Tale of Two Universities

In Broad Institute, Inc. et al. v. Regents for the University of California et al., ____ F.3d ___ (Fed. Cir. September 10, 2018) [hereinafter ‘Broad’ and ‘UC’] the United States Court of Appeals for the Federal Circuit [hereinafter ‘the Federal Circuit’] held that Broad’s bioengineered molecule differed sufficiently from UC’s bioengineered molecule [hereinafter CRISPR-Cas9] to qualify as a separate invention. If this CRISPR-Cas9 could successfully function within animal cells, then the first and sole invention owner would possess enormous commercial potential for medical applications.

UC originally requested the Patent Trial and Appeal Board [hereinafter ‘the Board’] to resolve which entity was first to invent CRISPR-Cas9 that functions within animal cells.   Broad owns patents and patent applications for a method in which CRISPR-Cas9 successfully severs genetic molecules in animal cells. UC also requested patent protection for CRISPR-Cas9 that functions within animal cells. However, UC’s patent application and earlier research publication exclusively disclosed operable isolated CRISPR-Cas9 in environments without any kind of cells.

Before the Board UC maintained that Broad’s animal cell CRISPR-Cas9 was too similar to UC’s CRISPR-Cas9 to qualify as a different invention.  However, Broad observed that soon after publication of UC’s first research paper about CRISPR-Cas9, UC’s own scientists stated that achievement of functional CRISPR-Cas9 in animal cells was uncertain for several technical reasons. Based in large part upon these statements, the Board concluded that UC’s and Broad’s CRISPR-Cas9 sufficiently differed from each other to each be eligible for patents to separate inventions. The Board also relied upon evidence that additional research was required to achieve success in animal cells, and that Broad’s CRISPR-Cas9 implemented this innovation.

Before the Federal Circuit, UC contended in relevant part that the Board had improperly relied upon statements of UC’s inventors and professional witness which were made shortly after its original research publication. However, the Federal Circuit affirmed the Board’s decision because it was supported by credible, reliable and relevant substantial evidence.   In reaching its conclusion the court stated that the Board properly relied upon statements by UC’s inventors and expert which were not prepared for litigation.  The court also looked at UC’s and Broad’s evidence regarding predictable development of other gene editing systems.   On this basis, the court concluded that successful transfer of isolated gene editing systems, such CRISPR-Cas9, to animal cells from other environments remained extremely limited. The court also concluded that such transfers invariably require nonroutine and non-predictable research and development.

After addressing UC’s remaining contentions, the court agreed that there were two distinct inventions, and that there was no reasonable expectation of success for predictably developing Broad’s operable CRISPR-Cas9 in animal cells.  The court further observed that the degree of predictability, and therefore a reasonable expectation of success, is determined on a technology by technology basis.  In this instance, the prior technology offered as evidence by both UC and Broad established that gene editing results, of which CRISPR-Cas9 is one example, were highly unpredictable.

In sum, the judicial result is that UC’s application does not describe the same invention (CRISPR-Cas9) as Broad, there is no sole initial inventor, and so each entity may continue patent prosecution. Whether UC’s application will withstand challenges to patentability during prosecution remains to be seen.

©2018 Adrienne B. Naumann, Esq. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann.wordpress.com.

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