Sequenom’s Patent No. 6,258,540 is really fascinating. The inventors (Oxford Professors Lo and Wainscoat) had previously discovered that human fetal DNA existed in small quantities within the pregnant mother’s blood plasma. That discovery was important because it would allow for non-invasive prenatal genetic testing without risking the health and safety of the unborn child. However, a sticking point was the difficulty in separating-out the very small number of fetal-DNA from the large quantity of mother-DNA. That problem was solved by recognizing the fundamental genetic difference between mother and child DNA is the addition of DNA from the biological father. With that insight the inventors were able to use 1997 PCR technology to particularly amplify DNA that included elements inherited from the father. Those amplified nucleic acid molecules can then be tested for various potential genetic anomalies. The test (commercialized by Sequenom) is hugely popular because it does not involve sticking a needle through the placenta and the resulting significant likelihood of miscarriage.
The patent here does not actually cover the diagnostic tests done on the fetal DNA but instead covers simply the method of finding the fetal DNA in the first place. Thus claim 1 includes two steps: (1) “amplifying” the paternal-inherited DNA from the maternal plasma then (2) “detecting” the presence of the paternally-inherited DNA. Independent claims 24 and 25 provide some further limitations such as fractioning the maternal blood sample to isolate only the plasma.
Despite the patent, Ariosa launched its competing fetal sampling services and in 2011 filed for declaratory judgment of invalidity of the patent. On Summary Judgment, the district court agreed with the DJ plaintiff – finding the claimed invention ineligible under 35 U.S.C. 101. That case is now on appeal before the Federal Circuit. (Docket 14-1139).
In invalidating the patent, the district court followed the two-step method of Mayo: First finding that the presence of fetal-DNA within the maternal plasma is an unpatentable natural phenomena; and Second finding that the PCR methods used to take advantage of the phenomena used lacked sufficient inventiveness. In the patent document, the patentee had identified these methods as conventional. The court also considered preemption – and determined that the patents carry “substantial risk” of preemption because there was no evidence any of the alternative methods of finding fetal-DNA (proposed to the court by the patentee) were both available at the time of the application filing and also currently commercially practical.
In the appeal, the patentee makes several arguments:
1. Sure, it is a natural phenomena that fetal-DNA is present in maternal blood plasma DNA. However, the core invention here is the process of detecting the fetal-DNA from the blood plasma that had previously been discarded as waste and uses technology to solve the medical dilemmas created by amniocentesis.
2. The practical limits found in the the claim are themselves inventive because no-one had ever accomplished the combinations of claimed steps.
3. The PCR process actually creates new DNA molecules – this case should be analyzed under Myriad not Mayo.
4. There are several scientifically validated methods of accomplishing the goals of the invention that do not infringe the patent — thus, the claims are not preemptive.
MBHB attorney Kevin Noonan has filed an Amicus brief on behalf of BIO supporting the patentee’s position. The primary thrust of Noonan’s argument is to show a strong policy argument that this type of innovation is important and that the research should be supported by patent protection. Noonan also highlights the district court’s commercially viable” requirement as problematic and not historically required in the law. (but query the “substantial practical application” language of Benson). A responsive amicus brief filed by the genetic testing company Invitae pushes back against Dr. Noonan’s arguments and argues that allowing this type of patent will “bury” the genomics industry and that (if they were ever useful) patents are no longer needed to research in this area because of the fallen price of genetic lab work and data anlaysis. SDIPLA also filed a brief making an interesting point: Here, the diagnostic process was only found ineligible because the subject matter being detected was a natural phenomena. If instead, the same process was being used to detect the presence of a man-made compound then the test would not be challenged on 101 grounds. SDIPLA then argues that distinction does not make sense.
In its responsive brief, the patent challenger pushes in several ways. Most squarely, the brief recognizes that the discovery of a natural phenomena may be very important, but even when a critical breakthrough, that discovery is not patent eligible. Rather, to make something patent eligible, the inventors must then take the discovery and apply it in a way that adds substantial and inventive limitations. The argument here is that the patentee’s addition (the process of detection) was well known at the time of the patent filing and offered no inventiveness. Ariosa seemingly does not defend the “commercially viable” requirement for preemption, but does indicate that the time-focus of preemption should be at the time the patent application was filed.
The outcome of this case will be fascinating.
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- This same case was previously before the Federal Circuit with regard to a preliminary injunction (Federal Circuit vacated lower court’s denial of preliminary relief to the patentee). That decision was written by Judge Rader and joined by Judges Dyk and Reyna. On appeal, I believe that the case will go back to Judges Dyk and Reyna with a third judge added based upon the Federal Circuit’s internal operating procedure.
- I apologize, but I accidentally deleted the briefs (can someone email them to me?).