Details for Patent: 9,493,470

Which drugs does patent 9,493,470 protect, and when does it expire?

Patent 9,493,470 protects ICLUSIG and is included in one NDA.

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

Summary for Patent: 9,493,470

Title:	Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Abstract:	Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyljbenzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methyl piperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein. The instant application is directed to novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl}phenyl}benzamide and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, compositions comprising such crystalline forms, and to methods of their preparation and use.
Inventor(s):	Murray; Christopher K. (Lexington, MA), Rozamus; Leonard W. (Andover, MA), Chaber; John J. (Westford, MA), Sharma; Pradeep (Westford, MA)
Assignee:	ARIAD PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:	14/651,577
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,493,470
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Detailed Analysis of the Scope and Claims of United States Patent 9,493,470

Introduction

United States Patent 9,493,470, issued on November 15, 2016, is a crucial patent in the pharmaceutical sector, particularly in the treatment of certain types of leukemia. This patent is held by ARIAD Pharmaceuticals, Inc., now part of Takeda Pharmaceuticals. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The patent in question is related to crystalline forms of ponatinib hydrochloride and their use in treating specific types of leukemia. Ponatinib hydrochloride is a tyrosine kinase inhibitor marketed under the brand name ICLUSIG, used primarily for treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and chronic myeloid leukemia (CML), especially in patients resistant or intolerant to other tyrosine kinase inhibitors[2][4].

Scope of the Patent

The scope of the patent encompasses several key aspects:

Crystalline Forms of Ponatinib Hydrochloride

The patent describes various crystalline forms of ponatinib hydrochloride, which are critical for the stability, efficacy, and bioavailability of the drug. These crystalline forms are specified in detail, including their physical and chemical properties[4].

Methods of Treatment

The patent includes claims for methods of treating Ph+ ALL and CML using these crystalline forms of ponatinib hydrochloride. These methods are outlined in specific claims that detail the administration of the drug to subjects in need thereof[1][2].

Claims of the Patent

The patent contains multiple claims that can be categorized into several types:

Composition Claims

These claims pertain to the crystalline forms of ponatinib hydrochloride and compositions that include these forms. For example, claims 1-7, 10, and 12-15 of the '470 patent describe the specific crystalline forms and their compositions[2].

Method Claims

These claims are related to the methods of treating Ph+ ALL and CML using ponatinib hydrochloride. Claims 8, 9, 11, 16, and 17, among others, specify the administration of ponatinib to subjects in need thereof, including those resistant or intolerant to other tyrosine kinase inhibitors[1][2].

Claim Construction and Legal Standards

In patent infringement cases, claim construction is a critical step. The court must determine the meaning of the claims in the patent, a process that can be contentious. For the '470 patent, the court has had to construe key terms, such as the definition of "subject" in the method claims. The court has ruled that the term "subject" specifically refers to human subjects, based on the specification's description of the method-of-treatment aspects of the invention[1].

Patent Infringement Litigation

Takeda Pharmaceuticals and ARIAD Pharmaceuticals have been involved in several patent infringement cases related to the '470 patent. These cases typically arise when generic pharmaceutical companies, such as Apotex or Teva, seek FDA approval for generic versions of ICLUSIG before the expiration of the patents-in-suit. The plaintiffs allege that these generic versions infringe on the claims of the '470 patent, among others[1][2].

Patent Landscape

The patent landscape surrounding the '470 patent includes several related patents:

Related Patents

Other patents, such as U.S. Patent Nos. 11,192,895, 11,192,897, and 11,384,086, also cover crystalline forms of ponatinib hydrochloride and their use in treating leukemia. These patents are often consolidated in litigation to ensure consistent claim construction and infringement determinations[1][2].

Patent Expiration Dates

The '470 patent is set to expire on January 24, 2027. Other related patents have similar expiration dates, with some expiring as late as December 12, 2033. These expiration dates are crucial for understanding when generic versions of the drug can enter the market without infringing on the existing patents[4].

Impact on the Pharmaceutical Industry

The '470 patent and related patents have significant implications for the pharmaceutical industry:

Innovation and Competition

These patents protect the intellectual property of Takeda and ARIAD, ensuring that they can recoup their investment in research and development. However, they also limit competition from generic manufacturers until the patents expire, which can affect drug prices and accessibility[3].

Litigation Costs

The ongoing litigation related to these patents highlights the complexities and costs associated with patent disputes. These costs can be substantial and may deter some generic manufacturers from entering the market, even after the patents expire[3].

Key Takeaways

• Crystalline Forms: The patent covers specific crystalline forms of ponatinib hydrochloride, crucial for the drug's stability and efficacy.
• Methods of Treatment: The patent includes claims for treating Ph+ ALL and CML using these crystalline forms.
• Claim Construction: The court's interpretation of key terms, such as "subject," is critical in determining infringement.
• Patent Infringement: Takeda and ARIAD have been involved in several infringement cases against generic manufacturers.
• Patent Landscape: The patent is part of a broader landscape that includes related patents with similar expiration dates.
• Industry Impact: The patents protect intellectual property but also limit competition, affecting drug prices and accessibility.

FAQs

Q: What is the primary use of the drug covered by U.S. Patent 9,493,470?

A: The primary use is for treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and chronic myeloid leukemia (CML), especially in patients resistant or intolerant to other tyrosine kinase inhibitors.

Q: What are the key claims of the '470 patent?

A: The patent includes claims for crystalline forms of ponatinib hydrochloride and methods of treating Ph+ ALL and CML using these forms.

Q: Why is claim construction important in patent infringement cases?

A: Claim construction determines the meaning of the patent claims, which is essential for comparing the claims to the allegedly infringing product.

Q: What is the current status of generic versions of ICLUSIG?

A: Generic versions are pending FDA approval but are held up due to ongoing patent infringement litigation.

Q: When does the '470 patent expire?

A: The '470 patent is set to expire on January 24, 2027.

Sources

1. Takeda Pharm. Am. v. Apotex, Inc. - Casetext
2. Case 2:22-cv-07454 Document 1 Filed 12/21/22 - Insight.RPXCorp
3. Patent Claims and Patent Scope - SSRN
4. Generic Iclusig Availability - Drugs.com

Drugs Protected by US Patent 9,493,470

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	9,493,470		Y	Y		A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	9,493,470		Y	Y		A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	9,493,470		Y	Y		A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Foreign Priority and PCT Information for Patent: 9,493,470

PCT Information
PCT Filed	December 12, 2013	PCT Application Number:	PCT/US2013/074571
PCT Publication Date:	June 19, 2014	PCT Publication Number:	WO2014/093579

International Family Members for US Patent 9,493,470

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013204506
Australia	2016210725
Australia	2018201013