Details for Patent: 11,045,474

Which drugs does patent 11,045,474 protect, and when does it expire?

Patent 11,045,474 protects OLUMIANT and is included in one NDA.

This patent has eleven patent family members in seven countries.

Summary for Patent: 11,045,474

Title:	Antiviral JAK inhibitors useful in treating or preventing coronaviridae infections
Abstract:	Compounds, compositions, and methods of treatment and prevention of HIV infection are disclosed. The compounds are pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidine JAK inhibitors. Combinations of these JAK inhibitors and additional antiretroviral compounds, such as NRTI, NNRTI, integrase inhibitors, entry inhibitors, protease inhibitors, and the like, are also disclosed. In one embodiment, the combinations include a combination of adenine, cytosine, thymidine, and guanine nucleoside antiviral agents, optionally in further combination with at least one additional antiviral agent that works via a different mechanism than a nucleoside analog. This combination has the potential to eliminate the presence of HIV in an infected patient.
Inventor(s):	Gavegnano; Christina (Decatur, GA), Schinazi; Raymond F. (Miami, FL)
Assignee:	Emory University (Atlanta, GA) The United States Government as Repersentative by the Department of Veterans Affairs (Washington, DC)
Application Number:	16/816,901
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 11,045,474

To conduct a detailed analysis of the scope and claims of a specific patent, such as United States Patent 11,045,474, it is essential to delve into several key aspects, including the patent's claims, scope, and the broader patent landscape.

Understanding Patent Claims

What are Patent Claims?

Patent claims are the legal definitions of what the inventor considers to be their invention. They define the scope of protection granted by the patent and are crucial in determining the patent's validity and enforceability[3].

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 the Claims of US Patent 11,045,474

To analyze the claims of US Patent 11,045,474, one would typically start by identifying the independent and dependent claims.

Independent Claim Length and Count

Research suggests that the length and count of independent claims can be indicative of the patent's scope. Longer independent claims and a higher count of such claims may indicate a broader patent scope[3].

Claim Language and Dependency

The language used in the claims and the dependency relationships between claims are critical. Claims with clear, concise language and well-defined dependencies are generally considered stronger and more enforceable[2].

Patent Scope

Metrics for Measuring Patent Scope

• Independent Claim Length: Longer independent claims often indicate a more detailed and possibly broader scope.
• Independent Claim Count: A higher number of independent claims can suggest a more comprehensive invention.
• Claim Dependency: The structure of claim dependencies can affect the overall scope and clarity of the patent[3].

Impact on Innovation and Competition

A patent with a broad scope can influence innovation and competition. Broad patents may increase licensing and litigation costs, potentially diminishing incentives for further innovation[3].

The Broader Patent Landscape

Orange Book Patents

For pharmaceutical patents, the Orange Book is a critical resource. It lists patents that cover approved drugs, and improper listings can hinder competition. The FTC has been active in challenging such improper listings to promote competition[5].

Government Funding and March-In Rights

Patents resulting from government-funded research, such as those under the Bayh-Dole Act, may be subject to march-in rights. This allows the government to step in if the patent holder fails to make the invention available to the public on reasonable terms[1].

Patent Databases and Research Tools

USPTO Patent Claims Research Dataset

This dataset provides detailed information on claims from US patents granted between 1976 and 2014 and patent applications published between 2001 and 2014. It includes claim-level statistics and document-level statistics, which can be used to analyze the scope and claims of patents[2].

PatentsView Database

The PatentsView Database is another valuable resource, providing raw text of government-interest statements in all patents issued since 1976. This is particularly useful for identifying patents with government funding and potential march-in rights[1].

Case Studies and Industry Examples

Olumiant Patent Example

The drug Olumiant, owned by Eli Lilly and Co., is protected by several US patents. Analyzing the patent landscape for such drugs involves looking at the patent term extensions, terminal disclaimers, and other legal actions that affect the patent's validity and expiration[4].

Challenges and Controversies

Terminal Disclaimers and Patent Thickets

Terminal disclaimers are used to overcome rejections based on double patenting, but they can also be exploited to extend patent terms improperly. This practice can lead to patent thickets, which can stifle innovation and competition[5].

Improper Orange Book Listings

The FTC has challenged numerous patents listed in the FDA’s Orange Book, highlighting the issue of improper listings that can harm competition. Ensuring the accuracy of these listings is crucial for maintaining a fair and competitive market[5].

Key Takeaways

• Patent claims are the cornerstone of a patent, defining its scope and enforceability.
• Metrics such as independent claim length and count can help measure a patent's scope.
• The broader patent landscape, including government funding and Orange Book listings, can significantly impact a patent's validity and competition.
• Databases like the USPTO Patent Claims Research Dataset and PatentsView are essential tools for analyzing patents.
• Challenges such as terminal disclaimers and improper Orange Book listings must be addressed to maintain a competitive and innovative environment.

Frequently Asked Questions

What are the key components of a patent claim?

The key components include the preamble, the transition phrase, and the body of the claim, which together define the invention.

How do independent and dependent claims differ?

Independent claims stand alone and define the invention without reference to other claims, while dependent claims refer back to and further limit an independent claim.

What is the significance of the Orange Book in pharmaceutical patents?

The Orange Book lists patents that cover approved drugs, and improper listings can hinder competition and violate antitrust laws.

What are march-in rights, and how do they apply to government-funded patents?

March-in rights allow the government to step in if the patent holder fails to make the invention available to the public on reasonable terms, often applicable to patents resulting from government-funded research.

Why are terminal disclaimers important in patent law?

Terminal disclaimers are used to overcome rejections based on double patenting but can also be exploited to extend patent terms improperly, leading to patent thickets that stifle innovation and competition.

Cited Sources:

1. The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research
2. Patent Claims Research Dataset - USPTO
3. Patent Claims and Patent Scope - Hoover Institution
4. Olumiant patent expiration - Pharsight
5. FTC Comment to the USPTO on Terminal Disclaimer Practice - Federal Trade Commission

Drugs Protected by US Patent 11,045,474

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No						TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NON-INVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No						TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NON-INVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022		RX	Yes	Yes						TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NON-INVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

International Family Members for US Patent 11,045,474

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012345732
Australia	2016244212
Brazil	112014013224
Canada	2856722
Canada	3131037
China	104185420
China	107898790