Details for Patent: 9,555,004

Which drugs does patent 9,555,004 protect, and when does it expire?

Patent 9,555,004 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 9,555,004

Title:	Sustained-release formulations of topiramate
Abstract:	Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s):	Liang; Likan (Boyds, MD), Wang; Hua (Clarksville, MD), Bhatt; Padmanabh P. (Rockville, MD), Vieira; Michael L. (Gaithersburg, MD)
Assignee:	Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	14/630,099
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,555,004
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,555,004

Introduction to Patent 9,555,004

United States Patent 9,555,004, titled "Sustained-Release Formulations of Topiramate," is a crucial patent held by Supernus Pharmaceuticals, Inc. This patent is part of a broader portfolio of patents protecting the company's drug product, Trokendi XR®, an extended-release formulation of topiramate.

Patent Background and Issuance

• Issuance Date: The patent was issued on January 31, 2017[4].
• Priority Date: It claims priority to U.S. Provisional Patent Application No. 60/859,502, filed on November 17, 2006[1][4].
• Application Number: The patent issued from U.S. Patent Application No. 15/259,842[1].

Scope of the Patent

The patent 9,555,004 is focused on sustained-release formulations of topiramate, a medication used primarily for the treatment of epilepsy and other neurological conditions.

Key Claims

• The patent includes multiple claims, but the specific claims relevant to the scope of protection are detailed in the patent document.
• For example, similar patents in the same family, such as U.S. Patent 9,549,940, claim formulations comprising between 0.5% to 85% by weight of topiramate, which is released immediately and continuously upon administration[1].

Claim Analysis

Claim Structure and Requirements

• Patent claims are the most critical part of a patent application as they define the exclusive rights granted to the patent applicant. According to 35 USC 112, the applicant must particularly point out and distinctly claim the subject matter of the invention[5].
• The claims in patent 9,555,004 would follow a similar structure, detailing the specific components and characteristics of the sustained-release formulation of topiramate.

Claim Interpretation

• Claim interpretation is a critical aspect of patent litigation. The claims themselves, along with the specification and other claims in the patent, provide substantial guidance on the meaning of particular claim terms[4].
• The court may look to the context in which a term is used in the asserted claim, other claims of the patent, and the specification to determine the scope of the claims.

Patent Landscape and Related Patents

Family of Patents

• The patent 9,555,004 is part of a larger family of patents related to sustained-release formulations of topiramate. Other patents in this family include U.S. Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, 8,992,989, 9,549,940, 9,622,983, and 10,314,790[1][4].
• These patents collectively protect various aspects of the formulation, including different particle sizes, release mechanisms, and composition.

Orange Book Listings

• The FDA's Orange Book lists the patents covering Supernus's Trokendi XR®, including the patents-in-suit such as U.S. Patent 9,555,004. This listing is crucial for generic drug manufacturers seeking to market a generic version of Trokendi XR®, as it alerts them to potential patent infringement issues[1].

Litigation and Settlements

Hatch-Waxman Litigation

• The patent 9,555,004 has been involved in Hatch-Waxman litigation, where Supernus Pharmaceuticals has sued generic drug manufacturers for patent infringement. For example, in the case against Ajanta Pharma, Supernus alleged that Ajanta's ANDA (Abbreviated New Drug Application) products infringed on several patents, including those related to sustained-release formulations of topiramate[4].
• Settlements in such cases often involve the dismissal of claims and counterclaims, with the generic manufacturer being enjoined from infringing the patents-in-suit unless authorized by the settlement agreement[2].

Patent Analytics and Claim Coverage

Claim Coverage Matrix

• To manage and understand the complex patent landscape, companies use patent analytics tools such as Claim Coverage Matrix. This tool helps identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
• For Supernus Pharmaceuticals, such tools would be essential in tracking the claims and scope concepts of their patents, including 9,555,004, to ensure comprehensive protection of their products.

Claim Charts and Scope Concepts

• Claim charts generated by tools like ClaimScape® software can help technical experts review patent coverage and determine if there are gaps in the current claim coverage. These charts categorize claims by scope concepts, which can be high, medium, or low value to the company[3].
• This approach helps in identifying future design opportunities and ensuring that the patent claims align with the company's strategic goals.

Key Takeaways

• Patent Scope: U.S. Patent 9,555,004 protects specific sustained-release formulations of topiramate, which are critical for Supernus Pharmaceuticals' product Trokendi XR®.
• Claim Analysis: The claims define the exclusive rights and must be interpreted in the context of the specification and other claims.
• Patent Landscape: The patent is part of a larger family of patents related to topiramate formulations and is listed in the FDA's Orange Book.
• Litigation: The patent has been involved in Hatch-Waxman litigation, and settlements often involve the dismissal of claims and injunctions against generic manufacturers.
• Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and understanding the patent landscape.

FAQs

Q: What is the main subject matter protected by U.S. Patent 9,555,004? A: The patent protects sustained-release formulations of topiramate, specifically those used in Supernus Pharmaceuticals' product Trokendi XR®.

Q: When was U.S. Patent 9,555,004 issued? A: The patent was issued on January 31, 2017.

Q: What is the significance of the Orange Book listing for this patent? A: The Orange Book listing alerts generic drug manufacturers to potential patent infringement issues when seeking to market a generic version of Trokendi XR®.

Q: How are patent claims interpreted in litigation? A: Claims are interpreted in the context of the specification, other claims in the patent, and the overall scope of the invention.

Q: What tools are used to manage and analyze the patent landscape for such patents? A: Tools like Claim Coverage Matrix and Claim Charts are used to track claims, identify gaps, and determine the value of patent claims to the company.

Sources

1. Supernus Pharm. v. Torrent Pharm. - Casetext
2. ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
3. Patent Analytics | Intellectual Property Law - Schwegman Lundberg & Woessner
4. Supernus Pharm. v. Ajanta Pharma. - Casetext
5. Understanding Patent Claims - IPWatchdog.com

Drugs Protected by US Patent 9,555,004

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE

International Family Members for US Patent 9,555,004

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007319141
Canada	2618240
Germany	07870164