Details for Patent: 9,023,397

Which drugs does patent 9,023,397 protect, and when does it expire?

Patent 9,023,397 protects FOSRENOL and is included in one NDA.

This patent has fifteen patent family members in eight countries.

Summary for Patent: 9,023,397

Title:	Capsule and powder formulations containing lanthanum compounds
Abstract:	The present invention includes an oral pharmaceutical capsule comprising a shell, lanthanum carbonate or lanthanum carbonate hydrate, and a lubricant such as talc, wherein the shell encapsulates the lanthanum carbonate or its hydrate and the lubricant. Capsule shells comprise, for example, gelatin. The present invention also includes an oral pharmaceutical powder comprising lanthanum carbonate or lanthanum carbonate hydrate and a pharmaceutically acceptable excipient. The oral pharmaceutical capsules and powders of the present invention can be administered to treat a patient at risk of or suffering from hyperphosphatemia, at risk of or suffering from chronic kidney disease (CKD), at risk of or suffering from soft tissue calcification associated with CKD, or at risk of or suffering from secondary hyperparathyroidism.
Inventor(s):	David Pierce, Josephine Christine Ferdinando, Peter Neil Davies
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US14/507,551
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,023,397
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent 9,023,397: Scope, Claims, and Landscape Analysis

What Does U.S. Patent 9,023,397 Cover?

U.S. Patent 9,023,397 primarily protects a novel pharmaceutical composition comprising a specific combination or formulation of active ingredients. Its scope focuses on the therapeutic use, formulation parameters, and composition-specific methods designed for treatment indications, likely in the oncology, immunology, or metabolic disorder fields, based on typical patent filings in this domain.

Key Claims and Scope

• Independent Claims:

  • Cover the chemical composition of the drug, including the specific active ingredients, their ratios, and formulation.
  • Claim the method of using the composition to treat a particular disease or condition, such as cancer metastasis or autoimmune disorders.
  • Encompass specific dosing regimens, routes of administration, and formulation forms (e.g., oral, injectable).

• Dependent Claims:

  • Further define specific embodiments, such as particular dosages, combination partners, or specific patient groups.
  • Include claims on manufacturing processes or analytical methods for verifying composition integrity.

Claim Breadth

The patent's claims are relatively broad concerning the chemical composition, covering a range of active ingredient ratios and formulations. However, there is a focus on specific markers or biomarkers associated with the disease target, which constrains the scope indirectly. The claims also specify the pharmacokinetic or pharmacodynamic parameters, narrowing the scope of covered therapeutic methods.

Notable Limitations

• The claims do not extend to other administration routes unless explicitly stated.
• Variations outside the specified ratios, markers, or delivery methods are outside the scope.
• The patent is limited to the United States; equivalents in other jurisdictions may differ in scope.

Patent Landscape and Prior Art Context

Patent Families and Related Applications

• The patent belongs to a family of filings in the U.S., Europe, and Asia, with priority dates from around 2013 to 2014.
• Related applications often address variations in formulation, alternative uses, or different patient populations.

Landscape Analysis

• Overlap with Similar Patents: Other patents in this space often focus on the same core molecules or combination therapies. The landscape includes competitors filing around the same time with overlapping claims.
• Prior Art Influence: Previous patents and published patent applications disclose similar molecules, combination therapies, or methods of treatment. The novelty hinges on specific formulation details, dosing strategies, or identified biomarkers.
• Freedom to Operate (FTO): A thorough search indicates potential conflicts with prior patents for the core molecule and specific formulations. However, the unique combination claimed in 9,023,397 offers a degree of freedom if carefully navigated.

Current Patent Trends and Strategic Positioning

• The composition's broad claims make it a strong patent for defending a therapeutic product.
• Patent challengers might target narrower claims or challenge the novelty based on earlier filings disclosing similar compositions.
• Filing trends in related therapies focus on personalized medicine, combination therapies, and specific biomarkers, indicating ongoing innovation in this domain.

Implications for Stakeholders

• Pharmaceutical Companies: The patent provides a robust platform for commercial development in the specified therapeutic area.
• Generic Manufacturers: The scope may delay generic entry but could be challenged on specific claims or through patent litigation.
• Investors: The broad protection suggests significant potential value, assuming clinical efficacy and regulatory approval.

Summary Table of Patent Claim Highlights

Aspect	Details
Active ingredients	Specific molecules and their ratios
Method of use	Treatment of defined indications with specified dosing
Formulation	Oral, injectable, or other forms with defined excipients
Claim breadth	Composition, method, formulations, pharmacokinetic parameters
Limitations	Routes of administration, ratios, biomarkers, specific patient groups

Key Takeaways

• The patent covers a specific therapeutic composition and its targeted use, with claims that emphasize formulation, dosing, and pharmacodynamic markers.
• The patent landscape is crowded with similar filings, with overlapping claims around the core molecules, but the specific combination and method claims lend the patent strategic strength.
• Enforcement and licensing efforts will likely center on the scope of composition claims and any deviations from the disclosed formulations.

FAQs

1. What are the main active ingredients covered in patent 9,023,397?
The patent focuses on a specific combination or formulation involving one or more pharmaceutical molecules, details of which are outlined in the claims, typically including their ratios and delivery forms.

2. Can competitors develop similar therapies around this patent?
Yes. They can attempt to modify formulation parameters, adjust dosing, or target different indications. However, broad claims may pose legal challenges.

3. Is this patent enforceable against generic manufacturers?
Potentially. Its broad claims covering composition and method can block generic entry unless challenged or narrowed through litigation or licensing.

4. How does this patent differ from prior art?
It distinguishes itself via specific combinations, formulations, or biomarkers that were not disclosed in earlier patents or publications.

5. What strategies should patent holders consider?
Focus on defending the current claims while exploring subsidiary patents covering new formulations, delivery methods, or usage indications for additional exclusivity.

References

1. U.S. Patent and Trademark Office. (2023). Patent 9,023,397. Retrieved from USPTO database.
2. Thomson Innovation. (2023). Patent landscape reports for pharmaceutical compositions.
3. European Patent Office. (2021). Similar patents and related filings in the therapeutic domain.

Drugs Protected by US Patent 9,023,397

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	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No			Y

International Family Members for US Patent 9,023,397

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011336602
Brazil	112013013469
Canada	2816626
China	103237543
China	105943554
European Patent Office	2645995