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Becton Dickinson and Nova Biomedical Win Another Important Victory in Therasense Inequitable Conduct Saga

Practices: Intellectual Property Litigation, Copyright Infringement, Patent Litigation, Patent Trial & Appeal Board (PTAB) Proceedings, Trademark & Related IP Litigation, Trade Secrets

Ropes & Gray clients Becton Dickinson & Co. and Nova Biomedical Corp. scored a major victory on March 27 when a court ruled that their opponent, Therasense (now Abbott Laboratories), had procured its patent on diabetes monitoring technology through inequitable conduct, rendering it unenforceable. The Court found that an attorney and a scientist working for the plaintiff committed inequitable conduct by concealing information about the patent from the U.S. Patent and Trademark Office.

The favorable ruling was the second time the U.S. District Court for the Northern District of California has found in favor of BD and Nova on the issue of inequitable conduct. The matter was on remand from the Court of Appeals for the Federal Circuit, and was decided under tougher, new legal standards for establishing inequitable conduct.

The ruling caps eight years of litigation during which Abbott accused BD and Nova of infringing four separate U.S. patents. Abbott had sought more than $80 million in damages, and Ropes & Gray won on behalf of its clients on all four patents for a complete victory.

Two of the four patents were disposed of on summary judgment (both declared not infringed and one invalid). The third patent was declared invalid and unenforceable after a bench trial, and the fourth patent was invalidated after a jury trial. The Court found the case to be exceptional and awarded BD and Nova attorney fees. All decisions were affirmed on appeal, but the inequitable conduct issue was later reconsidered by the Federal Circuit en banc.

On May 25, 2011, the en banc Federal Circuit raised the standard for inequitable conduct and sent the case back to the District Court with instructions to reconsider its finding under the heightened standards.

On March 27, 2012, the District Court again found that Lawrence Pope, in-house attorney for Abbott Laboratories, and Dr. Gordon Sanghera, Abbott’s research director for managing IP applications, committed inequitable conduct. They procured the ‘551 patent in question by telling the Patent Office that an earlier Abbott patent did not disclose the new patent claims they sought, while deliberately withholding papers that Dr. Sanghera had previously submitted to the European Patent Office (EPO) saying the opposite. The District Court held that the withheld EPO briefs were material under the new “but-for” test. It ruled that the “omission of the EPO brief was but-for material, leading to the allowance of the ‘551 patent,” and that “the [U.S. Patent and Trademark Office] examiner would not have finally allowed the ‘551 patent had the EPO briefs been submitted.”

The District Court also was instructed to determine whether Mr. Pope and Dr. Sanghera knew of the EPO briefs and their materiality and still decided not to disclose them. The Court held unequivocally that “Dr. Sanghera and Attorney Pope knew the content of the EPO briefs and knew that the EPO briefs, standing alone, would so seriously undermine their submission that the examiner would have reverted to unpatentability.” The Court concluded that “Attorney Pope and Dr. Sanghera committed inequitable conduct, even under the new law to be applied on remand.”

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