Details for Patent: 9,732,075

Which drugs does patent 9,732,075 protect, and when does it expire?

Patent 9,732,075 protects QUVIVIQ and is included in one NDA.

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

Summary for Patent: 9,732,075

Title:	Benzimidazole-proline derivatives
Abstract:	The present invention relates to compounds of the formula (I) ##STR00001## wherein Ar.sup.1, R.sup.1, R.sup.2, R.sup.3, R.sup.4a, R.sup.4b and (R.sup.5).sub.n are as described in the description, to their preparation, to pharmaceutically acceptable salts thereof, and to their use as pharmaceuticals, to pharmaceutical compositions containing one or more compounds of formula (I), and especially to their use as orexin receptor antagonists.
Inventor(s):	Boss; Christoph (Allschwil, CH), Brotschi; Christine (Allschwil, CH), Gude; Markus (Allschwil, CH), Heidmann; Bibia (Allschwil, CH), Sifferlen; Thierry (Allschwil, CH), Williams; Jodi (Allschwil, CH)
Assignee:	IDORSIA PHARMACEUTICALS LTD (Allschwil, CH)
Application Number:	14/405,649
Patent Claim Types: see list of patent claims	Composition; Compound;

Understanding the Scope and Claims of United States Patent 9,732,075

Introduction

United States Patent 9,732,075 is a significant patent that has garnered attention due to its implications in the pharmaceutical industry. This analysis will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.

Patent Overview

Patent Number and Title

• The patent in question is U.S. Patent 9,732,075. While the specific title is not provided in the sources, it is associated with pharmaceutical compounds, as indicated by related patents and applications[1].

Foreign Priority and PCT Information

• This patent has its roots in foreign priority applications. It was initially filed in foreign countries, with priority dates starting from June 4, 2012. The PCT (Patent Cooperation Treaty) application was filed on June 3, 2013, with the PCT publication number WO2013/182972[1].

Claims and Scope

• The scope of a patent is defined by its broadest claims, known as independent claims. These claims are crucial as they outline the legal right to exclude others from making, using, or selling the invention. A broader patent typically offers more protection against infringers because it is harder to design around[3].

Independent vs. Dependent Claims

• Independent claims are the core of the patent's protection. Dependent claims, on the other hand, are narrower and serve as fallback positions if an independent claim is ruled invalid. The number of claims does not necessarily indicate the breadth of the patent; rather, it is the scope of the independent claims that matters[3].

Measuring Patent Scope

• The breadth of a patent's scope can be measured by the number of words in its first claim. Generally, more words in a claim indicate a narrower scope because a competitor must meet every condition of the claim to infringe it[3].

Patent Expiration and Generic Entry

• The expiration date of the patent is crucial for understanding when generic versions of the drug can enter the market. For U.S. Patent 9,732,075, the estimated expiration dates and any supplementary protection certificates (SPCs) would be key factors in determining the timeline for generic entry. However, specific expiration dates are not provided in the sources without subscription or further details[1].

International Patent Landscape

• The patent has been filed and granted in various jurisdictions, including the European Patent Office. For example, the European Patent Office granted patent number 2855453, which has different estimated expiration dates and SPCs in various European countries like Lithuania, the Netherlands, and Belgium[1].

Challenges in Patent Scope Measurement

• Traditional measures of patent scope, such as the number of patent classes or citations, have been found to be weak or misleading. Instead, the number of words in the first claim and the scope toughness measure are more predictive of a patent's actual scope[3].

Criticisms and Regulatory Considerations

• The issuance of patents with large claim sets, such as those seen in pharmaceutical patents, has been criticized. For instance, patents with over 100 claims are rare and often seen as problematic because they can block generic competition without providing significant innovation. Regulatory bodies like the USPTO and FDA are urged to reassess their practices regarding such patents to balance innovation incentives with public health needs[4].

Impact on Generic Competition

• Patents listed in the FDA's Orange Book, such as those with extensive claim sets, can significantly delay the entry of generic drugs into the market. This is because these patents can invoke a 30-month stay under the Hatch-Waxman Act, preventing generic manufacturers from selling their products until the patent issues are resolved[4].

Expert Insights

• Patent attorneys emphasize that broad patents offer more protection but are harder to design around. For example, Thomas Kulaga notes that "broad patents typically offer more protection against infringers than a narrow patent" because they are "oftentimes very hard to design around"[3].

Statistical and Data-Driven Analysis

• Studies have shown that the number of claims in a patent does not strongly correlate with its scope. Instead, the focus should be on the breadth of the independent claims. Data from the USPTO and other sources highlight the importance of standardized measures to evaluate patent scope accurately[3].

Conclusion

U.S. Patent 9,732,075 operates within a complex patent landscape, particularly in the pharmaceutical sector. Understanding its scope and claims requires a nuanced approach, considering the breadth of independent claims and the regulatory environment. The patent's international filings and potential expiration dates are critical for both the innovator and generic drug manufacturers.

Key Takeaways

• Patent Scope Measurement: The breadth of a patent is best measured by the number of words in its first claim, not by the number of claims or citations.
• International Filings: Patents like 9,732,075 are often filed in multiple jurisdictions, affecting their global protection and expiration.
• Regulatory Challenges: Large claim sets in pharmaceutical patents can delay generic competition and are subject to regulatory scrutiny.
• Impact on Generic Drugs: Patents listed in the FDA's Orange Book can invoke significant delays for generic drug entry.
• Expert Insights: Broad patents offer more protection but are harder to design around.

FAQs

1. What is the significance of the number of words in a patent claim?

   • The number of words in a patent claim, especially the first claim, is a strong indicator of the patent's scope. More words generally mean a narrower scope because each condition must be met to infringe the patent[3].

2. How do international filings affect patent protection?

   • International filings extend the patent's protection to multiple countries, each with its own estimated expiration dates and supplementary protection certificates (SPCs)[1].

3. Why are large claim sets in pharmaceutical patents criticized?

   • Large claim sets can block generic competition without providing significant innovation, leading to delays in the entry of generic drugs into the market[4].

4. What is the role of the FDA's Orange Book in patent disputes?

   • The FDA's Orange Book lists patents identified by brand-name pharmaceutical firms, which can invoke a 30-month stay under the Hatch-Waxman Act, delaying generic competition[4].

5. How do patent attorneys measure the effectiveness of a patent's scope?

   • Patent attorneys often measure the effectiveness of a patent's scope by its breadth, which is harder to design around, and use metrics like the number of words in the first claim to assess this breadth[3].

Sources

1. DrugPatentWatch - Summary for Patent: 9,732,075
2. Unified Patents Portal - HR-P20170351-T1
3. Boston University Law - The Ways We've been Measuring Patent Scope are Wrong
4. Regulations.gov - Listening Session on Joint USPTO-FDA Collaboration Initiatives
5. Unified Patents Portal - EP-2855453-A1 - Benzimidazole-proline Derivatives

Drugs Protected by US Patent 9,732,075

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No	9,732,075		Y	Y		TREATMENT OF INSOMNIA
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes	9,732,075		Y	Y		TREATMENT OF INSOMNIA

Foreign Priority and PCT Information for Patent: 9,732,075

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	12170748	Jun 4, 2012
	13158520	Mar 11, 2013

PCT Information
PCT Filed	June 03, 2013	PCT Application Number:	PCT/IB2013/054567
PCT Publication Date:	December 12, 2013	PCT Publication Number:	WO2013/182972

International Family Members for US Patent 9,732,075

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2855453		PA2022518	Lithuania
European Patent Office	2855453		301197	Netherlands
European Patent Office	2855453		2022C/543	Belgium