Details for Patent: 9,549,899

Which drugs does patent 9,549,899 protect, and when does it expire?

Patent 9,549,899 protects ARYMO ER and is included in one NDA.

This patent has twelve patent family members in twelve countries.

Summary for Patent: 9,549,899

Title:	Abuse deterrent pharmaceutical compositions for controlled release
Abstract:	The present disclosure relates to pharmaceutical compositions that are abuse resistant and may also provide controlled release. The present disclosure also relates to the use of pharmaceutical compositions in the treatment of pain.
Inventor(s):	Tygesen; Peter Holm (Vaerlose, DK), Lindhardt; Karsten (Haslev, DK), Olsen; Martin Rex (Holbaek, DK), Fischer; Gina Engslev (Vaerlose, DK), Overgard; Jan Martin (Frederikssund, DK), Boye; Georg (Hedehusene, DK), Skak; Nikolaj (Virum, DK), Elhauge; Torben (Copenhagen K, DK)
Assignee:	EGALET LTD. (London, GB)
Application Number:	13/933,053
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,549,899
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 9,549,899

Introduction

United States Patent 9,549,899, issued to Egalet Corporation, covers the formulation and method of manufacture for ARYMO ER (morphine sulfate) extended-release tablets. This patent is significant in the pharmaceutical industry, particularly in the field of pain management. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Background of the Patent

The patent in question pertains to a specific formulation of morphine sulfate, an opioid used for managing severe pain. The extended-release formulation is designed to provide a controlled release of the active ingredient over a prolonged period, enhancing patient compliance and reducing the risk of abuse[5].

Scope of the Patent

The scope of a patent is defined by its claims, which outline the specific aspects of the invention that are protected. For U.S. Patent 9,549,899, the scope includes:

Claims

• Independent Claims: These claims define the broadest aspects of the invention. For example, Claim 1 might describe the composition of the extended-release tablet, including the specific ratio of morphine sulfate to other excipients.
• Dependent Claims: These claims build upon the independent claims and provide more detailed descriptions. For instance, a dependent claim might specify the method of manufacturing the tablets or the particular release profile of the morphine sulfate.

Claim Language and Scope

The language used in the claims is crucial for determining the patent's scope. Metrics such as independent claim length and independent claim count can provide insights into the breadth and clarity of the patent. Generally, narrower claims are associated with a higher probability of grant and a shorter examination process[3].

Patent Eligibility and Subject Matter

Patent eligibility under 35 U.S.C. § 101 is a critical aspect of any patent. The Supreme Court's "Alice" test is often applied to determine if claims are directed to patent-eligible subject matter. This involves two steps:

• Step One: Determine if the claims are directed to an abstract idea, law of nature, or natural phenomenon.
• Step Two: If they are, assess whether the claims include elements that transform them into a patent-eligible application[2].

For pharmaceutical patents like U.S. Patent 9,549,899, the focus is on whether the claims describe a practical application that provides concrete benefits, such as a specific formulation or method of manufacture that improves the delivery of the drug.

Examples and Case Law

Recent updates and case law can provide guidance on how to draft and evaluate patent claims. For instance, the 2024 USPTO guidance update on AI patents, while not directly applicable to pharmaceuticals, emphasizes the importance of integrating judicial exceptions into practical applications. This principle can be applied broadly to ensure that claims are specific and provide tangible benefits, rather than merely abstract ideas[1].

Patent Landscape

The patent landscape for pharmaceuticals, particularly for opioid formulations, is complex and highly competitive. Here are some key points:

Competing Patents

Other companies may hold patents for similar opioid formulations or delivery systems. These patents could potentially limit the scope of U.S. Patent 9,549,899 or create opportunities for licensing and collaboration.

Global Dossier and International Patents

The Global Dossier service provided by the USPTO allows for the tracking of related patent applications across different jurisdictions. This can be crucial for understanding the global patent landscape and ensuring that the patent is not infringing on existing international patents[4].

Public Search Facilities and Resources

Utilizing resources such as the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and the Electronic Official Gazette can help in conducting thorough searches and ensuring the novelty and non-obviousness of the invention[4].

Key Takeaways

• Specific Claims: The patent's claims must be specific and detailed to ensure broad protection without being overly broad.
• Practical Application: The claims must describe a practical application that provides concrete benefits, such as improved drug delivery.
• Global Considerations: Understanding the global patent landscape is essential for navigating potential infringements and opportunities.
• Resources: Leveraging USPTO resources and case law can help in drafting and evaluating patent claims effectively.

FAQs

1. What is the main subject of U.S. Patent 9,549,899?

   • The main subject is the formulation and method of manufacture for ARYMO ER (morphine sulfate) extended-release tablets.

2. How is the scope of a patent determined?

   • The scope is determined by the claims, which outline the specific aspects of the invention that are protected.

3. What is the significance of the "Alice" test in patent eligibility?

   • The "Alice" test determines whether claims are directed to patent-eligible subject matter by assessing if they are abstract ideas and if they include elements that transform them into a practical application.

4. How can the Global Dossier service be useful for patent holders?

   • It allows for the tracking of related patent applications across different jurisdictions, helping to understand the global patent landscape.

5. What resources are available for conducting thorough patent searches?

   • Resources include the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and the Electronic Official Gazette.

Cited Sources

1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
2. CONTOUR IP HOLDING LLC v. GOPRO, INC. - CAFC
3. Patent Claims and Patent Scope - SSRN
4. Search for patents - USPTO
5. Egalet Announces Issuance Of New U.S. And International Patents - BioSpace

Drugs Protected by US Patent 9,549,899

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-001	Jan 9, 2017		DISCN	Yes	No	9,549,899		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	9,549,899		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	9,549,899		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Foreign Priority and PCT Information for Patent: 9,549,899

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	PA 2012 70405	Jul 6, 2012

International Family Members for US Patent 9,549,899

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013285988
Brazil	112015000150
Canada	2877183
China	104684548
Eurasian Patent Organization	201590165
European Patent Office	2877161
Hong Kong	1210599