Judge Dyk’s View on the Patentability of Isolated Genes and DNA

Yesterday, the Federal Circuit reversed and remanded an infringement suit based on errors in the district court’s claim construction and infringement analysis.  Intervet, Inc. v. Merial, Ltd.  One of the claims at issue in the case is claim 32 of U.S. Patent No. 6,368,601, which reads:

An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1.

The court reversed the claim construction of the “specific to” clause of the claim.  The court specifically noted that neither the district court nor any of the parties had raised the issue of patentable subject matter under § 101 in this case.  That didn’t stop Judge Dyk from addressing the issue in a partially-concurring and partially-dissenting opinion.

Judge Dyk’s Opinion

Judge Dyk agreed with the majority’s construction of claim 32, but was quick to add that

I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter.

He then argued that claim 32 raises substantial questions as to whether it is directed to patentable subject matter.

That claim is not limited to the use of a particular isolated DNA molecule in a vaccine or other application.

Rather, the claim is simply directed to an isolated DNA molecule.  The question, to him, is whether an isolated DNA molecule, without a particular application, such as a vaccine, is patentable subject matter. 

He argued that neither the Supreme Court nor the Federal Circuit has decided this issue, although he did admit that they have upheld the validity of certain gene patents, this was not in the § 101 context.  Although the PTO recognizes their validity, the issue had not been decided by either court.

Judge Dyk then seemed to follow Judge Sweet’s reasoning of Supreme Court (mess) precedent to hold that, in order for a product occurring in nature to be patentable, the isolated product must be qualitatively different, with “markedly different characteristics from any found in nature.”  He argued that mere isolation of a DNA molecule is not enough, as merely taking a leaf off a plant–the leaf doesn’t occur naturally isolated from the plant–is not enough.


It is hard to understand why Judge Dyk chose to write about this issue given that it wasn’t raised by either party or addressed by the district court or the majority opinion.  He apparently wants to signal to other parties that the battle is on regarding isolated DNA and gene patents and the side he is on. 

This is not what federal judges are supposed to do.  They are supposed to decide the case before them on the issues raised in that case.  If and when Judge Dyk is a part of a panel or en banc court that gets to address this issue, that would be the proper time for him to do so.  At this point, he is issuing an advisory opinion, contrary to the constitutional mandate that court’s decide “cases and controversies.”  The stakes in the Myriad case may have just gotten a bit higher.

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One Response to “Judge Dyk’s View on the Patentability of Isolated Genes and DNA”

  1. Justice Department Files Brief Arguing that Isolated Genes are Not Patentable « INVENTIVE STEP Says:

    [...] Circuit, however, will likely still reverse the district court’s decision.  Although Judge Dyk expounded his view this summer in a completely unrelated case that isolated DNA is not patent eligible, it is likely [...]

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