Details for Patent: 9,079,912

Which drugs does patent 9,079,912 protect, and when does it expire?

Patent 9,079,912 protects OPZELURA and JAKAFI and is included in two NDAs.

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

This patent has one hundred and fifty-three patent family members in thirty-five countries.

Summary for Patent: 9,079,912

Title:	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Abstract:	The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Inventor(s):	Rodgers; James D. (Landenberg, PA), Shepard; Stacey (Wilmington, DE)
Assignee:	Incyte Corporation (Wilmington, DE)
Application Number:	14/274,948
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,079,912
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 9,079,912: A Detailed Analysis

Introduction

United States Patent 9,079,912, though not directly provided in the sources, can be analyzed within the context of similar patents related to Janus kinase (JAK) inhibitors, which are a class of drugs used to treat various diseases, including immune-related disorders, skin conditions, and cancer. Here, we will delve into the general scope and claims of such patents, using relevant examples to illustrate the key points.

Background on Janus Kinase Inhibitors

Janus kinases are a family of enzymes that play a crucial role in the signaling pathways of cells, particularly in the immune system. Inhibitors of these enzymes, such as those described in patents related to pyrrolo[2,3-b]pyrimidines and pyrrolo[2,3-d]pyrimidines, are designed to modulate JAK activity and are used in treating diseases associated with abnormal JAK signaling[1][5].

Scope of the Patent

Chemical Formulations

The scope of patents like US 9,079,912 typically includes specific chemical formulations of JAK inhibitors. For example, patents may cover heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines, or pyrazolyl substituted pyrrolo[2,3-d]pyrimidines. These compounds are designed to inhibit JAK activity and are useful in treating a range of diseases, including immune-related diseases, skin disorders, myeloid proliferative disorders, and cancer[1][5].

Therapeutic Applications

The therapeutic applications of these JAK inhibitors are a critical aspect of the patent scope. These drugs are used to treat various conditions, such as atopic dermatitis, psoriasis, rheumatoid arthritis, and certain types of cancer. The patents often detail the specific diseases and conditions for which the inhibitors are effective[2][5].

Claims of the Patent

Composition of Matter Claims

These patents typically include composition of matter claims that describe the specific chemical structures of the JAK inhibitors. For instance, the claims might specify the heteroaryl substitutions, the pyrrolo[2,3-b]pyrimidine or pyrrolo[2,3-d]pyrimidine backbone, and other structural elements that are crucial for the compound's activity[1][5].

Method of Use Claims

Method of use claims are also common, detailing how the JAK inhibitors are administered and used to treat specific diseases. This can include dosage forms, such as topical creams or oral tablets, and the dosing regimens for different conditions[2][5].

Manufacturing Process Claims

Some patents may also claim the manufacturing processes for these compounds, including the synthesis of intermediate compounds and the final active pharmaceutical ingredients. These claims protect the proprietary methods developed by the inventors[4].

Patent Landscape

Patent Expiration Dates

The patent landscape for JAK inhibitors is complex, with various patents expiring at different times. For example, patents related to ruxolitinib, a well-known JAK inhibitor, are set to expire between 2027 and 2040, depending on the specific formulation and use claims[2][5].

Competing Patents

Multiple companies and inventors hold patents related to JAK inhibitors, leading to a competitive landscape. Incyte Corporation, for instance, holds several patents related to pyrrolo[2,3-b]pyrimidine and pyrrolo[2,3-d]pyrimidine compounds[1][5].

Generic Availability

As patents expire, generic versions of these drugs become available. For example, generic versions of ruxolitinib and other JAK inhibitors are expected to enter the market as their respective patents expire[2][5].

Measuring Patent Scope

Independent Claim Length and Count

The scope of a patent can be measured using metrics such as independent claim length and count. Narrower claims with fewer and more specific assertions tend to have a higher probability of grant and a shorter examination process[3].

Patent Maintenance and Forward Citations

The maintenance payments and forward citations of a patent can also indicate its scope and significance. Patents with more forward citations and higher maintenance payments generally have broader and more impactful claims[3].

Impact on Innovation

Patent Quality and Litigation

The quality and scope of patents can significantly impact innovation. Broad and unclear claims can lead to increased litigation costs and may diminish the incentives for further innovation. Conversely, well-defined and narrow claims can facilitate clearer boundaries and encourage more targeted research and development[3].

Key Takeaways

• Chemical Formulations: Patents for JAK inhibitors cover specific chemical structures and their therapeutic applications.
• Therapeutic Applications: These inhibitors are used to treat a range of diseases, including immune-related disorders and cancer.
• Claims: Composition of matter, method of use, and manufacturing process claims are common.
• Patent Landscape: The landscape is complex with varying expiration dates and competing patents.
• Generic Availability: Generic versions become available as patents expire.
• Measuring Scope: Metrics like independent claim length and count, and patent maintenance and forward citations are used.

FAQs

What are Janus kinase inhibitors?

Janus kinase inhibitors are a class of drugs designed to modulate the activity of Janus kinases, enzymes involved in cell signaling pathways, particularly in the immune system.

What diseases are treated with JAK inhibitors?

JAK inhibitors are used to treat various diseases, including immune-related disorders, skin conditions like atopic dermatitis and psoriasis, myeloid proliferative disorders, and certain types of cancer.

How long do patents for JAK inhibitors typically last?

Patents for JAK inhibitors generally last 20 years from the date of filing but can vary based on factors such as new formulations and patent infringement litigation.

What happens when a patent for a JAK inhibitor expires?

When a patent expires, generic versions of the drug can be developed and marketed, increasing competition and potentially reducing costs for patients.

How are the scopes of patents measured?

The scope of patents can be measured using metrics such as independent claim length and count, patent maintenance payments, and forward citations.

Sources

1. EP 1966202 B1: Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors.
2. Drugs.com: Generic Opzelura Availability.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: Processes for preparing JAK inhibitors and related intermediate compounds.
5. Drugs.com: Generic Jakafi Availability.

Drugs Protected by US Patent 9,079,912

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	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No	9,079,912*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No	9,079,912*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No	9,079,912*PED				Y
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	9,079,912*PED				Y

International Family Members for US Patent 9,079,912

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1966202		C300574	Netherlands
European Patent Office	1966202		PA2013002	Lithuania
European Patent Office	1966202		CA 2013 00005	Denmark
European Patent Office	1966202		C20130003 00072	Estonia