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

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

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  In a sense, it has been replaced by pleas for enhanced damages, sanctions for misbehavior during litigation, and even anti-trust violations.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

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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USPTO Publishes Interim Process for Director’s Review of PTAB Decisions

Information from the USPTO:

[The USPTO’s] webpage houses useful information regarding the implementation of an interim Director review process in Patent Trial and Appeal Board (PTAB) proceedings following Arthrex.


On June 21, 2021, the U.S. Supreme Court issued a decision in United States v. Arthrex, Inc., Nos. 19-1434, 19-1452, 19-1458, 2021 WL 2519433, addressing the Constitution’s appointments clause as it relates to PTAB administrative patent judges (APJs). The court considered whether APJs are “principal officers” who must be appointed by the President with the Senate’s advice and consent, or, as the United States Patent and Trademark Office (USPTO) and the U.S. government argued, whether they are “inferior officers” who can be appointed by the Secretary of Commerce.

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