PATENTING NATURAL ELEMENTS
The U.S. Supreme Court holds that a naturally occurring DNA segment is a product of nature and therefore is not eligible to be patented simply because it has been isolated. That said, the court also found that cDNA --complimentary DNA which has been synthesized -- can be patented because it is not naturally occurring.
The Patent Act permits issuance to those who invent or discover any new and useful "composition of matter," but it specifically exempts "laws of nature, natural phenomena, and abstract ideas" as basic tools of scientific and technological work which are outside the scope of patent protection.
The nation's highest court ruled that Myriad Genetics' claim to the BRCA1 and BRCA2 discovery fell within the nature exception because the company did not create or alter the genetic information it discovered.
Yet, cDNA does not present the same obstacle as it is not a product of nature and its creation results in a molecule that is not naturally-occurring. While the order of the molecule may be dictated by nature, the court found lab technicians unquestionably created something new through cDNA.
OPINION OF THE COURT
Justice Clarence Thomas delivered the opinion of the court, and he was joined by Chief Justice John Roberts as well as Justices Anthony Kennedy, Ruth Bader Ginsberg, Samuel Alito, Sonya Sotomayor and Elena Kagan. Justice Antonin Scalia joined in part, but he also penned a concurring opinion.
While the opinion acknowledged Myriad Genetics' discovery of the BRCA1 and BRCA2 genes as a "medial breakthrough," Thomas argued that scientists already knew heredity played a role in cancer risks.
The opinion explained that attempting to patent a naturally occurring thing presents considerable danger of tying up scientific tools and thereby inhibiting future innovations, thus contradicting the purpose of a patent, which is to promote creation.
Sentiment: Strong Buy
The title of this post is misleading. For the sake of accuracy, the recent Supreme Court case affirms that Inovio's synthetic vaccines, including Inovio's Syncon platform, constitutes patentable subject matter. Whether Inovio's DNA vaccines are "fully protected" depends on Inovio's IP portfolio and how well its patents are drafted.
The antigens are totally protected because they are synthetic nucleotides and they are in a unique, small circular configurations which make them foreign to any cells they enter and thereby rejected by the immune system. I always wondered why the Intro page to the Inovio website was a bunch of circles. Then I read what it was about. Normally DNA or RNA is in a double helix configuration (a long strand). So Inovio just tied the ends together. It cannot function like a strand of nucleotide inside a cell. Thus it cannot infect, only get rejected.
Sentiment: Strong Buy