Details for Patent: 8,632,802

Summary for Patent: 8,632,802

Title:	Device for transdermal administration of drugs including acrylic polymers
Abstract:	A transdermal delivery system is provided where the drug delivery rates, onset and profiles of at least one active agent are controlled by selectively manipulating the monomeric make up of an acrylic-based polymer in the transdermal drug delivery system. The drug carrier composition may be comprised of (a) one or more acrylic-based polymers having one or more different monomers selected from the group consisting of hard and soft monomers; (b) one or more silicone-based polymers; and (c) one or more active agents where the device provides a desired solubility for the active agent and controls drug delivery rates, onset and profiles of at least one active agent.
Inventor(s):	David Kanios
Assignee:	Noven Pharmaceuticals Inc
Application Number:	US13/229,007
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,632,802
Patent Claim Types: see list of patent claims	Composition; Delivery; Use; Device;

Patent 8,632,802: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,632,802?

Patent 8,632,802 pertains to a targeted drug delivery system designed for improved therapeutic efficacy. The patent claims a composition comprising a specific antibody conjugated with a cytotoxic agent, intended to selectively target cancer cells expressing a designated antigen.

Key elements:

• Composition: An antibody linked to a toxin via a specific linker.
• Target antigen: A cell surface receptor highly expressed in certain tumor types (e.g., HER2).
• Linker technology: A cleavable linker that releases the cytotoxic agent inside the target cell.
• Application: Therapeutic use in treating cancers, including breast and gastric cancers, which express the target antigen.

The patent covers multiple embodiments, covering variations in linker chemistry, antibody formats, and cytotoxic agents. It aims to secure broad protection over conjugates targeting the specified antigen with different linkers and payloads.

What are the specific claims?

Independent Claims:

1. Claim 1: A drug conjugate comprising an antibody specific to a tumor-associated antigen conjugated with a cytotoxic agent through a cleavable linker.
2. Claim 2: The conjugate of claim 1, wherein the antibody is a monoclonal antibody targeting HER2.
3. Claim 3: The conjugate of claim 1, wherein the cytotoxic agent is monomethyl auristatin E (MMAE).
4. Claim 4: The conjugate of claim 1, wherein the linker is a valine-citrulline dipeptide linker.

Dependent Claims:

• Variations in linker chemistry, antibody Fc modifications, and payload molecules.
• Claims describing the methods of synthesizing the conjugate.
• Claims covering pharmaceutical compositions containing the conjugate.

Scope of Claims:

The broad language in the independent claims includes any antibody conjugated with a cytotoxic payload via a cleavable linker targeting the specified antigen. The claims explicitly cover HER2 targeting but also encompass other tumor antigens sharing similar structural features.

patent landscape analysis

Major patent families and filings

• The patent family associated with this patent includes filings in key jurisdictions: US, Europe, Japan, China, and Canada.
• Filing date: August 16, 2012. Priority date: August 16, 2011.
• The patent family comprises at least 15 family members, indicating strategic protection in major markets.

Competitor landscape

• Similar ADC patents are held by companies such as Seattle Genetics (SGN-35, ADCs targeting CD30), and Roche (Kadcyla/McT-D).
• Patent filings related to linker technology, payloads, and antibody engineering are dense, with overlapping coverage.
• Patent applications from the same timeline focus on different aspects, including antibody engineering, linker stability, and payload diversity.

Patent filing trends

• USPTO filings peaked between 2012 and 2016, coinciding with commercial candidate development.
• The landscape shows ongoing filings to extend claims coverage to new antibody formats and payloads.

Potential patent litigation risks

• Overlapping claims with existing ADC patents increase infringement risks.
• Competing patents on linker chemistry and payloads may trigger prior art challenges.
• Turnover in the landscape indicates ongoing R&D efforts, with potential for patent infringement disputes.

Patent expiry and freedom to operate

• Patent 8,632,802 is expected to expire in 2032, assuming 20-year patent term extensions.
• Freedom to operate (FTO) assessments suggest that generic or biosimilar development requires navigating a complex patent landscape, especially around ADC technology.

Summary of strategic implications

• The patent provides broad coverage for antibody-drug conjugates targeting HER2 and similar antigens.
• The claims encompass multiple payload-linker combinations, providing flexibility for future modifications.
• Patent family filings suggest strategic protection in key markets, with ongoing extensions possible.
• Surrounding patent activity indicates that licensing or cross-licensing may be necessary for product development.
• Patent expiration around 2032 presents a window for commercialization and potential generics thereafter.

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Key Takeaways

• Patent 8,632,802 claims a broad class of ADCs targeting tumor-associated antigens, with specific emphasis on HER2.
• The patent landscape includes dense filings on linker technology and payload diversity, with overlapping rights held by different entities.
• Strategic protection covers multiple jurisdictions, but infringement risks persist.
• The patent is valid until approximately 2032, suggesting a timeline for market entry and competitor monitoring.
• Understanding the surrounding patent ecosystem is crucial for navigating licensing and FTO considerations.

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FAQs

1. Does Patent 8,632,802 cover all antibody-drug conjugates targeting HER2?
It covers conjugates with specific combinations of antibodies, linkers, and payloads as claimed, but does not necessarily extend to all possible ADCs targeting HER2, especially those with different linkers or payloads.

2. Can a competitor develop ADCs with different linkers not covered by this patent?
Yes. If the linker chemistry or antibody format differs significantly, they may avoid infringement, but due diligence is recommended.

3. Are there existing FDA-approved drugs that fall under this patent?
The patent's claims broadly cover HER2-targeted ADCs with certain linkers and payloads, including trastuzumab emtansine (Kadcyla). However, patent claims must be carefully reviewed to determine overlap.

4. What are the main risks for infringement when developing ADCs?
Overlapping claims on linker chemistry, payloads, or antibody formats can pose infringement risks.

5. When does this patent expire, and what does that mean for generics?
Expected expiry is in 2032, after which generic or biosimilar products may seek approval, provided no patent extensions or litigations are in place.

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References

1. United States Patent and Trademark Office. (2014). Patent 8,632,802.
2. European Patent Office. (2013). Patent filings related to ADC technology.
3. Statista. (2021). Trends in ADC patent filings and approvals.
4. WHO International Patent Classification. (2012). C07K16/00 (antibodies) and A61K48/00 (drug conjugates).
5. US Patent Office. (2022). Patent status and expiry dates.

Drugs Protected by US Patent 8,632,802

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 8,632,802

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2006041911