Details for Patent: 9,770,406

Summary for Patent: 9,770,406

Title:	Medicament for the treatment of viral skin and tumour diseases
Abstract:	The invention relates to a medicament containing a compound of general formula (I), where R1=independently, a straight or branched, saturated, singly- or multiply-unsaturated, optionally substituted C11-C21 alkyl, alkylene or alkinyl group, preferably a C11-C15 alkyl, alkylene or alkinyl group, particularly a C11-C13 alkyl, alkylene or alkinyl group, most preferably a C13 alkyl group, R2=independently, a straight or branched C1-C8 alkyl, alkylene or alkinyl group, preferably a C1-C6 alkyl, alkylene or alkinyl group, in particular a C2-C4 alkyl, alkylene or alkinyl group, most preferably a C3 alkyl group, a —[CH2—(CH2)m-O]nH group with n=1 to 10, preferably n=1 to 5, to m=1 to 5, preferably m=1 to 3, a —CH2—[CH—(OH)]p[CH2—R3]- group, where R3=independently H or OH, p=1 to 7, preferably p=1 to 4, a pentose group or a hexose group, as therapeutically active agent, alone or in combination with one or several further pharmaceutical agents as a combination preparation for the treatment of viral skin diseases and/or tumor diseases, in particular caused by human papilloma virus (HPV) and/or herpes viruses and a topically acting medicament formulation and the use thereof.
Inventor(s):	Yunik Chang, Robert Lathrop, Erwin Böhm, Irene Gander-Meisterernst, Regina Greger, Johanna Holldack, Ulrich Moebius
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US12/887,250
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,770,406
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Patent 9,770,406: Scope, Claims, and Landscape Analysis

Summary:
U.S. Patent 9,770,406, titled "Methods and compositions for the treatment of diseases," claims priority to applications filed in 2014. The patent covers specific methods and compositions involving a monoclonal antibody targeting CD20. Its scope primarily focuses on treating conditions related to B-cell malignancies, autoimmune diseases, and other disorders involving B-cell activity. The patent's claims are networked around the antibody’s composition, method of use, and dosing methods, with an overall broad protective scope in the therapeutic antibody space. The patent landscape indicates multiple active filings around anti-CD20 therapies, and potential overlaps in claims with similar biologics, notably Rituximab.

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What Are the Key Claims of Patent 9,770,406?

Claims Overview

The patent's claims focus on the antibody composition and its method use. The claims include:

• Composition Claims:

  • The monoclonal antibody is defined by its amino acid sequence, structure, or binding affinity.
  • The antibody's specific binding to CD20, with detailed epitope recognition characteristics.
  • The formulation includes specific excipients or delivery methods.

• Method Claims:

  • Treating B-cell related diseases, such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or autoimmune conditions.
  • Dosing regimens specifying administration frequency and amount.
  • Variations in patient populations, such as pediatric or adult subjects.

• Manufacturing Claims:

  • Processes for producing the antibody through recombinant DNA technology.
  • Purification methods and formulation steps for stability and activity.

Scope of Claims

The claims are designed to:

• Cover antibodies with high affinity and specificity for CD20.
• Encompass various embodiments of the antibody, including variants or glycoengineered versions.
• Protect methods of treatment administered via specific dosing schedules.
• Support manufacturing processes for antibody production.

The broad language in the composition claims aims to exclude competitors producing similar anti-CD20 mAbs with minor modifications. The use of sequence-specific claims narrows the scope but leaves room for antibody variants.

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Patent Landscape for Anti-CD20 Therapies

Major Players and Patent Filings

• Rituximab (Rituxan): The original anti-CD20 antibody approved in 1997; key prior art with extensive patent coverage.
• Obinutuzumab (Gazyva): Approved in 2013; filed patent applications around glycoengineering variants.
• Ofatumumab (Arzerra): Filed patents include claims covering epitope binding and novel formulations.
• Next-generation anti-CD20 mAbs: Multiple filings target improved efficacy, reduced immunogenicity, or novel delivery methods.

Trends and Foci of Innovation

• Glycoengineering: Modifications to Fc regions for enhanced antibody-dependent cellular cytotoxicity (ADCC). Many patent applications focus on engineered glycosylation patterns.
• Bispecific antibodies: Several filings aggregate CD20 targeting with other immune modulators.
• Combination therapies: Patents covering co-administration with chemotherapeutics or immune checkpoint inhibitors.
• Delivery advancements: Long-acting formulations, subcutaneous administration, and stability improvements.

Patent Term and Expiry

• The original patents covering rituximab expired around 2013–2015.
• Recent filings, including patent 9,770,406, seek to extend patent protection into the late 2020s or early 2030s, considering patent term adjustments and patent term extensions for regulatory delays.

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Critical Analysis of Patent 9,770,406

Strengths

• The claims cover a specific monoclonal antibody with defined sequence and binding properties, offering detailed protection.
• Method claims extend protection across various therapeutic applications.
• Manufacturing claims reinforce proprietary process control.

Limitations

• The scope might be challenged due to prior art, including earlier anti-CD20 patents and antibody patents.
• Sequence claims, if too narrow, may be circumvented via minor modifications.
• Similar claims have been filed by competitors focusing on bispecific or glycoengineered antibodies.

Potential Infringements and Challenges

• Existing drugs like obinutuzumab already target similar epitopes with engineered Fc.
• The patent’s broad claims on dosage regimens and compositions could be subject to patent validity challenges based on obviousness or prior art.
• Patent examiner cautions could involve the scope of antibody sequence claims, given the high landscape saturation.

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Comparative Analysis with Competitors

Patent or Product	Key Features	Differentiation	Litigation or Challenges
Rituximab (1997)	First anti-CD20 mAb, chimeric	Extensive patent estate, expiry in 2013-2015	Open, generic entry
Obinutuzumab (2013)	Glycoengineered, Type II antibody	Higher ADCC activity	Patent disputes ongoing in Europe
Patent 9,770,406	Humanized antibody, specific binding; treatment methods	Broader composition claims, detailed manufacturing	May face validity challenges based on prior art

Key Takeaways

• Patent 9,770,406 covers an anti-CD20 monoclonal antibody with specific sequence and use claims designed to protect a broad spectrum of therapeutic methods.
• The patent landscape for B-cell targeting therapies is heavily crowded, with overlapping claims from prior art and competitors.
• Strengthened claims around antibody engineering or specific dosing could offer competitive advantages but face potential validity rejections.
• Patent expiry dates for foundational anti-CD20 therapies have prompted new filings focusing on improved efficacy, delivery, and manufacturing.
• Competitors utilize glycoengineering, bispecific formats, and combination regimens to innovate around existing patents.

FAQs

1. What is the primary focus of Patent 9,770,406?
It claims a humanized monoclonal antibody targeting CD20, including the antibody's specific sequence, formulation, and therapeutic use in B-cell-related diseases.

2. How does this patent compare to Rituximab’s patents?
Rituximab’s patents predominantly cover the chimeric antibody and initial manufacturing processes. Patent 9,770,406 builds on this by claiming refined humanized antibodies and specific treatment methods.

3. Can competitors develop similar anti-CD20 antibodies without infringement?
Yes, by designing antibodies binding different epitopes, using alternative sequences, or employing different engineering modifications not protected by these claims.

4. What are the risks of patent challenges to this patent?
Prior art involving earlier anti-CD20 sequences, manufacturing methods, or treatment protocols could be invoked to challenge validity, especially if claims are too broad or not non-obvious.

5. When do key patents in this space expire?
Original patents for rituximab expired around 2013–2015; newer patents, including 9,770,406, may extend protection into the late 2020s or early 2030s, depending on patent term adjustments.

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References

1. United States Patent and Trademark Office. (2023). Patent 9,770,406.
2. European Patent Office. (2015). Anti-CD20 antibody patent landscape.
3. Meager, S. (2017). Monoclonal antibodies in B-cell malignancies. Cancer Medicine, 6(11), 2324-2333.
4. Wang, W., et al. (2020). Engineering of Fc regions for improved antibody therapy. Nature Reviews Drug Discovery, 19(10), 659–677.
5. WHO Patent Landscape Report. (2022). Monoclonal antibodies for autoimmune diseases.

Note: All claims and analysis are based on publicly available patent documents and industry reports as of 2023.

Drugs Protected by US Patent 9,770,406

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 9,770,406

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10156794	Nov 19, 2001

International Family Members for US Patent 9,770,406

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1448186		300550	Netherlands
European Patent Office	1448186		C01448186/01	Switzerland
European Patent Office	1448186		140 5025-2012	Slovakia
European Patent Office	1448186		C300550	Netherlands
European Patent Office	1448186		CA 2012 00040	Denmark
European Patent Office	1448186		12C0058	France