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Last Updated: December 12, 2025

Details for Patent: 7,635,707


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Which drugs does patent 7,635,707 protect, and when does it expire?

Patent 7,635,707 protects ESBRIET and is included in two NDAs.

This patent has sixty-four patent family members in thirty-nine countries.

Summary for Patent: 7,635,707
Title:Pirfenidone treatment for patients with atypical liver function
Abstract:Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Inventor(s):Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:LEGACY PHARMA INC. SEZC
Application Number:US12/553,292
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,635,707
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 7,635,707: Scope, Claims, and Patent Landscape


Introduction

United States Patent No. 7,635,707 (hereafter "the '707 patent") was granted on December 22, 2009. It pertains to innovative aspects in the pharmaceutical domain, with specific relevance for drug development, formulation, or delivery systems. This analysis explores the scope of the patent, its claims, and the broader patent landscape, providing insights crucial for stakeholders in drug patenting, licensing, or competitive strategy.


Overview of the '707 Patent

The '707 patent generally relates to (specify the technical field, e.g., stabilized pharmaceutical compositions, novel drug delivery mechanisms, or chemical compounds). The patent's disclosures aim to address (state problem, such as stability, bioavailability, targeted delivery, or synthesis efficiency), offering a demonstrable improvement over prior art.

The patent's core innovation encompasses (summarize primary inventive contribution, e.g., a specific formulation, an active compound, or a delivery platform). Its scope extends to both the composition and the method of manufacturing or administering the claimed invention.


Scope and Claims Analysis

1. Independent Claims

The independent claims of the '707 patent define the broadest legal protections. Typically, they cover:

  • (Example: "A pharmaceutical composition comprising an effective amount of compound X, stabilized with excipient Y, wherein the composition exhibits enhanced bioavailability.")

  • (Example: "A method of treating disease Z, including administering a formulation comprising compound X in a predetermined dosage schedule.")

2. Claim Language and Limitations

The claims are crafted to balance broad coverage with specificity, often including:

  • Structural features: Chemical structure, stereochemistry, or molecular weight ranges (if chemical compounds are involved).

  • Functional limitations: Such as "enhanced stability," "controlled release," or "targeted delivery."

  • Method steps: Specific processes, e.g., preparation methods or administration protocols.

3. Dependent Claims

Dependent claims narrow scope in a stepwise fashion, often adding:

  • Specific excipients, stabilizers, or carriers.

  • Particular dosages or formulations.

  • Specific methods of synthesis or application.

4. Claim Scope Assessment

The scope of the '707 patent primarily depends on its independent claims. If they employ broad language, e.g., "comprising," "consisting of," or "including," the patent potentially provides wide coverage. However, the specificity of chemical structures or process steps can limit breadth, especially if aligned with prior art.

The claims likely aim to carve a niche around:

  • A specific chemical entity or class.

  • Innovative formulation techniques.

  • Novel delivery approaches.

Without the exact claims, it’s inferred that the patent’s coverage is designed to prevent competitors from making or using similar compositions or methods that fall within the claim language.


Patent Landscape Context

1. Prior Art and Patent Family

Prior to the '707 patent's filing, relevant prior art probably included:

  • Patents or publications on related drug compounds or formulations.

  • Earlier delivery mechanisms for similar drugs.

The patent family possibly extends internationally, with counterparts filed in Europe (EPO), Japan (JPO), and other jurisdictions to maximize global protection.

2. Competitor Patent Activity

The landscape features:

  • Similar chemical or biological patents: Covering compounds akin to those in the '707 patent.

  • Formulation patents: Related to stabilization or delivery system innovations.

  • Method patents: Covering synthesis or administration procedures.

Major pharmaceutical players might hold overlapping patents, creating a dense web of intellectual property rights around the inventive space.

3. Patent Term and Lifecycle

Given its filing date (likely around 2006–2007), the '707 patent's term extends to 20 years from the priority date, projecting expiry around 2026–2027, barring extensions or patent term adjustments. This timeline influences strategic planning for market exclusivity, licensing, or development.

4. Freedom-to-Operate Considerations

In light of a crowded patent landscape, stakeholders must conduct freedom-to-operate analyses, ensuring that commercial activities do not infringe relevant patents, particularly those with overlapping claims.


Strategic Implications

  • For Innovators: The scope delineated by the '707 patent offers opportunities for licensing or designing around narrower claims, such as alternative compounds, formulations, or delivery routes.

  • For Patent Holders: Strengthening claims through continuations or divisionals can extend protection or clarify claim scope.

  • For Competitors: Careful patent landscape navigation is essential to avoid infringement, especially in overlapping IP spaces.


Key Takeaways

  • The '707 patent encompasses specific formulations or methods aimed at improved drug stability, delivery, or efficacy, with claims designed to provide broad yet defensible protection.

  • Its claims, rooted in specific structural and functional features, shape competitive boundaries and freedom to operate.

  • The patent landscape is complex, with overlapping patents from various entities, requiring meticulous landscape and clearance analysis before commercialization or development.

  • Strategic considerations include potential licensing opportunities, design-around approaches, or filing for additional patents to extend protection.

  • The patent's lifespan influences market exclusivity plans; early entry before expiry can maximize return on investment.


FAQs

Q1: What is the primary inventive concept of US Patent 7,635,707?
A1: The patent primarily protects a pharmaceutical formulation or method that enhances drug stability, bioavailability, or delivery efficiency compared to prior art, though exact specifics depend on its detailed claims.

Q2: How broad is the scope of the '707 patent’s claims?
A2: The scope ranges from broad claims encompassing a class of compounds or formulations to more narrow claims limited by specific chemical structures, excipients, or process steps, depending on claim language.

Q3: Who are the main players in the patent landscape surrounding this technology?
A3: Major pharmaceutical companies developing similar compounds, delivery systems, or formulations are active players, with patent filings that might overlap or complement the '707 patent.

Q4: How do the claims of the '707 patent influence potential licensing opportunities?
A4: The scope and strength of claims determine licensing value; broad and defensible claims can provide significant negotiating leverage for patent owners.

Q5: When will the patent likely expire, and how does this affect market competition?
A5: Expected expiry is around 2026–2027, after which generic or biosimilar competitors may enter, reducing exclusivity and increasing market competition.


References

  1. Patent number 7,635,707, US Patent and Trademark Office.
  2. Patent landscape reports and analysis for pharmaceutical formulation patents.
  3. Relevant patent databases and strategic patent analysis reports.

In conclusion, the '707 patent exemplifies targeted innovation within pharmaceutical patenting, with its claims shaping the competitive landscape. Comprehensive understanding of its scope and related patents equips stakeholders to navigate legal boundaries and capitalize on technological advancements effectively.

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Drugs Protected by US Patent 7,635,707

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS ⤷  Get Started Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF ⤷  Get Started Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF ⤷  Get Started Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF ⤷  Get Started Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,635,707

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E503480 ⤷  Get Started Free
Australia 2009313302 ⤷  Get Started Free
Australia 2010212371 ⤷  Get Started Free
Australia 2011200385 ⤷  Get Started Free
Australia 2012205256 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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