United States Patent 8,436,190: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,436,190, titled "Bendamustine Pharmaceutical Compositions," is a significant patent in the pharmaceutical industry, particularly in the context of cancer treatment. This patent, issued on May 7, 2013, to Jason Edward Brittain and Joe Craig Franklin, is part of a broader patent landscape that protects various aspects of bendamustine formulations.
Background and History
The '190 patent originated from U.S. Patent Application No. 11/330,868, filed on January 12, 2006, which claims priority to U.S. Provisional Application No. 60/644,354, filed on January 14, 2005. This patent is part of a series of continuations and continuations-in-part, indicating a thorough and iterative development process[2][4].
Patent Scope and Claims
Claims Overview
The '190 patent includes several claims that define the scope of the invention. Key claims include:
- Claim 5: Describes a lyophilized pharmaceutical composition containing bendamustine or bendamustine hydrochloride at a concentration of about 12 to 17 mg/ml, mannitol at about 20-30 mg/ml, and tertiary-butyl alcohol at about 10-50% (v/v)[4].
- Claim 8: Specifies a lyophilized pharmaceutical composition containing not more than about 0.5% bendamustine ethylester[4].
These claims are crucial as they define the specific composition and characteristics of the bendamustine formulations protected by the patent.
Claim Construction
The court has provided detailed constructions of the terms used in the asserted claims of the '190 patent. For instance, the term "stable lyophilized preparation" has been construed to mean a preparation that remains in a stable form under specified conditions. Such constructions are essential for determining infringement and validity[5].
Patent Landscape
Related Patents
The '190 patent is part of a family of patents related to bendamustine pharmaceutical compositions. Other notable patents in this family include:
- U.S. Patent No. 8,609,863 ('863 patent): Issued on December 17, 2013, and related to similar bendamustine compositions[2].
- U.S. Patent No. 8,791,270 ('270 patent): Issued on July 29, 2014, and also related to bendamustine formulations[2].
- U.S. Patent No. 8,895,756 ('756 patent): Issued on November 25, 2014, covering additional aspects of bendamustine compositions[2].
These patents collectively form a robust intellectual property portfolio protecting various aspects of bendamustine formulations.
Expiry Dates and Exclusivity
The '190 patent is set to expire on October 26, 2030, with pediatric exclusivity expiring on April 26, 2031. This timeline is critical for understanding the remaining period of exclusivity and planning for generic or biosimilar entries into the market[2].
Litigation and Infringement
Consolidated Cases
The '190 patent has been involved in several consolidated cases, notably the In re Bendamustine Consolidated Cases. In these cases, Cephalon, Inc. alleged that various pharmaceutical companies infringed the asserted claims of the patents-in-suit. The court held a bench trial and made several findings regarding the validity and infringement of the patents[2][4].
Validity and Non-Obviousness
The court concluded that the asserted claims of the '190 patent were not invalid as obvious under 35 U.S.C. ยง 103. This determination was based on an analysis of prior art, the level of ordinary skill in the art, and secondary considerations of non-obviousness[4].
Impact on the Pharmaceutical Industry
Protection of Innovations
The '190 patent and its related patents provide significant protection for innovations in bendamustine formulations. This protection is crucial for encouraging investment in research and development in the pharmaceutical sector.
Generic and Biosimilar Entries
The expiry dates of these patents are closely watched by generic and biosimilar manufacturers. The expiration of these patents will open the market to generic versions of bendamustine, potentially reducing costs and increasing accessibility for patients.
Patent Scope Metrics
Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of patent scope. Narrower claims, such as those in the '190 patent, are often associated with a higher probability of grant and a shorter examination process[3].
Conclusion
The United States Patent 8,436,190 is a pivotal patent in the pharmaceutical industry, particularly in the context of bendamustine formulations. Its scope, claims, and the broader patent landscape it is part of are critical for understanding the intellectual property protection and the potential for future generic or biosimilar entries.
Key Takeaways
- The '190 patent protects specific bendamustine pharmaceutical compositions.
- It is part of a larger family of patents related to bendamustine formulations.
- The patent has been involved in significant litigation, with the court upholding its validity.
- The expiry dates of the patent and related patents are crucial for the pharmaceutical industry.
- Patent scope metrics indicate that narrower claims, like those in the '190 patent, have a higher probability of grant.
Frequently Asked Questions
What is the main subject of U.S. Patent 8,436,190?
The main subject of U.S. Patent 8,436,190 is bendamustine pharmaceutical compositions, specifically lyophilized formulations.
Who are the inventors of the '190 patent?
The inventors of the '190 patent are Jason Edward Brittain and Joe Craig Franklin.
When does the '190 patent expire?
The '190 patent is set to expire on October 26, 2030, with pediatric exclusivity expiring on April 26, 2031.
What are the key claims of the '190 patent?
Key claims include Claim 5, which describes the composition of the lyophilized pharmaceutical, and Claim 8, which specifies the concentration of bendamustine ethylester.
Has the '190 patent been involved in any significant litigation?
Yes, the '190 patent has been involved in consolidated cases where Cephalon, Inc. alleged infringement by several pharmaceutical companies.
Cited Sources:
- FDA Document: "208194Orig1s000 - accessdata.fda.gov"
- Casetext: "In re Bendamustine Consol. Cases - Casetext"
- Hoover Institution: "Patent Claims and Patent Scope - Hoover Institution"
- Morris James LLP: "Civil Action No. 13-2046-GMS - Morris James LLP"
- District of Delaware: "Civil Action No. 13-2046-GMS - District of Delaware"
