Loren Donald Pearson

Loren Donald Pearson is a Registered Patent Attorney and a Florida Bar Board Certified Intellectual Property Attorney.  He is a partner at Assouline & Berlowe, PA and leads its intellectual property group.  Read his profile

  Email Newsletter icon, E-mail Newsletter icon, Email List icon, E-mail List iconJoin Email List  

Entries in Federal Circuit (1)


Myriad Genetics v. USPTO

The Federal Circuit upheld Myriad’s right to patent “isolated” genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancer.  But the court denied the biotechnology company’s effort to patent methods of “comparing” or “analyzing” DNA sequences.

Read the Federal Circuit Opinion.

Dennis Crouch summarized the opinion in Patently-O:

On remand from the Supreme Court (GVR), a three-member panel of the Court of Appeals for the Federal Circuit has released its highly anticipated decision in AMP v. Myriad. The key results:

  1. Affirmed: The courts properly have jurisdiction over the declaratory judgment case.
  2. Reversed: Myriad's composition claims to isolated DNAs, including cDNAs fall within the scope of Section 101 patentable subject matter.
  3. Affirmed: Myriad's method claims directed to comparing or analyzing gene sequences are not subject matter eligible.
  4. Reversed: Myriad's method claim to screening potential cancer therapeutics via in vitro changes is subject matter eligible."

This decision largely follows the decision previously released by the same panel in 2011. Each member of the court wrote separate opinions, with the opinion of the court filed by Judge Lourie, Judge Moore concurring in part and Judge Bryson dissenting in part. In dissent, Judge Bryson again employed his leaf analogy – arguing that a gene that was merely isolated from the human body cannot itself be patentable in the same way that a naturally grown leaf does not become patentable simply because it is plucked from its tree. Judge Bryson writes:

[E]xtracting a gene is akin to snapping a leaf from a tree. Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.

The majority (here judges Lourie and Moore) disputed the leaf analogy based upon the apparent technical difficulty of isolating human DNA.

It is also important to dispute the dissent's analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.

Prof. Crouch comments continue that he expects the decision to be reheard en banc.

The opinion shows that patent relating to DNA remain patentable subject matter.  However, care must be taken in drafting the claims.

Also notable, the ACLU was one of the appellants.  The American Civil Liberties Union, which brought the case, argued that patents on human genes violated the First Amendment and patent law because genes are “products of nature.”