Claims that a patent is unenforceable because of inequitable conduct on the part of the patentee are frequently made but rarely effective. To render a patent unenforceable, the challenging party must demonstrate by clear and convincing evidence that the patentee made a material misrepresentation with the intent to deceive the Patent Office. Normally, this is very difficult, but following a recent Federal Circuit decision, the failure to maintain detailed laboratory records might result in a court finding a patent unenforceable.
Last week, Bayer succeeded in having four patents held by Housey Pharmaceuticals rendered unenforceable. Bayer convinced the trial court that the inventor had submitted false experimental results to the USPTO. That is, that the inventor had not actually performed the experiment from which he reportedly derived the results he submitted to the USPTO. The trial court agreed with Bayer because the patentee failed to produce detailed data of the experiment, people who shared laboratory space with the inventor did not recall him conducting the experiment, and there were inconsistencies between the inventor’s trial testimony and deposition testimony.
In an effort to bolster his credibility, the inventor replicated the experiment and confirmed the results of the data he had submitted to the PTO. According to the patentee, his original results could not have been predicted in advance and therefore, confirmation of their accuracy by a second experiment was nearly conclusive evidence that he actually performed the original experiment. Unfortunately, the inventor provided no evidence to support his claim that the original results could not have been predicted in advance. Furthermore, the declaration that the inventor submitted to support his replicating the experiment contained no raw data or detail, merely a statement that the inventor performed the experiment and obtained the results he claimed. As a result, the Federal Circuit held that the trial court did not commit clear error in rendering the patents unenforceable.
Patent disputes typically occur several years after the patent is filed. Given this timing it is not unusual for colleagues not to recall when or if certain experiments were conducted, even when they share laboratory space with inventor. Bayer AG v. Housey Pharmaceuticals highlights the importance of maintaining detailed laboratory records and of providing these records when submitting declarations to the court.