Sequenom, Inc., owned patent US6,258,540 (‘540) which describes a method of using foetal DNA isolated from the maternal blood stream to determine various factors about the foetus, for example, gender, paternity, and the presence or absence of certain genetic defects, e.g. Down’s syndrome. The patented method of using the circulating foetal DNA (known as cell free-floating foetal DNA or cffDNA) allowed, for the first time, a simple blood test from the mother to determine these factors. Prior techniques called for a foetal tissue sample and were invasive and sometime dangerous.
Ariosa Diagnostics, Inc. filed for invalidity of the patent on the grounds that it related to patent ineligible subject matter, and the case was recently heard by the US Court of Appeal for the Federal Circuit.
Following the US Supreme Court decisions in Mayo v. Prometheus and Association for Molecular Pathology v. Myriad, the USPTO issued guidance on determining the patentability of claims involving natural phenomena such as DNA. The USPTO guidance provided a multistep test for assessing patentability. The core of this test involves
• determining if the claims of a patent application describe in any way a law of nature or natural phenomenon and, if so, then
• determining if there are any additional features that significantly transform the nature of the claim into something patentable.
The first independent claim of ‘540 recited:
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
In Ariosa v. Sequenom, the US Federal Circuit held that “the asserted claims of the ’540 patent are directed to a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum—a naturally occurring non-cellular foetal DNA that circulates freely in the blood stream of a pregnant woman... It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.” So the Court turned to the next step of determining if the claims added additional features that significantly transformed the subject matter beyond a natural phenomena.
Despite the inventors demonstrating that cffDNA could be amplified from a maternal blood sample and that the amplified cffDNA could be used to analyse the genetic code of the foetus, the Court held that this was not enough to “transform” the claimed invention.
The Court provided the following reasoning:
Mayo made clear that transformation into a patent eligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features” to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful... The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.
From the above, we must conclude that the US courts believe that diagnostic methods are not patentable if they only recite the use of known DNA amplifications and sequencing techniques. It does not appear to matter that the DNA being sequenced is detected from a place within a human body where it was previously thought not to exist, e.g. foetal DNA in maternal blood, or that the DNA was not previously known to be relevant to a particular disease, e.g. the link between the BRCA1 and BRCA2 genes and an increased risk of breast cancer (see Association for Molecular Pathology v. Myriad decision).
The closing statement of the decision did show some recognition for the importance of the invention:
While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable contributions can fall short of statutory patentable subject matter, as it does here.
However, in a concurring opinion, Circuit Judge Linn perhaps “hit the nail on the head” in clarifying why the decision was not more favourable to the patentability of the invention:
but for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.
This is perhaps an indication that not all judges in the US courts are unsympathetic to those attempting to patent diagnostic technology.
US Courts strict on patentable subject matter
In conclusion, following the US Supreme Court Mayo v. Prometheus decision, the US courts appear to be bound by a very narrow interpretation to what constitutes “significant” additional features in order for an invention to not merely be considered a law of nature or natural phenomena. The decision in Ariosa v. Sequenom perhaps even raises the bar on what is and is not “significant”. This approach by the CAFC suggests that diagnosis of an illness by analysing DNA sequences is unpatentable in the US. It may lead to a lack of investment in new diagnostic tests and research into personalised medicine, and may hurt sufferers of many conditions.
EPO continues to offer protection for this technology
According to Article 53(c) of the European Patent Convention a diagnostic method is excluded from patentability only if it is practised on the human body. Methods of analysing blood or cell samples in vitro are patentable as they are conducted away from the body (see Patent issues Spring 2007 for more details).*
Representation Before the UPC
European Patent Attorneys who are entitled to act as professional representatives before the EPO and who have “appropriate qualifications such as a European Patent Litigation Certificate” will have rights of audience before the Unified Patent Court (under Article 48(2) of the UPC Agreement).
The preparatory committee has published draft Rules on the European Patent Litigation Certificate and other Appropriate Qualifications to clarify how this will work.
Draft Rule 11 addresses what additional qualifications are necessary. It brings in European Patent Attorneys holding law degrees or their equivalent. To ensure a satisfactory number of EPAs will be “grandfathered in” and be available to represent litigants from the outset, draft Rule 12 provides for a one-year transitional period in which certain other qualifications will be sufficient. These include IPReg qualifications held by all Jenkins patent partners and most associates.
Thereafter, a European Patent Litigation Certificate will be available for EPAs to qualify for the UPC List.