The Hottest Issue for Healthcare IP in 2015: Claims to Natural Materials

The Federal Circuit will grapple with the fallout from the high court’s recent patent-eligibility ruling. While the justices busy themselves with new areas of patent law, the Federal Circuit, the Patent Trial and Appeal Board and the district courts will deal with the impact of the high court’s recent Myriad decision on patent eligibility. Myriad Genetics was a case which created plenty of buzz and in return received lots of attention this past year. Watch for fallout from the Myriad case in 2015.

In the Myriad Genetics case, the Supreme Court invalidated gene patents which covered isolated DNA sequences by holding that merely isolating existing genes or matter found in nature does not constitute a patentable invention, since these materials are not inventive but instead produced by nature.

Since this decision, many courts have cited it to invalidate patents that only claim natural materials. The Federal Circuit and the Patent Trial and Appeal Board will likely face multiple cases regarding the implications of this decision this year.

Based on public feedback and in light of the recent Supreme Court decision in Myriad and other cases, the USPTO issued new examination guidance regarding subject matter eligibility (what sort of subject matters are eligible to be patented). The guidance was published in the Federal Register since December 16, 2014. Focarino addressed the USPTO’s interpretation of subject matter eligibility and the change from previous examination guidance in this blog post.