Details for Patent: 8,222,219

Which drugs does patent 8,222,219 protect, and when does it expire?

Patent 8,222,219 protects INVOKAMET XR, INVOKAMET, and INVOKANA, and is included in three NDAs.

This patent has one hundred and seventy patent family members in thirty-six countries.

Summary for Patent: 8,222,219

Title:	Glucopyranoside compound
Abstract:	A compound of the formula: ##STR00001## wherein Ring A and Ring B are: (1) Ring A is an optionally substituted unsaturated monocyclic heterocyclic ring, and Ring B is an optionally substituted unsaturated monocyclic heterocyclic ring, an optionally substituted unsaturated fused heterobicyclic ring, or an optionally substituted benzene ring, (2) Ring A is an optionally substituted benzene ring, and Ring B is an optionally substituted unsaturated monocyclic heterocyclic ring or an optionally substituted unsaturated fused heterobicyclic ring, or (3) Ring A is an optionally substituted unsaturated fused heterobicyclic ring, and Ring B are independently an optionally substituted unsaturated monocyclic heterocyclic ring, an optionally substituted unsaturated fused heterobicyclic ring, or an optionally substituted benzene ring; X is a carbon atom or a nitrogen atom; Y is --(CH.sub.2).sub.n-- (n is 1 or 2); or a pharmaceutically acceptable salt thereof, or a prodrug thereof.
Inventor(s):	Nomura; Sumihiro (Kawaguchi, JP), Kawanishi; Eiji (Kitamoto, JP), Ueta; Kiichiro (Wako, JP)
Assignee:	Mitsubishi Tanabe Pharma Corporation (Osaka, JP)
Application Number:	13/174,814
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,222,219
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,222,219: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,222,219, issued on July 17, 2012, is a significant patent in the pharmaceutical industry, particularly in the treatment of type 2 diabetes. This patent, along with others, has been at the center of several legal battles and regulatory discussions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and Inventors

The patent was granted to Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.), with Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta listed as the inventors. The patent matured from a series of divisional and continuation-in-part applications, tracing back to a provisional application filed on August 1, 2003[1].

Patent Scope and Claims

Active Ingredient and Use

The patent claims the use of canagliflozin, an active pharmaceutical ingredient in the treatment of type 2 diabetes. Canagliflozin is classified as an SGLT-2 inhibitor, which works by inhibiting the reabsorption of glucose in the kidneys, thereby reducing blood glucose levels[5].

Specific Claims

The patent includes several claims, with claim 22 being particularly notable. This claim is directed to a method of treating or delaying the progression or onset of type 2 diabetes using canagliflozin[4].

Patent Landscape and Related Patents

Associated Patents

The '219 patent is part of a family of patents related to canagliflozin, including U.S. Patent Nos. 7,943,788 ('788 patent) and 8,785,403 ('403 patent). These patents collectively cover various aspects of the pharmaceutical composition and methods of treatment involving canagliflozin[4].

Litigation and Infringement

Mitsubishi Tanabe Pharma Corporation, along with Janssen and Cilag, has been involved in several patent infringement lawsuits against generic drug manufacturers, such as Zydus. These lawsuits were based on Abbreviated New Drug Applications (ANDAs) filed by the defendants seeking approval to market generic versions of the Invokana and Invokamet products before the expiration of the patents-in-suit[2][4].

Validity and Obviousness Challenges

Obviousness

Zydus and other defendants have challenged the validity of the '219 patent, among others, alleging that the claims are obvious and therefore invalid. However, the District Court of New Jersey has consistently found that the patents-in-suit are not invalid as obvious[2][4].

Obviousness-Type Double Patenting

Defendants have also argued that certain claims of the '788 patent are invalid under the doctrine of obviousness-type double patenting. This doctrine aims to prevent applicants from obtaining additional protection for claims that are not patentably distinct from earlier patents or applications. The court has rejected these claims as well, finding that the patents do not violate this doctrine[2][4].

Regulatory and Extension Considerations

FDA Approval and Regulatory Review

The '219 patent is associated with the FDA-approved drugs Invokana and Invokamet. The regulatory review process for these drugs involved significant interactions between the FDA and the marketing applicants, as documented in the patent's regulatory review period chronology[1].

Patent Term Extension

The patent holders have sought an extension of the patent term under 35 U.S.C. §156, which allows for the extension of a patent term due to delays in the FDA approval process. The patent term for the '219 patent is set to expire on July 30, 2024, and the applicants have argued that it meets all the requirements for such an extension[1].

Metrics for Patent Scope

Claim Length and Count

Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims, as seen in the '219 patent, are often associated with a higher probability of grant and a shorter examination process[3].

Industry Impact and Innovation

Innovation and Licensing Costs

The quality and scope of patents, including those like the '219 patent, have significant implications for innovation in the pharmaceutical industry. Broad or unclear claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation[3].

Market Domination

The '219 patent, along with related patents, has allowed Mitsubishi Tanabe Pharma Corporation and its partners to maintain market exclusivity for Invokana and Invokamet. This exclusivity is crucial for the commercial success of these drugs and underscores the importance of robust patent protection in the pharmaceutical sector.

Key Takeaways

• Patent Scope: The '219 patent specifically claims the use of canagliflozin for treating type 2 diabetes.
• Litigation: The patent has been central in several infringement lawsuits against generic drug manufacturers.
• Validity: The patent has been upheld against challenges of obviousness and obviousness-type double patenting.
• Regulatory Considerations: The patent term is set to expire in 2024, with potential for extension due to FDA approval delays.
• Industry Impact: The patent plays a critical role in maintaining market exclusivity and influencing innovation in the pharmaceutical industry.

Frequently Asked Questions

What is the main claim of U.S. Patent 8,222,219?

The main claim of U.S. Patent 8,222,219 is directed to a method of treating or delaying the progression or onset of type 2 diabetes using the compound canagliflozin.

Who are the inventors of the '219 patent?

The inventors of the '219 patent are Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta.

What is the significance of the '219 patent in the pharmaceutical industry?

The '219 patent is significant because it covers the use of canagliflozin, an SGLT-2 inhibitor used in the treatment of type 2 diabetes, and has been crucial in maintaining market exclusivity for the drugs Invokana and Invokamet.

Have there been any legal challenges to the '219 patent?

Yes, the '219 patent has faced legal challenges, including allegations of obviousness and obviousness-type double patenting, but these challenges have been rejected by the courts.

When is the patent term for the '219 patent set to expire?

The patent term for the '219 patent is set to expire on July 30, 2024, although there is a potential for extension due to delays in the FDA approval process.

Sources:

1. In re U.S. Patent of: Sumihiro NOMURA et al. - U.S. Patent No. 8,222,219 B2[1]
2. Extending Ezra: Federal District Court Declines To "Cut Off" Patent - Vlex[2]
3. Patent Claims and Patent Scope - Hoover Institution[3]
4. MITSUBISHI TANABE PHARMA CORPORATION NV LLC v. Zydus Pharmaceuticals (USA) Inc. - FindLaw[4]
5. Case 3:17-cv-05319-FLW-DEA Document 173 Filed 06/15/20 - GovInfo[5]

Drugs Protected by US Patent 8,222,219

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No						REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No						REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No						TREATMENT OF TYPE 2 DIABETES MELLITUS
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No						REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No						TREATMENT OF TYPE 2 DIABETES MELLITUS
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No						REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

International Family Members for US Patent 8,222,219

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1651658		2014/029	Ireland
European Patent Office	1651658		PA2014008	Lithuania
European Patent Office	1651658		CA 2014 00024	Denmark
European Patent Office	1651658		C300670	Netherlands
European Patent Office	1651658		92426	Luxembourg
European Patent Office	1651658		C20140011 00102	Estonia