Details for Patent: 8,198,262

Which drugs does patent 8,198,262 protect, and when does it expire?

Patent 8,198,262 protects POMALYST and is included in one NDA.

Protection for POMALYST has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has three hundred and six patent family members in forty countries.

Summary for Patent: 8,198,262

Title:	Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Abstract:	Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.
Inventor(s):	Zeldis; Jerome B. (Princeton, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	12/229,074
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,198,262
Patent Claim Types: see list of patent claims	Use; Dosage form; Delivery;

United States Patent 8,198,262: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,198,262, owned by Celgene Corporation, is a significant patent in the pharmaceutical industry, particularly in the treatment of multiple myeloma. This patent, issued on June 12, 2012, covers methods for treating multiple myeloma using a specific compound. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Inventor and Issuance

The patent was invented by Jerome B. Zeldis and issued on June 12, 2012. It is titled "Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione"[4].

Scope of the Patent

Claimed Subject Matter

The patent claims methods for treating multiple myeloma, a type of blood cancer, using the compound 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione. This compound is part of the drug Pomalyst®, which is a key product of Celgene Corporation.

Specific Claims

The patent includes multiple claims, with Claim 1 being a representative claim:

• "A method of treating multiple myeloma, which comprises administering to a patient having multiple myeloma: (a) from about 1 mg to about 5 mg per day of a compound having the structure 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione"[4].

Claim Construction and Interpretation

Legal Context

The interpretation of patent claims is crucial in determining their scope and validity. In the context of this patent, claim construction has been a subject of litigation. For instance, in the case of Celgene Corp. v. Hetero Labs Ltd., the court had to interpret the claims of this patent along with other related patents to determine infringement and validity[1].

Role of Specification

The specification of the patent plays a significant role in claim construction. The Federal Circuit has emphasized that the specification informs the proper construction of the claims, but it is inappropriate to read limitations from the specification into the claims[1].

Patent Landscape

Related Patents

The patent 8,198,262 is part of a larger family of patents related to the treatment of multiple myeloma and the formulation of Pomalyst®. Other patents in this family include U.S. Patent Nos. 8,673,939, 8,735,428, 8,828,427, and 9,993,467, which cover various aspects of the treatment and formulation[1][2].

Litigation and Infringement

This patent has been involved in several litigation cases, particularly against generic drug manufacturers seeking to market generic versions of Pomalyst®. For example, Celgene has filed infringement actions against companies like Hetero Labs Limited, Sandoz Inc., and others, alleging that their ANDA submissions constitute infringement of Celgene's patents[1][2].

Patent Term and Extension

Expiration Date

The original expiration date of the patent was October 19, 2024. However, Celgene Corporation has sought and obtained an extension of the patent term under 35 U.S.C. § 156, which extends the term by 523 days due to regulatory delays[4].

Impact on Innovation and Competition

Patent Scope and Quality

The scope and quality of patents like 8,198,262 are critical in the pharmaceutical industry. Broad and unclear claims can impede innovation by increasing licensing and litigation costs. However, narrower and clearer claims, as seen in this patent, can facilitate innovation by providing clear boundaries for competitors[3].

Generic Competition

The patent's expiration and any extensions significantly impact the entry of generic competitors. Generic manufacturers often file ANDA applications, which can lead to litigation over patent infringement. The resolution of these cases determines when generic versions of the drug can enter the market, affecting competition and drug prices[1][2].

Key Takeaways

• Specific Compound: The patent covers the use of 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione for treating multiple myeloma.
• Claim Construction: The interpretation of claims is crucial and relies heavily on the patent specification.
• Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
• Patent Term: The patent term has been extended due to regulatory delays.
• Impact on Innovation: Clear and narrow claims facilitate innovation and competition in the pharmaceutical industry.

FAQs

What is the main subject matter of U.S. Patent 8,198,262?

The main subject matter is methods for treating multiple myeloma using the compound 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione.

Who is the inventor of U.S. Patent 8,198,262?

The inventor is Jerome B. Zeldis.

What is the significance of this patent in the pharmaceutical industry?

This patent is significant because it covers the treatment of multiple myeloma using a specific compound that is part of the drug Pomalyst®, a key product of Celgene Corporation.

How has this patent been involved in litigation?

This patent has been involved in several infringement cases against generic drug manufacturers seeking to market generic versions of Pomalyst®.

What is the current status of the patent term for U.S. Patent 8,198,262?

The patent term has been extended by 523 days due to regulatory delays under 35 U.S.C. § 156.

How does the scope of this patent impact innovation in the pharmaceutical industry?

The clear and narrow claims of this patent facilitate innovation by providing clear boundaries for competitors and reducing the likelihood of overly broad or unclear claims that could impede innovation.

Sources

1. Celgene Corp. v. Hetero Labs Ltd. - Casetext
2. Life Sciences Court Report - July 2018 - JD Supra
3. Patent Claims and Patent Scope - Hoover Institution
4. Application for Extension of Patent Term Under 35 U.S.C. § 156 - Regulations.gov

Drugs Protected by US Patent 8,198,262

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	AB	RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,198,262

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2105135		1590004-6	Sweden
European Patent Office	2105135		C300717	Netherlands
European Patent Office	2105135		CA 2015 00006	Denmark
European Patent Office	2105135		92642	Luxembourg
European Patent Office	2105135		C20150005 00140	Estonia