Bhanu Sadavisan

Sadasivan, a partner in McDermott’s Silicon Valley office, focuses her practice on the life sciences industry. She represents clients in high-stakes litigation involving breakthrough technologies, including diagnostics, pharmaceutical formulations and therapeutics. Her clients include Amgen, Aurinia Pharmaceuticals, Alnylam Pharmaceuticals and Quidel Corp.

“Marrying the science with law is just really cool,” said Sadasivan, who has a Ph.D. in Immunology from Yale. “It’s highly challenging; you need to really know the law, but you also really need to know the science.”

She is currently leading two cases for Natera Inc., a pioneer in noninvasive, cell-free DNA testing.

“There are pieces of DNA floating in the blood. As cells break down, they release these pieces of DNA. Turns out, you can use these DNA in different testing applications,” Sadasivan explained. “Natera is using these pieces to test for cancer and for monitoring. It’s powerful because all you need is to take a tube of blood — you don’t have to get a biopsy of the tumor.”

The highly sensitive technology can also be used to monitor patients in remission and can identify a relapse sooner than traditional tools.

The cases assert patent infringement over several of ArcherDx’s oncology testing products. Natera, Inc. v. ArcherDX, Inc., No. 1-20-cv-00125 (D. Del., filed Jan. 27, 2020); Natera, Inc. v. ArcherDX, Inc., No. 1-20-cv-01047 (D. Del., filed Aug. 6, 2020).

Natera filed its first complaint in January 2020 and a second in August 2020. In October 2020, following a Section 101 Day, Judge Stark denied ArcherDx’s motion for judgment on the pleadings on all issues.

“Something that’s naturally occurring, you can’t really patent it — that’s the general argument. In general, courts have been holding patents for diagnostic testing and detecting to be unpatentable. We were going against the trend at the time. But we were able to convince the court that this particular technology that the patent is covering is something that is innovative, that Natera had come up with, and that is a patentable subject matter.”

In June 2021, the court issued a Markman order construing patent claims in favor of Natera and finding that the defendants had not shown that two of the claim terms were invalid or indefinite. Natera also successfully fended off ArcherDx’s summary judgment motion.

The case was scheduled to be tried before a jury this month.

—Jennifer Chung Klam