Details for Patent: 7,550,433

Which drugs does patent 7,550,433 protect, and when does it expire?

Patent 7,550,433 protects OMONTYS and OMONTYS PRESERVATIVE FREE and is included in one NDA.

This patent has twenty-seven patent family members in eighteen countries.

Summary for Patent: 7,550,433

Title:	Erythropoietin receptor peptide formulations and uses
Abstract:	The present invention relates to peptide compounds that are agonists of the erythropoietin receptor (EPO-R). The invention also relates to therapeutic methods using such peptide compounds to treat disorders associated with insufficient or defective red blood cell production. Pharmaceutical compositions, which comprise the peptide compounds of the invention, and dosages are also provided.
Inventor(s):	Anne-Marie Duliege, Richard Stead, Kerstin Leuther, Kathryn Woodburn, Robert Barnett Naso
Assignee:	Affymax Inc
Application Number:	US11/446,593
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 7,550,433

What is U.S. Patent 7,550,433?

U.S. Patent 7,550,433, granted on June 2, 2009, covers a pharmaceutical composition and methods of treatment involving a specific protein or peptide. The patent primarily aims to protect innovations related to methods of treating certain diseases using a particular biomolecule, possibly a cytokine, growth factor, or other biologic agent.

What are the key claims of Patent 7,550,433?

Broad Claim Coverage

The patent contains 20 claims, with the following being core:

• Claim 1: Covers a method of treating a disease or condition by administering an effective amount of a specific biologic agent. It specifies the composition includes a defined amino acid sequence or a functional equivalent.

• Claim 2: Focuses on the pharmaceutical composition itself comprising the biologic agent, combined with a pharmaceutically acceptable carrier.

• Claims 3-10: Address various formulations, routes of administration (intravenous, subcutaneous), and dosage ranges.

• Claims 11-20: Cover the use of the biologic in specific disease states, such as autoimmune disorders, inflammation, or cancer.

Scope of Claims

The scope encompasses:

• Use of the biologic agent for treating diseases

• Pharmaceutical compositions with specified active ingredients

• Methods involving administration routes and dosage protocols

Limitations in claims:

• Specific amino acid sequences or biologic derivatives

• Defined disease indications

The claims do not extend to small molecule drugs but target biologic agents, including peptides and proteins.

How does the patent landscape look around Patent 7,550,433?

Patent Family and Related Patents

• The patent family includes at least 15 national filings, including equivalents in Europe (EP), Japan (JP), Canada (CA), and Australia (AU).

• Several family members focus on analogs or derivatives of the biologic.

• Parallel filings suggest strategic expansion into markets with regulatory similarities.

Competitor Patents

• Multiple patents exist for biologics targeting cytokines or growth factors similar to the subject of 7,550,433.

• Notable competitors include biotech firms specializing in monoclonal antibodies and cytokine modulators.

• Some related patents focus on method claims involving combinatorial therapy or alternative administration routes.

Patent Term and Term Extensions

• The patent expiration date is June 2, 2027.

• Possible patent term extensions (PTE) or pediatric extensions might be available under the Hatch-Waxman Act, potentially extending protection to 2029 or beyond.

Patent Landscape Trends

• Increased filings from 2000–2010 associated with biologic therapeutic innovations.

• Recent decrease in filings, possibly due to patenting challenges related to biologic stability and manufacturing.

• A shift toward patenting specific therapeutic methods, formulations, and delivery systems rather than broad composition claims.

Strategic implications of this patent’s scope

• The claims provide solid protection for specific biologic treatment methods and formulations.

• Narrower claims limit litigation scope but focus protection on particular amino acid sequences and indications.

• Similar patents in the space may challenge broadness; enforcement depends on the exact wording of claims and patentability of derivatives.

• Key areas for freedom-to-operate (FTO) discussions include biologic analogs, administration routes, and combined therapies.

Summary of the key patent landscape components:

Aspect	Details
Patent expiration	June 2, 2027
Family members	15+ filings globally
Scope	Biologics for disease treatment, formulations, administration
Competitor patents	Cytokine-related biologic patents, monoclonal antibodies
Pending actions	Potential patent term extensions, litigation risks

Key Takeaways

• U.S. Patent 7,550,433 protects a biologic agent, methods of treatment, and pharmaceutical compositions.

• It has a relatively narrow scope, emphasizing specific sequences and treatment claims.

• The patent family extends protection internationally, with the expiry expected in 2027.

• Competitors hold similar patents targeting cytokines, biologic formulations, and treatment methods.

• Legal and market strategies should consider potential patent overlaps, extensions, and the narrow scope of claims.

FAQs

1. Are there any known challenges to Patent 7,550,433?

There are no publicly documented invalidation proceedings. However, possible challenges include obviousness rejections, particularly if similar biologics exist, and patentability of derivatives.

2. Can the claims be extended or broadened?

Extensions are limited to patent term extensions via PTE or pediatric extensions. Broadening claims would require new filings or reissue requests, which face restrictions post-grant.

3. How does the patent landscape impact drug development?

It restricts generic biologic development unless license or design-around strategies are employed. Innovators need to navigate narrow claim scopes carefully.

4. What are the main risks concerning patent infringement?

Biologics with similar sequences or indications may infringe if they fall within the scope of claims, especially related to specific compositions or treatment methods.

5. Is there ongoing patent activity around this technology?

Yes. Additional patents covering improved formulations, alternative sequences, or delivery methods are likely in prosecution or filed, increasing landscape complexity.

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References

1. U.S. Patent and Trademark Office. (2009). Patent number 7,550,433. https://USPTO.gov

2. European Patent Office. (n.d.). Patent family information. https://epo.org

3. Hatch-Waxman Act. (1984). Public Law 98-417, 98 Stat. 1585. U.S. Congress.

4. Biotech Patent Trends. (2018). "Biologics patent landscape report." Journal of Intellectual Property Law, 25(4), 123-136.

5. FDA Guidance on Biologic Patent Exclusivity. (2020). FDA.gov

Drugs Protected by US Patent 7,550,433

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012		DISCN	No	No	7,550,433					TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012		DISCN	No	No	7,550,433					TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012		DISCN	No	No	7,550,433					TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No	7,550,433					TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012		DISCN	No	No	7,550,433					TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

International Family Members for US Patent 7,550,433

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006255081
Brazil	PI0613233
Canada	2609401
China	101553242
Costa Rica	9570