Details for Patent: 8,999,932

Which drugs does patent 8,999,932 protect, and when does it expire?

Patent 8,999,932 protects PARSABIV and is included in one NDA.

This patent has fifty-four patent family members in thirty countries.

Summary for Patent: 8,999,932

Title:	Therapeutic agents for reducing parathyroid hormone levels
Abstract:	Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X.sub.1-X.sub.2-X.sub.3-X.sub.4-X.sub.5-X.sub.6-X.sub.7, wherein the X.sub.1 subunit comprises a thiol-containing moiety and the distribution of charge on the X.sub.2-X.sub.7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
Inventor(s):	Karim; Felix (Walnut Creek, CA), Baruch; Amos (San Francisco, CA), Maclean; Derek (Los Altos, CA), Das; Kanad (San Francisco, CA), Yin; Qun (Palo Alto, CA)
Assignee:	KAI Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:	12/846,724
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,999,932
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding the Scope and Claims of United States Patent 8,999,932

Introduction

United States Patent 8,999,932, titled "Therapeutic agents for reducing parathyroid hormone levels," is a significant patent in the pharmaceutical industry, particularly in the treatment of conditions related to elevated parathyroid hormone (PTH) levels. This patent is held by KAI Pharmaceuticals, Inc. and is part of a broader portfolio of patents related to therapeutic agents.

Patent Overview

• Issuance Date: April 7, 2015
• Inventors: Felix Karim, Amos Baruch, Derek Maclean, Kanad Das, and Qun Yin
• Assignee: KAI Pharmaceuticals, Inc.[2][4]

Claims and Scope

The patent 8,999,932 includes several claims that define the scope of the invention. Here are some key aspects:

Independent Claims

• The patent contains multiple independent claims that describe the therapeutic agents and their compositions. These claims are crucial as they define the boundaries of the invention and what is protected under the patent.
• For example, the claims might include specific compounds, their structures, and the methods of using these compounds to reduce PTH levels[4].

Dependent Claims

• Dependent claims build upon the independent claims and provide additional details or limitations. These claims help to narrow down the scope and ensure that the patent covers specific aspects of the invention without being overly broad.
• Dependent claims might include variations in the chemical structure, dosages, or methods of administration[3].

Therapeutic Agents

The patent focuses on therapeutic agents designed to lower parathyroid hormone levels. These agents are critical in treating conditions such as secondary hyperparathyroidism, which is often seen in patients with chronic kidney disease.

Chemical Compounds

• The patent describes specific chemical compounds and their derivatives that have been found to be effective in reducing PTH levels.
• These compounds are detailed in terms of their chemical structure, synthesis methods, and pharmacological properties[4].

Patent Landscape

The patent landscape surrounding 8,999,932 is complex and involves several related patents.

Related Patents

• U.S. Patent 8,377,880: This patent, also held by KAI Pharmaceuticals, Inc., is related to the same therapeutic area and shares some common inventors. It was issued on February 19, 2013[2].
• U.S. Patent 9,278,995: This patent is a continuation of the earlier patents and extends the protection to include additional claims and aspects of the therapeutic agents. It was issued to ensure continued protection of the invention through regulatory review periods[1].

Regulatory Review and Patent Term Extension

• The patent 8,999,932 is eligible for a patent term extension under 35 U.S.C. § 156 due to the regulatory review period associated with the FDA approval process.
• The extension is calculated based on the time spent in regulatory review, ensuring that the patent holder has adequate time to recoup their investment in the drug development process[1].

Litigation and Enforcement

The patents related to therapeutic agents for reducing PTH levels have been involved in various legal disputes.

Generic Challenges

• Generic manufacturers have sought to challenge the validity and enforceability of these patents through Paragraph IV certifications under the Hatch-Waxman Act.
• For example, Aurobindo’s ANDA (Abbreviated New Drug Application) included certifications that the asserted patents, including 8,999,932, are invalid, unenforceable, or not infringed by their proposed generic product[5].

Metrics for Measuring Patent Scope

The scope of a patent like 8,999,932 can be measured using various metrics.

Independent Claim Length and Count

• Research has shown that the length and count of independent claims can be indicative of the patent's scope. Narrower claims with shorter lengths and fewer counts are often associated with a higher probability of grant and shorter examination processes[3].

Impact on Innovation

The breadth and clarity of patents like 8,999,932 can have significant implications for innovation in the pharmaceutical industry.

Patent Quality and Litigation Costs

• Overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation.
• However, well-defined and narrowly scoped patents can facilitate clearer boundaries and reduce legal disputes, thereby encouraging further research and development[3].

Key Takeaways

• Patent Claims: The patent includes multiple claims that define the therapeutic agents and their compositions.
• Therapeutic Agents: The patent focuses on compounds designed to reduce parathyroid hormone levels.
• Related Patents: The patent is part of a broader portfolio that includes related patents such as 8,377,880 and 9,278,995.
• Regulatory Review: The patent is eligible for a term extension due to regulatory review periods.
• Litigation: The patent has been involved in legal disputes related to generic challenges.

FAQs

1. What is the primary focus of United States Patent 8,999,932?

   • The primary focus is on therapeutic agents designed to reduce parathyroid hormone levels.

2. Who are the inventors of the patent?

   • The inventors include Felix Karim, Amos Baruch, Derek Maclean, Kanad Das, and Qun Yin.

3. What is the significance of the patent term extension under 35 U.S.C. § 156?

   • The extension ensures that the patent holder has adequate time to recoup their investment in the drug development process after regulatory review.

4. How can the scope of a patent like 8,999,932 be measured?

   • The scope can be measured using metrics such as independent claim length and count.

5. What are the potential implications of overly broad patents on innovation?

   • Overly broad patents can increase licensing and litigation costs, potentially diminishing incentives for innovation.

Sources

1. U.S. Patent and Trademark Office. Patent No. 9,278,995 Application for Extension of Patent Term.
2. Drugs.com. Generic Parsabiv Availability.
3. SSRN. Patent Claims and Patent Scope.
4. DrugPatentWatch. Summary for Patent: 8,999,932.
5. RPX Insight. In the United States District Court.

Drugs Protected by US Patent 8,999,932

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y		A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes			Y	Y		A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y		A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)

International Family Members for US Patent 8,999,932

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2459208		PA2017007	Lithuania
European Patent Office	2459208		300864	Netherlands
European Patent Office	2459208		122017000021	Germany
European Patent Office	2459208		C20170006 00208	Estonia
European Patent Office	2459208		CA 2017 00006	Denmark
European Patent Office	2459208		8/2017	Austria
European Patent Office	2459208		LUC00008	Luxembourg