The US Court of Appeals for the Federal Circuit (CAFC) ruled on 12 June 2015 that Sequenom Inc’s patent directed to a method for detecting a paternally inherited nucleic acid sequence of fetal origin (cell-free fetal DNA (cffDNA)) in maternal serum or plasma from a pregnant woman is invalid and ineligible for patent protection because it applies to a natural phenomenon.
The dispute began several years ago when Sequenom claimed that Ariosa diagnostics’ harmony Test, a non-invasive test for prenatal diagnosis of certain fetal characteristics, infringed US patent number 6,258,540, which was issued in 2001.
Following Sequenom’s action against it, Ariosa sought a declaratory judgment from the US district court for the northern district of california that it did not infringe the patent. Sequenom counterclaimed, alleging infringement and seeking to preliminarily enjoin Ariosa from selling the harmony Test. In 2012 the district court rejected Sequenom’s request for a preliminary injunction, indicating that Ariosa’s harmony Test did not infringe Sequenom’s patent and, further, that the patent was invalid. The court found that the asserted claims of the patent were not directed to patent-eligible subject matter and were invalid under 35 USc §101.
The CAFc’s Sequenom ruling supports the district court ruling with all three judges deciding in Ariosa’s favour. In a concurring opinion by Judge Linn, he acknowledged that the inventors’ discovery regarding cffdnA may have been a significant contribution to the medical field, but that alone does not make it patentable. he distinguished Sequenom’s claimed invention from the claims in the Mayo case, however it was clear that he felt his hands were tied by the Supreme court’s ruling in that case. Based on Mayo, Judge Linn and the court agreed that detecting cffdnA in maternal plasma or serum is a positive and valuable contribution to science, although it still falls short of statutory patentable subject matter.
Reflecting on the Sequenom, Mayo and prior Myriad decisions (the latter two which we discussed in our previous article a question arises as to what constitutes a new and patent-eligible invention today in the diagnostics and personalised medicine fields in the United States and are the patent owners in Sequenom, Mayo and Myriad victims of early disclosure for inventions that have been acknowledged as being important to science and medicine? Patent law is designed to encourage inventors to disclose their new technology to the world as soon as possible by offering the incentive of a limited time to prevent others from making, using or selling their technology.
The lesson from these cases is that while the discovery or observation of a natural phenomenon may be very important, and in certain instances reflects a critical medical breakthrough, discovery or observation alone does not rise to the level of patent-eligible subject matter. In order to take the discovery or observation to the next level to be considered patent eligible the inventors must apply it in a way that adds substantially more, including identification and application of novel mutations or polymorphisms, for example.
It is becoming abundantly clear that the courts and the US Patent and Trademark Office are consistently relaying a message that if method claims do no more than recite routine or conventional methods and steps, and the claims do not provide significantly more, then they will be found to be invalid or patent ineligible, regardless of the significance of the invention to science and medicine.
On 13 August 2015, Sequenom requested an en banc review of the cAFc’s decision to invalidate its patent in its dispute with Ariosa arguing that decision creates an “existential threat” to patent protection. Sequenom’s petition for en banc review is based on the premise “that the panel’s decision allegedly misinterprets Mayo both by failing to read that decision in light of the key Supreme court precedent that Mayo endorses and by reaching a result the Supreme court has twice disavowed in recent opinions.” It is unclear whether the Federal circuit will hear the case with several Supreme court cases hanging over it in the diagnostics field.
Unfortunately, the diagnostics and personalised medicine industry is many years into the patent process relying on specifications filed with early priority dates but with the rules of the game changing mid-stream. If the Sequenom patent had disclosure in it at the time of filing based on certain novel mutations that correlated with the diagnosis of foetal characteristics, claims including these mutations in the method of amplifying and detecting cffdnA may be considered patent-eligible and valid.
In pursuing claims today, rather than trying to pre-empt the broad scope of a natural phenomenon or observation, it is more realistic for companies to initially focus on claiming their commercial embodiments first and work outward from there. clearly this is counterintuitive to the approach taken to obtain patents in the past, where one would start as broad as possible and work inward.