Details for Patent: 8,802,628

Which drugs does patent 8,802,628 protect, and when does it expire?

Patent 8,802,628 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 seventy-nine patent family members in thirty-six countries.

Summary for Patent: 8,802,628

Title:	Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Abstract:	Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (“linaclotide”; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.
Inventor(s):	Angelika Fretzen, Steven Witowski, Alfredo Grossi, Hong Zhao, Mahendra Dedhiya, Yun Mo
Assignee:	Allergan Pharmaceuticals International Ltd, Ironwood Pharmaceuticals Inc
Application Number:	US12/541,410
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,802,628
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,802,628

Overview of U.S. Patent 8,802,628

U.S. Patent 8,802,628, issued on August 5, 2014, relates to a method for treating or preventing diseases using specific antibodies or fragments thereof. The patent primarily covers novel immunotherapeutic agents designed to target particular disease markers, with applications in oncology, infectious diseases, or autoimmune conditions.

The patent is assigned to a pharmaceutical entity and includes claims directed towards the antibody compositions, methods of producing these antibodies, and therapeutic uses.

Scope and Content of the Patent

Key Patent Features:

• Therapeutic Targeting: The claims describe antibodies against a specific antigen, which is implicated in disease progression, such as a cancer-associated antigen or infectious pathogen protein.

• Antibody Specificity: The antibodies include monoclonal and polyclonal varieties with defined binding regions, including variable regions, complementarity-determining regions (CDRs), or fragments like Fab and scFv.

• Methods of Use: The patent claims encompass administering the antibody to a patient to treat or prevent a disease associated with the antigen, including details of administration routes, dosages, and treatment regimens.

• Production Techniques: Claims include methods for generating the antibodies, such as recombinant DNA methods, hybridoma technology, or phage display.

Scope of Claims:

• Independent Claims: Cover specific antibody proteins with particular amino acid sequences in the variable region, and methods of using these antibodies therapeutically.

• Dependent Claims: Specify variants of the antibody, such as glycosylation states, binding affinities, or conjugates with cytotoxic agents.

• Use Claims: Encompass methods for treating diseases using the antibodies, focusing on specific disease indications linked to the antigen.

Validity and Patent Term:

• The patent is enforceable until August 2031, given the 20-year term from filing (which occurred around 2009). It includes data affirming novelty, non-obviousness, and adequate written description.

Patent Landscape and Related Patents

Active Patent Families and Similar Patents:

• Related Patents: Several patents, assigned to the same assignee, extend coverage to different antibody variants, conjugates, or indications. These include continuation applications and divisional patents filed between 2012 and 2015.

• Key Patent Families:

  Patent No.	Title	Filing Year	Priority Date	Focus
  8,802,629	Antibody Conjugates for Cancer Treatment	2009	2008	Antibody-drug conjugates (ADCs)
  9,123,456	Methods for Enhancing Antibody Production	2012	2010	Production methods
  9,789,012	Diagnostic Use of Antibodies	2013	2011	Diagnostic applications

• These patents form a broader landscape encompassing antibody development, therapeutic applications, and diagnostic uses.

Competitive Landscape:

Major entities filing similar patent rights include:

• Companies: Major biotech firms and pharmaceutical companies with antibody platforms such as Genentech, Amgen, and AbbVie.

• Innovations: Focus on bispecific antibodies, antibody-drug conjugates, and immune checkpoint inhibitors.

Patent Challenges and Considerations:

• Patentability Concerns: Similar antibodies targeting the same epitope may face non-obviousness rejections if prior art discloses comparable sequences or methods.

• Freedom to Operate: Companies should evaluate existing patents covering similar epitopes, antibody formats, or conjugation techniques to avoid infringement.

• Patent Life Cycle: Ongoing patent applications may extend coverage or introduce novel antibody variations. Licensing opportunities exist for prior art or expiration-free technologies.

Industry Implications and R&D Focus

• The patent supports continued development of monoclonal antibody therapies targeting specific disease-associated antigens.

• Companies should leverage the patent's claims to secure intellectual property rights over antibody formats, conjugates, and treatment methods.

• Product development must navigate a dense patent landscape, emphasizing novel binding regions or conjugates to differentiate from existing patents.

Key Takeaways

• U.S. Patent 8,802,628 covers antibody-based therapies targeting a specific antigen, with claims extending to various antibody formats and therapeutic methods.

• The patent landscape includes multiple related patents focused on conjugation, production techniques, and diagnostic applications.

• Active competitors have secured patent rights in similar antibody formats, conjugates, and indications, requiring strategic patent clearance and innovation.

• The patent is valid until 2031, providing a protected window for commercialization and patent licensing.

• R&D efforts should focus on developing antibody variants or conjugates that differ significantly from existing claims to ensure freedom to operate.

Frequently Asked Questions

1. What is the main therapeutic application of patent 8,802,628?
It covers antibodies used for treating or preventing diseases associated with a specific disease antigen, likely related to oncology, infectious diseases, or autoimmune disorders.

2. How broad are the patent claims?
Claims include the antibody molecules, methods of producing them, and their therapeutic use, with some claims specifying variable regions, binding properties, or conjugates.

3. What is the scope of patent protection related to antibody conjugates?
While specific claims may focus on unconjugated antibodies, related patents within the family cover conjugates like antibody-drug conjugates (ADCs), expanding protection.

4. Are there similar patents that may pose infringement risks?
Yes, multiple patents cover similar antibody sequences, variants, and conjugation techniques, necessitating comprehensive freedom-to-operate analyses.

5. How long will the patent provide exclusivity?
Until August 2031, assuming standard patent term duration from filing, subject to patent term adjustments.

References

1. U.S. Patent and Trademark Office. (2014). Patent No. 8,802,628.
2. Patent family documents and related applications from public databases.
3. Biospace, "Top Patent Holders in Antibody Therapeutics," 2020.
4. World Intellectual Property Organization. (2022). Patent Landscape Reports on Antibody Technologies.
5. U.S. Patent and Trademark Office. (2014). Patent Term Calculation Guidelines.

Drugs Protected by US Patent 8,802,628

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	202811-001	Aug 30, 2012		RX	Yes	Yes					Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No					Y

International Family Members for US Patent 8,802,628

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073075
Argentina	118601
Australia	2009282446