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A 'Substantial Portion' Doesn't Mean One, SCOTUS Rules in DNA Testing Patent Dispute

By Casey C. Sullivan, Esq. on February 23, 2017 | Last updated on March 21, 2019

When does something constitute a 'substantial portion of the components of a patented invention' under the Patent Act? Not when that thing is only one of many components, the Supreme Court ruled yesterday, in a fun little case involving DNA testing, international supply chains, and patent law.

The case, Life Technologies v. Promega, involves a patent on a genetic testing kit made of five components. The Promega company was the exclusive licensee of that patent and licensed Life Technologies for the manufacture and sale of the kids to law enforcement. All but one of the kits five components, the Taq polymerase, were manufactured in the U.K. Life then shipped the Taq polymerase to the U.K. to be combined. After four years of this, Promega sued, claiming that Life Technologies had infringed the patent. Liability, according to Promega, was trigged by the shipment of the Taq polymerase abroad.

The Patent Act Goes Abroad

Promega pointed to the shipment of Taq polymerase because of the territorial limits of the Patent Act. The Patent Act is, generally, applicable within the borders of the United States. But there's an important exception. Liability for patent infringement can be found when a company exports form the U.S. "all or a substantial portion of the components of a patented invention" for combination abroad, when such action would infringe on the patent if done domestically.

The combination of the Taq polymerase with the four U.K.-produced components, Promega argued, triggered such liability.

One Is Not Substantial

But just one component wasn't enough, according to a unanimous Supreme Court. Justice Sotomayor, wrote the majority opinion. Justices Alito and Thomas joined only in part; Chief Justice Roberts recused himself from the case -- quite belatedly. The text at of the Patent Act section at issue, 35 U. S. C. §271(f )(1), the Court explained created "quantitative threshold" requiring more than one component.

The court rejected the argument advanced by Promega and adopted by the Sixth Circuit that a single component could be "substantial" if it was important enough. While the Act didn't define "substantial," the Court reasoned, its context alongside requirements pertaining to "all" and "portions," plus the sections' acknowledgment of multiple components, all lean toward a quantitative requirement.

When a product is made abroad, "and all components but a single commodity article are supplied from abroad," the Court concluded, "this activity is outside the scope of the statute."

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