Prior art

Here's an analysis of the most relevant patent prior art for US Patent 8,377,903, based on the citations listed within the patent text.

Overview of Patent 8,377,903 Claims

The independent claims of US 8,377,903, specifically Claims 1 and 17, define a method for treating relapsing-remitting multiple sclerosis (RRMS) or early secondary progressive multiple sclerosis (SPMS) using an orally administered cladribine formulation. The core inventive step lies in a specific sequential dosing regimen:

• An induction period (2-4 months) with a total cladribine dose of 1.7 mg/kg to 3.5 mg/kg.
• A cladribine-free period (8-10 months).
• A maintenance period (2-4 months) with a total cladribine dose lower than the induction dose (Claim 1) or specifically about 1.7 mg/kg (Claim 17).
• A second cladribine-free period.

This regimen emphasizes oral administration, specific dose ranges, durations for each phase, and the relationship between induction and maintenance doses, with the possibility of re-treatments.

Analysis of Patent Citations

Here are the patent citations listed in US 8,377,903, along with their potential for anticipating the claims under 35 U.S.C. § 102:

1. US 5,506,214 A

   • Full Citation: US 5,506,214 A, "Use of substituted adenine derivatives for treating multiple sclerosis", issued April 9, 1996, to The Scripps Research Institute.
   • Publication/Filing Date: Filed February 3, 1986; Published April 9, 1996.
   • Brief Description: This patent broadly teaches the use of substituted adenine derivatives, including 2-chloro-2'-deoxyadenosine (cladribine), for the treatment of multiple sclerosis. It is also cited in US 8,377,903 for representative oral formulations of 2-CdA.
   • Potential Anticipation (35 U.S.C. § 102): This reference anticipates the general concept of using cladribine to treat multiple sclerosis. While it mentions oral formulations, it does not disclose the specific sequential multi-phase oral dosing regimen—including the defined durations of induction, cladribine-free, and maintenance periods, the specific total dose ranges, and the relationship of a lower maintenance dose to an induction dose—as claimed in US 8,377,903. Therefore, it does not anticipate claims 1-29 in their entirety under 35 U.S.C. § 102.

2. US 4,964,848 A

   • Full Citation: US 4,964,848 A, "Treatment of multiple sclerosis with lymphocytapheresis and chemo-immunosuppression", issued October 23, 1990, to Bloom Philip M.
   • Publication/Filing Date: Filed June 27, 1988; Published October 23, 1990.
   • Brief Description: This patent describes a method for treating multiple sclerosis using lymphocytapheresis in combination with chemo-immunosuppression.
   • Potential Anticipation (35 U.S.C. § 102): This patent does not disclose cladribine or any specific oral cladribine dosing regimen. It pertains to a different treatment approach for multiple sclerosis. Therefore, it does not anticipate any claims of US 8,377,903 under 35 U.S.C. § 102.

3. EP 0 626 853 B1

   • Full Citation: EP 0 626 853 B1, "Use of substituted adenine derivatives for treating multiple sclerosis", issued April 26, 2000, to The Scripps Research Institute.
   • Publication/Filing Date: Filed February 19, 1992; Published April 26, 2000.
   • Brief Description: This European patent is a counterpart to US 5,506,214 A, broadly disclosing the use of substituted adenine derivatives (like cladribine) for treating multiple sclerosis. It is cited in US 8,377,903 as suggesting cladribine's usefulness in MS.
   • Potential Anticipation (35 U.S.C. § 102): Similar to US 5,506,214 A, this patent anticipates the general concept of using cladribine to treat multiple sclerosis. However, it does not explicitly disclose the specific multi-phase oral dosing regimen, including the defined durations, dose relationships, and sequential steps, as claimed in US 8,377,903 (Claims 1-29). Therefore, it does not anticipate claims 1-29 in their entirety under 35 U.S.C. § 102.

4. WO 2004/087101 A2

   • Full Citation: WO 2004/087101 A2, "Oral formulations of cladribine", published October 14, 2004, to Ivax Corporation.
   • Publication/Filing Date: Filed March 28, 2003; Published October 14, 2004.
   • Brief Description: This international patent application specifically describes various oral formulations of cladribine, particularly cyclodextrin formulations. US 8,377,903 explicitly references this patent (WO 2004/087101) for the cladribine cyclodextrin formulation used in its own Example 1.
   • Potential Anticipation (35 U.S.C. § 102): This reference explicitly discloses oral formulations of cladribine, including specific cyclodextrin formulations. Therefore, it anticipates any claim of US 8,377,903 that broadly covers an "oral administration of a formulation comprising cladribine" (e.g., Claims 1, 9, 11, 12, 17, 25, 26, and their dependents). If WO 2004/087101 A2 also explicitly discloses the use of these oral cladribine formulations for treating MS, it would further anticipate that combination. However, it is highly unlikely that WO 2004/087101 A2, primarily focused on formulations, would anticipate the specific sequential multi-phase dosing regimen (induction, cladribine-free, maintenance periods with their specific durations and dose relationships) as defined in Claims 1 and 17.

5. US 2010/0021429 A1

   • Full Citation: US 2010/0021429 A1, "Cladribine regimen for treating multiple sclerosis", published January 28, 2010, to Laboratories Serono Sa.
   • Publication/Filing Date: Filed May 24, 2006; Published January 28, 2010.
   • Brief Description: The abstract and title of this patent application are identical to those of US 8,377,903, describing the oral administration of cladribine for the treatment of multiple sclerosis, including relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, with provisions for re-treatments. This application details the same sequential steps and dose ranges as US 8,377,903.
   • Potential Anticipation (35 U.S.C. § 102): Given the identical abstract and title, and its publication date (January 28, 2010) preceding the filing date of US 8,377,903 (April 23, 2010), this reference would literally anticipate all claims (Claims 1-29) of US 8,377,903 under a strict interpretation of 35 U.S.C. § 102, as it describes the identical invention. However, it is highly probable that US 2010/0021429 A1 is an earlier-published application within the same patent family, sharing a common priority date (December 22, 2004) with US 8,377,903, and by the same inventive entity/assignee. In such a scenario, while it literally discloses the claimed subject matter, it would not typically serve as invalidating prior art under current US patent law due to common ownership/inventorship and proper priority claims.

Most Relevant Prior Art:

For purposes of anticipation under 35 U.S.C. § 102, US 2010/0021429 A1 is the most relevant reference as it literally discloses the entire claimed invention, including the specific sequential oral dosing regimen for cladribine in MS. Following that, WO 2004/087101 A2 is highly relevant for its disclosure of oral cladribine formulations, which forms a fundamental component of the methods claimed in US 8,377,903.