of a PHOSITA[1].

Prior Art and Secondary Considerations

The patent's validity also depends on the prior art and secondary considerations such as commercial success, long-felt but unsolved needs, and failure of others to achieve the same result. The patent must demonstrate that it provides a novel and nonobvious solution that was not readily apparent from the existing body of knowledge[1].

Regulatory and Litigation Context

The patent is part of a larger litigation involving Incyte and Padagis, where Padagis has submitted an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Opzelura®. Incyte alleges that this submission would infringe on several of its patents, including the '870 patent. The litigation highlights the importance of patent protection in the pharmaceutical industry and the challenges faced by generic manufacturers in navigating the complex patent landscape[2][5].

Patent Landscape

Related Patents

The '870 patent is part of a family of patents related to ruxolitinib formulations. Other patents in this family include the '543, '624, '923, '425, '136, '137, and '138 patents, all of which pertain to different aspects of ruxolitinib formulations and their uses. This extensive patent portfolio helps Incyte to maintain a strong market position and protect its intellectual property[2][5].

Examination Process

The examination process for these patents involves a thorough review by the USPTO to ensure that the claims are novel, nonobvious, and directed at patentable subject matter. The process can be lengthy and may involve multiple rounds of amendments and responses to office actions. The scope of the patent claims can be narrowed during this process to ensure that they meet the statutory requirements[3].

Impact on Innovation and Drug Pricing

Patents like the '870 patent play a crucial role in the development and commercialization of pharmaceuticals. They provide the necessary incentives for innovation by granting exclusive rights to the patent holder for a specified period. However, they can also impact drug pricing by limiting competition from generic manufacturers. The balance between encouraging innovation and ensuring affordable access to drugs is a ongoing debate in the pharmaceutical industry[4].

Key Takeaways

• Patent Scope: The '870 patent is specific to a topical formulation of ruxolitinib, with claims that define the composition, method of preparation, and use cases.
• Obviousness: The patent's validity hinges on the obviousness standard, which requires that the invention was not obvious to a PHOSITA.
• Litigation: The patent is involved in ongoing litigation with Padagis over ANDA submissions.
• Patent Landscape: The patent is part of a larger family of patents related to ruxolitinib formulations.
• Impact on Innovation: Patents like the '870 patent are crucial for innovation but can also affect drug pricing.

FAQs

1. What is the main subject of the '870 patent? The '870 patent pertains to a topical formulation of the JAK inhibitor ruxolitinib.

2. Why is the obviousness standard important for this patent? The obviousness standard determines whether the invention would have been obvious to a PHOSITA, which is crucial for the patent's validity.

3. What is the litigation context surrounding this patent? The patent is part of a litigation involving Incyte and Padagis over an ANDA submission for a generic version of Opzelura®.

4. How does this patent fit into the broader patent landscape? The '870 patent is part of a family of patents related to ruxolitinib formulations, helping Incyte protect its intellectual property.

5. What is the impact of this patent on drug pricing and innovation? The patent provides incentives for innovation but can limit competition from generic manufacturers, potentially affecting drug pricing.

Citations

1. Gao, Y. (2016). Lead Compound Analysis for Chemicals: Obvious or Nonobvious? Michigan State University College of Law.
2. Case 2:23-cv-21826-MCA Document 1 Filed 11/02/23. Insight.RPXCorp.
3. Patent Claims and Patent Scope. Hoover Institution.
4. Drug Prices: The Role of Patents and Regulatory Exclusivities. Congressional Research Service.
5. Case 2:23-cv-21826-MCA-ESK Document 44 Filed 03/21/24. Insight.RPXCorp.

Drugs Protected by US Patent 10,869,870

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	10,869,870*PED				Y

International Family Members for US Patent 10,869,870

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	084691
Argentina	124134
Australia	2011255443
Australia	2014202896
Australia	2016204689
Australia	2018201889
Australia	2020201151