|Send to printer »|
Legal Affairs : Jan 1, 2010 ( )
Lab Notebook Tips from a Patent Litigator
Such Journals Are Integral to Protecting IP and Should Be Created and Preserved with Great Care!--h2>
An important task for in-house counsel is managing laboratory notebook practices. Laboratory notebooks are where inventions start, and they are key to successful patent enforcement. This article contains some guidelines for maximizing patent protection through laboratory notebooks.
There’s been a fundamental shift in the law. Prior to the Supreme Court’s 2007 decision in KSR v. Teleflex, the mainstay of judges’ attention to patent validity focused on novelty—whether a claimed invention was disclosed in the prior art, whether there was an on-sale event, etc. Obviousness challenges were effective in those limited situations when there were specific teachings in the prior art to combine or extend references. Largely, however, questions of obviousness were simply given to juries. KSR has changed that.
Now, judges are squarely confronting whether a claimed invention, even if novel, would have been obvious. Trial themes must be shaped around whether there were unexpected results, a surprise, or an upsetting of conventional wisdom, etc. Proving this starts with your laboratory notebook.
The passage of time often makes telling the invention story difficult. Years, or even decades, will pass between a discovery and the inventor’s day in court. On the stand, the inventor needs to credibly recount recognizing the importance of the invention when it happened. Without contemporaneous documents to back up this story, testimony may seem contrived. Therefore, a key component of an invention strategy is the maintenance of laboratory notebooks and surrounding documents to memorialize discoveries.
The key exhibits for telling the story of invention tend to be laboratory notebooks and the regular project reports that track a team’s developments. These two sets of records can be effectively used in tandem. Laboratory notebooks are good sources to prove that a particular event happened on a particular date, and to show that the inventor appreciated its importance.
Simple statements of success are important to show that the scientist recognized the significance of a development. Even remarks such as “Wow, it worked” can be golden in litigation. Otherwise, it is difficult to have an inventor credibly recount an invention story five, ten, or fifteen years later in litigation.
A team’s regular project reporting provides a good place for more detailed invention statements. These may discuss when the team overcame interim hurdles, or learned why things were (or were not) working. These remarks can later be used to prove that the inventors overcame conventional wisdom—another key criteria for beating an obviousness challenge.
It is a good idea for in-house counsel to be involved at these points in development, to help the team record these developments in the best possible light. To be useful in litigation, these statements need to be nonprivileged, and thus separate from the more formalized and privileged records of invention that might be generated for obtaining patents.
Recording failures can be as important as memorializing success. False starts along the path of invention help show that the invention wasn’t obvious. Whereas a challenger will try to argue that the patentee used known techniques to meet a known goal, the patentee will want evidence that the results were not predictable. Therefore, failures can rebut an obviousness challenge.
Note, however, that failed experiments can be trouble. Challengers may seize upon failures to show that the inventors are not entitled to claim a broad “genus” under the written description requirement. Failures may suggest that the inventions are not enabled. Failures may also show that an inventor lacked complete conception of an invention.
Once a patent application has been filed, statements disparaging the claimed technology are particularly problematic, not only for a trial story, but also for the duty to disclose. Accordingly, while failed experiments may help beat obviousness, these same failures may be problematic for other reasons. A good approach is to record the data but avoid elaborating on failures.
Dates of Invention
Laboratory notebooks are often relied upon to establish dates of invention, which are frequently necessary to swear behind prior art. Good notebooks practices should address a number of factors to prove dates of invention.
First, there must be a recognition that an inventor appreciated the invention’s significance. Legalistically, there is no nunc pro tunc conception. The contemporaneous documents must show a “complete conception”, i.e., that the inventor appreciated the discovery, and that the discovery met all the elements of what is later claimed.
Merely reciting data may be insufficient to prove that, as of a certain date, the inventor appreciated the discovery. Therefore, inventors should include a certain amount of narrative in laboratory notebooks or in surrounding progress reports to show that they appreciated what they discovered. Although excess discussion should be avoided, some simple statements that the experiments succeeded in demonstrating [x] are invaluable in litigation.
Second, independent corroboration is a legal requirement for substantiating the date of invention. Notebooks should be countersigned in as timely and regular a fashion as possible. The countersigning witness should be familiar with the work being performed, and should not be an inventor on the patent, so the corroboration is independent.
Third, an inventor may not be able to establish a conception date without demonstrating a “reasonable expectation of success.” A mere hope that something might work or a mere research plan to accomplish an ambitious objective may be insufficient to uphold a conception date. Rather, documenting successes along the way to show that the chosen path is working are important to demonstrate that the project is not merely a “hope.”
There is, however, tension between demonstrating a “reasonable expectation of success” and rebutting nonobviousness. Ideally, the reasonable expectation of success should come from positive developments along the course of research, not from expectations on Day 1. Likewise, when preparing documents for funding entities, optimism about chances for success may be problematic when later defending against an obviousness challenge.
Privileged information should never go into laboratory notebooks. Laboratory notebooks are typically handwritten, often badly. Reviewing stacks of notebooks is an arduous task and it is common for privileged material to slip through the review.
The privileged material might be descriptions of other companies’ patents, discussions of other prior art, notes of meetings with lawyers, or efforts to design around a patent. Scientists must not put in their notebooks information about patents or information directed by or directed to lawyers. Reviews of prior art need to go into a separate document marked “privileged.” Attempts to design around a patent should also be tracked in a separate notebook.
Personal matters should never go in laboratory notebooks. Although attorneys will do their best to withhold embarrassing personal matters, it is not privileged, and redacting out personal remarks looks suspicious.
Half-baked ideas and random thoughts should not be put in laboratory notebooks either. Laboratory notebooks are formal records and should be used for methodical recording of experiments. Incomplete or inaccurate ideas that are written down will have the veneer of truth years later in litigation. Attempts to distance the story from these inaccurate records may sound disingenuous at trial.
Laboratory notebook entries should never be altered. Modifications, deletions, or additions to a laboratory notebook can cast a huge cloud of suspicion. In the infamous case of Aptix v. Quickturn, allegations of tampering ended the case and landed Aptix’ inventor/CEO in prison.
Even where the allegations are unjustified, they are a huge and costly distraction. To avoid any suspicion, laboratory notebooks should be bound, written in ink, and the inventor should avoid blank spaces (crossing out blank spaces) and start each new day on a new page. And laboratory notebooks should be carefully preserved—their disappearance would be an invitation for trouble.
© 2013 Genetic Engineering & Biotechnology News, All Rights Reserved