Patent 8,114,836 Overview
United States Patent 8,114,836 (the '836 patent) pertains to methods for identifying and treating diseases using specific biomarkers. Filed by Isis Innovation Limited and licensed to Regeneron Pharmaceuticals, Inc., it claims methods of screening for disease states via particular protein markers and applying designated therapeutic interventions.
Claims Analysis
What specific methods are claimed in the '836 patent?
The patent primarily claims methods involving:
- Detecting the presence or level of specific biomarkers in a biological sample.
- Correlating these biomarker levels with disease states.
- Using the biomarker information to tailor treatment regimens.
It emphasizes the detection of particular protein or nucleic acid biomarkers associated with diseases such as inflammatory conditions, cancers, or neurodegenerative disorders.
Are the claims broad or narrow?
The claims are relatively broad, encompassing any method of detecting the identified biomarkers for diagnosing or guiding the treatment of multiple diseases. This includes various assay techniques like immunoassays, nucleic acid detection, and other analytical methods.
Are there limitations or dependencies?
Most claims depend on the detection of certain biomarkers in a specific manner. Limitations include the requirement that the biomarkers be validated for a particular disease and the detection method meet sensitivity and specificity criteria.
Have the claims been successfully enforced?
While there are no enforcement actions publicly documented, the patent has been referenced in numerous patent filings and research publications, indicating recognition of its foundational role in biomarker-based diagnostics.
Patent Landscape and Prior Art
Similar patents and their scope
The '836 patent references earlier biomarker patents, such as US patent 7,990,862, which describes detection of inflammation-related biomarkers. Patents filed by competing entities, such as Abbott, Roche, and Qiagen, focus on different biomarker panels or detection methods but often overlap in disease applications.
Patent families and continuations
The original application was filed in 2008, granting in 2012. Several continuation applications have been filed, aiming to expand claims to include new biomarkers, detection technologies, and disease indications. These continuations potentially extend patent exclusivity until approximately 2030 under U.S. law, considering PTE adjustments.
Critical prior art
Key prior art includes:
- Patent WO 2008/130234 A2, detailing biomarker panels for disease diagnosis.
- Scientific publications predating the application date (2006-2008) describing similar biomarkers and detection methods.
These references challenge the novelty or non-obviousness of certain claims within the '836 patent.
Patentability challenges
Given the prior art, patent examiners likely questioned the patent's claims for obviousness, especially claims covering general biomarker detection techniques. Nonetheless, the patent's detailed particular biomarkers and their combinations have sustained its validity.
Legal and Commercial Implications
The '836 patent is foundational for diagnostics and personalized medicine efforts. Its broad claims have spurred licensing, collaborations, and follow-up patents. Companies developing biomarker-based tests citing '836 must navigate potential patent infringement risks or seek license agreements.
Litigation and licensing history
No publicly known litigation involving the '836 patent exists. Licensing agreements have been reported with third-party biotech firms aiming to develop companion diagnostics.
Critical Evaluation
The patent's strength derives from claim breadth and its alignment with emerging diagnostic technologies. However, challenges exist due to prior art and technological overlaps. Its enforceability depends on maintaining the specificity and novelty of claimed biomarkers and methods.
Key Takeaways
- The '836 patent claims methods for disease diagnosis and treatment based on biomarker detection.
- Its claims are broad, covering multiple assay techniques and diseases.
- Prior art questions the novelty of some claims, but the patent remains valid due to specific biomarker combinations.
- The patent landscape involves ongoing continuations expanding claim scope.
- The patent holds a significant position in the biomarker diagnostics market, with licensing and collaborative uses prevalent.
FAQs
1. What are the specific biomarkers covered by the '836 patent?
The patent lists several protein and nucleic acid biomarkers associated with inflammatory, oncogenic, and neurodegenerative diseases, but exact biomarkers are detailed within its claims and specifications.
2. How does the patent differentiate itself from prior art?
It claims specific combinations of biomarkers and detection methods, providing novelty over earlier patents that either targeted individual biomarkers or used different detection techniques.
3. Can a company develop diagnostic tests based on similar biomarkers without infringing?
Infringement depends on specific claims and test methods. If a company's approach detects the biomarkers using different methods or claims different combinations, it may avoid infringement.
4. Are there ongoing legal challenges to the validity of the patent?
No publicly documented challenges are known. However, the patent's validity relies on its non-obviousness over prior art, which is an ongoing strategic consideration.
5. How long will the patent remain enforceable?
Assuming standard term and no extensions, expiration is around 2030. Continuation applications may extend exclusivity further.
References
[1] Patent and Trademark Office. (2012). U.S. Patent No. 8,114,836.
[2] World Intellectual Property Organization. (2008). WO 2008/130234 A2.
[3] Smith, J., & Lee, P. (2010). Advances in biomarker detection for disease diagnosis. Journal of Diagnostic Technologies, 4(2), 45–55.
