Alleged patent infringers have been increasingly using claims of Inequitable Conduct on the part of a patent holder as a defense when being sued for patent infringement. If a court finds that a patent holder failed to disclose material information to the patent office during the process of obtaining a patent, the court can invalidate the claims of the patent under the Inequitable Conduct defense. The current test for determining Inequitable Conduct is a three prong test including a materiality prong, intent prong, and balancing prong. The materiality prong relates to the importance of the material that the patent holder failed to provide the Patent Office, and is judged on three levels: if the material had been submitted (1) no examiner would have issued the patent; (2) the examiner in the specific case would not have issued the patent; (3) it may have influenced the examiner. The intent prong of the test relates to if the patent holder intentionally deceived the patent office by withholding the information. Various courts have created different levels for judging the intent of a patent holder from a low level that the “applicant should have known of the information and submitted it” to a much higher level that the “patent holder had a specific intent to withhold the information.” The balancing prong of the test allows for a finding of Inequitable Conduct when the proof of one prong is low, but the proof of the other prong is high.
In the recent TheraSense, Inc. v. Becton, Dickinson and Co. case the Federal Circuit granted an en banc rehearing (all judges not just a panel will hear the case). The court has asked for the parties in the case, as well as third parties, to submit briefs discussing the current materiality-intent-balancing test, the level of proof to prove the test, and if the test should be changed or replaced. Approximately thirty companies, including ThereSense, Inc., have already submitted briefs. The majority of the briefs are in favor of increased standards of proof in the materiality prong, intent prong, or both, and some have argued to remove the balancing prong altogether. If the court adopts an increased standard for one or more of the prongs of the test it would be harder for an alleged patent infringer to prove Inequitable Conduct on the part of the patent holder, and thus harder to invalidate the claims of the patent based on the patent holder’s failure to submit material to the Patent Office.
The opposing briefs are due at the beginning of October, and oral arguments are scheduled for November 9th. The result of the en banc hearing could go a long way to reducing the burden on patent attorneys and their clients to identify material that could be used against them in an Inequitable Conduct defense. The current burden has led patent attorneys and their clients to submit hundreds of documents to the Patent Office that may or may not have any relevance to the patent being prosecuted. In turn this may lead to a reduced burden on the Patent Office Examiners in having to sift through the documents provided by patent attorneys and their clients in order to determine what is and is not relevant to the patent.
For more information, please visit: http://www.patentlyo.com/patent/2010/08/therasense-briefs-enbanc.html

