The second viewpoint is that expressed by Colin Sandercock (Perkins Coie LLP) at the recent IQPC ELN conference in Barcelona.  This is a brief summary of the points that Colin raised:

(1) Interferences may continue in force for many years and involve inventions made after March 16 2013.

Some of the wording of the new act would potentially lead to interferences and interfering patent actions continuing for many years.  More specifically, preserving the right to an interference requires only that the application ‘contains or contained at any time’ a claim to an invention having an effective filing date that occurs before March 16, 2013, or a specific reference (under section 120, 121 0r 365(c) of title 35, United States Code) to any patent or application that contains or contained at any time such a claim.

(2) Derivation proceedings will replace interferences for certain types of inventorship disputes

Derivation requires proof of prior conception and communication to the competing inventor(s).  i.e. records may be critical in proving derivation or defending against a derivation claim.

(3) Proof of inventive activities may be needed to remove prior art under exception for joint research activities.

For more detail about the Leahy Smith America Invents Act :

America Invents Act of 2011

Leahy-Smith America Invents Act Implementation

Patent Reform’s ‘Brave New World’ (from Bio-IT World)

One of the most significant components of the new legislation concerns what is widely described as a move from a first-to-invent system to a first-to-file system. However, the inclusion of both first-to-file language and a grace period in the new patent law creates what could amount to a hybrid between first-to-invent and first-to-file.

Employees engaged in IP creation can be made aware that there is an increased need to actively and timely pursue steps aimed at securing patent protection on new inventions. Internal company systems for documenting, reporting, and rewarding innovations can be modified to better match the new law. In particular, the issue of rights to an invention prior to a filing date will be depend more on the history of relevant disclosures and less on nonpublic, internal company documents such as laboratory notebooks. (Quoted from the Brookings article).

I scribble notes on a pad when I conduct interviews for my business. I don’t write many words because I’m trying to understand what people are saying and can’t write and think at the same time. (Half-Polish, can’t chew gum either). My notes are becoming more difficult to reread after a period of time too because my handwriting skills have diminished. Except for my grocery shopping list, I rarely use paper Post Its anymore, preferring electronic versions that are available on most newer PCs and phones. Like most people with Smart phones, I take out mine out frequently so see the reminders often. So this approach works well for me. I do have a paper scribble pad (recycled paper!) that I use every day with a pencil to capture transient bits of information that I use during the day. I throw out the scribbles next day and start a new sheet. This is still more efficient and convenient than a computer based approach.

The way that we read information to acquire knowledge has been gradually transforming. Before electronics, brief communication of information (today’s tweets, text messages or emails) was commonly done via oral interaction or sign images like smoke signals, semaphores, etc. The telegraph and telephone replaced these and has broadened the potential audience. Global electronic networks are the phase that we are in now. These kinds of communications usually only convey relatively small bits of information or knowledge. Think about trying to get a university degree by only reading tweets and text messages. That’s not going to get it done.

The applicability of collaborative space has been spotty. There are some specific successes, but in general this idea has not expanded significantly over the past 20 years. Remember Lotus Notes?

Conveying more complex concepts and ideas, requires a much more structured use of many words than these communication vehicles can easily provide. Most people scan through pages bought up by web search results looking for key words of phrases. They rarely read a page word by word.

So what’s the best medium to read a book or long document? I can tolerate reading no more than 3 pages max word for word on my PC screen. Some days, like today, it’s less than one page. It’s the screen angle and overall brightness that gets to me. You can carry around and tilt paper pages, books and eReaders to accommodate your sitting or standing position. Also, most eReaders have the capability of increasing font size which I often do when my eyes get tired at the end of a day. They also are not overly bright, but have good black/white contrast. Most models can’t be read in the dark. I often print a few pages of information to read and then reuse the paper for scribbling. I don’t keep the printed sheets for very long.

I print fewer items to read than I did last year and think that this is because I am scanning, skimming speed reading more. Everyone seems to be doing this and I’m not sure whether it is good or bad. Are we learning less and just recycling information more?

When paper was king, I read many articles and books word for word then composed my original work. I’m sure I plagiarized some things without giving credit to the proper author, but I (as do many university professors) are seeing many articles, blogs and white papers that are primarily information that has been cut and pasted from other sources and advertised as “original” work.

I think that we have to be more selective in the use of our time to acquire new knowledge. Texting, tweeting, information skimming, social networking and other activities can take away too many hours every day and inhibit our capability to compose original ideas.

Electronic Lab Notebooks / Lab Information Management Systems
Labtronics Inc. has released a Connector for Nexxis ELN that allows the Electronic Laboratory Notebook to connect to any LIMS.
Nexxis ELN makes use of the industry standard integration tool, LimsLink, to provide direct connection with any LIMS. The connection provides bi-directional connectivity allowing the Electronic Notebook to retrieve sample lists from LIMS and report results back to LIMS

All three posts serve as a timely reminder that there are basic skills in some of the processes that we try to automate or computerise, and no amount of slick software can replace that. But there were a few other points in the blog posts that could raise eyebrows. I’m totally impressed by Tim Ferriss’ organisational skills and habits with paper notebooks, but there’s a lot of us who aren’t in his league. And when it comes to any requirement for sharing….I have to conclude that Tim’s notebooks are for his eyes only.

The other point that caught my attention was in Jill Hubbard Bowman’s post, which contains some great advice on recording and maintaining intellectual property; Jill made the point that ‘Courts don’t trust electronic documents’. Well, this seems to run contradictory to a lot of the advice Lawyers and Patent Attorneys are passing on in organisations where paper lab notebooks are being replaced with electronic lab notebooks. Since courts make decisions based on evidence, it is the relevance, integrity and authenticity of the evidence, not the medium, that determine trustworthiness. Of course, the approach with digital records is different to that with paper records, but courts in the US and Western Europe are quite comfortable with electronic records, to the extent that most major pharmaceutical companies have switched to fully electronic records for their scientific IP. But it does mean that a robust and reliable process for managing electronic records, able to stand up to the court’s scrutiny, is essential. This throws a lot of emphasis on the underlying process; so the advice given in Jill’s post is very valid.

Here’s a couple of links to relevant posts on this site:
Good Laboratory Notebook Practice
Legal Issues of ELNs

There were a couple of points that did arise in the formal programme that are worth recording. The legal implications of ELNs has been a feature of ELN conferences since they first started. Generally the theme of the presentations has been the reassurance to potential purchasers of ELN systems that electronic records are acceptable in patent litigation and interference cases. There were two presentations in the SMi conference relating to legal issues of ELNs, firstly by Colin Sandercock and then by Matthew Dick (Bristows). Colin’s presentation focused primarily on the situation in the US, whereas Matthew gave an overview of the UK situation, plus some insights into the broader European situation. Surprisingly, there is no harmonization regarding discovery/disclosure relating to electronic records across the European Union.

The most significant message that came from the two presentations was a subtle change of emphasis from ‘it’s perfectly OK to use electronic records in court’ to ‘there are some distinct benefits to using electronic records’. The benefits accrue mainly with the enhanced speed and accuracy of searching electronic records. Since the number of records presented in the discovery phase can be significant, computerised search tools can significantly shorten the time to extract relevant data, and hence reduce costs.

The other presentation that was of particular interest was by Jo Mulgrew of Pfizer. Jo gave a detailed description of the support structure that Pfizer have put in place for a range of laboratory applications. The support system is based on ‘compliance’ of user adoption and uses a range of ‘Enterprise 2.0’ tools during and after implementation to optimise roll out and the on-going user experience of the application. I’m hoping, in due course, to post more details of Pfizer’s approach to in-house support as it seems to represent a benchmark and may offer some best practice ideas to other organisations.

Within the context of laboratory data and information management, raw data tends to draw out some interesting debate along the lines of what constitutes raw data, how and where do we store it, and for how long?

Those of us involved in the business of laboratory systems and laboratory integration can be kept pretty busy with the technological challenges of acquiring, managing and storing ever increasing volumes of raw data, but behind these challenges are some more fundamental questions that need to be answered before we can even start thinking about a solution.

So, if we assume that we know what the raw data is, the decision about how long we keep it is influenced by three different considerations.

Firstly, scientists are often hoarders of data and like to hang on to raw data as basic scientific evidence, for reference purposes,  or for re-assessment in the light of future scientific or technological advances. This requirement has no definable timeframe.

Secondly, there is an ethical position, largely determined by regulatory bodies, to allow for the re-examination of data in the light of the consequences of unforeseen defects, failures or adverse effects of products or processes.  This timeframe may be determined by, or related to the lifetime of the product or process.

Thirdly, there is a business requirement to address IP protection in terms of the underlying value of the data to the business.  This may have a long timeframe if it is relevant to a patent, but could in other circumstances have a relatively short timeframe.

Making the decision on what to store and for how long has its complexities, but the combination of regulatory and legal guidance, business best practice, good technology and hopefully, common sense, is helping shape a way forward.  However, it is always good to remember that the scientific knowledge food-chain starts with the raw data, and an item by Derek Lowe (Data, Raw and Otherwise), loosely connected to ‘Climategate’ on In the Pipeline serves as a good reminder of the importance of raw data from the scientist’s perspective.

With grateful thanks to Colin for permission to post the presentation here.

As far as ELNs are concerned, the almost universal requirements to comply with ‘first-to-invent’ are that records must be kept in the ordinary course of business and must include:

• Conception Date – the date that you conceived your invention
• Date of reduction to practice – the date that you made a working embodiment of your invention
• Diligence in reducing your invention to practice – diligence refers to your intent and conscious effort to make a working embodiment.

The record must be made by or from by a knowledgeable source (e.g. trained scientists) and must be made contemporaneously (e.g. at the time of the experiment) and witnessed.

[Here’s an interesting case that emphasises the importance of reduction to practice: Inventorship: Conception does not Require Scientific Certainty; Rather, "Proof that the Invention Works to a Scientific Certainty is Reduction to Practice"]

But what if the US decides to go to first-to-file?  Well, the US Congress is embarking on its third successive attempt (Patent Reform Act of 2009) to introduce changes to US patent law, which include the proposal to switch to first-to-file.  It’s too early to understand what the implications would be for the laboratory notebook, and furthermore, previous attempts to progress patent reform in 2005 and 2007 came to nothing, but the US has a new administration now, so could it happen this time?  Anyway, here’s an article by Justin Simpson and Jeff Sweetman which asks the question, ‘Is the U.S. Serious about International Patent Harmonization?’ and gives some background, although it is important to bear in mind that first-to-file is only one of a number of proposed changes.  Any thoughts on what it would mean for ELNs?

As an extension to this, and slightly away from the laboratory, I’ve just finished reading Bad Science by Ben Goldacre; actually, it’s the second time I’ve read it.  Ben Goldacre is a writer, broadcaster and doctor, known for his Bad Science column in the Guardian newspaper which is presented as a  weblog.  The book attacks the misuse of science, primarily in the field of medicine and nutrition.  If you work for a pharmaceutical company, it could make for some uncomfortable reading, but the underlying principles of data-based decision making and risk management will be appreciated by any scientist who has squirmed at some of the nonsense that is fed to the public at large.  And it is very funny……

• Tips on creating a lab notebook that contains convincing evidence
• Walking the tightrope between scientists and lawyers
• An overview of Patent Law

In addition, on the Contur website, there is an Interview with legal expert Colin G. Sandercock on the subject of ‘Understanding the legal issues surrounding electronic laboratory notebook (ELN) records’.  (You need to scroll some way down the page to find the interview.)  Anybody who has attended an ELN conference over the past few years is likely to have come across Colin and recognise his reputation as a leading authority on the legal compliance of ELNs.

I was therefore surprised to come across an article on the Linex Legal website entitled ‘The importance of good laboratory notebook practice’ which contained the sentences: ‘Significantly, USPTO has not yet recognised electronic laboratory notebooks in patent interferences……….  Therefore, a hard copy of all electronic records should be kept until electronic data is accorded the same legal status.”  The article was published in Chemistry in Australia (May 2009).

You will need to subscribe (free) to Linex Legal in order to read the article.

Colin Sandercock states in his interview “- To be clear, the admissibility of electronic records has been recognized by major U.S. courts for over 30 years. And in 2006, the U.S. Supreme Court promulgated new rules of the Federal Rules of Civil Procedure, which new rules specify procedures relating to discovery of electronic records. These new rules make clear what has been the practice in courts for decades, namely that electronic records (in human-readable form) are admissible evidence.”

Unfortunately, the Chemistry in Australia article is rather misleading on this point, which is a shame since the rest of the article gives an excellent account of good laboratory notebook practice.