Details for Patent: 7,943,788

Which drugs does patent 7,943,788 protect, and when does it expire?

Patent 7,943,788 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: 7,943,788

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); 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:	11/045,446
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,943,788
Patent Claim Types: see list of patent claims	Compound; Composition; Process;

United States Patent 7,943,788: A Detailed Analysis of Scope, Claims, and Patent Landscape

Overview of the Patent

The United States Patent 7,943,788, hereafter referred to as the '788 Patent, was issued on May 17, 2011, by the United States Patent and Trademark Office (USPTO). This patent is titled "Glucopyranoside Compound" and is associated with the pharmaceutical composition and method of treatment for type 2 diabetes using the drug canagliflozin, marketed as Invokana and Invokamet[1][2].

Inventors and Patent History

The '788 Patent lists Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta as the named inventors. It was filed as part of U.S. Patent Application No. 11/045,446 on January 31, 2005, which is a continuation of International Application No. PCT/JP2004/011312, filed on July 30, 2004. This application also claimed priority to U.S. provisional application No. 60/491,534 filed on August 1, 2003[1][4].

Claims of the Patent

The '788 Patent includes several claims, with specific focus on claims 12 and 20. These claims are directed to the compound canagliflozin, which is a glucopyranoside compound used in the treatment of type 2 diabetes. Canagliflozin belongs to the class of SGLT-2 inhibitors, which work by inhibiting the sodium-glucose cotransporter 2 (SGLT2) in the kidneys, thereby reducing glucose reabsorption and increasing its excretion in the urine[1][2].

Patent Scope and Claim Metrics

The scope of the '788 Patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics are important in assessing patent quality and scope. Narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are generally associated with higher patent quality and a shorter examination process[3].

Litigation and Validity Challenges

The '788 Patent has been involved in significant litigation, particularly against generic pharmaceutical companies like Zydus Pharmaceuticals. Zydus filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking approval to manufacture and market generic versions of Invokana and Invokamet before the expiration of the patents-in-suit. In response, the patent holders filed a patent infringement lawsuit against Zydus. Zydus defended by arguing that the patents-in-suit, including the '788 Patent, are invalid as obvious and that claims 12 and 20 of the '788 Patent are invalid under the doctrine of obviousness-type double patenting. However, the court found that the patents-in-suit are not invalid as obvious and that claims 12 and 20 of the '788 Patent are not invalid under the doctrine of obviousness-type double patenting[1][2].

Expert Testimony and Secondary Considerations

During the litigation, expert testimony played a crucial role. Plaintiffs presented testimony from experts such as Dr. Gavin, Dr. Davies, and Mr. Sims to demonstrate secondary considerations that support the nonobviousness of the patents. These secondary considerations include unexpected results, long-felt but unsolved needs, and commercial success, which are often used to rebut prima facie cases of obviousness[2].

Regulatory Approval and Patent Term

The '788 Patent is closely tied to the regulatory approval process for canagliflozin. An original Investigational New Drug Application (IND) was filed on April 25, 2007, and a New Drug Application (NDA) was submitted on May 31, 2012, which was approved by the FDA on March 29, 2013. The patent term for the '788 Patent and related patents has been a subject of consideration, with the patent holders seeking extensions under 35 U.S.C. §156 due to the regulatory review period[4].

Patent Landscape and Competitors

The patent landscape surrounding the '788 Patent is complex, with multiple patents and applications related to canagliflozin and its use in treating type 2 diabetes. Other patents, such as U.S. Patent Nos. 8,222,219 and 8,785,403, are also part of this landscape and have been asserted in the same litigation against generic manufacturers. These patents collectively protect the intellectual property related to Invokana and Invokamet, ensuring market exclusivity for the patent holders until the patents expire[1][2][4].

Impact on Innovation and Market

The '788 Patent and related patents have significant implications for innovation and market competition in the pharmaceutical industry. The protection afforded by these patents allows the patent holders to recoup their investment in research and development, but it also delays the entry of generic competitors into the market. This balance between innovation incentives and market competition is a critical aspect of patent law and policy[3].

Key Takeaways

• Patent Scope and Claims: The '788 Patent is focused on the glucopyranoside compound canagliflozin, with claims 12 and 20 being central to its validity.
• Litigation: The patent has been involved in significant litigation, with challenges to its validity as obvious and under obviousness-type double patenting.
• Regulatory Approval: The patent is closely tied to the regulatory approval process for canagliflozin, with extensions sought under 35 U.S.C. §156.
• Patent Landscape: The patent is part of a broader landscape including other related patents that protect the intellectual property of Invokana and Invokamet.
• Impact on Innovation and Market: The patent affects the balance between innovation incentives and market competition in the pharmaceutical industry.

FAQs

Q: What is the main compound protected by the '788 Patent?

A: The main compound protected by the '788 Patent is canagliflozin, a glucopyranoside compound used in the treatment of type 2 diabetes.

Q: Who are the inventors listed on the '788 Patent?

A: The inventors listed on the '788 Patent are Sumihiro Nomura, Eiji Kawanishi, and Kiichiro Ueta.

Q: What is the significance of claims 12 and 20 in the '788 Patent?

A: Claims 12 and 20 are directed to the compound canagliflozin and have been central in the litigation regarding the patent's validity.

Q: How has the '788 Patent been involved in litigation?

A: The '788 Patent has been involved in litigation against generic manufacturers like Zydus, with challenges to its validity as obvious and under obviousness-type double patenting.

Q: What is the current status of the patent term for the '788 Patent?

A: The patent term for the '788 Patent and related patents has been subject to extensions under 35 U.S.C. §156 due to the regulatory review period.

Cited Sources

1. MITSUBISHI TANABE PHARMA CORPORATION NV LLC v. Zydus Pharmaceuticals Inc., FindLaw, https://caselaw.findlaw.com/court/us-dis-crt-d-new-jer/2126788.html
2. Case 3:17-cv-05319-FLW-DEA Document 173 Filed 06/15/20, GovInfo, https://www.govinfo.gov/content/pkg/USCOURTS-njd-3_17-cv-05319/pdf/USCOURTS-njd-3_17-cv-05319-0.pdf
3. Patent Claims and Patent Scope, Hoover Institution, https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
4. In re U.S. Patent of: Sumihiro NOMURA et al., FDA, https://downloads.regulations.gov/FDA-2014-E-1234-0002/attachment_1.pdf

Drugs Protected by US Patent 7,943,788

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			Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No			Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes			Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No			Y	Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No			Y	Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-002	Aug 8, 2014		RX	Yes	No			Y	Y

International Family Members for US Patent 7,943,788

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