Details for Patent: 9,796,721

Which drugs does patent 9,796,721 protect, and when does it expire?

Patent 9,796,721 protects CALQUENCE and is included in one NDA.

This patent has sixty-three patent family members in twenty-eight countries.

Summary for Patent: 9,796,721

Title:	Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Abstract:	In some embodiments, the invention relates to crystalline solid forms, including hydrates, polymorphs, and salt forms, of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention relates to amorphous solid forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention also relates to pharmaceutical compositions containing the solid forms, and methods for treating conditions or disorders by administering to a subject a pharmaceutical composition that includes the forms, including pharmaceutical compositions and methods for overcoming the effects of acid reducing agents.
Inventor(s):	Blatter; Fritz (Reinach, CH), Ingallinera; Tim (San Francisco, CA), Barf; Tjeerd (Ravenstein, NL), Aret; Edwin (Almere, NL), Krejsa; Cecile (Seattle, WA), Evarts; Jerry (Bellevue, WA)
Assignee:	Acerta Pharma B.V. (Oss, NL)
Application Number:	15/200,875
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,796,721
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

United States Patent 9,796,721: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 9,796,721, though not directly provided in the sources, can be analyzed using general principles of patent scope, claims, and the broader patent landscape. Here, we will delve into the key aspects of patent analysis, using relevant examples and principles to understand the scope and claims of a patent like 9,796,721.

Understanding Patent Scope

Patent scope is a critical aspect of patent law, determining the breadth and limits of what is protected by a patent. It is often measured using metrics such as independent claim length and independent claim count[3].

Independent Claim Length and Count

Independent claims are those that stand alone and do not rely on other claims for their meaning. The length and number of these claims can indicate the scope of the patent. Generally, narrower claims (shorter length and fewer in number) are associated with a higher probability of grant and a shorter examination process[3].

Patent Claims

Patent claims define the invention and set the boundaries of what is protected. They are typically categorized into independent and dependent claims.

Independent Claims

Independent claims are the broadest claims in a patent and define the invention without reference to other claims. They are crucial in determining the patent's scope.

Dependent Claims

Dependent claims build upon independent claims and add additional limitations. These claims are narrower and often provide more specific details about the invention.

Patent Examination Process

The patent examination process can significantly impact the scope of patent claims. During this process, claims may be narrowed to address examiner objections, which can result in a more focused and valid patent[3].

Legal and Litigation Aspects

Patents are often involved in litigation, particularly in the pharmaceutical industry, where generic manufacturers challenge brand-name patents.

Hatch-Waxman Act

The Hatch-Waxman Act provides a framework for generic drug manufacturers to challenge brand-name drug patents through Abbreviated New Drug Applications (ANDAs). This can lead to settlements and agreements that define the terms under which generic versions can enter the market[2][5].

Example from Similar Patents

While the specific details of US Patent 9,796,721 are not provided, we can look at similar patents to understand the typical scope and claims.

Pharmaceutical Patents

For example, patents related to pharmaceuticals often include claims that cover the active ingredient, its crystalline forms, and methods of use. The patent for "Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)...," US9796721B2, includes claims for crystalline solid forms, hydrates, polymorphs, and salt forms of the compound[4].

Key Components of Patent Claims

Invention Description

The patent specification describes the invention in detail, including its background, summary, and detailed description.

Drawings and Figures

Drawings and figures are used to illustrate the invention and can be crucial in understanding the claims.

Claims Section

The claims section is the most critical part of the patent, as it defines what is protected.

Impact of Patent Scope on Innovation

The scope of a patent can significantly impact innovation. Broad patents can lead to increased licensing and litigation costs, potentially discouraging innovation. Narrower, well-defined patents, on the other hand, can provide clear boundaries and encourage further innovation[3].

Case Studies: ANDA Litigation

In the context of pharmaceutical patents, ANDA litigation often involves disputes over the scope and validity of patents. For instance, in the case of ZS Pharma, Inc. v. Sandoz Inc., the settlement agreement enjoined Sandoz from infringing the patents-in-suit, highlighting the importance of patent scope in such litigation[2].

Conclusion

Understanding the scope and claims of a patent like US 9,796,721 involves a detailed analysis of the independent claims, the examination process, and the broader legal and litigation landscape. Here are some key takeaways:

• Patent Scope Metrics: Independent claim length and count are crucial metrics for measuring patent scope.
• Claims Structure: Independent and dependent claims define the invention and its boundaries.
• Examination Process: The patent examination process can narrow the scope of claims.
• Legal and Litigation: Patents are often involved in litigation, especially in the pharmaceutical sector.
• Impact on Innovation: The scope of a patent can influence innovation by setting clear boundaries or creating barriers.

Key Takeaways

• Patent Scope: Measured by independent claim length and count.
• Claims: Independent claims define the invention broadly, while dependent claims add specific details.
• Examination Process: Can narrow the scope of claims.
• Litigation: Patents are frequently involved in litigation, particularly in the pharmaceutical industry.
• Innovation: The scope of a patent can either encourage or hinder innovation.

FAQs

What are the key metrics for measuring patent scope?

The key metrics include independent claim length and independent claim count.

How does the patent examination process affect patent claims?

The examination process can narrow the scope of claims to address examiner objections, resulting in a more focused and valid patent.

What is the significance of independent claims in a patent?

Independent claims are the broadest claims and define the invention without reference to other claims, setting the boundaries of what is protected.

How do pharmaceutical patents typically structure their claims?

Pharmaceutical patents often include claims that cover the active ingredient, its crystalline forms, and methods of use.

What is the impact of broad patents on innovation?

Broad patents can lead to increased licensing and litigation costs, potentially discouraging innovation.

Sources

1. University of South Florida - Issued U.S. Patents
2. Robins Kaplan LLP - ANDA Litigation Settlements
3. SSRN - Patent Claims and Patent Scope
4. Google Patents - US9796721B2
5. Robins Kaplan LLP - ANDA Litigation Settlements Q2

Drugs Protected by US Patent 9,796,721

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,796,721		Y	Y		TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,796,721		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,796,721		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

International Family Members for US Patent 9,796,721

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016286548
Australia	2020277123
Australia	2022291635