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What it does 

Life Technologies Corp. v. Promega Corp. is a Supreme Court case addressing patent infringement under section 271 of U.S. patent law (35 U.S.C. 1 et seq.). The Court interpreted the language of section 271(f)(1) and its legislative purpose; it found that what constitutes "a substantial portion" of the components of an invention is to be determined quantitatively rather than qualitatively. Furthermore, by contrasting the language of 271(f)(1) and 271(f)(2), the Court determined that a single component could not be considered a substantial quantity for the purposes of violating 271(f)(1).

In effect, a licensor cannot claim patent infringement under 271(f)(1) of the Patent Act if the licensee has only shipped a single component of a multicomponent invention outside of the United States. The court did not rule on what indeed constitutes a quantitively substantial portion for the purposes of infringing a United States patent.        

Relevant Science 

DNA (deoxyribonucleic acid) consists of two linear strands of nucleotides that are complementarily linked by nucleotide (or base) pairing, thus forming the familiar double helix structure. One strand of the helix runs in the opposite direction of the other (antiparallel). All DNA consists of four nucleotides; adenine pairs with thymine, and cytosine pairs with guanine. The sequence of nucleotides in a DNA strand encodes instructions for the cell's machinery to create proteins and perform vital functions. 

DNA can be copied, or amplified, in the lab by a process called polymerase chain reaction (PCR), which mimics the mechanism by which cells copy DNA in vivo. The Tautz patent, at issue in this case, claims a genetic testing toolkit that takes advantage of certain features of PCR. This toolkit finds application in law enforcement settings, for example, by helping investigators amplify DNA samples to create genetic profiles of individuals.   

The kit consists of five components:

  • Primers: pairs of short DNA sequences, usually fifteen to twenty-five nucleotides long, that complement known segments in the DNA being copied. These primers, which serve as starting points for the new copies of DNA, flank the sequence of DNA that is intended to be amplified.
  • Nucleotides: the components of DNA, which link in a strand to create a sequence.
  • Taq polymerase: a heat-resistant enzyme that replicates the DNA sample. Taq polymerase attaches to DNA-bound primers and moves along the template strand of DNA, linking nucleotides onto the ends of the primers in a sequence that complements the template DNA (and thus has the same sequence as the opposite strand of DNA). 
  • Buffer solution: solution which creates conditions suitable for PCR.
  • Control DNA: segments of DNA with known properties (for example, length) that can be amplified and compared to the non-control DNA amplification.

Repeating the process of DNA copying allows users of the kit to amplify the target sequence exponentially, in that each new copy can serve as a template in the next PCR cycle. 

The Tautz patent specifically claimed methods of using PCR to amplify regions of short tandem repeats, which are regions of DNA that feature consecutive repeats of short sequences, often two to five nucleotides in length. These areas of DNA are naturally prone to deletions or duplications of the repeated sequence such that there is a lot of variation across individuals, making them useful for identification purposes. After a region of short tandem repeats has been amplified by PCR, researchers can compare the sample to the control DNA, for example by size-separation on a gel, to determine the number of tandem repeats contained in the DNA sample.   

Decision Points 

The Court sought to determine the meaning of "a substantial portion" for the purposes of 271(f)(1) of the Patent Act. In doing so, it looked to a number of interpretive authorities:

  • The ordinary meaning of the term "substantial" may refer to either the qualitative importance or quantitative size of a component of a whole. However, a contextual reading reveals that "substantial" was likely meant to refer to a quantitative amount. The phrase "all or a substantial portion" suggests a quantity because it makes no reference to importance. That "substantial portion of" modifies "components of a patented invention" and not just “a patented invention” also supported a quantitative reading.     
  • The purpose of 271(f) of the Patent Act was to fill a gap in patent infringement liability that was exposed in Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 92 S. Ct. 1700 (1972). Under Deepsouth, a United States product covered by a combination patent could be domestically manufactured as unassembled components to be sold and assembled outside the United States without infringing on the patent. Subsections (f)(1) and (f)(2) were thus introduced to assign liability if the export was of a (quantitatively) substantial portion of the invention or a single component that was especially made or adapted for use in the invention.  

The Court conceded that the word "substantial" is ordinarily ambiguous. Nonetheless, it declined to give to juries the task of deciding on a case-by-case basis whether a quantitative or qualitative meaning should govern. Furthermore, because the use of "substantial" within the context of 271(f)(1) supported a quantitative interpretation, the Court declined to take into account qualitative meanings when determining whether Life Technologies had infringed the patent. The Court also decided that a qualitative definition of “substantial” would be too subjective to be of much use to courts or market participants.     

The Court then determined that a single component did not constitute a substantial portion of components for the purposes of violating 271(f)(1). Section 271(f)(2) assigns liability for the supply of "any component" (singular) abroad. Though the two sections of the Patent Act serve different purposes, interpreting a single component as being sufficient for liability under 271(f)(1) would undermine the effect of 271(f)(2). On this basis, the Court decided that the American production of Taq polymerase, as one out of five components of the Life Technologies kit assembled in the UK, was insufficient to constitute infringement of the Tautz patent. 

In doing so, the Court identified a gap in legislation, holding that cases in which an insubstantial portion of a multicomponent invention is shipped out of the United States are not within the scope of 271(f)(1). However, the court did not decide how many components of a multicomponent invention constitute "a substantial portion" for the purposes of 271(f)(1). 

The facts 

Promega Corporation holds an exclusive license for the Tautz patent, which claims a genetic toolkit that amplifies DNA, along with variations on methods for its use. Promega sublicensed the patent to Life Technologies Corporation, allowing Life Technologies to manufacture and sell the kits claimed by the Tautz patent.

Life Technologies manufactured Taq polymerase, one of the five components of the kit, in the United States. The polymerase was shipped to the United Kingdom, where the remaining four components were manufactured. The components were assembled, and the kits sold, in the United Kingdom. 

Promega sued Life Technologies for violating 271(f)(1) of the Patent Act of 1952, which reads:

“Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.” (emphasis added)

The District Court granted Life Technologies' motion for judgment as a matter of law. The Court of Appeals for the Federal Circuit reversed, finding that "a substantial portion" could refer to a single important component of an invention. Justice Sotomayor, for the Supreme Court of the United States, reversed and remanded the decision.  

Where & When 

The United States Supreme Court delivered its ruling on February 22, 2017.

Relevant Experts 

Dr. Misha Angrist, MFA, MS, & PhD, is an Associate Professor of the Practice at SSRI and a Senior Fellow in Science & Society. As the fourth participant in the Personal Genome Project, he was among the first to have his entire genome sequenced and made public.

Background 

Deepsouth Packing Co. v. Laitram Corp. was a United States Supreme Court case over a patent for a shrimp deveining machine. Laitram held a patent for the particular combination of component machinery that automated the deveining process. Because of this patent, Deepsouth was barred from using, making, or selling the deveining machine in the United States, but sought judicial approval to ship parts abroad for foreign customers to assemble and use. The Court acknowledged that its patent system did not cover such a scenario, and allowed Deepsouth to continue its foreign business.

Twelve years after Deepsouth was decided, Congress amended the Patent Act in 1984 to include 271(f), "a legislative solution to close a loophole in patent law." Section 101 of the Patent Law Amendments Act of 1984, (HR 6286, 98th Congress).    

Status 

The Supreme Court reversed and remanded the decision of the Court of Appeals for the Federal Circuit. The lower court must enter a judgment consistent with the Supreme Court decision, meaning Life Technologies will prevail against Promega.

Primary Author 
Karina Moy, JD Candidate
Editor(s) 
Kelly Todd, JD/MA Candidate; Alex Robeson, PhD
Recommended Citation 

Duke SciPol, "Life Technologies Corp. V. Promega Corp." available at http://scipol.duke.edu/content/us-supreme-court-rules-liability-supplying-components-abroad-under-patent-act-life (04/11/2017).