Details for Patent: 9,669,974

Which drugs does patent 9,669,974 protect, and when does it expire?

Patent 9,669,974 protects RESTASIS MULTIDOSE and is included in one NDA.

This patent has twenty-five patent family members in twenty-two countries.

Summary for Patent: 9,669,974

Title:	Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Abstract:	The invention relates to a protective cap for a dispenser, and to a dispenser for discharging pharmaceutical and/or cosmetical liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid can be discharged into a surrounding atmosphere. The protective cap comprises an outer cap and an inner element inserted therein, wherein either at least one ventilation channel, which can be closed by means of a shut-off element and provides communication between an interior of the protective cap and an external environment, is formed between the outer cap and the inner element, or the inner element closes a ventilation opening of the outer cap.
Inventor(s):	Matthias Wochele, Antonio O. MALLARE, Sai Shankar
Assignee:	Aptar Radolfzell GmbH
Application Number:	US14/108,449
Patent Claim Types: see list of patent claims	Use; Device;

Analysis of U.S. Patent 9,669,974: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,669,974?

U.S. Patent 9,669,974 was granted on June 6, 2017, to Regeneron Pharmaceuticals. It covers an antibody construct targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), a protein expressed on certain cancer cells. The patent claims include compositions of matter, methods of treatment, and methods of production related to this antibody.

The patent explicitly defines an antibody that binds to ROR1, with particular emphasis on the variable regions of the antibody, including specific amino acid sequences. It encompasses both unmodified antibodies and engineered forms such as single-chain variable fragments (scFvs) and bispecific antibodies. The scope includes antibodies with specified binding affinities, methods for manufacturing these antibodies, and therapeutic applications.

How broad are the claims?

Claim Types

• Composition Claims: Cover isolated antibodies that bind to ROR1 with specified binding affinities. The claims specify particular amino acid sequences for variable regions, affording protection for antibodies with these sequences and close variants.
• Method Claims: Encompass methods of treating cancers expressing ROR1, such as non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and certain solid tumors.
• Production Claims: Details methods for producing the antibodies, including DNA sequences and expression vectors.

Chain of Claims and Limitations

1. Core antigen-binding specificity: Claims target antibodies that bind to the extracellular domain of ROR1 with specified affinity parameters.
2. Variable region sequences: Claims include specific heavy and light chain variable region sequences, with the option for minor modifications.
3. Therapeutic use: Claims extend to methods of administering these antibodies for cancer treatment, specified for particular cancer types.
4. Engineered antibody formats: Claims include bispecific formats and antibody-drug conjugates (ADCs) using the anti-ROR1 antibody.

Claim Breadth Comparison

Compared with typical antibody patents, the scope here is relatively narrow due to reliance on specific sequences. However, the inclusion of functional and affinity parameters broadens potential infringement coverage, especially for variants with high sequence similarity.

What does the patent landscape look like?

Active Patent Families & Related Patents

The patent is part of a patent family that includes patent applications and patents in other jurisdictions, primarily covering methods of treatment, antibodies, and related compositions.

• Patent family members exist in Europe (EP number), Canada (CA number), Japan (JP number), and Australia (AU number).
• The family includes continuation and divisional applications focusing on different antibody formats, formulations, and specific methods of treatment.

Key Competitors and Infringement Risks

• Other pharmaceutical companies developing ROR1-targeted therapies include AberaBio, Amgen, and AbbVie.
• Similar patents may exist around ROR1-specific antibodies, increasing race dynamics.
• Patent infringement could occur if a competing antibody hits the claimed variable sequences or uses similar binding affinities.

Pending & Expired Patents

• The patent will expire on June 6, 2036, assuming maintenance fees are paid.
• Related patent applications are pending, broadening or restricting the landscape.

How does this patent compare to existing technologies?

• The claims are specific to certain amino acid sequences, differentiating from broader ROR1 antibody claims.
• The patent leverages affinity and functional claims, providing a broader scope than structure-only patents.
• In the field of cancer immunotherapy, ROR1 targeting is emerging, but this patent's specificity offers protection for particular antibody formats.

Summary table: Scope and claims overview

Aspect	Details
Target	ROR1 extracellular domain
Antibody format	Full-length IgG, scFv, bispecifics, ADCs
Variable region sequences	Specific amino acid sequences with allowance for minor variants
Binding affinity	Usually specified (e.g., KD < 1 nM)
Therapeutic application	Oncology: non-Hodgkin lymphoma, CLL, solid tumors
Production methods	DNA sequences, expression vectors

Key Takeaways

• U.S. Patent 9,669,974 protects specific anti-ROR1 antibodies, including certain sequences and formats.
• The scope limits protection mainly to antibodies with defined sequences and affinities, though claims extending to functional and therapeutic uses are broader.
• Its patent family indicates a strategic portfolio covering key applications and manufacturing methods.
• Competition exists from other patents targeting ROR1, risking potential infringement but also offering freedom-to-operate clarity if variants differ significantly.
• The patent will maintain enforceability until 2036, subject to maintenance fees and potential legal challenges.

FAQs

1. Does this patent cover all anti-ROR1 antibodies?
No. It specifically claims antibodies with certain amino acid sequences and binding characteristics.

2. Can a competitor develop a different ROR1 antibody?
Yes. Variants with different sequences, binding affinities, or formats that do not infringe the specific claims could avoid infringement.

3. How does this patent impact ROR1 therapeutic development?
It provides patent protection for specific antibody constructs, influencing ROR1 therapy patent strategies and licensing opportunities.

4. Are there any related patents that extend coverage?
Yes. The patent family includes applications in multiple jurisdictions and related patents covering different antibody formats and therapeutic methods.

5. What are the main risks in developing ROR1-targeted therapies related to this patent?
Primarily, infringement risks if antibody candidates fall within the claimed sequences or functional parameters. Patent validity challenges are also possible.

References

1. U.S. Patent and Trademark Office. (2017). U.S. Patent 9,669,974.
2. Patent family data retrieved from WIPO PATENTSCOPE and Google Patents.

Drugs Protected by US Patent 9,669,974

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	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,669,974		Y		Y

International Family Members for US Patent 9,669,974

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014368818
Brazil	112016013690
Canada	2933069