• Stripped of the aura of past PTO practice of allowing patents on such sequences, Myriad cDNA patents may face a stiffer §§ 102, 103 challenge this time around
  • Prior art that may not have been used by the PTO because of this aura are now available to defendants in challenging these patents
  • Also called into question is the presumption of patentability of these cDNA patents

In the tale “Emperor’s New Clothes” by Hans Christian Anderson, two weavers promise an Emperor a new suit of clothes that is invisible to those who are unfit for their positions, stupid or incompetent. As the Emperor parades before his subjects in his new clothes, one child cries out “the Emperor isn’t wearing any clothes.” Myriad may be parading its cDNA patents before the court, but it remains to be seen whether those cDNA claims are wearing any 102/103 clothes.

In our blog on the Supreme Court Myriad Decision, we raised the question whether cDNA patents are now more vulnerable to §§ 102/103 challenges now that the Court has stripped away the presumptive patentability enjoyed by gene patents under the PTO’s prior practice of awarding gene patents. The patent community should get an answer to that question soon enough. On July 9, 2013, less than a month after the Supreme Court issued its decision, Myriad filed a lawsuit against Ambry Genetics. Having slipped through the § 101 gateway, Myriad cDNA patents are now back.  But stripped of the aura of past PTO practice of allowing patents on such sequences, this time around, the cDNA patents are likely to face a stiffer §§ 102, 103 challenge.

The ruling by the Supreme Court decision in Myriad was a narrow one. Isolated DNA is not eligible patent matter, while cDNA is.  On the face of it, the ruling by the Court on the patent eligibility of cDNA seems an unequivocal victory for Myriad. But that victory came not without a cost. In striking down the patent eligibility of isolated DNA, the Court has called into question the longstanding PTO practice of allowing patents on such sequences, which had heretofore created an aura of presumptive patentability around gene patents. Under this PTO practice, gene patents have been sailing through the §§ 101, 102, 103 gateways of patentability under an aura of presumptive patentability. This while other patents that were without this aura were being examined with the kind of rigor called for under §§ 101,102, 103 of the patent laws.

As explained in the John Hopkins amicus brief before the Supreme Court in Myriad, “the process for creating these probes is well known.”  (“In order to locate and identify the quiescent gene on a complex DNA molecule packed with thousands of other genes, scientists create “probe” molecules that bind to the region of interest and locate the targeted gene. Id. at *28-30. Because DNA contains two complementary strands with each nucleotide sequence binding to its complement, these laboratory-created probes bind to complementary regions of native DNA. The process for creating such probes is well-known: ‘reverse transcription’ of an mRNA molecule creates a copy of an in vivo anti-sense DNA strand’s coding regions, known as “complementary DNA,’ or cDNA (because it is complementary to the mRNA template.)”  John Hopkins Amicus in Myriad  p. 11)

If the process of creating these probes is “well known” and the “location of the gene sequence” is not eligible patent matter per the Supreme Court in Myriad, then what remains in the Myriad cDNA patents under §§ 102, 103 may not be enough.

With the aura of patentability removed, cDNA patents may now be more vulnerable to §§102, 103 challenges. Because of this aura, Myriad cDNA patents may not have been properly examined under §§ 102, 103 by the PTO.  Hence, prior art not used by the PTO may now be available to the defendants in challenging the patents. The “soft” examination by the PTO of cDNA patents in the past on account of this “aura” may also call into question whether cDNA patents should even be entitled to the presumption of patentability bestowed upon an issued patent; which places a heightened burden of clear and convincing evidence to invalidate on the defendants.

About The Juhasz Burge PC Firm

The Juhasz Burge PC Firm is a patent and intellectual property (IP) protection, counseling, licensing and litigation firm. Combining deep patent/IP experience, broad capabilities across a wide spectrum of industries and technologies, and extensive expertise in strategic counseling, The Juhasz Burge PC Firm collaborates with clients to help them better see, understand and realize the potential strategic value from their patents and intellectual property.

Paul R. Juhasz has written extensively on matters of genetic patents, including Myriad, and including amicus briefs filed in the Prometheus and Myriad cases.