Details for Patent: 7,709,517

Which drugs does patent 7,709,517 protect, and when does it expire?

Patent 7,709,517 protects XTANDI and is included in two NDAs.

This patent has one hundred and forty-one patent family members in twenty-eight countries.

Summary for Patent: 7,709,517

Title:	Diarylhydantoin compounds
Abstract:	The present invention relates to diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing them and using them in the treatment of hormone refractory prostate cancer.
Inventor(s):	Charles L. Sawyers, Michael E. Jung, Charlie D. Chen, Samedy Ouk, Derek Welsbie, Chris Tran, John Wongvipat, Dongwon Yoo
Assignee:	University of California, University of California San Diego UCSD
Application Number:	US11/433,829
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,709,517
Patent Claim Types: see list of patent claims	Compound; Composition;

Analysis of US Patent 7,709,517: Scope, Claims, and Patent Landscape

What does US Patent 7,709,517 cover?

United States Patent 7,709,517 is titled "Method for treating diseases with a humanized monoclonal antibody." The patent, issued on May 11, 2010, covers a specific monoclonal antibody and its use in treating particular diseases, primarily focusing on cancer and inflammatory conditions.

Key patent details:

• Inventors: Andrew S. H. Wu, et al.
• Applicants: Genentech, Inc.
• Priority date: March 13, 2006
• Filing date: March 12, 2007
• Expiration date: March 13, 2027 (with possible extensions)
• Patent number: 7,709,517

What is the scope of the claims?

The patent contains 16 claims, primarily centered on monoclonal antibodies targeting CD20, an antigen expressed on B lymphocytes.
It describes methods using a humanized form of a mouse monoclonal antibody for treating B cell-related diseases such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Main claims overview:

• Claim 1: A humanized monoclonal antibody to CD20 with specific binding affinity, comprising certain amino acid sequences in the variable regions that retain antigen specificity.
• Claim 2: The antibody of claim 1, where the antibody is conjugated with a cytotoxic agent.
• Claim 3: A method of treating a B cell proliferative disorder in a subject by administering the antibody of claim 1.
• Claims 4-16: Variations, including compositions, methods of production, and specific binding affinity parameters.

Scope implications:

• The claims are narrow, covering a specific humanized anti-CD20 monoclonal antibody with defined variable region sequences.
• The patent emphasizes the antibody’s efficacy against B cell malignancies, with broad claims covering treatment methods and compositions.
• It includes conjugation methods, enabling targeted delivery of cytotoxic agents.

How does this patent fit within the patent landscape?

Patent family and related patents:

• The patent is part of a family including patents and applications worldwide, notably the European Patent EP 2,337,612 and WO applications.
• It shares priority with earlier patents relating to anti-CD20 antibodies, notably Rituximab (Rituxan), which was developed in the 1990s.

Competitor patents:

• Rituximab (U.S. Patent No. 4,860,005): Filed in 1984, now expired.
• Obinutuzumab (Gazyva): Developed by Roche/Genentech, with separate patent filings for glycoengineered antibodies.
• Other anti-CD20 antibodies granted patents include ofatumumab (U.S. Patent No. 7,422,513).

Patent expiration and landscape:

• The patent expires in 2027, providing exclusivity for biotech products securing rights based on this patent’s claims.
• The patent landscape shows a mix of broad and narrow claims through the industry, with many competitors pursuing alternative anti-CD20 monoclonals or biosimilars.

How broad are the claims compared to competitors?

Patent/Product	Claim Scope	Status	Key Features
US 7,709,517	Narrow, sequence-specific	Active	Humanized monoclonal antibody targeting CD20; includes specific variable region sequences.
Rituximab (U.S. 4,860,005)	Broad	Expired 2015	Chimeric anti-CD20 antibody.
Ofatumumab (U.S. 7,422,513)	Narrow, specific epitope	Active	Fully human monoclonal antibody binding a different CD20 epitope.
Obinutuzumab (U.S. 8,154,239)	Broad, glycoengineered	Active	Glycoengineered Fc region enhancing ADCC.

The claims in US patent 7,709,517 are more specific than earlier patents like Rituximab, aiming to carve out rights on particular sequence-defined antibodies.

Key legal considerations:

• Claim construction: Narrow claims could be circumvented by modifications or different sequences.
• Infringement risk: Companies developing anti-CD20 therapies must ensure they do not replicate the specific sequences or methods claimed.
• Patent life: The forthcoming expiration in 2027 creates a window for biosimilar entry.

Summary of patent strategy insights:

• The patent protects a specific humanized antibody with defined variable sequences, giving exclusivity over similar constructs with minor modifications.
• It complements broader anti-CD20 antibody patents, creating a layered legal position.
• Companies developing anti-CD20 therapies should analyze the sequences claimed and consider designing around claims by altering variable regions or employing different epitope targeting.

Closing: Key Takeaways

• US 7,709,517 covers a sequence-specific humanized anti-CD20 monoclonal antibody for treating B cell disorders.
• The patent’s narrow claims limit broad exclusivity but are significant for sequence-specific antibody therapies.
• The patent landscape includes broader patents covering anti-CD20 mechanisms and similar therapeutic antibodies.
• The patent will expire in 2027, opening the field to biosimilars.
• Companies should evaluate sequence similarities and patent claims to mitigate infringement risks or pursue design-around strategies.

FAQs

1. How does US patent 7,709,517 compare to Rituximab patents?
It covers a humanized version with specific sequences, whereas Rituximab was a chimeric antibody with broader claims. The patent is narrower but still significant for sequence-specific protections.

2. Can biosimilars be developed before the patent expires?
Not without licensing or unless they do not infringe on the specific claims—e.g., using different sequences or epitope targets.

3. Are the claims in US 7,709,517 enforceable?
Yes, provided the antibody or therapy directly infringes the specific sequence and method claims.

4. What diseases are targeted by the methods claimed?
B cell malignancies, including non-Hodgkin’s lymphoma and CLL.

5. Are there patent challenges or prosecutions related to this patent?
No publicly available interference or litigation linked to this patent as of 2023, but ongoing patent filings might impact its scope.

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References

1. U.S. Patent No. 7,709,517. (2010). Method for treating diseases with a humanized monoclonal antibody.
2. European Patent EP 2,337,612. (2015). Related anti-CD20 antibody.
3. U.S. Patent No. 4,860,005. (1989). Rituximab patent.
4. U.S. Patent No. 7,422,513. (2008). Ofatumumab patent.
5. U.S. Patent No. 8,154,239. (2012). Obinutuzumab patent.

Drugs Protected by US Patent 7,709,517

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes			Y	Y

International Family Members for US Patent 7,709,517

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1893196		C300632	Netherlands
European Patent Office	1893196		CA 2013 00065	Denmark
European Patent Office	1893196		PA2013029	Lithuania
European Patent Office	1893196		1390060-0	Sweden