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Submitted by patentadmin on Mon, 03/01/2010 - 10:36

A patent which is procured through “inequitable conduct” is unenforceable. Periodically, the C.A.F.C. states that the defense of inequitable conduct is over-utilized and, therefore, it is looked upon – by the C.A.F.C. – with “disfavor.” Of course, these pronouncements do not prevent the trial courts from finding inequitable conduct, nor the C.A.F.C. from affirming these findings. Most claims of inequitable conduct arise out of allegations that the patentee has withheld prior art from the patent examiner. A more unusual case involved a patentee who argued one position as to the teachings of a prior art reference in the USPTO, while failing to disclose that it had taken the opposite position in arguments presented in the EPO (European Patent Office). (Therasense, Inc. et al. v. Becton Dickinson And Company et al.)

Therasense is the owner of the `551 patent which is directed to a test strip with an electrochemical sensor for testing a patient’s blood to measure insulin levels. The original application giving rise to the `551 patent was filed in 1984. Over the next 13 years, this application and half-a-dozen continuation applications were repeatedly rejected as being either anticipated by the prior art or obvious in light of it. Many of these rejections were based on a prior art reference known as the `382 patent. Finally, in 1997, the applicants devised a new argument to distinguish their invention from the teachings of the `382 patent. On the basis of this new argument, they secured allowance of what became the `551 patent.

So far, so good. Now, they are engaged in litigation with Becton Dickinson, which introduced evidence that the patentees, themselves owners of the `382 patent, had previously taken a contrary position as to the teachings of the `382 patent, in the EPO, when they were seeking to patent a European equivalent of the `382 patent. Therasense had failed to disclose this fact to the U.S. patent examiner.

There seemed little dispute that the information that the patentees had withheld was material to the allowance of the `551 patent. The real issue was whether the withholding was done with “intent to deceive.” The court noted that “[c]ases involving affidavits or declarations are held to a higher standard.” It went on to find the explanations for the failure to disclose, offered by Therasense’s two witnesses – a declarant and the patent attorney who prosecuted the final application to allowance – to be “so incredible that they suggested intent to deceive.” So, the `551 patent is unenforceable due to inequitable conduct.

Therasense, now known as Abbott Diabetes Care, Inc., announced that it continues to believe the `551 patent is valid and enforceable and is “evaluating” its options – like the Supreme Court is really going to hear this case.

THE LESSON TO BE LEARNED: Tell the patent examiner EVERYTHING.

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