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Rory Pheiffer serves as counsel on amicus brief for the Boston Patent Law Association

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August 2010

Rory P. Pheiffer, member of the firm’s Intellectual Property Department, served as counsel on an amicus brief on behalf of the Boston Patent Law Association (BPLA), in an appeal scheduled to be heard by the Federal Circuit Court of Appeals en banc in November 2010, Therasense, Inc. v. Becton, Dickinson and Co. and Nova Biomedical Corp. and Bayer Healthcare LLC. The Therasense appeal promises to mark a significant reshaping of the inequitable conduct doctrine, a defense whereby alleged infringers seek to render a patent unenforceable on the grounds that the patentee misled the United States Patent and Trademark Office (PTO) in obtaining the patent. Derek P. Roller and Michael P. Visconti, members of the firm’s Intellectual Property Department, also contributed to the brief.

In Therasense, the Federal Circuit decided to rehear the appeal of the district court’s decision that Abbott Diabetes Care Inc.’s (Abbott) patent was unenforceable because its in-house attorney and Director of Research and Development committed inequitable conduct by failing to disclose attorney argument from a European Patent Office proceeding about an Abbott-owned prior art reference that the PTO cited against Abbott during prosecution of the patent-in-suit. Abbott is the successor to Therasense, Inc.

Issues related to inequitable conduct have a significant impact on the practice of patent practitioners and litigators alike. Under 37 C.F.R. § 1.56 (Rule 56), patent applicants and practitioners have a duty to disclose information that is “material” to patentability (e.g., prior art references and other information). Today, the Federal Circuit employs no less than five different tests to determine whether information is material such that it should be cited during prosecution. This creates unpredictability, not only in federal court litigation, but also before the PTO, because practitioners must operate under the shadow of all five tests, none of which offer bright-line guidance and all of which inevitably conflict with one another. Ironically, under the current framework, applicants and practitioners can comply with its duty of disclosure established by Rule 56 before the PTO and yet still be found by a court to have committed inequitable conduct for duty of disclosure-related issues.

The amicus brief addresses the proper standard for materiality and the role that the rules of the PTO should play in defining materiality, which is one of the six issues on which the court requested briefing. The brief argues that the Federal Circuit should scrap its multiple materiality tests in favor of a single test: an objective “but for” test whereby information would not be deemed material unless it invalidates one or more patent claims. This bright-line test has several advantages. For example, it would realign the inequitable conduct doctrine with its roots in common law fraud, under which only misrepresentations and omissions that are truly outcome determinative are deemed material. Such a test would also make the defense of inequitable conduct more difficult to allege and prove than under the currently existing tests. Additionally, an objective “but for” test would further the goal of providing the PTO with the information most pertinent to patentability without the extraneous material that is often included today because of the uncertainty surrounding the competing materiality tests.

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