A Gene-Editing Patent Dispute – What Does It Mean?

Written By: Charles Cheng

Is this just another ordinary patent dispute? Time will tell. A high profile patent dispute between the University of California, Berkeley and the Broad Institute of MIT and Harvard has just concluded a year-long proceeding called interference proceeding at US Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB).[1] On February 15, 2017, PTAB announced its decision after both parties presented their oral arguments before a three-judge panel in December 2016.[2] The proceeding was to determine which party has actually “invented” a gene-editing technology called CRISPR-cas9.[3]

Despite the dispute between the well-regarded scientists of high-prestige universities, this technology is considered the biggest biotechnology breakthrough in recent memory. CRISPR is like “molecular scissors” that allow scientists to replace unwanted parts of genome with new sections of DNA, and thus has opened up potentially limitless applications in numerous areas, including medicine and agriculture.[4] The 2006 Nobel Prize laureate, Craig Mello, said that this powerful genetic tool allow you to “essentially change a genome at will to almost anything you want,” and “the sky’s the limit.”[5]

The “senior party” of the proceeding is Jennifer Doudna, a UC Berkeley Professor of Chemistry,[6] who observed how a microbe defends an invading virus by using Cas enzymes to modify its DNA sequences, and became the first to demonstrate CRISPR’s potential use in lab.[7] Doudna filed a patent application on this technology first with priority date in May 2012.[8] The “junior party” is Feng Zhang from the Broad Institute, who roughly in parallel, was working on using CRISPR to edit human genes and filed a number of patent applications claiming priority date in December 2012.[9] The Broad Institute requested an Accelerated Examination at USPTO,[10] which allows an application to move ahead in line and be examined before other pending applications in the same field by filing a petition.[11] As a result, the Broad Institute has been awarded twelve patents on the CRISPR technology. However, since the PTAB believes a possible conflict exists between the inventions of both parties, the interference proceeding may call into question the patents issued to the Broad Institute.[12]

PTAB initiated the interference proceeding in January 2016 to resolve a dispute when both parties claimed the same invention,[13] because they filed their patent applications under the old “first-to-invent” patent system.[14] In fact, the U.S. switched to the “first-to-file” patent system under America Invents Act in March 2013, which makes the proceeding unnecessary because the party who files first should prevail when both claim the same patentable invention.[15] Based on the arguments made by UC Berkeley and the Broad Institute, the central issue of this interference is likely a question about obviousness.[16] A patentable invention must be both novel and non-obvious. Novelty means the invention involves one or more differences over a prior art.[17] Non-obviousness means subject matter of the invention must be sufficiently different from one or more prior art judged by a person having ordinary skill in the area of technology related to the invention.[18] To determine obviousness, the question is whether an invention can be made by modifying or combining known prior art references to produce predictable results.[19] Therefore, if PTAB finds the Broad’s invention is obvious in light of UC Berkeley’s invention, it will have to determine who is the first to invent.

The dispute however has significant impact beyond research in the labs. Several companies have invested over a billion dollars behind the technology of these patents.[20] If the result is a dominant patent, it could mean a win or loss to many companies and the universities for licensing revenue, which clearly a concern for investors.[21] Also, the ultimately recognized inventor of CRISPR may earn a Nobel Prize for this transformative technology.[22]

From its decision on February 15, 2017, PTAB has determined that there is no interference, which means the inventions from both parties are distinct, and each party is entitled to a patent of its own. But this would be a win for the Broad Institute since its invention is more commercially attractive for editing genes of higher organisms, such as human, as compared to UC’s invention of using single-molecule guide RNA.[23] However, the scope of invention will largely depend on the ultimately issued patent claims of both parties.[24] The PTAB decision may not be an end to the patent dispute. According to Summerfield, the losing party may appeal to the U.S. Court of Appeals for the Federal Circuit, and the fight could go on for years.[25] Alternatively, since no single patent can occupy the whole CRISPR field, both parties and associated companies may cross-license each other’s patents. [26] Nevertheless, one thing is for sure–the innovation will not slow down, but accelerate and thrive on the existing foundation, because unlike trade secret, the goal of U.S. patent system is “to promote the progress of science and useful arts” by encouraging disclosing inventions through giving “limited times to inventors the exclusive rights to their writings and discoveries” as incentive.[27]

 

[1] https://e-foia.uspto.gov/Foia/RetrievePdf?system=BPAI&flNm=fd106048-02-15-2017-1

[2] https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-patent-interference-updates

[3] http://blog.patentology.com.au/2016/12/crispr-patent-interference-hearing-how.html

[4] https://www.wallstreetdaily.com/2017/01/16/gene-editing-crispr-patent-dispute-cant-slow-innovation/

[5] http://www.npr.org/sections/health-shots/2014/06/26/325213397/a-crispr-way-to-fix-faulty-genes

[6] https://www.law360.com/articles/745661/tough-ptab-fight-ahead-for-breakthrough-gene-editing-tech

[7] https://www.quantamagazine.org/20150206-crispr-dna-editor-bacteria/

[8] – [9] Davis, supra note 6.

[10] https://law.stanford.edu/2015/12/29/the-crispr-patent-interference-showdown-is-on-how-did-we-get-here-and-what-comes-next/

[11] https://en.wikipedia.org/wiki/Petition_to_make_special

[12] Davis, supra note 6.

[13] Broad Institute, supra note 2.

[14] Sherkow, supra note 10.

[15] Davis, supra note 6.

[16] Summerfield, supra note 3.

[17] – [18] https://www.uspto.gov/patents-getting-started/general-information-concerning-patents

[19] http://www.ipwatchdog.com/2014/02/01/when-is-an-invention-obvious/id=47709/

[20] – [22] http://www.npr.org/sections/health-shots/2016/12/05/504454201/scientists-battle-in-court-over-lucrative-patents-for-gene-editing-tool

[23] Summerfield, supra note 3.

[24] http://www.ipscell.com/2016/01/patent-expert-weighs-in-on-crispr-dispute-between-uc-broad/

[25] – [26] http://blog.patentology.com.au/2017/02/uspto-board-terminates-crispr-patent.html

[27] USPTO, supra 17.

 

Charles Cheng

Charles Cheng is a part-time 2L at USF School of Law. He received his undergraduate degree in Taiwan, and a Master of Science degree in Engineering from University of Southern California. Charles is a patent agent registered to practice before U.S. Patent and Trademark Office who currently works at patent legal department of Oracle Corporation.

michael