Patent Docs: Impact of Advances in DNA Sequencing Technology on Genetic Diagnostic Testing


We are pleased to share the latest from our friends at, the Biotech and Pharma Patent Law and News Blog. The authors, Donald Zuhn and Kevin Noonan, are partners at McDonnell Boehnen Hulbert & Berghoff, LLP, and contribute to Patent Docs on a daily basis. Today’s post is entitled, “Impact of Advances in DNA Sequencing Technology on Genetic Diagnostic Testing”, and it discusses how because DNA sequencing soon may be within the reach of the consumer, the current patent protection (and the IP protection model underlying it) for genetic diagnostic testing may become obsolete.

Here is an excerpt:

First, determination of an entire sequence does not per se infringe gene-specific DNA or method claims unless gene-specific primers are used (and even these claims are subject to some reevaluation; see “Caught in a Time Warp: the (In)validity of BRCA1 Oligonucleotide Claims“).  This is one reason why the majority of the claims at issue in the Myriad case (i.e., claims to isolated genes) are not infringed by the practice of genetic diagnostic methods and why even if the plaintiffs and their ACLU masters prevail, the women will have no remedy.  Thus, the only direct infringer using these “mini-sequencer” devices would be the consumer, and unlike situations where suing consumers has been successful (like music file-sharing), the individual damage from any specific consumer defendant’s infringement would be minimal.  While the damage to the patent-holder might be large cumulatively, it is unlikely that a patentee could successfully sue consumers as a class.  Inducement to infringe might also be challenging to prove since it is unlikely that Oxford Nanopore Technologies will provide instructions relating to any particular gene with specificity.  In any event, the identity of disease-related mutations is (and might continue to be) in the public record and so the consumer herself would remain the only infringer.

It may also be expected that Oxford Nanopore Technologies will provide information on genetic counselors to be consulted to assist the consumer to interpret the meaning of her deduced nucleotide sequence.  These genetic counselors will be practicing a method involving comparing the deduced consumer sequence with the canonical “normal” sequence, and should not be infringing any valid claims.  This is because the Federal Circuit unanimously held in AMP v. USPTO (the “Myriad” case) that mere “comparison” claims do not satisfy the Bilski test and are thus invalid.  In addition, under this scenario the issue of “joint infringement” would arise, because the consumer would produce the sequence and its interpretation relating to inherited propensity for disease would be performed by the genetic counselor.  Unless the Federal Circuit dramatically changes the jurisprudential landscape in deciding the McKessonand Akamai cases en banc, infringement would not lie against either Oxford Nanopore Technologies or the genetic counselors.

The development of such an eventuality provides yet one more impetus for genetic diagnostic testing to avoid patents as a protection for the technology, and to use instead trade secret protection and other means that avoid disclosure.  These prospects make it even more imperative, perhaps, that whatever actions are taken by the Office, Congress, or the courts regarding genetic diagnostic testing be done cautiously and in a limited fashion.  Otherwise, we may find that we have imposed impediments to future technologies, just as progress in the technologies we intend to regulate make the regulation obsolete.  Certainly this can’t be the kind of progress the Founders had in mind. (emphasis added).

To read, “Impact of Advances in DNA Sequencing Technology on Genetic Diagnostic Testing” in full, please click here.

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