Strathclyde v. Clear-Vu – A Class in Obviousness

In fact, it was Clear-Vu that got “schooled” in the law of obviousness, but this case would be a good teaching—or review—article for anyone on this subject. I admit, it was refreshing to re-read some of the classic quotes from Fed. Cir. panels that set the standards for s. 103 inquiries. I know that patent eligibility and even s. 112(1) are the hot topics of the day. This decision by Judges Reyna, Cleavinger and Stoll (writing)  felt like encountering the ghost of s. 103 past—when the entire IP world seemed like a friendlier place.

Continue reading

Posted in Obviousness | Tagged , | Leave a comment

Inequitable Conduct Lives! Therasense Update and Refresher

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 –

Posted in Inequitable Conduct/Rule 56 | Tagged , | Leave a comment

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.

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , | Leave a comment

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).

Continue reading

Posted in Inequitable Conduct/Rule 56 | Tagged | Leave a comment