In the recent decision PacificBiosciences of California, Inc. v. Oxford Nanopore Techs., Inc., No. 20-2155 issued on May 11, 2021, the Federal Circuit affirmed the district court’s holdings on two important issues, which are particularly of present-day relevance: (1) the influence of the global COVID-19 crisis on the public or jury’s view of the enforcement of intellectual property; and (2) the question of enablement.
New Issues and Disputes Incited by the Global COVID-19 Crisis
The COVID-19 pandemic has indisputably changed the world in almost every industry. Unavoidably, this radical change has not left patent litigation unaffected. Aside from adapting to virtual “appearances” for meetings and court hearings, the fundamental balance between the policy of intellectual property protection to encourage innovation and the temporary block of competitors in the market have resulted in renewed questions and disputes on the consequences of this balance, particularly in the field of biotechnology, including pharmaceuticals, vaccines, and new drugs. Patent protection offers incentives for the development of new drugs. However, when facing the crisis of an emerging and ongoing COVID-19 pandemic, the general public naturally reassesses whether such a monopoly, albeit temporary, causes too much exclusion of other companies in the market to solve the crisis.
In this case, PacBio objected to Oxford’s opening statement for extensively discussing the new coronavirus, while also mentioning that PacBio was attempting to exclude Oxford from the nanopore sequencing market, which was then painted in the media that the trial was about PacBio attempting to take the coronavirus technology off the market. PacBio indicated that the opening statement violated the district court’s grant of PacBio’s motion in limine (MIL) to prohibit statements before the jury, about the potential impact of a verdict in favor of PacBio, such as higher prices or slower medical research. PacBio argued that a new trial was necessary based on Oxford’s statements regarding COVID-19 and the possible consequences of an infringement verdict for COVID-19, indicating that the statements caused prejudice that would have influenced the jury’s verdict.
Nevertheless, the Federal Circuit found no abuse of discretion in the district court’s determination that the opening remarks were not sufficiently likely to have prejudicially influenced the jury’s verdict. In its analysis, the court held that PacBio did not object to Oxford’s notice that COVID-19 would be mentioned in its opening in advance, the court gave curative instructions that PacBio requested as related to the MIL Order, and PacBio failed to request a new trial based on the remarks until after the verdict. Further, the Federal Circuit found that the jury performed a careful and substantive analysis regarding the invalidity challenge, which was apparent in its conclusion reflecting the distinction between the written-description challenge and the enablement challenge, in which the jury rejected Oxford’s written-description challenge, but accepted the enablement challenge.
This case provides an example of the recent tension between biotechnology and pharmaceutical companies, particularly during patent litigation, during this time of the COVID-19 pandemic.
Another Invalidated Patent on Lack of Enablement
Aside from the very contemporary discussion related to the coronavirus and the possible relevant effects the Federal Circuit decision would have on the market, this case also provides another example of yet another patent invalidated for lack of enablement. The jury of the district court had found all asserted claims of U.S. Patent Nos. 9,546,400 and 9,772,323 infringed, but also invalid under 35 U.S.C. § 112 for lack of enablement. Claim 1 of the ’400 patent reads as follows:
1. A method for sequencing a nucleic acid template comprising:
a) providing a substrate comprising a nanopore in contact with a solution, the solution comprising a template nucleic acid above the nanopore;
b) providing a voltage across the nanopore;
c) measuring a property which has a value that varies for N monomeric units of the template nucleic acid in the pore, wherein the measuring is performed as a function of time, while the template nucleic acid is translocating through the nanopore, wherein N is three or greater; and
d) determining the sequence of the template nucleic acid using the measured property from step (c) by performing a process including comparing the measured property from step (c) to calibration information produced by measuring such property for 4 to the N sequence combinations.
The patent describes a method for sequencing a nucleic acid (e.g., DNA) using nanopore technology. The particular limitations at issue were regarding the step of “measuring a property which has a value that varies for N monomeric units” and the step of “determining the sequence of the template nucleic acid.” Particularly, the patents did not distinguish between the particular type or character of the template nucleic acid to be sequenced. The Federal Circuit affirmed the judgment of the district court for lack of enablement for the following reasons.
1. Expert testimonies
The expert, Dr. Goldman, testified that the asserted claims of the two patents lack enablement because of the required element of determining N. Further, Dr. Akeson testified that his research, leading to the Akeson grant, was limited to DNA-hairpins, whereas the asserted claims reciting “nucleic acid template”, as broadly interpreted, includes the synthetic nucleic acids Akeson addressed and biological DNA.
2. Knowledge of POSITA at time of filing
The court concluded that there was sufficient evidence to support that before the 2009 priority date of the two patents, a person of ordinary skill in the art did not know how to perform nanopore sequencing for more than a narrow range of the full scope of nucleic acids covered by the claims. Oxford had provided witness testimony that the first successful nanopore sequencing of biological DNA molecules did not occur until 2011. The court also noted that when Oxford announced its success in 2012 at a large meeting of scientific professionals, an audience of 700 reacted in a manner that demonstrated that the achievement was major and innovative.
3. No Reduction to Practice
Perhaps one of the most noteworthy facts that led to the verdict of non-enablement was that PacBio had no evidence of actual reduction to practice of its own, whereas Oxford provided evidence and testimonies of non-enablement. PacBio had acknowledged that there was no real-world reduction to practice, and one of the inventors, Dr. Stephen Turner, stated that PacBio never performed nanopore sequencing in 2009.
4. Undue Experimentation
In its ultimate determination, the court found that the record supports the conclusion that in view of the knowledge of a person of ordinary skill in the art at the time of filing the ’400 and ’323 patents, and the disclosures of the ’400 and ’323 patents, it would have taken undue experimentation to enable the full scope of the claims.
Here, we are reminded once again of the factual considerations, known as the “Wands factors” to help determine whether a disclosure meets the enablement standard:
- The quantity of experimentation necessary,
- The amount of direction or guidance presented,
- The presence or absence of working examples,
- The nature of the invention,
- The state of the prior art,
- The relative skill of those in the art,
- The predictability or unpredictability of the art, and
- The breadth of the claims.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988).
As demonstrated by the recent trend in patents invalidated for lack of enablement, it has become more difficult to meet the enablement burden. Thus, there is an increase in importance that applicants and patentees with groundbreaking inventions put extra deliberation and focus on ensuring that the specification provides proper enablement for the claimed invention – particularly in the fields of biotechnology and pharmaceuticals.