Details for Patent: 10,112,909

Which drugs does patent 10,112,909 protect, and when does it expire?

Patent 10,112,909 protects TEMBEXA and is included in one NDA.

This patent has twenty-eight patent family members in fourteen countries.

Summary for Patent: 10,112,909

Title:	Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Abstract:	The disclosure describes methods of synthesis of phosphonate ester compounds. The methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity and stability. Also disclosed are morphic forms of phosphonate ester compounds.
Inventor(s):	Ware; Roy Wendell (Raleigh, NC), Downey; Aaron Leigh (Durham, NC)
Assignee:	Chimerix, Inc. (Durham, NC)
Application Number:	15/828,935
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Understanding the Scope and Claims of United States Patent 10,112,909: A Comprehensive Analysis

Introduction

U.S. Patent 10,112,909, like any other patent, is governed by the stringent criteria outlined in Sections 101, 102, and 103 of the U.S. Patent Law. To delve into the specifics of this patent, it is crucial to understand these sections and how they apply to the patent's claims and overall landscape.

Section 101: Patentable Subject Matter

Section 101 of the U.S. Patent Act defines what constitutes patentable subject matter. It states that a patent may be obtained for "any new and useful process, machine, manufacture, or composition of matter, or any improvement thereof"[5].

The Alice Test

The Supreme Court's decision in Alice Corp. v. CLS Bank International (2014) introduced a two-step test to determine the eligibility of subject matter for patenting:

• Step 1: Determine if the claim is directed to a process, machine, manufacture, or composition of matter.
• Step 2A: Assess if the claim is directed towards a law of nature, natural phenomenon, or abstract idea.
• Step 2B: Evaluate if the claim includes additional elements that constitute significantly more than the judicial exception identified[1].

Application to U.S. Patent 10,112,909

To analyze the patentability of U.S. Patent 10,112,909 under Section 101, one must apply the Alice test.

Step 1: Subject Matter Eligibility

The patent must be directed to a process, machine, manufacture, or composition of matter. If the claims do not meet this criterion, they are not eligible for patent protection.

Step 2A: Judicial Exceptions

If the claims are directed towards abstract ideas, laws of nature, or natural phenomena, they must be scrutinized further. For instance, if the patent involves software or AI-related inventions, it must be evaluated to ensure it does not preempt an abstract idea without additional concrete elements[4].

Step 2B: Transformative Elements

The claims must include elements that transform the abstract idea into a patent-eligible application. This involves assessing whether the additional elements impose meaningful limits on the exception, thereby offering a concrete technological improvement[4].

Section 102: Novelty

Section 102 deals with the novelty of an invention, ensuring that the invention is new and not obvious from prior art.

Prior Art Analysis

Conducting an extensive prior art search is essential to determine the novelty of the invention. This involves analyzing existing patents and publications in the relevant field to ensure that the invention is not anticipated by prior art[1].

Section 103: Non-obviousness

Section 103 focuses on the non-obviousness of an invention, requiring that it is not readily apparent to a person having ordinary skill in the art (PHOSITA).

Determining Non-obviousness

Several factors are considered, including:

• Commercial Success: If the invention achieves significant commercial success, it can be an indicator of non-obviousness.
• Long-Felt but Unsolved Needs: Addressing a long-standing problem without a previous solution can indicate non-obviousness.
• Failure of Others: The inability of others to develop the claimed invention can also be evidence of non-obviousness[1].

Patent Scope and Claims Analysis

The scope and claims of U.S. Patent 10,112,909 must be carefully analyzed to ensure they meet the criteria outlined in Sections 101, 102, and 103.

Claim Language and Scope

The patent's claims should be precise and clearly articulate how the invention operates. Metrics such as independent claim length and independent claim count can be used to measure patent scope, which can influence the likelihood of grant and the examination process[3].

Practical Insights and Strategic Considerations

Aligning with Section 101

Innovators should focus on highlighting the tangible and applicable aspects of the invention. Providing clear, concrete embodiments and detailing practical applications can help navigate the nuances of Section 101[1].

Precision in Patent Applications

Precision in the patent application is crucial. Clearly articulating how the invention operates in a specific, tangible manner is essential. This portrayal can aid in demonstrating the invention’s practical utility and concrete implementation[1].

Recent Developments and Guidance

2024 USPTO Guidance Update on AI Patents

For patents involving AI technology, the 2024 USPTO guidance update is significant. It emphasizes evaluating whether a claim integrates a judicial exception into a practical application and ensures that AI-assisted inventions are evaluated on equal footing with other technologies, provided there is significant human contribution[4].

Case Studies and Examples

Real-World Applications

Case studies such as Alice Corp. v. CLS Bank International and Adams Battery (1966) illustrate how these sections are applied in real-world scenarios. These cases highlight the importance of thorough examination and strategic alignment with the statutory provisions and judicial interpretations[1].

Key Takeaways

• Section 101 Eligibility: Ensure the patent claims are directed to eligible subject matter and include transformative elements beyond judicial exceptions.
• Section 102 Novelty: Conduct thorough prior art searches to establish novelty.
• Section 103 Non-obviousness: Demonstrate non-obviousness through factors like commercial success, long-felt needs, and failure of others.
• Precision in Claims: Clearly articulate the invention's operation and practical applications.
• Recent Guidance: Adhere to updated guidance, especially for AI-related inventions.

FAQs

1. What is the Alice test, and how does it apply to patent claims? The Alice test is a two-step process to determine the eligibility of subject matter for patenting. It involves determining if the claim is directed to a process, machine, manufacture, or composition of matter and assessing if it includes additional elements that transform an abstract idea into a patent-eligible application[1].

2. How does Section 102 ensure the novelty of an invention? Section 102 ensures novelty by requiring that the invention is new and not obvious from prior art. This involves conducting extensive prior art searches and analyzing existing patents and publications in the relevant field[1].

3. What factors are considered in determining non-obviousness under Section 103? Factors such as commercial success, long-felt but unsolved needs, and the failure of others to develop the claimed invention are considered in determining non-obviousness[1].

4. How does the 2024 USPTO guidance update impact AI-related patent applications? The update refines the process for determining the patent eligibility of AI-related inventions, emphasizing the integration of judicial exceptions into practical applications and ensuring AI-assisted inventions are evaluated on equal footing with other technologies[4].

5. Why is precision in patent claims important? Precision in patent claims is crucial as it helps in clearly articulating how the invention operates and demonstrating its practical utility and concrete implementation, which can aid in navigating the nuances of Section 101 and ensuring the patent's validity[1].

Sources

1. TT Consultants: Exploring Sections 101, 102, & 103 of U.S. Patent Law.
2. CAFC: AI Visualize, Inc. v. Nuance Communications, Inc.
3. SSRN: Patent Claims and Patent Scope.
4. Mintz: Understanding the 2024 USPTO Guidance Update on AI Patent.
5. BitLaw: Section 101 Subject Matter Eligibility Index.

Drugs Protected by US Patent 10,112,909

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes						METHOD OF TREATING HUMAN SMALLPOX DISEASE

International Family Members for US Patent 10,112,909

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014349103
Australia	2017202386
Australia	2017203315
Brazil	112016010862
Canada	2929593
China	105899215
China	111777639