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Want to Patent Natural Biological Material? Try Australia -- Maybe

By Casey C. Sullivan, Esq. on December 22, 2015 | Last updated on March 21, 2019

If you want to patent non-modified biological material - say, genes as they occur in nature -- you're largely out of luck in the U.S. In 2013, the Supreme Court invalidated two patents for breast cancer-related genes, BRCA1 and BRCA2, on the basis that naturally occurring DNA segments can't be patented. The USPTO's eligibility guidance has followed suit.

Down Under, however, things may be different. Recent guidance from the Australian Patent Office indicates that it could be possible to patent biological subject matter that is ineligible in the United States.

The Yanks and the Aussies on Gene Patents

First, a little background. In the early 1990s, scientists at the University of California, Berkeley discovered that BCRA genes were related to breast cancer. Myriad Genetics, a genetic diagnostics company, was founded shortly after, eventually patenting the BCRA genes and offering breast cancer diagnostic tests based on genetic sequencing.

Those patents were invalidated by the U.S. Supreme Court in 2013, in the case of Association for Molecular Pathology v. Myriad Genetics. In Myriad, the Court ruled that "a naturally occurring DNA segment is the product of nature and not patent eligible merely because it has been isolated." Synthetic or modified "complementary DNA," however, could qualify for patent protection.

A year later, the USPTO interpreted that decision in its interim subject matter eligibility guidance, also known as USPTO 101 guidance. The test, according to the USPTO, is whether a claim is "effectively drawn to something that is naturally occurring."

But the Supreme Court wasn't the only court of last resort to address the BRCA patents. Earlier in 2015, the Australian High Court decide D'Arcy v. Myriad Genetics. They also tossed myriad's patents, but under the reasoning that the BRCA genes did not constitute "a manner of manufacture."

What's Up Down Under

Subsequent guidance from the Australian Patent Office has opened the possibility that certain biological material may be patentable in Australia but not the U.S., according to a recent blog post from Foley and Lardner. That guidance rejected the idea that natural products could not be patentable, noting that the American dichotomy between "products of nature" and "artificially created products," was not deliberated by the High Court. According to Foley:

Where the USPTO extrapolated from the U.S. Supreme Court decision when it promulgated its patent eligibility guidance, [the Australian Patent Office] seems to have taken a more conservative approach. This means that despite similar rulings against the patent eligibility of Myriad's BRCA DNA claims, it may be possible to patent subject matter in Australia that no longer can be patented in the U.S.

First, patents on DNA or RNA are - excuse the pun - patently ineligible down under. But other natural material might be eligible. The Australian guidance notes that recombinant and isolated proteins have been patented "without rejection," and suggests that "claims to plants and micro-organisms should be considered carefully as there are significant factors supporting eligibility of this subject matter."

But there is still a big "maybe." Both Australia and America's guidance is too new to know exactly how it will be implemented as pharmaceutical and biotech science, and IP law, develop over the coming years.

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