Supreme Court rules on liability for supplying components abroad under the Patent Act (Life Technologies Corporation v. Promega Corporation)

The Policy

What it does

Holds that a quantitative standard is used to determine whether "a substantial portion" of components of an invention has been supplied abroad in violation of section 271(f)(1) of the Patent Act.

Synopsis

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.        

Context

<p><a href="https://supreme.justia.com/cases/federal/us/406/518/case.html"><em>Deeps... Packing Co. v. Laitram Corp.</em></a> 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.</p>

<p>Twelve years after <em>Deepsouth</em> 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, (<a href="https://www.gpo.gov/fdsys/pkg/STATUTE-98/pdf/STATUTE-98-Pg3383.pdf">HR 6286</a>, 98th Congress). &nbsp;&nbsp;&nbsp;</p>

The Science

Science Synopsis

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.   

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.