Details for Patent: 10,314,790

Which drugs does patent 10,314,790 protect, and when does it expire?

Patent 10,314,790 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 10,314,790

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:	15/474,809
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,314,790
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 10,314,790

Introduction

The United States Patent 10,314,790, hereinafter referred to as the '790 Patent, is part of a series of patents held by Supernus Pharmaceuticals, Inc., related to pharmaceutical compositions for topiramate, particularly the extended-release formulation known as Trokendi XR®. This analysis delves into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The '790 Patent, filed on March 30, 2017, is one of several patents in the Trokendi XR® family, which includes other patents such as U.S. Patent Nos. 8,298,580, 8,663,683, 8,877,248, 8,992,989, 9,549,940, 9,622,983, and 9,555,004[1][4].

Claim Construction

Key Claim Terms

The '790 Patent involves several key claim terms that have been subject to judicial interpretation. Here are the most critical ones:

Extended Release (XR) Topiramate-Containing Component

The term "an extended release (XR) topiramate-containing component" has been construed to mean "a component that releases topiramate over a prolonged period of time," with the clarification that "prolonged period of time" means "a continuous period of time of greater than about 1 hour"[4].

At Least Two Extended Release (XR) Topiramate-Containing Components

The term "at least two extended release (XR) topiramate-containing components" has been interpreted to mean "at least two components that release topiramate over a prolonged period of time, each component having a different release rate"[4].

Judicial Interpretation

In the case of Supernus Pharm., Inc. v. Lupin Ltd., the United States District Court for the District of Delaware provided a detailed construction of these claim terms. The court emphasized that the specifications of the '790, '989, '940, and '983 Patents are substantially identical and can be cited interchangeably[4].

Patent Scope and Claims

Independent Claim 1

Independent claim 1 of the '790 Patent recites a sustained release formulation of topiramate comprising topiramate as an active ingredient. This claim is representative of the broader scope of the patent, which focuses on the formulation and release characteristics of topiramate[5].

Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and clarity. The '790 Patent, along with its related patents, undergoes a narrowing process during the examination phase, which can affect the patent's scope and validity[3].

Prosecution History

Impact on Claim Construction

The prosecution history of related patents is crucial in claim construction. However, the court in Supernus Pharm., Inc. v. Lupin Ltd. did not apply the prosecution history of the parent application to narrow the claims at issue. This decision highlights that statements made during the prosecution of a narrower parent application do not necessarily limit a child patent[5].

Person of Ordinary Skill in the Art (POSA)

Claims are construed from the vantage point of a POSA at the time of the invention. For the '790 Patent, the court considered the perspective of a POSA to interpret terms such as "continuous" release, ensuring that the construction aligns with the understanding of someone skilled in the art[1].

Patent Landscape

Related Patents

The '790 Patent is part of a family of patents related to Trokendi XR®, including U.S. Patent Nos. 8,298,580, 8,663,683, 8,877,248, 8,992,989, 9,549,940, 9,622,983, and 9,555,004. These patents share common inventors and are often cited interchangeably due to their similar specifications[1][4].

Generic Challenges

The '790 Patent, along with other Trokendi XR® patents, has faced challenges from generic drug manufacturers. For instance, Lupin Limited and other defendants have filed Abbreviated New Drug Applications (ANDAs) with the FDA, asserting that their generic versions do not infringe on the patents in suit[1][2].

Litigation and Enforcement

Supernus Pharmaceuticals, Inc. v. Ajanta Pharma and Lupin Limited

The litigation surrounding the '790 Patent and other related patents involves complex claim constructions and infringement disputes. The courts have carefully reviewed intrinsic and extrinsic evidence to determine the scope of the claims and whether generic versions infringe on these patents[1][4].

Key Takeaways

• Claim Construction: The '790 Patent's key claim terms, such as "extended release (XR) topiramate-containing component" and "at least two extended release (XR) topiramate-containing components," have been judicially interpreted to clarify their scope.
• Prosecution History: The court's decision not to apply the prosecution history of the parent application to narrow the claims highlights the importance of considering each patent's unique context.
• Patent Scope: The patent's scope is influenced by the length and count of independent claims, as well as the narrowing process during the examination phase.
• Litigation: The '790 Patent is part of ongoing litigation involving generic drug manufacturers, emphasizing the need for precise claim constructions to determine infringement.

FAQs

What is the '790 Patent related to?

The '790 Patent is related to pharmaceutical compositions for topiramate, specifically the extended-release formulation known as Trokendi XR®.

How have the claim terms of the '790 Patent been construed?

The claim terms have been construed to mean "a component that releases topiramate over a prolonged period of time" and "at least two components that release topiramate over a prolonged period of time, each component having a different release rate."

What is the significance of the prosecution history in claim construction?

The prosecution history of related patents can be relevant, but the court may not apply it to narrow the claims if it does not align with the specific context of the patent in question.

Which companies are involved in the litigation related to the '790 Patent?

Supernus Pharmaceuticals, Inc., and generic drug manufacturers such as Lupin Limited and Ajanta Pharma are involved in the litigation.

How does the scope of the '790 Patent compare to other related patents?

The '790 Patent is part of a family of patents with similar specifications, and its scope is influenced by the same inventors and prosecution history as these related patents.

Sources

1. Supernus Pharm. v. Ajanta Pharma., Civ. 21-6964 (GC) | Casetext
2. Topiramate Extended-Release Capsules - accessdata.fda.gov
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. 21-1293.pdf - District of Delaware
5. Statements Made When Prosecuting Narrower Parent Application ... - finnegan.com

Drugs Protected by US Patent 10,314,790

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 THE TREATMENT OF EPILEPSY
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	201635-002	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	201635-002	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	201635-003	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	201635-003	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	201635-004	Aug 16, 2013	AB1	RX	Yes	Yes			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE

International Family Members for US Patent 10,314,790

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007319141
Canada	2618240
Germany	07870164
European Patent Office	1973528
European Patent Office	2394643
Spain	2312308
Spain	2555066