Inequitable Conduct Lives! Therasense Update and Refresher

Posted on October 27, 2021 by Warren Woessner

On November 3 at 12:30 EST, I will be participating in an AIPLA webinar with Prof. David Hricik (Mercer College of Law) and William Covey, Director of the OED at the USPTO. We will present:

Inequitable Conduct Lives!

This presentation will provide information of use to old pros and new practitioners. The panelists will provide an overview of the ethical obligations of practice as well as the substantive law of inequitable conduct and related disciplinary matters, including several recent cases finding inequitable conduct despite the barriers created in 2011 by Therasense.  It will also provide practical procedures and practices to avoid creating a record that leads to inequitable conduct and for more compact prosecution.

To register, visit the AIPLA website. For further information contact Dominique Fields at AIPLA – dfields@aipla.org.

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CareDx v. Natera – Are Processing Steps Known to the Art Always “Conventional”?

Posted on October 15, 2021 by Warren Woessner

In CareDx (Stanford U.) v. Natera Civ. Action No. 19-0567-CFC-CJB Consolidated (Sept. 28, 2021, D. Delaware), Judge Connolly ruled that the diagnostic method claimed in U. S. Pat. No. 8,703,652 and two others was a patent-ineligible natural phenomenon. The method is based upon the known correlation between the presence of donor-specific cell-free DNA (cfDNA) in a transplant recipient’s tissue and transplant rejection. Since the correlation was known, CareDx was left to argue that the improvement in sensitivity provided by the combination of known steps—which improvement was even recited in claim 1—was sufficient to satisfy the Mayo/Alice test for patent eligibility. However, by now we know that even discovery of a natural correlation and the discovery of its utility as a diagnostic is not enough to satisfy the requirement for the further “inventive concept” required by Step 2 of the Mayo/Alice test.

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Belcher v. Hospira – Inequitable Conduct is Still in Your Invalidity Toolbox

Posted on September 3, 2021 by Warren Woessner

Ever since Therasense made it more difficult to plea and prove inequitable conduct (IC), I feel that practitioners and litigators have pushed this defense to patent infringement out of the front lines of infringement attacks. In fact, I know of only a handful of cases in the pharma space in which an inequitable conduct defense was successful.  In a sense, it has been replaced by pleas for enhanced damages, sanctions for misbehavior during litigation, and even anti-trust violations. This despite invalidations of a variety of patents post-Therasense in decisions such as GS Cleantech v. Adkins Energy, Appeal No. 2016-2231, 2017-1838 (Fed. Cir., March 2, 2020), Apotex v. UCV, 763 F.3d 354 (Fed. Cir. 2019) and Aventis Pharma. v. Hospira, 675 F.3d 1324 (Fed. Cir. 2012).

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Chemours Co. v. Daikin Industries – Back to Some IP Basics

Posted on July 28, 2021 by Warren Woessner

After trying to untie the Gordian knot of patent eligibility, it is almost IP comfort food to read a Fed. Cir. decision that deals with obviousness. In Chemours Co. FC, LLC v Daikin Industries, Ltd., Appeal Nos. 2020-1289 and 2020-1290 (Fed. Cir., July 22, 2021) a split panel of Reyna (writing) and Newman (Happy Birthday!) with Dyk dissenting, reversed a PTAB final written decision that a co-polymer useful for coating cables at high extrusion speeds (30 +/- 3 g/10 minutes) is obvious. Claim 1 of U.S. Pat. No. 7,126,609 reads:

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