Supreme Court Myriad Decision: Isolated DNA Is Not, While cDNA Is, Patent Eligible

//Supreme Court Myriad Decision: Isolated DNA Is Not, While cDNA Is, Patent Eligible

Supreme Court Myriad Decision: Isolated DNA Is Not, While cDNA Is, Patent Eligible

By |2013-06-26T09:42:02+00:00June 26, 2013|

Simultaneously, Supreme Court Clarifies and Clouds The Issue of New Versus Invention in § 101 Patent Eligibility

 

  • Isolated DNA not an “invention” under 35 U.S.C. § 101 and not patent eligible
  • cDNA is patent eligible because it is “new” (but is it truly an invention?)
  • S. Ct. rules: the more a claimed DNA looks like natural DNA, the more likely it is to be considered natural; the less it looks like natural DNA, the more likely it is to be patent eligible
  • S. Ct. missed opportunity by not remanding the cDNA claims to the Federal Circuit for further briefing on the “new” versus “invention” issues
  • the “physical and virtual links” test reveals what is missing from this Court’s Myriad decision: a clear basis for why cDNA is patent eligible and isolated DNA is not
  • An early Markman Hearing to properly construe the claims may prevent a claim from being summarily dismissed
  • cDNA patents may be more vulnerable to §§ 102/103 challenges now that the Court has stipped the presumptive patentability enjoyed by gene patents under the past PTO practice of generally awarding gene patents

 

On June 13, 2013, the Supreme Court handed down its highly anticipated decision in Myriad. The ruling is a narrow one. Isolated DNA is not eligible patent matter, while cDNA is.

In the Supreme Court Myriad decision, isolated DNA is not patent eligible because it is not an “invention” under 35 U.S.C. § 101. “Separating a gene from its surrounding genetic material [to isolate it] is not an act of invention,” the Court explained. Op. 12. “Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes “new . . . composition[s] of matter,” §101, that are patent eligible. Op. 13

cDNA, on the other hand, is patent eligible because it is “new;” it is not naturally occurring. “[B]ut the lab technician unquestionably creates something new when cDNA is made,” the Court explained. “As a result, cDNA is not a “product of nature” and is patent eligible under § 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.” Op. 17

Does it quack like a duck, or doesn’t it?

One take-away from Myriad appears to be that if it looks like natural DNA, as does isolated DNA, it is considered to be natural and not patent eligible. If it does not look like natural DNA, as does cDNA because it is missing introns, then it is considered new, and thus, patent eligible. But in going on to make the function of isolated DNA the focus of its decision, the Court is effectively saying that, whether or not isolated DNA looks like natural DNA, the isolated DNA still swims and quacks like natural DNA and so it is not an invention and not patent eligible.

The difficulty comes in squaring this rationale with the Court’s decision on cDNA, which was found to be patent eligible because it does not look like natural DNA.

As the Court explained, “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.” Op 16  But arguably cDNA still swims and quacks just like natural DNA. While it does not code for amino acids because it is without introns, the coding sequences contained in the cDNA appear to be identical to those found in native DNA. Indeed the utility of cDNA relies on the behavior of the remaining nucleotide sequence as nature designed them to be. (“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 p. 11)

Missed Opportunity Increases Importance of Markman Hearings

This incongruity leads to a second take-away from Myriad, the importance of an early Markman Hearing to properly construe the claims. This could have kept the claims from being summarily dismissed on the chemical composition issue deemed critical to the analysis of the lower court and Federal Circuit.

The Federal Circuit found isolated DNA markedly unlike isolated DNA in appearance because of the severed chemical bonds resulting from isolating the DNA from natural DNA. The Court’s finding of isolated DNA to the contrary was explained away with this, “Myriad’s claims are simply not expressed in terms of chemical composition . . .” Op. 14   This statement by the Court underscores the need for a claim construction hearing before deciding a § 101 issue. The lower court and Federal Circuit interpreted the term “isolated DNA” as a chemical composition without formal construing of the term by Markman proceeding. Not so with the Court, which did not read those severed chemical bond limitations into the claims.

But even had the Court given weight to the severed chemical bonds existing in isolated DNA, the decision would have likely been the same since “the claims understandably focus on the genetic information encoded in the BRCA1 and  BRCA2 genes.” Op 14, 15 As the Court explained “. . . its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule. Op. 15  Everything else is insignificant.

The Myriad decision raises also the question whether cDNA patents are now more vulnerable to §§ 102/103 challenges now that the Court has stipped away the presumptive patentability enjoyed by gene patents under the PTO’s prior practice of awarding gene patents. The corollary is whether the Patent Office should now be engaging in a more rigorous examination of gene patents under §§ 102/103 in view of Myriad. The cDNA patents may have survived the Myriad decision, but they can no longer rely on discovery of the location of the gene as the invention. Absent a specific process limitation not known in the art (or possibly limitations imposed by composition or product by process claims), claiming cDNA alone may not be enough.

The practice pointer for practitioners thus may be to draft claims on genes to look as different from natural DNA as possible, such as by removing an intron or other genetic material as discussed in the first takeaway above. That difference alone may uphold patent eligibility in the future. Even though the claimed gene may swim and quack like natural DNA, they won’t look like natural DNA and so may be patent eligible.

The Myriad decision on isolated DNA provides insight into the evolution of the body of law on what amounts to insignificant extra-solution activity; thereby relieving some tension regarding what constitutes “invention” under § 101. The steps of “isolating” in Myriad, the “eyeballing” of a correlation in Prometheus, the mere recitation of an abstract principle in Bilski, the recitation of a general computer as in Benson and Flook are all insignificant extra-solution activity that do not add to patent eligibility.

Simultaneously, the Myriad decision on cDNA has arguably heightened tension regarding what is required to be “new” under § 101. Simply not looking like a duck, even though swimming and quacking like one, may not be the final answer on this point.

We continue to believe that the “physical and virtual links” test provides a useful tool for determining the patent eligibility of cDNA. According to this test, first described by a Juhasz Law Blog in November 2010 following Bilski, isolated DNA is not patent eligible because the only manipulation of native DNA, the process of isolating, is insignificant extra-solution activity. Conversely, if the more involved process of making cDNA includes a significant manipulation of genetic material, then cDNA is a patent eligible invention.

This clarification reveals what is missing from the Court’s Myriad decision: a clear basis for why cDNA is patent eligible and isolated DNA is not, despite the fact that the behavior of the nucleotide sequences in each is as nature designed them to be.

By not remanding the cDNA claims to the Federal Circuit for further briefing on both “new” and “invention” issues, as we urged the Court to do in an amicus filed by The Juhasz Law Firm, Myriad may stand in the annals of legal jurisprudence as a missed opportunity to provide greater insight on these important points.

A complete description of the Juhasz Law Physical and Virtual Links Test can be read here

About The Juhasz Law Firm

The Juhasz Law 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 Law 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 software and genetic patents, including amicus briefs filed in the CLS Bank, Myriad and Prometheus cases.

The Firm appreciates the input of Steve Witters to this blog.