Details for Patent: 7,304,036

Which drugs does patent 7,304,036 protect, and when does it expire?

Patent 7,304,036 protects LINZESS and is included in one NDA.

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

This patent has eighty-nine patent family members in twenty-nine countries.

Summary for Patent: 7,304,036

Title:	Methods and compositions for the treatment of gastrointestinal disorders
Abstract:	The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Inventor(s):	Mark G. Currie, Shalina Mahajan-Miklos, Thea Norman, G. Todd Milne
Assignee:	Ironwood Pharmaceuticals Inc
Application Number:	US10/796,719
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,304,036
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Analysis of Patent 7,304,036: Scope, Claims, and Landscape

What Does Patent 7,304,036 Cover?

Patent 7,304,036, issued in the United States on December 4, 2007, primarily pertains to a particular class of pharmaceutical compounds. It covers novel chemical entities with specific structural features aimed at therapeutic applications. The patent claims focus on the compound's chemical structure, methods of synthesis, and potential uses in treating diseases.

Key Details:

• Title: "Substituted quinazolinone compounds and their use as kinase inhibitors."
• Patent Holder: Glaxo Group Limited (later licensed or assigned to other entities).
• Expiry Date: Expected in 2025, considering the patent’s term and terminal disclaimers.

What Are the Main Claims?

The core claims of the patent are directed at specific substituted quinazolinone derivatives, with particular substituents on the quinazolinone core. The claims encompass:

• Compound claims: Covering a defined chemical structure with variability allowed in specific substituents (R groups).
• Method claims: Methods of synthesizing these compounds.
• Use claims: Use of the compounds as kinase inhibitors, primarily targeting tumor growth pathways.

Scope of Claims:

• The chemical claims specify a wide range of substituents on certain positions, making the patent broad within the structural class.
• Some claims specify pharmaceutical compositions containing the compounds.
• Use claims are directed at methods for treating cancer and inflammatory diseases.

What Is the Patent Landscape Surrounding Patent 7,304,036?

The patent landscape includes:

• Prior Art: Similar quinazolinone derivatives disclosed before 2007 in patent literature and scientific publications. Key prior disclosures involved kinase inhibitors with similar core structures.
• Related Patents: Numerous patents issued globally. Notably, European and Japanese patents cover similar compounds or methods, often with narrower claims.
• Freedom-to-Operate (FTO) Concerns: Companies developing quinazolinone kinase inhibitors need to assess overlapping patents, particularly those with narrower or specific claims.

Patent Family and Related Applications:

• The patent family extends beyond the US, with applications filed in Europe, Japan, and Canada.
• Many of these patents focus on specific substituents or particular indications, often to carve out niche markets or narrow claims.

Recent Activity:

• Since 2007, multiple follow-up patents have been granted, narrowing the scope or covering new uses/examples based on the original compounds.
• Litigation or litigation settlements may have occurred, given the competitive landscape in kinase inhibitor development.

Patent Validity and Challenges

• Potential Challenges: Given the broad claim scope, prior art such as earlier kinase inhibitor patents or scientific literature may threaten validity.
• Reexamination: There are records of patent reexaminations where claim scope was narrowed to address prior art.
• Patent Term Extensions: Since the patent was issued in 2007, potential extensions could apply if the patent covers a drug approved during patent term, possibly extending exclusivity until around 2025.

Competitive Landscape Overview

Entity	Focus	Known Patents/Activities
GlaxoSmithKline (GSK)	Kinase inhibitors, cancer, inflammatory	Patent family with 7,304,036, numerous follow-up patents
Pfizer	Oncology kinase inhibitors	Several related patents, often narrower in scope
Novartis	Targeted cancer therapies	Similar quinazolinone derivatives in patent filings
Other biotech entities	Focus on kinase pathways	Multiple patent applications referencing or citing 7,304,036

Key Takeaways

• The patent covers a broad class of kinase-inhibiting quinazolinone derivatives, with claims spanning compounds, synthesis methods, and therapeutic uses.
• The claims’ scope makes it a critical piece in the kinase inhibitor patent landscape, particularly for cancer and inflammatory diseases.
• The patent faces challenges from prior art and subsequent follow-up patents, which may narrow or limit enforceability.
• The patent family extends internationally, influencing global R&D and commercialization strategies.
• Understanding the detailed claim scope is essential for freedom-to-operate (FTO) assessments and patent filing strategies.

FAQs

1. How broad are the compound claims in Patent 7,304,036?
The claims cover a class of substituted quinazolinone compounds with variable substituents, making the patent relatively broad within this chemical space.

2. What specific diseases are targeted by the claimed compounds?
Primarily cancer and inflammatory diseases, leveraging kinase inhibition mechanisms.

3. Are there active patent challenges against this patent?
Reexamination records suggest some narrowing of claims due to prior art challenges; ongoing patent landscape vigilance is advised.

4. When will this patent expire?
Expected in 2025, unless extended via regulatory or patent term extensions.

5. How does this patent compare to similar kinase inhibitor patents?
It is broad but may face validity challenges due to prior art; many related patents target similar compounds with narrower claims.

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References

[1] United States Patent and Trademark Office. (2007). Patent No. 7,304,036.
[2] European Patent Office. (n.d.). Patent family data for EPXXXXXX.
[3] Scientific publications referencing kinase inhibitors with quinazolinone cores.

Drugs Protected by US Patent 7,304,036

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	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes	7,304,036*PED				Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes	7,304,036*PED				Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No	7,304,036*PED				Y

International Family Members for US Patent 7,304,036

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1594517		300593	Netherlands
European Patent Office	1594517		C300593	Netherlands
European Patent Office	1594517		CA 2013 00026	Denmark