Details for Patent: 9,820,985

Which drugs does patent 9,820,985 protect, and when does it expire?

Patent 9,820,985 protects TALZENNA and is included in two NDAs.

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

Summary for Patent: 9,820,985

Title:	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Abstract:	A compound having the structure set forth in Formula (I) and Formula (II): ##STR00001## wherein the substituents Y, Z, A, B, R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are as defined herein. Provided herein are inhibitors of poly(ADP-ribose)polymerase activity. Also described herein are pharmaceutical compositions that include at least one compound described herein and the use of a compound or pharmaceutical composition described herein to treat diseases, disorders and conditions that are ameliorated by the inhibition of PARP activity.
Inventor(s):	Wang; Bing (San Jose, CA), Chu; Daniel (Santa Clara, CA)
Assignee:	Medivation Technologies LLC (New York, NY)
Application Number:	14/632,825
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 9,820,985

Introduction

United States Patent 9,820,985, titled "Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)," is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment. This patent, owned by Pfizer Inc., protects a class of compounds known as dihydropyridophthalazinones, which are inhibitors of the PARP enzyme.

Patent Overview

The patent was granted on October 22, 2017, and is currently active, with an expected expiration date in July 2029[1][4].

Claims Structure

The patent includes multiple claims that define the scope of protection for the invention. Here’s a breakdown of the claims structure:

Independent Claims

Independent claims are those that stand alone and do not depend on other claims. For US Patent 9,820,985, the independent claims focus on the specific chemical structures of the dihydropyridophthalazinone compounds and their use as PARP inhibitors. These claims are crucial as they define the core invention and set the boundaries for what is protected under the patent[4].

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims can include specific substituents, formulations, or methods of use that are derived from the independent claims. By including dependent claims, the patentee can ensure broader protection for various aspects of the invention[4].

Patent Scope

The scope of a patent is determined by the language of its claims. Here are some key aspects that define the scope of US Patent 9,820,985:

Chemical Structure

The patent protects compounds with specific chemical structures, as defined in Formulas (I) and (II). These structures include various substituents (Y, Z, A, B, R1, R2, R3, R4, and R5) that are crucial for the compounds' activity as PARP inhibitors[4].

Use as PARP Inhibitors

The patent specifies the use of these compounds as inhibitors of the PARP enzyme, which is involved in DNA repair and is a target for cancer therapy. This use is a key aspect of the patent's scope, as it defines the therapeutic application of the compounds[4].

Formulations and Administration

While the primary focus is on the chemical compounds, the patent may also include claims related to formulations and modes of administration, such as oral tablets, capsules, or liquids. These claims ensure that the patent covers not just the active ingredient but also how it is delivered to patients[1].

Patent Landscape

The patent landscape surrounding US Patent 9,820,985 involves several factors:

Exclusivities and Patent Term

The patent is part of a larger portfolio of patents and exclusivities granted to Pfizer for Talzenna, the drug that utilizes these PARP inhibitors. These exclusivities, in addition to the patent term, delay the entry of generic or bioequivalent versions of the drug into the market[1].

Legal Activities

The patent's life and scope can be influenced by various legal activities such as maintenance fee payments, amendments to claims, and regulatory reviews. For example, recent activities include payments of maintenance fees and communications with regulatory agencies, which are crucial for maintaining the patent's validity and term[1].

Strategic Claim Management

Effective claim management is vital for maximizing the value of the patent. This includes ensuring that the patent utilizes its full entitlement of claims, consolidating dependent claims into broader independent claims, and adding new dependent claims for canceled ones. This strategy enhances the patent's defensive capabilities and its value in licensing and infringement disputes[5].

Metrics for Measuring Patent Scope

To understand the scope of US Patent 9,820,985 better, metrics such as independent claim length and independent claim count can be used. These metrics, as discussed in the USPTO Economic Working Paper 2016-04, provide insights into the breadth and clarity of the patent claims. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process, indicating a more focused and robust patent scope[3].

Impact on Innovation and Commercial Success

The strategic management of claims and the scope of the patent can significantly impact innovation and commercial success. By ensuring comprehensive protection through well-crafted claims, Pfizer can safeguard its investment in research and development, deter competitors, and enhance the value of the patent in licensing and potential litigation scenarios[5].

Key Takeaways

• Patent Scope: Defined by the specific chemical structures and therapeutic use as PARP inhibitors.
• Claims Structure: Includes independent and dependent claims to ensure broad and nuanced protection.
• Legal Activities: Ongoing activities such as maintenance fee payments and regulatory reviews are crucial for maintaining the patent's validity.
• Strategic Claim Management: Essential for maximizing the patent's value and defensive capabilities.
• Metrics for Patent Scope: Independent claim length and count provide valuable insights into the patent's breadth and clarity.

FAQs

1. What is the expected expiration date of US Patent 9,820,985?

   • The patent is expected to expire in July 2029[1].

2. What is the primary therapeutic use protected by US Patent 9,820,985?

   • The primary therapeutic use is as inhibitors of the PARP enzyme, which is a target for cancer therapy[4].

3. How do exclusivities affect the generic launch of Talzenna?

   • Exclusivities granted to Talzenna delay the entry of generic or bioequivalent versions into the market, regardless of the patent status[1].

4. What is the importance of independent and dependent claims in a patent?

   • Independent claims define the core invention, while dependent claims provide additional details and limitations, ensuring broader protection for various aspects of the invention[4].

5. How can strategic claim management enhance the value of a patent?

   • Strategic claim management can enhance the patent's defensive capabilities, ensure comprehensive protection, and increase its value in licensing and potential litigation scenarios[5].

Sources

1. Pharsight: Talzenna patent expiration.
2. USPTO: Patent Claims Research Dataset.
3. SSRN: Patent Claims and Patent Scope.
4. Google Patents: US9820985B2 - Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP).
5. Harrity LLP: Maximizing Patent Value: A Strategic Approach to Claim Management.

Drugs Protected by US Patent 9,820,985

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-001	Mar 7, 2024		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-002	Mar 7, 2024		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-003	Mar 7, 2024		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER

International Family Members for US Patent 9,820,985

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2767537		CA 2019 00055	Denmark
European Patent Office	2767537		301021	Netherlands
European Patent Office	2767537		PA2019522	Lithuania
European Patent Office	2767537		LUC00140	Luxembourg
European Patent Office	2767537		2019C/551	Belgium
European Patent Office	2767537		122019000108	Germany
European Patent Office	2767537		1990055-4	Sweden