Details for Patent: 8,895,615

Which drugs does patent 8,895,615 protect, and when does it expire?

Patent 8,895,615 protects GOCOVRI and OSMOLEX ER and is included in two NDAs.

This patent has four patent family members in three countries.

Summary for Patent: 8,895,615

Title:	Composition and method for treating neurological disease
Abstract:	Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
Inventor(s):	Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Jasper, GA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee:	Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:	14/451,226
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,895,615
Patent Claim Types: see list of patent claims	Use; Composition; Device;

Understanding the Scope and Claims of United States Patent 8,895,615

Introduction to Patents in the United States

Patents in the United States are governed by the Patent Act (35 US Code) and administered by the United States Patent and Trademark Office (USPTO)[1].

Overview of Patent 8,895,615

To analyze the scope and claims of United States Patent 8,895,615, it is essential to start with a general understanding of the patent itself. Here are the key steps and considerations:

Identifying the Patent

• Patent Number: The first step is to identify the patent number, which in this case is 8,895,615.
• Search Tools: Utilize the USPTO's Patent Public Search tool or other databases like the Patent and Trademark Resource Centers (PTRCs) to locate the patent[4].

Understanding Patent Claims

What are Patent Claims?

Patent claims define the scope of the invention and are crucial for determining what is protected by the patent. These claims must be clear, concise, and supported by the patent's description[1].

Types of Claims

• Independent Claims: These claims stand alone and define the invention without reference to other claims.
• Dependent Claims: These claims refer back to and further limit an independent claim.

Analyzing Claims of Patent 8,895,615

To analyze the claims of this patent, you would need to:

• Read the Claims: Carefully read each claim to understand what is being protected.
• Identify Key Elements: Determine the essential elements of the invention as described in the claims.
• Compare with Prior Art: Compare the claims with prior art to ensure the invention is novel and non-obvious.

Patent Subject Matter Eligibility

Section 101 of the Patent Act

Section 101 of the Patent Act defines what subject matter is eligible for patent protection. The patent must fall within one of the four statutory categories: processes, machines, manufactures, or compositions of matter[1].

The Alice Test

For patents involving abstract ideas, the Alice test is applied:

• Step One: Determine whether the claim is directed to an abstract idea.
• Step Two: If it is, determine whether the claim contains an "inventive concept" that transforms the abstract idea into a patent-eligible application[1].

Scope of the Invention

Patent Scope Measurements

The scope of a patent can be measured using various metrics, such as the number of claims, the breadth of the claims, and the dependency relationship between claims. The USPTO's Patent Claims Research Dataset provides detailed information on these metrics[3].

Impact on the Market

Understanding the scope of the patent helps in assessing its impact on the market. A broader scope can provide more extensive protection but may also face more challenges during the patent prosecution process.

Searching and Analyzing Prior Art

Tools for Prior Art Search

• Patent Public Search: Use the USPTO's Patent Public Search tool to find existing patents and published patent applications that may be relevant to the invention[4].
• Global Dossier: Utilize the Global Dossier service to access file histories of related applications from participating IP Offices[4].

Importance of Prior Art

Prior art search is crucial to ensure the novelty and non-obviousness of the invention. It also helps in drafting claims that are distinct from existing patents.

Patent Landscape Analysis

International Considerations

• International Patent Offices: Search databases from other international intellectual property offices to see if similar inventions have been patented abroad[4].
• Common Citation Document (CCD): Use the CCD application to consolidate prior art cited by multiple offices for the same invention[4].

Market and Competitive Analysis

Analyzing the patent landscape involves understanding the competitive environment and how the patented invention fits into it. This includes identifying other patents in the same field and assessing their impact on market competition.

Legal and Policy Considerations

Patent Litigation and Enforcement

Understanding the legal framework surrounding patent litigation is crucial. For instance, the concept of a small claims patent court has been explored to address issues related to patent litigation costs and complexity[5].

Policy Implications

Patent policies can significantly impact the scope and enforcement of patents. For example, changes in patent subject matter eligibility can affect what inventions are considered patentable[1].

Key Takeaways

• Clear Claims: Ensure that the patent claims are clear, concise, and supported by the patent description.
• Subject Matter Eligibility: Verify that the patent falls within the statutory categories defined by Section 101 of the Patent Act.
• Prior Art Search: Conduct a thorough prior art search to ensure the novelty and non-obviousness of the invention.
• International Considerations: Analyze the international patent landscape to understand the global implications of the patent.
• Legal and Policy Framework: Be aware of the legal and policy considerations that can affect the scope and enforcement of the patent.

FAQs

Q: What is the purpose of the Alice test in patent law?

A: The Alice test is used to determine whether a patent claim involving an abstract idea contains an "inventive concept" that makes it patent-eligible[1].

Q: How do I search for prior art related to a patent?

A: You can use the USPTO's Patent Public Search tool, Global Dossier, and other international patent databases to search for prior art[4].

Q: What are the four statutory categories for patent subject matter eligibility?

A: The four categories are processes, machines, manufactures, and compositions of matter[1].

Q: Why is it important to analyze the scope of a patent?

A: Analyzing the scope helps in understanding the extent of protection provided by the patent and its impact on the market[3].

Q: How can I access the file histories of related patent applications from other countries?

A: Use the Global Dossier service, which provides access to file histories from participating IP Offices[4].

Sources

1. BitLaw: Patent Law in the United States - BitLaw
2. USA.gov: U.S. Patent and Trademark Office (USPTO) | USAGov
3. USPTO: Patent Claims Research Dataset - USPTO
4. USPTO: Search for patents - USPTO
5. ACUS: U.S. Patent Small Claims Court - ACUS

Drugs Protected by US Patent 8,895,615

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	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	AB	RX	Yes	No	8,895,615					TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	8,895,615					TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	8,895,615					TREATMENT OF PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	8,895,615					TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	8,895,615					TREATMENT OF PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	8,895,615					TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	8,895,615					TREATMENT OF PARKINSON'S DISEASE

International Family Members for US Patent 8,895,615

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2588296
European Patent Office	1845968
European Patent Office	2623099
World Intellectual Property Organization (WIPO)	2006058236