by Miriam Samis, Israel Patent Attorney and US Patent Agent, JMB Davis Ben-David

A basic requirement for patentability of a claim under US patent law is for an Applicant to describe in the specification how to make and use the claimed invention, without undue experimentation by one of skill in the art. This requirement is often met by including working examples in the specification. However, what if the Applicant is not able to include working examples? More particularly in the biotechnology field, what if the Applicant has no data to support the claimed invention? A recent decision by the Court of Appeals for the Federal Circuit (CAFC) addressed this question. 

This past May, the CAFC issued a decision in Pacific Biosciences v. Oxford Nanopore Technologies affirming a District Court’s decision that invalidated US Patents 9,546,400 and 9,772,323 as not sufficiently enabled. Pacific Biosciences (PacBio) is the Assignee of related US Patent Nos. 9,546,400 and 9,772,323, which describe and claim methods for sequencing a nucleic acid, such as DNA, by nanopore technologies. As described in the patents at issue, the claimed technology is based on the concept that the component nucleotides of any given nucleic acid are negatively charged. Therefore, in response to a voltage change in a fluid, nucleotides can be directed through nanometer sized holes in a substrate. While in transit through this “nanopore”, each nucleotide in a given nucleic acid can be identified by detection of nucleotide-specific changes in electric current. Both patents at issue claim priority to a U.S. provisional patent application filed in 2009, which did not contain any working examples; the only examples in the application were “prophetic.” 

At the District Court, although the patents were found to be infringed by Oxford, they were invalidated for lacking enablement of the full scope of the claimed invention and for insufficient description of necessary embodiments. In invalidating the patents, the District Court rejected PacBio’s assertions that by the patents’ priority date, the claimed technology was within the level of one of skill in the art, and therefore enabled in view of the provided description and prophetic examples. The District Court’s decision was based in part on Oxford’s presentation of expert witnesses who testified that nobody in the field was able to use nanopore technologies to sequence DNA until 2011. In addition, Oxford presented evidence that their announcement of successful nanopore DNA sequencing at a scientific conference in 2012 was met with reactions that indicated major success and advancement in the field. 

On appeal, the CAFC affirmed the District Court’s decision, and agreed that the specification, together with the knowledge of one skilled in the art in 2009, did not enable actual performance of the claimed methods in their full scope, which would have required undue experimentation. The CAFC stated that “[A] patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage”. The CAFC did not find the breadth of the claimed methods for “determining the sequence of the template nucleic acid” sufficiently defined, and found the description lacking regarding the necessary instruction needed for one of skill to perform the invention.  

So, what can an Applicant do if it has to file a patent application, but does not have working examples? Clearly, in the current case, if PacBio had working examples and demonstrated reduction to practice of the claimed invention, this story may have ended differently, and the issue of enablement might not even have been raised. However, the Court seems to understand that data is not always available, which is why the test for enablement does not rely entirely on the presence of working examples. 

When an application does not contain actual data and is limited to prophetic examples, it is likely that the Courts will scrutinize the specification in greater detail in order to verify that the Applicant was in actual possession of the claimed invention at the time of filing, in view of the level of skill in the art. In such cases, although the “enablement bar” regarding the amount of description necessary will likely be higher than the level of description required in a patent with working examples, it may nevertheless be possible to meet the requirement if there is a combination of both sufficient skill in the art at the time of filing and sufficient detail in the specification. 

In view of this decision, if an Applicant knows that data may soon be available, it is most often better to wait for the data before filing a patent application. However, if circumstances determine that a patent application must be filed before such data is available, then – together with the prophetic data – the description of the invention should clearly state and describe the invention, and all necessary embodiments to the fullest extent possible, in order to properly teach one of skill how to make and use the invention.  

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