THE SITUATION:
Cell-free DNA testing, an innovative technology that is transforming healthcare delivery, facilitates noninvasive prenatal screenings and early cancer detection.
Working at the forefront of the cell-free DNA testing space, Natera, Inc. has developed an array of personalized genetic tests that aim to help patients lead longer, healthier lives.
THE CHALLENGE:
Invitae Corporation and ArcherDX, Natera competitors, entered the early cancer screening market using Natera’s patented technology. Natera sued ArcherDX and Invitae for patent infringement in the US District Court for the District of Delaware and sought injunctive relief and monetary damages.
OUR OBJECTIVE:
Natera retained a McDermott team skilled in patent litigation, led by William Gaede and Bhanu Sadasivan. The company tasked McDermott with protecting its intellectual property (IP) by proving that ArcherDX and Invitae directly infringed the patents at issue and securing a permanent injunction (ensuring these competitors would no longer be able to use Natera’s IP to gain market share).
THE OUTCOME:
After three years of litigation, a jury in the district court awarded Natera more than $19 million in damages for royalties and lost profits as a result of the infringed patents. A few months later, the same district court issued a permanent injunction, ordering ArcherDX and Invitae to stop using products containing Natera’s patented technology (with some narrow exceptions).
Securing a permanent injunction in the healthcare space is unusual because of public health concerns. Courts are reluctant to enjoin products or processes that involve human health, taking the view that if an injunction will run counter to the public interest, they won’t issue it. To overcome that high bar was a significant win for Natera.
GO FURTHER:
Throughout the course of the litigation, Invitae and ArcherDX attempted a variety of defense tactics, but the McDermott team successfully advanced Natera’s interests.
Section 101: Early on, before it was acquired by Invitae, ArcherDX pled that Natera’s patents were directed to ineligible subject matter (DNA) and moved for judgment under Section 101. The judge denied the motion. At the time, this marked the second time ever (to the McDermott team’s knowledge) that a court found claims directed to DNA to be patent eligible.
Safe Harbor: Then, ArcherDX claimed that its products were covered by the safe harbor provision under Section 271(e)(1) and moved for judgment as a matter of law on that ground. The court denied the motion.
Markman Order and Summary Judgment: The court subsequently issued a Markman order finding that ArcherDX and Invitae (which by now had acquired ArcherDX) had not proved the patent claims to be indefinite (and therefore invalid). The McDermott team then successfully fended off the defendants’ summary judgment motion.
Jury Trial: Following a five-day trial, the jury found that the safe harbor provision did not protect Invitae and ArcherDX’s products and that they had directly infringed Natera’s patents. The jury also rejected the argument of improper inventorship (after Invitae and ArcherDX raised the issue of whether the proper inventors had been named on the asserted patents). All of the patents were found not invalid. The jury awarded Natera $19.3 million in damages for royalties and lost profits as a result of the infringed patents.
Prosecution Laches: Even after the jury verdict, during a one-day bench trial, Invitae and ArcherDX argued that Natera’s patents were unenforceable due to prosecution laches – namely, that Natera had unreasonably delayed prosecution, causing prejudice to the defendants. (The ruling in an unrelated case has led to a surge in the use of prosecution laches as a defensive weapon.) However, the court ultimately issued a resounding ruling in favor of Natera.
With precedent-setting decisions coming from the US Court of Appeals for the Federal Circuit and the Supreme Court of the United States, the patent litigation landscape is becoming more complex. McDermott’s IP team draws on a breadth of experience, as well as technical degrees in science and engineering, to deliver business-driven solutions and innovative strategies to help protect and enforce valuable patent assets throughout the IP life cycle.
Learn more about our intellectual property and patent litigation capabilities.