Federal Circuit Affirms Board: No Interference-in-Fact for CRISPR-Cas9 Technology

Federal CircuitThe Federal Circuit recently weighed in on an interference proceeding between the University of California (“UC”) and the Broad Institute over the use of CRISPR-Cas9 technology. The Court affirmed a Patent Trial and Appeal Board (“Board”) decision finding there was no interference-in-fact between UC’s patent application and the claims of twelve patents and one application owned by Institute. See Regents of the Univ. of Cal. v. Broad Inst., Inc., No. 2017-1907, 2018 U.S. App. LEXIS 25535 (Fed. Cir. Sept. 10, 2018) (Before Prost, Schall, and Moore, J.) (Opinion for the court, Moore, J.).

The claims at issue relate to use of the CRISPR-Cas9 system for targeted cutting of DNA molecules. CRISPR-Cas systems naturally occur in prokaryotic cells, but they have never been known to do so in eukaryotic cells. In August 2012, UC published an article discussing the use of CRISPR “in vitro in a non-cellular experimental environment.” The Broad Institute later published an article in February 2013 describing the use of CRISPR-Cas9 in a eukaryotic human cell line. Notably, UC’s article did not discuss using CRISPR-Cas9 in a eukaryotic cell. In contrast, the claims in Broad Institute’s patents and application were limited to use in eukaryotic cells.

The Board issued an interference, which Broad Institute moved to terminate. Broad Institute argued that its claims were patentably distinct from UC’s claims because a person of ordinary skill in the art (“POSA”) would not have reasonably expected the CRISPR-Cas9 system to work in a eukaryotic cell. The test to determine whether an interference has occurred considers “whether ‘the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa.’” A claim is rendered obvious if a POSA would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success.

The Board found that a POSA would not have had a reasonable expectation of success for applying the CRISPR-Cas9 system in a eukaryotic cell. Broad Institute’s expert testified that the differences between prokaryotic and eukaryotic cells made the CRISPR-Cas9 system unpredictable in eukaryotic cells, and that these differences would have caused a POSA not to have a reasonable expectation of success when applying CRISPR-Cas9 in eukaryotes. Further, UC’s expert witness recognized many of the same issues in applying the CRISPR-Cas9 system in eukaryotic cells, concluding that whether the system will work in eukaryotes “remains to be seen.”

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The Board also considered statements by UC inventors; one UC researcher noted that there were “many frustrations” in getting CRISPR-Cas9 to work in human cells, and that she thought success in doing so would be “a profound discovery.” Evidence in the record also showed the UC researcher’s colleagues recognized that Institute’s development was significant. The Board viewed this evidence as indicating that a POSA would have lacked a reasonable expectation of success. Finally, the Board considered evidence regarding the development of other gene editing systems that originated in prokaryotes and were later applied to eukaryotes. However, expert testimony led the Board to find that the success in applying similar prokaryotic systems in eukaryotes was unpredictable and relied on tailoring particular conditions to the technology.  In light of the evidence, the Board found that UC’s claims did not render Institute’s claims obvious.

UC timely appealed, but the Federal Circuit found there was substantial evidence to support the Board’s finding and affirmed. The Court noted that:

UC expended substantial time and effort to convince this court that substantial evidence supports . . . that a [POSA] would have had a reasonable expectation of success in implementing the CRISPR-Cas9 system in eukaryotes. . . . We are, however, an appellate body. We do not reweigh the evidence. It is not our role to ask whether substantial evidence supports fact findings not made by the Board, but instead whether such evidence supports the findings that were in fact made. Here, we conclude that it does.

The Federal Circuit also found no merit in UC’s arguments that the Board: (1) improperly adopted a test for obviousness that required the prior art contain specific instructions, and (2) erred in dismissing evidence of simultaneous invention as irrelevant.

With respect to specific instructions, the Board “look[ed] to whether or not there were instructions in the prior art that would be specifically relevant to CRISPR-Cas9,” as well as “whether there are examples in the prior art of the success or failure of similar systems.” The Court found that the Board never suggested there would not have been a reasonable expectation of success “solely because there were not specific instructions in the art describing how to apply CRISPR-Cas9 in eukaryotes,” and found no error in the Board’s consideration of the lack of specific instructions.

UC also argued simultaneous invention could be compelling evidence of obviousness, because it showed the claimed invention “was the product only of ordinary mechanical skill or engineering skill,” rather than genuine invention. UC noted that six research groups independently applied CRISPR-Cas9 in eukaryotic cells within months of its disclosures and argued that the Board treated this evidence as irrelevant. However, the Court found that the Board “expressly recognized the relevance of simultaneous invention to the question of obviousness” and rejected UC’s argument.

Considering the evidence of simultaneous invention, along with evidence regarding the state of the art, inventor statements, and application of similar technologies, the Court concluded the Board’s finding was supported by substantial evidence.

Take Away

Evidence showing frustration or doubt about the practicability or possible execution of an invention can support a finding of no reasonable expectation of success in an interference proceeding centered on obviousness.

The Author

Robert Schaffer

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Dustin Weeks is an associate in the intellectual property practice group at Troutman Sanders. His practice spans all areas of intellectual property law, including patent prosecution, patent litigation (including Hatch-Waxman litigation), and client counseling. He represents clients ranging from start-ups and solo inventors to Fortune 500 companies. Dustin works closely with his clients to learn their business objectives so that he can tailor strategies to procure, protect, and enforce their intellectual property. Dustin specializes in post-grant proceedings (e.g. Inter Partes Reviews) before the Patent Trial and Appeal Board (PTAB) where he has extensive experience representing both patent owners and petitioners across a wide range of technologies, including wireless networking, pharmaceuticals, MEMs devices, medical devices, and electro-mechanical consumer devices. Dustin's broad experience in patent prosecution, counseling, and patent litigation uniquely positions him to navigate the blended practice of post-grant proceedings.

For more information or to contact Dustin, please visit his Firm Profile Page.

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