US 7713947

The patent summary information can be directly extracted from the provided patent text.

Title: Cladribine regimen for treating multiple sclerosis
Assignee: Merck Serono SA
Inventors: Giampiero De luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
Filing Date: 2005-12-20
Issue Date: 2010-05-11
Abstract: The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be orally administered and wherein re-treatments are possible.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a method for treating multiple sclerosis using an oral cladribine formulation. The treatment involves a specific four-step sequence:

  1. Induction Period: Oral administration of cladribine where the total dose received by the patient is between approximately 1.7 mg/kg and 3.5 mg/kg.
  2. Cladribine-Free Period (first): A break from cladribine administration lasting between approximately 8 and 10 months.
  3. Maintenance Period: Further oral administration of cladribine, but the total dose during this period is lower than the total dose given during the initial induction period.
  4. Cladribine-Free Period (second): Another break from cladribine administration.

• Claim 20: This claim also describes a method for treating multiple sclerosis with oral cladribine, similar to Claim 1, but it specifies the duration of the administration periods more precisely:

  1. Induction Period: Oral administration of cladribine for approximately 2 to 4 months, with a total dose between approximately 1.7 mg/kg and 3.5 mg/kg.
  2. Cladribine-Free Period (first): A break from cladribine administration lasting approximately 8 to 10 months.
  3. Maintenance Period: Oral administration of cladribine for approximately 2 to 4 months, with a total dose lower than the induction period's total dose.
  4. Cladribine-Free Period (second): Another break from cladribine administration.

• Claim 36: This claim describes another method for treating multiple sclerosis with oral cladribine, similar to Claim 20, but with a specific total dose for the maintenance period:

  1. Induction Period: Oral administration of cladribine for approximately 2 to 4 months, with a total dose between approximately 1.7 mg/kg and 3.5 mg/kg.
  2. Cladribine-Free Period (first): A break from cladribine administration lasting approximately 8 to 10 months.
  3. Maintenance Period: Oral administration of cladribine for approximately 2 to 4 months, where the total dose reached at the end of this period is about 1.7 mg/kg.
  4. Cladribine-Free Period (second): Another break from cladribine administration.

CAFC 2026 Dockets for US7713947:

According to recent reports, US patent 7713947 has been involved in litigation. The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a lower tribunal's finding that US7713947B2 is unpatentable. This decision strengthens the position of TWI Pharmaceuticals and impacts Merck Serono's ability to enforce this patent.

Specifically, in "Merck Serono v. TWI Pharmaceuticals" (Case No. 25-1463), the Federal Circuit affirmed the unpatentability of US7713947B2 on October 30, 2025. The patent was found unpatentable due to obviousness, based on the combination of prior art references (Bodor and Stelmasiak). This ruling was finalized at the Federal Circuit level.

Another related case, "Merck KGaA v. Hopewell Pharma Ventures, Inc." (Case No. 1:22-cv-01365) in the Delaware District Court, also resulted in the invalidation of claims from US7713947, along with US8377903, due to obviousness. This judgment was entered on January 29, 2026, and was driven by a precedential Federal Circuit decision. Claims 36, 38, 39, and 41-46 of US7713947 were found invalid as obvious in this case.

Furthermore, in "Merck KGaA v. Apotex, Inc." (Case No. 1:23-cv-00655), the U.S. District Court for the District of Delaware entered judgment in favor of Apotex Inc. on February 2, 2026, also declaring claims 36, 38, 39, and 41-46 of US7713947 invalid as obvious. This decision cited the Federal Circuit's controlling decision in Merck Serono v. Hopewell.

Therefore, while the Google Patents status lists the patent as "Active, expires 2026-10-16", the overriding and more recent information from the CAFC dockets indicates that key claims of US7713947B2 have been found unpatentable and invalid due to obviousness by the Federal Circuit and district courts, significantly impacting its enforceability. The legal status presented in the search results contradicts the "Active" status on Google Patents (which appears to refer to maintenance fee payments) and should be prioritized.US patent 7713947, titled "Cladribine regimen for treating multiple sclerosis," was assigned to Merck Serono SA. The inventors are Giampiero De luca, Arnaud Ythier, Alain Munafo, and Maria Lopez-Bresnahan. The patent was filed on December 20, 2005, and issued on May 11, 2010.

The abstract describes the invention as the use of cladribine for preparing an orally administered pharmaceutical formulation to treat multiple sclerosis, specifically relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, allowing for re-treatments.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a treatment method for multiple sclerosis using an orally administered cladribine formulation. The method involves a sequence of four periods:

  1. An induction period where the cladribine formulation is given, with the total accumulated dose ranging from approximately 1.7 mg/kg to 3.5 mg/kg.
  2. A first cladribine-free period of about 8 to 10 months, during which no cladribine is administered.
  3. A maintenance period where the cladribine formulation is administered again, but the total dose during this period is less than the total dose from the induction period.
  4. A second cladribine-free period where no cladribine is administered.

• Claim 20: This claim outlines another method for treating multiple sclerosis with orally administered cladribine, similar to Claim 1, but with specified durations for the administration periods:

  1. An induction period lasting approximately 2 to 4 months, with an orally administered total cladribine dose between about 1.7 mg/kg and 3.5 mg/kg.
  2. A first cladribine-free period lasting approximately 8 to 10 months, with no cladribine administration.
  3. A maintenance period lasting approximately 2 to 4 months, with orally administered cladribine, where the total dose is less than that of the induction period.
  4. A second cladribine-free period with no cladribine administration.

• Claim 36: This claim describes a further method for treating multiple sclerosis with orally administered cladribine, similar to Claim 20, but with a specific total dose for the maintenance period:

  1. An induction period lasting approximately 2 to 4 months, with an orally administered total cladribine dose between about 1.7 mg/kg and 3.5 mg/kg.
  2. A first cladribine-free period lasting approximately 8 to 10 months, with no cladribine administration.
  3. A maintenance period lasting approximately 2 to 4 months, with orally administered cladribine, where the total dose reached by the end of this period is approximately 1.7 mg/kg.
  4. A second cladribine-free period with no cladribine administration.

CAFC 2026 Dockets for US7713947:

Despite being listed as "Active" with an expiration date of October 16, 2026, on Google Patents, judicial rulings have significantly impacted the enforceability of US7713947.

The U.S. Court of Appeals for the Federal Circuit (CAFC), in Case No. 25-1463 (Merck Serono v. TWI Pharmaceuticals), affirmed on October 30, 2025, that US7713947B2 is unpatentable due to obviousness. This decision followed a ruling by the Patent Trial and Appeal Board (PTAB) that the claims were obvious based on prior art. This Federal Circuit ruling is final at that level.

Additionally, in "Merck KGaA v. Hopewell Pharma Ventures, Inc." (Case No. 1:22-cv-01365) in the Delaware District Court, a final judgment was entered on January 29, 2026. This judgment, driven by a precedential Federal Circuit decision, invalidated claims 36, 38, 39, and 41-46 of US7713947 as obvious. Similarly, in "Merck KGaA v. Apotex, Inc." (Case No. 1:23-cv-00655), claims 36, 38, 39, and 41-46 of US7713947 were also declared invalid as obvious on February 2, 2026, by the U.S. District Court for the District of Delaware, citing the Federal Circuit's controlling decision in Merck Serono v. Hopewell.

These decisions mean that several key claims of US7713947 have been found unpatentable and invalid, significantly curtailing its legal standing and enforceability.