Friday, January 07, 2011

The intersection of electronic lab notebooks [ELN] and intellectual property

An article titled New Debates over Intellectual Property Protection and ELN gets to some issues with the use of electronic lab notebooks [ELN]:

It is interesting to note the majority of large pharmaceutical companies do not even consider ELN to be the primary repository of IP. Many have multiple ELN products to serve different domain requirements; a downside being the products representing records in different formats. And they desire long-term archiving — capabilities notably absent from most products. Many also question whether their chosen suppliers in a dynamically changing market will even be around 20 years from now. Therefore, ELN is the tool for IP authoring and the support of scientific knowledge management. IP records for long-term retention are increasingly being published in formats like PDF/A, digitally signed outside ELN, and pushed to solutions like enterprise content management (ECM). We are seeing a growing use of records forwarded to third party archive services like Iron Mountain as an additional precaution against data loss.

The movement of ELN into smaller organizations and markets like food, medical devices and consumer products is triggering new debates about the relationship between ELN and IP. Many of these companies do not have the resources or funding to implement additional repositories like ECM. Smaller organizations generally do not have ready access to general counsels, and even fewer have good records management practices. Also, the trend toward outsourced research is raising fresh concerns regarding the capturing of contractor-generated IP.

However, the article is a bit misleading about "first to file."

There have been several attempts in the U.S. Congress to reform patent law over the years. In 2007, reform passed the House of Representatives, but it died in the Senate. Most recently, The Patent Reform Act of 2010 introduced by Senators Patrick Leahy (D-VT) and Orrin Hatch (R-UT) was another attempt to move the U.S. to first-to-file.

One notes that S.515 was "first inventor to file", not "first to file." As pointed out by Harold Wegner:

Holding the PTO Hostage for First-inventor-to-file fools’ gold: Senate S.515 sui generis first-inventor-to-file is neither a first inventor nor first-to-file system; by substituting a totally new standard for the current first inventor system S.515 does not promote harmonization but instead creates yet another system for patent practitioners – and the courts – to understand and interpret.

S.515, More Draconian than True First-to-File: Under the global first-to-file system as it operates in Europe and Asia (but not under sui generis first-inventor-to-file), the second-to-file for a slightly different (obvious) innovation is given a patent for such different invention if he files within 18 months of the first-to-file inventor (and provided there is no intervening publication of the first invention).

Under true first-to-file there is no obviousness-defeating effect for the first-filed application until the application is published, and then the date for the obviousness-defeating effect is dated from the publication date 18 months after first filing. Hence, true first-to-file provides an 18 month safety net for second-to-file applicants who are able to scale back their patent protection to avoid a direct conflict with the first inventor. Thus, if the first inventor files today for “apples” and then 17 months later a second inventor files for “pears”, the “pears” inventor will also get his patent.


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