FIELD OF THE INVENTION

This disclosure relates to methods and systems for conducting genetic testing, facilitating the use of proprietary biomarkers across users and facilitating payment for the use of intellectual property rights between users of the systems and methods.

BACKGROUND

The proliferation of studies employing genetic information has led to the increasing use of genetic information for diagnostic purposes. Physicians often gather information from a patient to access risk for various conditions such that further diagnostic tests, follow-up visits and prophylactic measures can be employed in an efficient manner. For example, a physician utilizing their professional judgment may decide that a patient having a family history of breast cancer warrants more frequent mammogram screening. Similarly, a patient having certain combinations of physiological and demographic parameters, such as sex, age, weight and height, and blood test results, may require preventive measures to forestall the development of heart disease, diabetes or other lifestyle diseases.

Recent advances allow for genetic profiles of individual patients to be developed without prohibitive costs. In addition to genetic information, metabolic, proteomic, and lipidomic data are increasing available for profiling individual patients in a clinical setting. Genetic, metabolic, proteomic, lipidomic and metabolic data can serve as biomarkers amenable to profiling risk for various diseases or conditions. For example, mutations in the BRAC1 and BRAC2 genes are used in clinical settings as biomarkers for indication of risk for developing breast and ovarian cancer. Alternatively, an analysis of the pI and quantity of specific proteins can indicate an on-going disease process before other symptoms are readily apparent.

Because the protein or enzyme levels of a patient can change over time, repeated tests using enzyme or protein analysis requires repeated samplings of the patient's blood. A patient's genome, however, is static and does not change with time. Once sequenced, the patient's genome can be used for multiple tests and can be used repeatedly into the future each time a biomarker test is needed. There is a need for a system that can scan a patient's genome and provide a diagnosis equivalent to known enzyme or protein tests.

Further, diagnostic tests employing the use of biomarkers are frequently protected by intellectual property rights usually in the form of issued patent claims. Often times, identifying the presence of particular biomarkers does not necessarily require the acquisition of materials or equipment from the owner of the intellectual property associated with the biomarkers. By means of example, the presence or absence of specific genomic mutations can be performed through the use of multipurpose sequencing equipment or genechips. Further, the number of laboratories and clinical settings having access to equipment for determining genetic information and other biomarkers is becoming increasing widespread as cost barriers are decreased. As such, the benefit of diagnostic intellectual property rights can be accessed through the use of increasingly standardized equipment without the need for acquiring any materials from the rights holder of the intellectual property in question.

Licensing for the use of intellectual property traditionally results from direct negotiation between the rights holder and one or more users or licensees. However, transaction costs become prohibitive when many potential users or licensees are present on the landscape. This is particularly true when potential users or licensees occasionally perform diagnostic tests associated with particular intellectual property rights. In addition, a diagnostic service may perform a test resulting in a wide range of information such as whole genome shotgun sequencing (WGS) or a genome-wide SNP analysis using a genechip, where a wide range of potential proprietary markers useful for diagnostic purposes can be revealed. However, the individual or organization performing the diagnostic service is unaware how the generated information may be used by other parties or what intellectual property rights may be implicated. A further complication is that certain diagnostic tests may require the evaluation of biomarkers that may be covered by multiple patents belonging to multiple different rights holders. The acquisition of a comprehensive profile of biomarkers associated with a specific condition may implicate patents owned by several different entities thereby creating large transactional costs in directly licensing the relevant intellectual property.

The need to negotiate and manage a large number of licensing agreements is a disincentive for potential users or licensees to respect the intellectual property rights of patent rights holders. Alternatively, the need to manage a large number of licensing agreements can discourage the use, development and/or validation of biomarker-based diagnostic techniques, particularly in situations where it is difficult to determine all the rights holders that may be implicated. This challenge has been recognized as creating “patent thickets,” where commercial activity or legal compliance in an area is discouraged by a “thicket” of patent rights controlled by several different entities.

SUMMARY OF THE INVENTION

Disclosed herein are systems and methods for encoding and running biomarker tests and for facilitating licensing of intellectual property rights and transfer of payments between intellectual property rights holders (i.e. rights holders) and users or licensees. More particularly, systems and methods are disclosed for creating an algorithm for searching a patient's genome for particular biomarkers and reporting the results of the genetic test. The system and methods disclosed can also facilitate the use of proprietary biomarkers and genetic information by individual patients and transfer payments to interested rights holders when individual patients access or benefit from proprietary genetic information while ensuring patient privacy.

A method is provided for conducting a genetic test. A biomarker script is created that instructs the system on what portions of a genome the system should scan for particular mutations. The mutations of interest are defined and the system can determine the number of mutations corresponding to a biomarker that are present. Based on the mutations present, the system can determine a risk factor for a particular disease associated with the biomarker.

The method also facilitates transferring a payment to a rights holder of intellectual property rights in proprietary diagnostic information using a privacy facilitating system. Information contained in a patient records database is restricted such that one or more fields of information are not available to one or more users of the privacy facilitating system. The patient records database containing patient records including patient identification information and diagnostic information is accessed along with a proprietary records database containing records of proprietary biomarkers and rights holders of the proprietary biomarkers. Following accessing the databases, the patient records database and the proprietary records database are queried to determine the presence of a proprietary biomarker in a patient record of the patient records database and generating a result set including at least one results record. Optionally, the patient records database is updated to include the identification of a proprietary biomarker from the results record. Information obtained from the query is automatically forwarded or provided to one or more of a payer party user and a rights holder user associated with the proprietary biomarker used by the query of the patient records database. A payment or escrow between a payer party user and a rights holder user of the proprietary biomarker used by the query is accounted for by the privacy facilitating system.

A genetic testing system is provided. The system has a biomarker script database containing information corresponding to genetic mutations associated with a particular biomarker. The system can obtain a patient's genetic sequence and scan the sequence using the biomarker script in order to determine which, if any, mutations associated with the biomarker are present. The system can also provide a risk factor based on the number or identity of mutations found in the genome.

The genetic testing system can also have a privacy facilitating system or a payment system. The privacy facilitating system has a patient records database containing patient records including patient identification information and diagnostic information and a proprietary records database containing records of proprietary biomarkers and rights holders of the proprietary biomarkers. A patient information interface is configured to populate or update the patient records database, and a search engine facility is configured to query the patient records database and the proprietary records database to determine the presence of a proprietary biomarker in a patient record of the patient records database and generating a result set including at least one results record, where the results record contains patient identification information, payer party user information associated with the patient, and rights holder user information associated with the proprietary biomarker. A rights holders interface is provided and configured to allow selective access to the results record in accordance with privacy rules associated with the results record, and a payment facility is configured to account, process or escrow a payment from the payer party user to the rights holder user, with the proviso that the privacy facilitating system does not allow for the disclosure of patient identification information to the rights holder user. The payment facilitating system can have a search engine facility configured to parse the diagnostic information contained in individual patient records for the attributes of a proprietary biomarker and generate a results record associated with a specific patient record, wherein selective access to the results record is controlled by privacy rules. A payment log or database is provided containing information regarding a rights holder user having an intellectual property right in a proprietary biomarker used by the search engine and any payments due or made to the rights holder user and balances associated with specific patient records. A payment facility is provided that is designed to process, account or escrow a payment between a payer party user and a rights holder user having intellectual property rights in the proprietary biomarker identified by the search engine facility, wherein the payment facility processes a payment in a manner such that the rights holder user is blind to the patient identification information in the patient record having the proprietary biomarker identified by the search engine facility.

