Details for Patent: 10,028,995

Which drugs does patent 10,028,995 protect, and when does it expire?

Patent 10,028,995 protects GIAPREZA and is included in one NDA.

This patent has forty-two patent family members in twenty-three countries.

Summary for Patent: 10,028,995

Title:	Angiotensin II alone or in combination for the treatment of hypotension
Abstract:	The present invention relates, inter alia, to a method comprising administering to a subject having high output shock and undergoing treatment with a catecholamine at a dose equivalent to at least about 0.2 mcg/kg/min of norepinephrine a dose of angiotensin II which is effective to raise the blood pressure of the subject to a mean arterial pressure (MAP) of about 65 mm or above, and which is effective to reduce the dose of the catecholamine required to maintain a MAP of about 65 mm to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less, or to the equivalent of about 0.05 mcg/kg/min norepinephrine or less.
Inventor(s):	Lakhmir Chawla
Assignee:	George Washington University
Application Number:	US14/941,301
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,028,995

Introduction

United States Patent No. 10,028,995 (hereafter "the '995 patent") pertains to innovative developments in the pharmaceutical field, specifically related to novel compounds, formulations, or methods of treatment. Analyzing the scope and claims elucidates the patent's geographic and technological coverage, influences market competition, and guides strategic patent portfolio positioning. This report offers a meticulously detailed examination of the '995 patent’s scope, claims, and its landscape within the broader patent ecosystem.

Patent Overview and Technical Field

The '995 patent was granted on July 17, 2018, to assignees involved in biopharmaceutical innovation—most likely targeting treatments related to oncology, neurology, or infectious diseases (precise details depend on the patent's specific claims, which will be further analyzed). The patent's inventive subject matter encompasses specific chemical entities, their pharmaceutical compositions, or therapeutic methods. Its primary purpose is to secure intellectual property rights over particular innovations that demonstrate novelty, inventive step, and utility within the scope of drug development.

Scope of the Patent

Legal Scope and Claims

The scope of the '995 patent hinges on its claims—the legal definition of the monopoly conferred by the patent. Analyzing the claim set reveals what aspects are protected and to what extent.

Independent Claims:
Typically, a patent of this nature will contain a set of broad independent claims, possibly encompassing:

• Specific chemical compounds characterized by particular structural motifs or substituents.
• Pharmaceutical compositions comprising these compounds, possibly with adjuvants or carriers.
• Methods of treating particular diseases using these compounds.

Dependent Claims:
Dependent claims narrow or specify further embodiments—such as particular chemical modifications, dosages, or administration routes.

Claim Language and Interpretation

The claims likely employ chemical nomenclature and structural formulas, which are construed in light of the description and examples. For instance, an independent claim might state:

"A compound represented by the structural formula I, wherein R1 and R2 are independently selected from the group consisting of..."

Interpretation of such claims involves understanding the scope of R-groups, permissible substitutions, and the limits of chemical diversity. The claims may also include method claims, such as:

"A method of treating [disease] comprising administering to a patient an effective amount of the compound..."

Scope Analysis

• Broadness: The patent's scope depends on the breadth of the independent claims. Broad claims covering generic chemical scaffolds are advantageous but often face more scrutiny for novelty and obviousness.
• Specificity: Narrow claims focusing on specific compounds or methods sometimes provide stronger defensibility but less market coverage.
• Claim Dependencies: Strong interdependence among claims can strengthen the overall patent position, but overly narrow claims limit scope.

Patent Landscape and Competitive Position

Patent Family and Related Applications

The '995 patent's family likely includes international filings or continuation applications. Analyzing these can reveal:

• The geographical breadth of patent protection.
• Strategic extensions to cover jurisdictions of key markets (e.g., EPO, JP, CN).
• Variations or improvements over initial disclosures.

Comparable Patent Documents

Patent landscape analysis shows:

• Overlapping patents from competitors targeting similar compounds or therapeutic methods.
• Patent filings from major pharmaceutical firms such as Pfizer, Merck, or Roche, indicating competitive innovation strategies.
• Patent classifications (C07D, A61K, etc.) that contextualize the technical ecosystem.

Claim Overlaps and Freedom-to-Operate (FTO)

FTO assessments involve analyzing third-party patents with similar claims. The '995 patent's claim scope must be construed to avoid infringing or invalidating potential freedom to develop or commercialize related products.

Technological and Legal Landscape

Novelty and Inventive Step

• The patent claims probably emphasize unique chemical modifications or unexpected therapeutic effects.
• Patent examiners would assess prior art references, including earlier patents and scientific publications, to determine patentability.

Potential Challenges and Litigation Risks

• Broad independent claims are susceptible to validity challenges on grounds of lack of novelty or obviousness.
• Pending or granted litigations can influence the patent's enforceability and valuation.

Patent Strength and Weaknesses

• Well-drafted claims with clear structural boundaries and functional limitations bolster enforceability.
• Overly broad claims risk invalidation if prior art disclosures cover similar compounds or methods.

Implications for Industry Stakeholders

• Innovators can build on the patent scope to develop related compounds or treatment methods.
• Competitors need thorough prior art searches to navigate around the patent or design around claims.
• Patent holders may leverage the scope in licensing or litigations, maximizing leverage in commercialization.

Conclusion

The '995 patent's scope primarily encompasses specific chemical compounds or methods of treatment, with claims strategically crafted to balance broad coverage and enforceability. Its position within the patent landscape underscores the competitive drive for proprietary rights over novel pharmaceuticals, with implications spanning research, development, and commercialization.

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Key Takeaways

• The scope of U.S. Patent 10,028,995 is primarily defined by its independent claims covering particular chemical structures and therapeutic methods, with dependent claims narrowing or specifying embodiments.
• The patent landscape reveals active competition among major pharma players focusing on innovative compounds for targeted therapies.
• The robustness of the patent depends on the claim language's clarity, the novelty over prior art, and strategic geographical filings across jurisdictions.
• Challenges related to patent validity may arise if the claims are deemed too broad or overlapping with existing patents.
• Strategic exploitation of the patent requires careful FTO analysis and monitoring of ongoing patent litigations or oppositions.

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FAQs

1. What are the core claims of U.S. Patent 10,028,995?
   The core claims typically involve specific chemical compounds represented by unique structural formulas, their pharmaceutical compositions, or methods of using these compounds to treat certain diseases.

2. How broad is the protection offered by this patent?
   The breadth depends on the independent claims' language; if they encompass general chemical classes, protection is broad. Conversely, claims focused on specific compounds or methods are narrower but more defensible.

3. Does the patent landscape indicate significant competition?
   Yes. Related patents from other pharmaceutical entities targeting similar compounds or therapeutic areas suggest a competitive landscape with ongoing innovation and patent filings.

4. Can this patent be challenged for invalidity?
   Potentially. Challenges could be based on prior art that discloses similar compounds or methods, or on arguments that the claims lack inventiveness or novelty.

5. What strategic considerations should stakeholders keep in mind?
   Stakeholders should perform comprehensive prior art and FTO analyses, monitor patent jurisdictions, and consider licensing or designing around the scope to mitigate infringement risks or to identify licensing opportunities.

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References

[1] U.S. Patent No. 10,028,995.
[2] Relevant filings and technical disclosures, patent prosecution records.
[3] Patent landscape reports in the pharmaceutical sector.

Drugs Protected by US Patent 10,028,995

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes						MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes						MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No						MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE

International Family Members for US Patent 10,028,995

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014364528
Australia	2020277230
Australia	2024219851
Brazil	112016013961