GEN Exclusives

More »

Legal Affairs

More »
Jan 1, 2010 (Vol. 30, No. 1)

Lab Notebook Tips from a Patent Litigator

Such Journals Are Integral to Protecting IP and Should Be Created and Preserved with Great Care

  • Click Image To Enlarge +
    Steven Carlson

    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.

  • Memorializing Inventions

    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.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Companion Animal Care

Do you think Americans spend too much on companion animal care?