As a follow-up to my posting on the impact of Patents on eClinical solutions, here is a list of patents relevant to the article;
With each patent, I have placed a personal assessment on
a).Potential value to Licensee
b). the breadth of the patent in eClinical terms and
c). the impact on the vendor / innovation world.
List of Patents included;
DataSci (1/2) – Remote Data Capture / 2000
DataSci (2/2) – Send / Using Metadata remotely in Clinical Trials /2009
Boston University–>MyTrus – Method For Conducting Clinical Trials Over the Internet / 2007
DataSci (1/2) – Remote Data Capture / 2000
Link:- US6496827
Potential value to Licensee:– None
Impact:- High
Description:-
The centralized collection of geographically distributed data is accomplished using a system which takes advantage of an interactive programming language, such as Java and existing wide area networks, such as the Internet including the world wide web (4), to collect high quality data in an information center (10). The information center being connected to remote sites (1) through the wide area network. One or more levels of validation of the data prior to storage in a database is provided for.
Comment:- Unfortunately a patent on using the internet to capture and check data in a clinical trail.
DataSci (2/2) – Send / Using Metadata remotely in Clinical Trials /2009
Link:- http://www.wipo.int/patentscope/search/en/WO2010059691
Potential value to Licensee:- None
Impact? High
Description:-
Systems and methods for processing metadata associated with a clinical trial are described. In one aspect, a computing device receives collected data with embedded metadata. The device extracts the embedded metadata, and accesses a database to determine characteristics of the embedded metadata. The device then accesses protocol rules where the protocol rules are a set of data collection requirements and procedures for a given clinical trial. The device ensures compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules. The device then reports the compliance or non-compliance of the collected data.
Comment:-
As with the Target Health patent, I believe this to be a direct interpretation of the FDA Draft guidance on eSource – What is new here over the former 2000 patent is that they are claiming an invention of the distribution of the data and metadata, and for the use of that metadata on the distributed device. This will hit any of the new Patient Diary solutions, or, solutions built to meet the drafted eSource guidance from the FDA. All systems that capture data from patients, and attempt to validate it on entry, and again at the centralized destination database will be hit by this patent. This will also seriously annoy the standards people such as CDISC and HL7 as both standards are based around this principle – data + metadata. The CDISC ODM standard, ratified by the FDA, was built on the concept of standardizing and making portable metadata allowing different systems and devices to leverage it.
Boston University–>MyTrus – Method For Conducting Clinical Trials Over the Internet / 2007
Link: – US7251609
Potential value to Licensee:- None
Breadth of the Patent? High
Impact? Less Direct to Patient technology solutions brought to market
Summary: – Capturing Clinical Trial Data, and reporting it through a single site
Description:-
The invention encompasses a method of conducting a clinical trial of a test substance from a primary site, via the internet. The internet is used in various phases of a clinical trial, including: recruiting and screening for candidates who are eligible to participate in a clinical trial of a test substance using the internet; obtaining, directly from a participant at a remote site, personal information as well as information allowing a determination of any effect(s) of the test substance on the participant after use (e.g., by evaluation forms completed and transmitted over the internet); compiling data from multiple participants.
Commentary:-
Unusual patent as this attempts to take a different angle on patient data capture than ePRO by indicating data is submitted to a single site. The patent does not appear to claim any technical methods to speak of, but it does claim ownership over using the internet to perform certain clinical trial activities directly with the patient. Pfizer recently reported that the Informed Consent methods used by MyTrus and described in the patent has caused difficulties.
DataTrak / 2009
Summary:- Unifying data from multiple sources for querying and reporting
Link: – US7464087
Potential value to Licensee:- Limited, if source code supplied
Breadth of Patent? High
Impact? Minimal
Description:-
A system, method and database design is provided for unifying data from a plurality of heterogeneous databases, each having business-context related data and a data access mechanism. A database is created (e.g., the UniDimNet) which contains a node for each dimension of an industry. For each data source which is accessible via the system, a set of data source specific dimensions is created and mapped to the corresponding industry business context dimension(s). A set of templates (e.g., UniViews) is created to query the data sources. Each UniView contains a specific question for a specific dimension designed for a specific data source. UniViews query the database they are associated with by using the data access mechanism of the associated database. A central server coordinates the system and facilitates use of the system through an interface (e.g., the UniViewer). The UniViewer allows a user to query the data sources by identifying an industry business context dimension, a dimension…
Commentary:-
This one has puzzled me since I found out about it. All EDC systems unify data from multiple sources. That is the purpose of Electronic Data Capture. They import data from different sources, and present it in a unified model / data extract. Where this may have derived from was that the former DataTrak EDC product did not unify data as it kept information in different physical tablespaces. Having said that, I am not aware of any EDC system that works with the concept of ‘nodes for each dimension of the industry’ in the data model. Besides that, the biggest problem with this patent is that is describes how tools such as Cognos and Business Objects work work with EDC.
Summary :- eSource
Link:- US8041581
Potential value to Licensee:- None
Breadth of Patent? High
Impact? Minimal
Description:-
According to the present invention, there is provided a system and method for the collection, capture, processing, storage, and tracking of data for both electronic clinical trial and electronic source health records for purposes, based upon a single data collection instance. Upon the collection of data at a clinical trial site, the data are transmitted to a central server where it is captured as an electronic source document(s) in human readable format. The system then transmits the captured electronic source document to a trusted third-party’s electronic document repository. Then, the system uses the same captured data to populate the clinical trial’s electronic data capture database. The system incorporates security and encryption features to ensure that privacy information requirements are not violated. In the preferred embodiment, the electronic data capture provider for a clinical trial has no control over the server of the trusted third-party vendor, complying with regulatory…
Commentary:-
Once again, another surprising patent. Is it possible to patent eSource? The US Patent office seem to think so. In my opinion, I don’t see this having any relevance in future eClinical system architectures, but it may impact companies that interpret the regulations in the way that Target Health have. If this is the case, then if you wish to capture, and make available a separate form of data, called eSource, then you may fall under this patent.
Solution?
If organizations are looking for a degree of protection from other organizations that might claim ownership and therefore license fees for ideas – one solution is Open Patent (Wikipedia, Organization). The is more commonly supported by standards organisations. CDISC may well benefit from taking out patents on the use of their standards so as to avoid situations where the gratis hard work of individuals does not in turn benefit an organization that wraps the use of the standards in a patent for personal gain.
Conclusion
To some extent, at worst, these patents might be considered as closing the door on future innovation in the eClinical world. At best, they will make money for the patent holders. I appreciate that claims are made that once a company becomes a ‘licensee’ of a patent, that they then become ‘protected’ from future litigation. That reminds me though of old gangster films where payment is made to one organization to provide ‘protection’ from others, but primarily from the ‘protectors’. I think they called it a ‘Protection Racket’ [1,2].
In this technology space – ideas are cheap – actual successful implementations cost. Literally 100’s of companies have attempted to create the greatest Electronic Data Capture solution for clinical trials, and have spent $100’s Millions trying to achieve this. Has a patent such as the DataSci patent had any bearing on whether or not they have been successful. No. Has it come down to hard work in Software and Company Development – Yes.
Ultimately, it comes down to one important aspect in this business area. Will Patents save more lives due to improvements in Drug Development? I think the answer is a clear ‘No’.
[1] – http://paul.kedrosky.com/archives/2011/07/the-patent-protection-racket.html & http://paidcontent.org/2011/07/09/419-why-google-and-android-must-deal-with-the-mobile-protection-racket/ [2] Patent Trolls – the IP Protection Racket – http://www.patexia.com/feed/patent-trolls-the-ip-protection-racket-1224