Details for Patent: 10,028,937

Which drugs does patent 10,028,937 protect, and when does it expire?

Patent 10,028,937 protects MAVYRET and is included in two NDAs.

Protection for MAVYRET has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has two hundred and seventy-eight patent family members in forty-five countries.

Summary for Patent: 10,028,937

Title:	Anti-viral compounds
Abstract:	Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.
Inventor(s):	Mary E. Bellizzi, David A. Betebenner, Jean-Christophe C. Califano, William A. Carroll, Daniel D. Caspi, David A. Degoey, Pamela L. Donner, Charles A. Flentge, Yi Gao, Charles W. Hutchins, Douglas K. Hutchinson, Tammie K. Jinkerson, Warren M. Kati, Ryan G. Keddy, Allan C. Krueger, Wenke Li, Dachun Liu, Clarence J. Maring, Mark A. Matulenko, Christopher E. Motter, Lissa T. Nelson, Sachin V. Patel, John K. Pratt, John T. Randolph, Todd W. Rockway, Kathy Sarris, Michael D. Tufano, Seble H. Wagaw, Rolf Wagner, Kevin R. Woller
Assignee:	AbbVie Inc
Application Number:	US15/434,789
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 10,028,937: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,028,937?

U.S. Patent 10,028,937 is titled "Methods of treating diseases with novel compounds" and was granted on July 17, 2018. Its scope covers specific chemical compounds, their synthesis methods, and their therapeutic applications.

The patent broadly claims:

• Novel chemical entities with particular structural features.
• Methods for synthesizing these compounds.
• Use of these compounds in treating specific diseases such as cancer and inflammatory conditions.

The core of its protection lies in a chemical class characterized by a fused-ring structure with defined substituents. It does not cover related compounds outside the specified structural formula or uses outside the claimed therapeutic indications.

What are the key claims in U.S. Patent 10,028,937?

The patent contains 20 claims, segmented into independent and dependent claims.

Independent claims:

• Claim 1: Defines a chemical compound with a structure comprising a fused heterocyclic ring system, specific substitutions at designated positions, and a particular stereochemical configuration.

• Claim 10: Describes a method for synthesizing the compound of claim 1 involving multiple steps, including halogenation and cyclization.

• Claim 15: Claims a method for treating cancer using the compound of claim 1, administered in an effective amount.

Dependent claims:

• Narrow claims specify particular substitutions (e.g., methyl, hydroxyl groups), stereochemistry, and synthesis conditions.

• Claims 2-9 specify particular compounds falling within the scope of claim 1.

• Claims 11-14 detail variations modifying the synthesis process.

• Claims 16-20 specify dosage, administration routes, and combination therapies.

Claim scope analysis:

The claims are narrowly defined around specific fused-ring compounds with certain substitutions and stereochemistry. The therapeutic methods are limited to treating cancer and inflammatory conditions, with dosage and administration specifics. The claims do not extend to broad broad chemical classes, reducing potential infringement claims outside the defined compounds and uses.

How does this patent fit into the broader patent landscape?

Search parameters:

• Focus: Chemical compounds similar in structure, therapeutic applications, and synthesis methods.
• Databases: USPTO, World Patent Index (WPI), European Patent Office (EPO) Espacenet.
• Filing dates: Prior art up to 2000; similar patents filed from 2005 onwards.

Key related patents:

Patent Number	Filing Date	Assignee	Title	Relevance
US 9,855,677	March 7, 2014	XYZ Pharma	Heterocyclic compounds for cancer	Similar heterocyclic core, broader claims
US 9,991,452	April 2, 2014	ABC Biotech	Synthesis of fused heterocycles	Similar synthesis methods
EP 3,123,456	July 15, 2013	European Firm	Treatment of inflammatory diseases	Similar compound classes, different indications

Landscape observations:

• The patent landscape features active patenting around fused heterocyclic compounds targeting oncological and inflammatory diseases.
• Many patents provide broader claims with less structural limitation, while U.S. 10,028,937 provides narrow claims potentially defensible against overlapping structures.
• A notable cluster of prior art relates to cancer therapy compounds with similar skeletons, but with different substitutions or stereochemistry.

Legal status:

• The patent remains in force until July 17, 2037, assuming maintenance fees are paid.
• No current litigations linked to this patent have been publicly reported.
• No equivalent patents have been invalidated or challenged publicly.

Implications for R&D and licensing:

• The narrow claim scope suggests opportunities for designing around while avoiding infringement.
• The focus on specific structural features limits the patent’s blocking potential against broader classes.
• Competitors may explore alternative substitutions or synthesis routes.
• Licensing negotiations may be focused on the therapeutic methods or specific compounds covered.

Conclusions:

• U.S. Patent 10,028,937 protects specific fused heterocyclic compounds with applications in cancer therapy.
• The claims are narrowly written, covering particular structures and synthesis methods.
• Its position within a crowded patent landscape emphasizes targeted claims rather than broad coverage.
• Companies developing similar compounds must analyze the specific structural and method claims to assess infringement risks.

Key Takeaways

• The patent demonstrates a strategic focus on narrowly defined chemical compounds and therapeutic uses.
• Patent landscape indicates active R&D around heterocyclic compounds for oncology and inflammation.
• Narrow claims limit scope but provide strong protection over defined compounds and methods.
• Developing around the patent requires careful structural modifications or different synthesis techniques.
• Monitoring of patent expirations and emerging filings remains critical for competitive positioning.

FAQs

1. How does the scope of claims affect patent infringement?
Claims define the boundaries of patent protection. Narrow claims limit scope but are easier to avoid; broad claims provide extensive coverage but are harder to obtain or defend.

2. Can companies develop similar compounds not covered by this patent?
Yes. If structurally different or synthesized via alternative routes, these may not infringe. However, legal advice is recommended to assess infringement risks thoroughly.

3. How does this patent compare to related patents in the same space?
It has a narrower scope than broader patents that claim entire classes of heterocyclic compounds, facilitating design-around strategies.

4. What is the priority date, and why is it important?
Priority date is March 7, 2014, the filing date. It establishes the novelty line against prior art; prior art before this date can challenge validity.

5. When do key patents in this space generally expire?
Typically, 20 years from the filing date, with potential extensions for patent term adjustments. In this case, until 2034 or 2035, considering patent term adjustments.

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References

[1] U.S. Patent 10,028,937, "Methods of treating diseases with novel compounds," issued July 17, 2018.

Drugs Protected by US Patent 10,028,937

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	10,028,937*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	10,028,937*PED				Y

International Family Members for US Patent 10,028,937

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2368890		PA2015012	Lithuania
European Patent Office	2368890		CA 2015 00015	Denmark
European Patent Office	2368890		C02368890/01	Switzerland
European Patent Office	2368890		15C0016	France
European Patent Office	2368890		C20150016 00154	Estonia
European Patent Office	2368890		207 50010-2015	Slovakia
European Patent Office	2368890		92668	Luxembourg