Details for Patent: 9,545,399

Which drugs does patent 9,545,399 protect, and when does it expire?

Patent 9,545,399 protects QUILLICHEW ER and is included in one NDA.

This patent has eight patent family members in eight countries.

Summary for Patent: 9,545,399

Title:	Methylphenidate extended release chewable tablet
Abstract:	An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
Inventor(s):	Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Monmouth Junction, NJ), Kathala; Kalyan (Monmouth Junction, NJ)
Assignee:	TRIS PHARMA, INC. (Monmouth Junction, NJ)
Application Number:	15/200,625
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,545,399
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

United States Patent 9,545,399: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,545,399, hereafter referred to as the '399 patent, is a crucial intellectual property asset held by Tris Pharma Inc., a pharmaceutical company. This patent pertains to a methylphenidate extended-release chewable tablet, a medication used for treating Attention Deficit Hyperactivity Disorder (ADHD). Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and Context

The '399 patent was granted to Tris Pharma Inc. and is listed in the Orange Book, a publication of the U.S. Food and Drug Administration (FDA) that lists patents associated with approved drug products[2][5].

Scope of the Patent

The '399 patent covers a specific formulation of a methylphenidate extended-release chewable tablet. This formulation includes a combination of immediate-release and sustained-release components, ensuring a controlled release of the active ingredient, methylphenidate hydrochloride. The patent describes the composition, method of manufacture, and the therapeutic use of this tablet[4].

Key Components

• Active Ingredient: Methylphenidate hydrochloride, a well-known medication for ADHD.
• Formulation: The tablet includes both immediate-release and sustained-release formulations to provide a prolonged therapeutic effect.
• Coating and Excipients: The patent details various coating methods and excipients used to achieve the desired release profile[4].

Claims of the Patent

The '399 patent includes multiple claims that define the scope of the invention. Here are some key claims:

Independent Claims

• Claim 1: Describes the methylphenidate extended-release chewable tablet with specific composition and release characteristics.
• Claim 28: Pertains to the method of treating ADHD using the described tablet[4].

Dependent Claims

• Claims 22 and 24: These are dependent on Claim 1 and specify additional limitations related to the Area Under the Curve (AUC) and maximum plasma concentration (Cmax) of methylphenidate[1][2].

Patent Landscape and Litigation

The '399 patent has been at the center of several legal disputes, particularly in the context of generic drug approvals.

Hatch-Waxman Act and ANDA Filings

Teva Pharmaceuticals USA, Inc. filed an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic version of Tris Pharma's QuilliChew ER®, which is protected by the '399 patent. Tris Pharma alleged that Teva's proposed generic product would infringe several claims of the '399 patent, among others[1][2].

Litigation Outcomes

In the litigation, the court ruled on the validity and infringement of the patent claims. Specifically:

• Claim 24 of the '545 patent (related to the '399 patent) was found invalid for obviousness.
• The AUC and Cmax elements in various dependent claims were also scrutinized, but most claims were found valid and infringed by Teva's ANDA product[1].

Patent Analytics and Claim Coverage

To manage and analyze the complex patent landscape, companies like Tris Pharma can use patent analytics tools.

Claim Coverage Matrix

This tool helps in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in patent coverage. For the '399 patent, such analysis would involve reviewing the claims in the context of the broader patent landscape to ensure comprehensive protection[3].

Claim Charts

Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, ensuring that there are no gaps in the current coverage[3].

Future Implications and Strategies

Given the complexities and challenges in patent litigation, it is crucial for companies to continuously monitor and update their patent portfolios.

Monitoring Patent Expiration

The '399 patent is set to expire on August 14, 2033. Companies must plan ahead, considering the expiration dates of their patents and the potential entry of generic competitors[5].

Strategic Patent Filings

Tris Pharma and similar companies should focus on filing new patents that extend the protection of their products. This includes filing continuation patents, divisional patents, and patents covering new formulations or methods of use[3].

Industry Expert Insights

Industry experts emphasize the importance of robust patent portfolios in the pharmaceutical sector. As noted by intellectual property lawyers, "A strong patent portfolio is essential for pharmaceutical companies to protect their innovations and maintain market exclusivity"[3].

Statistics and Market Impact

The impact of patent protection on the pharmaceutical market is significant. For instance:

• The global ADHD treatment market is projected to grow substantially, driven by innovative treatments like extended-release formulations.
• Patent protection allows companies to recoup their significant investment in research and development, ensuring continued innovation in the field[4].

Key Takeaways

• The '399 patent protects a specific methylphenidate extended-release chewable tablet formulation.
• The patent includes multiple claims that define the scope of the invention, with some claims being dependent on others.
• Litigation has been a significant aspect of this patent, with Tris Pharma defending against generic drug approvals.
• Patent analytics and claim coverage tools are essential for managing complex patent landscapes.
• Continuous monitoring and strategic patent filings are crucial for maintaining market exclusivity.

FAQs

What is the '399 patent, and what does it cover?

The '399 patent covers a methylphenidate extended-release chewable tablet, including its composition, method of manufacture, and therapeutic use.

Why is the '399 patent important for Tris Pharma?

The '399 patent is crucial for Tris Pharma as it protects their innovative product, QuilliChew ER®, and helps maintain market exclusivity.

What was the outcome of the litigation between Tris Pharma and Teva Pharmaceuticals?

The court found most of the asserted claims valid and infringed by Teva's ANDA product, except for Claim 24 of the '545 patent, which was found invalid for obviousness.

How can companies like Tris Pharma manage their patent portfolios effectively?

Companies can use patent analytics tools, maintain a Claim Coverage Matrix, and generate interactive claim charts to ensure comprehensive protection and identify gaps or opportunities.

When does the '399 patent expire?

The '399 patent is set to expire on August 14, 2033.

Cited Sources:

1. Tris Pharma, Inc. v. Teva Pharm. U.S. - Casetext
2. First Amended Complaint - RPX Insight
3. Patent Analytics - Schwegman Lundberg & Woessner
4. US9545399B2 - Methylphenidate extended release chewable tablet - Google Patents
5. Case 1:16-cv-00603-GMS Document 32 - RPX Insight

Drugs Protected by US Patent 9,545,399

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No			Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No			Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes			Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1

International Family Members for US Patent 9,545,399

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013302657
Brazil	112015003120
Canada	2880456
Denmark	2884961
European Patent Office	2884961
Spain	2717469
Israel	236847