Details for Patent: 10,596,162

Which drugs does patent 10,596,162 protect, and when does it expire?

Patent 10,596,162 protects VIZIMPRO and is included in one NDA.

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

Summary for Patent: 10,596,162

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. (Middlesex, GB), Kwak; Eunice L. (Marlborough, MA), Rabindran; Sridhar Krishna (Eagleville, PA)
Assignee:	Wyeth LLC (New York, NY) The General Hospital Corporation (Boston, MA)
Application Number:	15/207,349
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,596,162: A Detailed Analysis

Introduction

United States Patent 10,596,162, titled "Method for treating gefitinib resistant cancer," is a significant patent in the pharmaceutical industry, particularly in the treatment of cancer. This patent, owned by Wyeth LLC, a subsidiary of Pfizer Inc., has been at the center of a high-profile dispute involving AstraZeneca Pharmaceuticals. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent in question addresses methods for treating cancers that are resistant to gefitinib and/or erlotinib, two commonly used tyrosine kinase inhibitors. These drugs are often prescribed for non-small cell lung cancer (NSCLC) but can lose effectiveness due to mutations in the epidermal growth factor receptor (EGFR), such as the T790M mutation[1].

Scope of the Patent

The patent describes a method for treating cancer in subjects with specific EGFR mutations, particularly the T790M mutation, which confers resistance to gefitinib and erlotinib. The method involves administering an irreversible EGFR inhibitor, which covalently binds to the EGFR receptor, thereby inhibiting cancer cell proliferation. This approach is distinct from reversible inhibitors like gefitinib, which do not provide lasting inhibition in the presence of resistance mutations[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

• Claim 1: A method of treating cancer in a subject having a mutation in EGFR, specifically the T790M mutation, by administering an irreversible EGFR inhibitor.
• Claim 2: The method includes monitoring the size of the cancer at multiple time points, with the later time points being at least 2 months, 6 months, 10 months, or one year after the preceding time point.
• Claim 3: The pharmaceutical composition comprises an irreversible EGFR inhibitor, such as HKI-357 or EKB-569, which are effective against cancers with altered EGFR trafficking[1].

Patent Landscape and Litigation

The patent has been central to a significant legal dispute between Wyeth LLC (Pfizer) and AstraZeneca Pharmaceuticals. AstraZeneca's drug Tagrisso, used for treating NSCLC, was found to infringe on Wyeth's patents, including US Patent 10,596,162. The jury awarded Pfizer $107.5 million in damages, finding that AstraZeneca had infringed upon specific claims of the patent[5].

However, in a subsequent ruling, the court vacated the jury verdict due to issues with the patent's enablement and written description. The court determined that the patents did not provide sufficient support for a safe and effective dosage, leading to a lack of enablement and written description under 35 U.S.C. § 112(a)[2].

Enablement and Written Description

The court's decision highlighted the importance of detailed descriptions in patent applications. For a patent to be valid, it must describe the invention in a way that allows persons of ordinary skill in the art to replicate it. In this case, the lack of specific dosage information and other critical details led to the invalidation of the patents[2].

Impact on Pharmaceutical Industry

This patent dispute underscores the competitive nature of the pharmaceutical industry, where intellectual property rights are crucial. The ruling against Wyeth LLC serves as a reminder that patents must be thoroughly described and enabled to withstand legal challenges. This is particularly important in the development of cancer treatments, where small differences in dosage and administration can significantly impact efficacy and safety[5].

Expert Insights

Industry experts emphasize the need for robust patent descriptions to avoid legal pitfalls. As noted by legal commentators, "a patent for a method of treatment should describe a completed invention, not an unfinished project"[2].

Statistics and Revenue

The financial stakes in such disputes are substantial. For instance, Tagrisso generated nearly $5.8 billion in revenue for AstraZeneca in 2023, highlighting the economic importance of these patents[2].

Broader Patent Landscape

The patent landscape in the pharmaceutical sector is complex and dynamic. Changes in patent laws, such as those introduced by the Leahy-Smith America Invents Act (AIA) in 2011, have influenced the number and nature of patent infringement lawsuits. The increase in such lawsuits can be attributed to various factors, including the anticipation of legal changes and the strategic filing of multiple lawsuits by plaintiffs[4].

Key Takeaways

• Irreversible EGFR Inhibitors: The patent introduces the use of irreversible EGFR inhibitors as a treatment for gefitinib-resistant cancers.
• Legal Challenges: The patent's validity was challenged due to lack of enablement and written description.
• Industry Impact: The dispute highlights the critical role of detailed patent descriptions in the pharmaceutical industry.
• Financial Significance: The revenue generated by drugs like Tagrisso underscores the economic importance of these patents.

FAQs

Q: What is the main focus of United States Patent 10,596,162? A: The patent focuses on methods for treating cancers resistant to gefitinib and/or erlotinib using irreversible EGFR inhibitors.

Q: What is the T790M mutation, and how does it affect cancer treatment? A: The T790M mutation in EGFR confers resistance to gefitinib and erlotinib, making irreversible EGFR inhibitors necessary for effective treatment.

Q: Why was the jury verdict against AstraZeneca vacated? A: The court vacated the verdict due to lack of enablement and written description in the patent, specifically the failure to provide support for a safe and effective dosage.

Q: How does this patent dispute impact the pharmaceutical industry? A: The dispute emphasizes the importance of detailed and enabled patent descriptions to avoid legal challenges and protect intellectual property rights.

Q: What are the financial implications of this patent dispute? A: The dispute involves significant financial stakes, with Tagrisso generating nearly $5.8 billion in revenue for AstraZeneca in 2023.

Cited Sources

1. US10596162B2 - Method for treating gefitinib resistant cancer - Google Patents
2. Wyeth LLC v. AstraZeneca Pharmaceuticals LP, patents worth billions were invalidated due to failure to identify a safe but effective dosage - Panitch Law
3. Patent Claims Research Dataset - USPTO
4. Assessing Factors That Affect Patent Infringement Litigation - GAO
5. Pfizer triumphs over AstraZeneca in cancer drug patent dispute - Patent Lawyer Magazine

Drugs Protected by US Patent 10,596,162

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						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION

International Family Members for US Patent 10,596,162

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