Details for Patent: 10,603,314

Which drugs does patent 10,603,314 protect, and when does it expire?

Patent 10,603,314 protects VIZIMPRO and is included in one NDA.

This patent has thirty-seven patent family members in twenty-seven countries.

Summary for Patent: 10,603,314

Title:	Method for treating gefitinib resistant cancer
Abstract:	The present invention is directed to methods for the treatment of gefitinib and/or erlotinib resistant cancer. An individual with cancer is monitored for cancer progression following treatment with gefitinib and/or erlotinib. Progression of the cancer is indicative that the cancer is resistant to gefitinib and/or erlotinib. Once progression of cancer is noted, the subject is administered a pharmaceutical composition comprising an irreversible epidermal growth factor receptor (EGFR) inhibitor. In preferred embodiments, the irreversible EGFR inhibitor is EKB-569, HKI-272 and HKI-357.
Inventor(s):	Haber; Daniel A. (Chestnut Hill, MA), Bell; Daphne Winifred (Chevy Chase, MD), Settleman; Jeffrey E. (Newton, MA), Sordella; Raffaella (Cold Spring Harbor, NY), Godin-Heymann; Nadia G. (Stanmore, GB), Kwak; Eunice L. (Marlborough, MA), Rabindran; Sridhar Krishna (Eagleville, PA)
Assignee:	The General Hospital Corporation (Boston, MA) Wyeth LLC (New York, NY)
Application Number:	11/883,474
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,603,314: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,603,314, along with its counterpart 10,596,162, has been at the center of a significant patent infringement dispute involving Wyeth LLC (a subsidiary of Pfizer Inc.) and AstraZeneca Pharmaceuticals LP. This analysis will delve into the scope, claims, and the broader patent landscape surrounding these patents.

Background of the Patents

The patents in question, 10,603,314 and 10,596,162, are directed to methods for treating gefitinib and/or erlotinib resistant non-small cell lung cancer (NSCLC). These patents are crucial in the field of oncology, particularly in the treatment of NSCLC, which is a common type of lung cancer[4].

Claims of the Patents

Method of Treatment

The asserted claims of the '314 patent describe a method for treating gefitinib and/or erlotinib resistant NSCLC. Specifically, the claims include:

• Administering an irreversible EGFR inhibitor to a patient with gefitinib and/or erlotinib resistant NSCLC.
• The method involves the irreversible EGFR inhibitor covalently binding to the cysteine 773 residue of EGFR.
• The route of administration is specified as oral[4].

Specific Mutations

The '162 patent focuses on EGFR with a specific mutation, the "T790M mutation," which is associated with gefitinib and erlotinib resistance. This mutation is a key factor in the development of resistance to first-line EGFR inhibitors[4].

Patent Scope and Enablement

Enablement Requirement

The enablement requirement is a critical aspect of patent validity. According to 35 U.S.C. § 112(a), a patent must include a specification that contains a written description of the invention and enables any person skilled in the art to make and use the invention. In the case of the '314 and '162 patents, AstraZeneca argued that these patents fail to meet the enablement requirement because the specification does not provide sufficient information to enable a person of ordinary skill in the art (POSA) to practice the claims with any irreversible EGFR inhibitor, especially larger compounds[4].

Court Ruling on Enablement

The court, however, did not find that the mention of "larger compounds" in the specification necessarily invalidated the patents. The court relied on the Supreme Court's decision in Amgen, which clarified that the specification must enable the full scope of the invention but does not require a detailed description of how to make and use every single embodiment. Instead, providing examples and disclosing general qualities that give the class a peculiar fitness for the particular purpose can suffice[4].

Patent Validity and Infringement

Lack of Written Description

In addition to the enablement issue, the court also considered the lack of written description. AstraZeneca argued that the patents fail to meet this requirement as well. However, the court's final ruling invalidated the patents primarily due to a lack of enablement and lack of written description, rather than anticipation or obviousness[2].

Infringement Dispute

Wyeth LLC alleged that AstraZeneca's anti-cancer drug, Tagrisso (osimertinib), induced infringement of several claims of the '314 and '162 patents. Initially, a jury found in favor of Wyeth, but AstraZeneca's motion for judgment as a matter of law led to the court invalidating the patents on the grounds of lack of enablement and written description[2].

Orange Book Listings and Patent Strategy

Orange Book Requirements

The Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations, requires innovator companies to list relevant patents within thirty days of FDA approval or patent issuance. Pfizer did not list the '314 and '162 patents for its drug Vizimpro, which led AstraZeneca to argue that Pfizer did not believe these patents covered the approved indication for Vizimpro, and by extension, Tagrisso[5].

Strategic Implications

The failure to list these patents in the Orange Book has significant strategic implications. It suggests that Pfizer may not have considered these patents to be relevant to the first-line treatment of NSCLC with specific EGFR mutations, which is the same indication for Tagrisso. This oversight or strategic decision can impact the validity and enforceability of the patents in future disputes[5].

Industry Impact and Expert Insights

Impact on Innovation

The invalidation of these patents due to lack of enablement and written description highlights the importance of clear and comprehensive patent specifications. This ruling can influence how pharmaceutical companies draft and defend their patents, emphasizing the need for detailed descriptions that enable POSA to practice the claimed inventions[4].

Expert Opinions

Industry experts often emphasize that patent quality is crucial for innovation. Patents that are overly broad or lack clarity can lead to increased litigation costs and diminished incentives for innovation. The metrics for measuring patent scope, such as independent claim length and count, can provide insights into the breadth and clarity of patents, which is essential for maintaining a healthy patent ecosystem[3].

Key Takeaways

• Patent Scope and Enablement: The '314 and '162 patents were invalidated due to lack of enablement and written description, highlighting the importance of comprehensive specifications.
• Claims and Method of Treatment: The patents describe methods for treating gefitinib and erlotinib resistant NSCLC using irreversible EGFR inhibitors.
• Orange Book Listings: The failure to list these patents in the Orange Book raises questions about their relevance to approved indications and impacts their enforceability.
• Industry Impact: The ruling underscores the need for clear and detailed patent specifications to support innovation and reduce litigation.

FAQs

Q: What are the main claims of the United States Patent 10,603,314?

A: The main claims involve methods for treating gefitinib and/or erlotinib resistant non-small cell lung cancer by administering an irreversible EGFR inhibitor.

Q: Why were the patents invalidated?

A: The patents were invalidated due to a lack of enablement and written description, as the court found that the specifications did not provide sufficient information to enable a POSA to practice the claims.

Q: What is the significance of Orange Book listings in this context?

A: The failure to list the patents in the Orange Book suggests that Pfizer may not have considered these patents relevant to the approved indication for Vizimpro, impacting their enforceability.

Q: How does this ruling affect the pharmaceutical industry?

A: The ruling emphasizes the importance of clear and comprehensive patent specifications, which can influence how pharmaceutical companies draft and defend their patents.

Q: What metrics are used to measure patent scope?

A: Metrics such as independent claim length and count are used to measure patent scope, providing insights into the breadth and clarity of patents[3].

Sources

1. Puma Biotechnology, Inc. v. Astrazeneca Pharm. - Casetext
2. Wyeth LLC v. AstraZeneca Pharmaceuticals LP, patents worth ... - Panitch Law
3. Patent Claims and Patent Scope - SSRN
4. 21-1338.pdf - District of Delaware
5. in the united states district court - District of Delaware

Drugs Protected by US Patent 10,603,314

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	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No	10,603,314					ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OF ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No	10,603,314					ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OF ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes	10,603,314					ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OF ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION

Foreign Priority and PCT Information for Patent: 10,603,314

PCT Information
PCT Filed	February 02, 2006	PCT Application Number:	PCT/US2006/003717
PCT Publication Date:	August 10, 2006	PCT Publication Number:	WO2006/084058

International Family Members for US Patent 10,603,314

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1848414		300824	Netherlands
European Patent Office	1848414		122016000056	Germany
European Patent Office	1848414		93160	Luxembourg
European Patent Office	1848414		C20160024 00190	Estonia