Details for Patent: 10,849,919

Which drugs does patent 10,849,919 protect, and when does it expire?

Patent 10,849,919 protects MAVENCLAD and is included in one NDA.

This patent has sixteen patent family members in fourteen countries.

Summary for Patent: 10,849,919

Title:	Cladribine regimen for treating progressive forms of multiple sclerosis
Abstract:	Specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine can be effective for the treatment of progressive forms of Multiple Sclerosis, especially Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis. Methods of treatment can be based on specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine.
Inventor(s):	Dangond; Fernando (Weston, MA), Dotzauer; Matthias (Erzhausen, DE)
Assignee:	Merck Patent GmbH (Darmstadt, DE)
Application Number:	16/199,119
Patent Claim Types: see list of patent claims	Use; Dosage form;

Understanding the Scope and Claims of United States Patent 10,849,919

Introduction

The United States Patent 10,849,919, titled "Cladribine Regimen for Treating Progressive Forms of Multiple Sclerosis," is a crucial patent in the pharmaceutical industry, particularly in the treatment of multiple sclerosis. This patent, owned by Ares Trading SA, is part of a broader patent landscape that includes other related patents such as the '947 and '903 patents owned by Merck Serono SA.

Background

The '919 patent was issued on December 1, 2020, and it is listed in the Orange Book as one of the patents covering the drug MAVENCLAD®, which is used for treating multiple sclerosis[5].

Patent Claims and Scope

Claims Overview

The '919 patent includes claims that describe specific regimens for administering cladribine to treat progressive forms of multiple sclerosis. These claims are designed to protect the intellectual property related to the dosage, administration schedule, and other aspects of the treatment regimen.

Dosage and Administration

The patent claims specify the total dose of cladribine and the timing of its administration. For instance, the patent describes a treatment regimen that includes an induction period followed by a maintenance period, with specific dosages and intervals between doses[4].

Maintenance and Induction Periods

Similar to the '947 and '903 patents, the '919 patent includes claims that detail the differences between the induction and maintenance periods. Some claims specify that the dose in the maintenance period can be the same as or lower than the dose in the induction period, depending on the claim language and the specification[2].

Prosecution History and Claim Construction

Prosecution History

During the prosecution of the patent, the patentee made statements that could impact the claim scope. Defendants in related litigation have argued that these statements amount to a prosecution history disclaimer, which could limit the scope of the claims. However, the court must carefully analyze these statements to determine their impact on the claim constructions[2].

Claim Construction

The court's construction of the claims is critical in determining the scope of the patent. The claim language and the specification are key factors in this analysis. For example, claims that do not explicitly state that the maintenance dose must be lower than the induction dose may allow for flexibility in the treatment regimen[1].

Patent Landscape and Industry Impact

Genus Claims and Pharmaceutical Industry

The '919 patent, like other patents in the pharmaceutical industry, often involves genus claims that aim to capture a broad range of embodiments. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain and maintain broad patent protection for drugs and biologics. The rigid application of § 112(a) of the patent statute, which requires a written description and enablement, has limited the scope of genus claims, making it difficult for innovators to protect their inventions without being too narrow or too broad[3].

Competitive Landscape

The pharmaceutical industry is highly competitive, and patent protection is crucial for innovators to recoup their investment in research and development. The '919 patent, along with the '947 and '903 patents, plays a significant role in protecting Merck's and Ares Trading SA's intellectual property related to MAVENCLAD®. Generic manufacturers, such as Aurobindo Pharma, must navigate these patents carefully to avoid infringement, often submitting Abbreviated New Drug Applications (ANDAs) that must be approved by the FDA before they can market their generic versions[5].

Litigation and Infringement

Hatch-Waxman Actions

The '919 patent has been involved in Hatch-Waxman litigation, where generic manufacturers have sought to market generic versions of MAVENCLAD®. Plaintiffs have alleged infringement of the '919 patent, along with the '947 and '903 patents, against defendants such as Aurobindo Pharma and Apotex Inc. These cases involve complex arguments over claim construction, prosecution history, and the scope of the patents[1][2].

Infringement Allegations

Defendants have submitted ANDAs to the FDA seeking approval for their generic products, which plaintiffs argue infringe the claims of the '919 patent. The court must determine whether these generic products infringe the patent claims, either literally or under the doctrine of equivalents[5].

Expiration Dates and Future Implications

The '919 patent has a later expiration date compared to the '947 and '903 patents, expiring on November 23, 2038. This extended protection period is significant for maintaining market exclusivity for MAVENCLAD® and preventing generic competition for a longer period[5].

Key Takeaways

• Patent Scope: The '919 patent includes specific claims related to the treatment regimen for progressive forms of multiple sclerosis, including dosage and administration schedules.
• Prosecution History: Statements made during patent prosecution can impact claim scope and are subject to careful analysis by the court.
• Industry Impact: The patent landscape in the pharmaceutical industry is challenging due to strict application of § 112(a), affecting the breadth of patent protection.
• Litigation: The '919 patent is involved in Hatch-Waxman actions, with ongoing disputes over claim construction and infringement.
• Expiration Dates: The '919 patent has a later expiration date, providing extended market exclusivity for MAVENCLAD®.

FAQs

1. What is the main subject of the '919 patent? The '919 patent is focused on a cladribine regimen for treating progressive forms of multiple sclerosis.

2. Who owns the '919 patent? The '919 patent is owned by Ares Trading SA.

3. What is the significance of the '919 patent in the pharmaceutical industry? The '919 patent is crucial for protecting the intellectual property related to the drug MAVENCLAD®, which is used to treat multiple sclerosis.

4. How does the '919 patent relate to other patents like the '947 and '903 patents? The '919 patent is part of a broader patent landscape that includes the '947 and '903 patents, all of which are related to cladribine regimens for treating multiple sclerosis.

5. What are the implications of the '919 patent's expiration date? The '919 patent expires on November 23, 2038, providing extended market exclusivity for MAVENCLAD® and preventing generic competition for a longer period.

Cited Sources

1. Merck KGaA v. Hopewell Pharma Ventures, Inc. - Casetext
2. Report and Recommendation in Merck KGaA, et al., v. Hopewell Pharma Ventures, Inc., et al. - District of Delaware
3. Eviscerating Patent Scope - DigitalCommons@NYLS
4. US10849919B2 - Cladribine regimen for treating progressive forms of multiple sclerosis - Google Patents
5. In the United States District Court - Insight.RPXcorp.com

Drugs Protected by US Patent 10,849,919

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	10,849,919					TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS

International Family Members for US Patent 10,849,919

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	113906
Australia	2018372007
Brazil	112020010282
Canada	3083328