U.S. Supreme Court to Weigh-in on DNA Test Kit Patent Dispute

The Supreme Court has agreed to review a patent-infringement case between Life Technologies and Promega, involving genetic testing technology.

One month after the federal government urged the high court to review the case, the Supreme Court agreed to grant Life Tech’s petition for a writ of certiorari stating, “the Federal Circuit’s holding is incorrect, and it subjects domestic exporters to the threat of liability for supplying a single staple article into the global stream of commerce.”

The Supreme Court’s review will shed light on the Federal Circuit ruling from 2014 on whether supplying a single component of a multi-component invention from the United States is an infringing act under patent law that would expose a manufacturer to liability for worldwide sales.

Component Uncertainty

Life Technologies, part of Thermo Fisher Scientific, manufactures a genetic test kit in the UK to be sold worldwide.

One element of the kit, called a Taq polymerase, is made in the U.S. and then shipped to the UK to be combined with the larger product. Taq polymerase is used to amplify DNA via the polymerase chain reaction.

In 2010, Promega sued Life Technologies for patent infringement, accusing the company of selling test kits not covered by a 2006 license agreement. Life Tech held a license from Promega to sell DNA test kits used in legal proceedings, but had been accused of allegedly selling the kits for unlicensed uses such as clinical diagnostics.

The kits are used by police for forensic identification, and by researchers for analyzing cancer cells.

Promega Corp. owns four patents and exclusively licenses a fifth related to “short tandem repeats” in DNA sequences, referred to in court documents as the “Tautz patent,” which covers methods for determining markers for genetic variations.

The jury determined that Promega was entitled to $52 million in lost profits due to LifeTech’s willful infringement of Promega’s patents.

Shortly after, the judge overturned the decision after trial, finding that merely shipping the polymerase from the U.S. wasn’t enough to warrant such a result because “all or a substantial portion” of an invention’s components to be shipped overseas requires that multiple components be involved.

Awaiting Damages

Promega took its case to the Federal Circuit, where the court did not reinstate the jury award, stating that new damages had to be assessed.

LifeTech petitioned the U.S. Supreme Court for review in 2015, arguing that the Federal Circuit misinterpreted the law when it found Promega was entitled to damages.

The U.S. Solicitor General advised the high court to take up the issue in May, arguing that the ruling was potentially harmful to business, since it “subjects domestic exporters to the threat of liability for supplying a single staple article into the global stream of commerce.”

Promega originally asserted five patents against Life Technologies, but four of those were invalidated during the litigation.

Life Technologies asked the Supreme Court to consider the issue of whether the party could “actively induce” itself to infringe a patent or whether that requires the involvement of a third party. The Supreme Court declined to take up that issue and will focus solely on the matter of whether creating a single component can lead to infringement.

Oral arguments will begin in October and end in June 2017. Read the court briefing document here: www.fdanews.com/06-30-16-DNAPatentCase.pdf. — Joya Patel