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Last Updated: December 22, 2024

Details for Patent: 8,785,403

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Which drugs does patent 8,785,403 protect, and when does it expire?

Patent 8,785,403 protects INVOKAMET XR and INVOKAMET and is included in two NDAs.

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

Summary for Patent: 8,785,403

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-Shi, JP)
Application Number:	13/494,602
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,785,403
Patent Claim Types: see list of patent claims	Composition; Compound;
Patent landscape, scope, and claims:	United States Patent 8,785,403: A Detailed Analysis of Scope, Claims, and Patent Landscape Introduction The United States Patent 8,785,403, hereafter referred to as the '403 Patent, is a crucial component in the patent portfolio related to the pharmaceutical compound canagliflozin, used in the treatment of type 2 diabetes. This patent is held by Mitsubishi Tanabe Pharma Corporation (MTPC) and is exclusively licensed or sublicensed to other entities such as Janssen Pharmaceuticals, Inc. and Cilag GmbH International. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent. Background The '403 Patent was issued by the United States Patent and Trademark Office (USPTO) on July 22, 2014. It is titled "Glucopyranoside Compound" and lists Drs. Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta as the inventors[2]. Patent Scope The '403 Patent is part of a series of patents related to canagliflozin, an active pharmaceutical ingredient in drugs marketed as Invokana and Invokamet. These drugs belong to the class of SGLT-2 inhibitors, which are used to treat type 2 diabetes by inhibiting the sodium-glucose cotransporter 2 (SGLT2) in the kidneys, thereby reducing glucose reabsorption and increasing its excretion in the urine[2]. Claims The '403 Patent includes specific claims related to the glucopyranoside compound, which is now known as canagliflozin. The patent was issued in connection with U.S. Patent Application No. 13/494,602, which was filed on June 12, 2012. This application was a continuation of earlier applications, indicating a thorough development and refinement of the invention[2]. Asserted Claims The '403 Patent includes claims that are critical for the protection of canagliflozin. Specifically, claim 26 of the '403 Patent is one of the asserted claims in the patent infringement action against Zydus Pharmaceuticals Inc. This claim is directed to the specific compound and its use in treating type 2 diabetes[2]. Patent Landscape The '403 Patent is part of a complex patent landscape involving multiple patents and ongoing litigation. Related Patents The '403 Patent is closely related to other patents such as U.S. Patent Nos. 7,943,788 ('788 Patent) and 8,222,219 ('219 Patent). These patents also pertain to canagliflozin and its use in treating type 2 diabetes. The '788 Patent, issued on May 17, 2011, and the '219 Patent, issued on August 21, 2012, cover various aspects of the compound and its method of treatment[2]. Litigation MTPC and its licensees have been involved in several patent infringement actions against generic drug manufacturers, including Zydus Pharmaceuticals Inc. and Sandoz Inc. These actions were filed in response to the defendants' filing of Abbreviated New Drug Applications (ANDAs) with the FDA, seeking approval to market generic versions of Invokana and Invokamet. Zydus has counterclaimed, alleging that the patents-in-suit, including the '403 Patent, are invalid due to obviousness and obviousness-type double patenting[2][5]. Obviousness and Obviousness-Type Double Patenting A key issue in the litigation surrounding the '403 Patent is whether the patent is invalid due to obviousness or obviousness-type double patenting. Zydus has argued that the patents are obvious over prior art, while MTPC has presented evidence of secondary considerations to demonstrate nonobviousness. The court has held that the patents-in-suit, including the '403 Patent, are not invalid for obviousness or obviousness-type double patenting[5]. Expert Testimony and Secondary Considerations In defending against the allegations of obviousness, MTPC has produced testimony from experts such as Dr. Gavin, Dr. Davies, and Mr. Sims. These experts have provided opinions on secondary considerations, such as the unexpected results and commercial success of the Invokana products, to support the nonobviousness of the patents[2]. Impact on the Pharmaceutical Industry The '403 Patent and related patents have significant implications for the pharmaceutical industry, particularly in the development and marketing of generic drugs. The protection afforded by these patents ensures that MTPC and its licensees maintain exclusivity over the market for canagliflozin-based treatments for a specified period. This exclusivity can influence the pricing and availability of these drugs, as well as the strategies of generic drug manufacturers[2]. Conclusion The United States Patent 8,785,403 is a critical component in the patent portfolio related to canagliflozin, a key treatment for type 2 diabetes. Understanding the scope, claims, and the broader patent landscape surrounding this patent is essential for navigating the complex legal and regulatory environment in the pharmaceutical industry. Key Takeaways Patent Scope: The '403 Patent covers the glucopyranoside compound canagliflozin and its use in treating type 2 diabetes. Claims: Claim 26 of the '403 Patent is specifically directed to the compound and its method of treatment. Related Patents: The '403 Patent is part of a series including U.S. Patent Nos. 7,943,788 and 8,222,219. Litigation: Ongoing patent infringement actions against generic drug manufacturers. Obviousness and Double Patenting: The court has ruled that the patents-in-suit are not invalid for obviousness or obviousness-type double patenting. Impact: Significant implications for the pharmaceutical industry, particularly in the development and marketing of generic drugs. FAQs Q1: What is the main subject of the United States Patent 8,785,403? The main subject of the '403 Patent is the glucopyranoside compound canagliflozin, used in the treatment of type 2 diabetes. Q2: Who are the inventors listed on the '403 Patent? The inventors listed on the '403 Patent are Drs. Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta. Q3: What are the related patents to the '403 Patent? The related patents include U.S. Patent Nos. 7,943,788 ('788 Patent) and 8,222,219 ('219 Patent), all covering aspects of canagliflozin. Q4: Why is the '403 Patent significant in the pharmaceutical industry? The '403 Patent is significant because it provides exclusivity over the market for canagliflozin-based treatments, influencing pricing and availability. Q5: What was the outcome of the litigation regarding the validity of the '403 Patent? The court ruled that the '403 Patent is not invalid for obviousness or obviousness-type double patenting. Sources MITSUBISHI TANABE PHARMA CORPORATION NV LLC v. Zydus Pharmaceuticals Inc. - FindLaw. Case 3:17-cv-05319-FLW-DEA Document 173 Filed 06/15/20 - GovInfo. Patent Claims and Patent Scope - Hoover Institution. United States Patent Wang et al. - Google APIs. Extending Ezra: Federal District Court Declines To "Cut Off" Patent - Vlex. More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 8,785,403

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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	⤷ Subscribe	⤷ Subscribe	Y				⤷ Subscribe
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y				⤷ Subscribe
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y				⤷ Subscribe
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

International Family Members for US Patent 8,785,403

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1651658	⤷ Subscribe	2014/029	Ireland	⤷ Subscribe
European Patent Office	1651658	⤷ Subscribe	PA2014008	Lithuania	⤷ Subscribe
European Patent Office	1651658	⤷ Subscribe	CA 2014 00024	Denmark	⤷ Subscribe
European Patent Office	1651658	⤷ Subscribe	C300670	Netherlands	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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