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CRISPR patent interference updates

The Broad Institute is currently participating in the interference process related to CRISPR patents held by the Broad, MIT, and Harvard College. This process is an effort to determine which inventor or inventors were the “first to invent” the overlapping subject matter of the claimed CRISPR technology by “reducing the concept to practice.”

Below are ongoing updates, along with links to pertinent resources. Documents referenced below are available at the Patent Trial and Appeal board (PTAB) interference file website.

January 6, 2017: On December 22, UCB requested a conference call seeking authorization to file additional evidence in the interference proceeding. PTAB denied UCB’s request. This order is available as document 891 on the PTAB interference website.

November 7, 2016: Oral arguments on the parties’ preliminary motions will take place December 6, 2016 at 10:00 a.m., at USPTO Headquarters in Alexandria, Va. This notification is available as document 888 on the PTAB interference website.

October 11, 2016: Broad and UCB filed motions requesting that PTAB exclude certain evidence from the record. The Broad motion is available as document 878 and the UCB motion as document 880 on the PTAB interference website.

Broad and UCB filed requests for oral arguments in regard to the motions and opposition motions filed earlier this year. The Broad request is available as document 877 and the UCB request as document 881 on the PTAB interference website.

As required by PTAB, both parties provided a list of current exhibits to opposing counsel. The Broad list is available as document 876 and the UCB list as document 879 on the PTAB interference website.

October 5, 2016: Broad served its objections to UCB’s evidence submitted with UCB’s reply briefs on September 28, 2016.

Notice of service is reported in document 871 on the PTAB interference website.

September 28, 2016: UCB filed replies to Broad’s opposition to UCB motions 3 and 4. These replies are available as documents 864 and 865 on the PTAB interference website.

Broad filed replies to UCB’s opposition to Broad motions 2, 3, 5, and contingent motion 6. These replies are available as documents 866, 867, 868, and 869 on the PTAB interference website.

As required by PTAB, both parties provided a list of current exhibits to opposing counsel. The UCB list is available as document 824 and the Broad list as document 870 on the PTAB interference website.

September 15, 2016: PTAB denied UCB’s request to seek additional discovery in response to Broad oppositions 3 and 4.

This order is available as document 801 on the PTAB interference website.  

September 14, 2016: Broad notified PTAB of further backup counsel.

This notice is available as document 800 on the PTAB interference website

September 9, 2016: Broad notified PTAB of its intent to video-record the cross-examinations of Dana Carroll and Carol Grieder, set to occur on September 13 and September 16, respectively.

This notice is available as document 798 on the PTAB interference website.

Also, UCB notified PTAB of further backup counsel.

This notice is available as document 799 on the PTAB interference website

September 8, 2016: UCB filed the explanation document previously authorized by PTAB. This document is in support of UCB’s request to seek additional discovery in response to Broad oppositions 3 and 4.

This notice is available as document 795 on the PTAB interference website.

UCB also notified PTAB of its intent to video-record the depositions of Ronald Breaker and Paul Simons, set to occur on September 13 and September 15, respectively.

These notifications are available as document 796 and 797 on the PTAB interference website

September 7, 2016: UCB requested a conference call seeking authorization to submit additional evidence in response to Broad oppositions 3 and 4. PTAB denied UCB’s request for a conference, instead asking that UCB include its request as part of the explanation document authorized in September 1.

This order is available as document 794 on the PTAB interference website

September 1, 2016: PTAB authorized further explanation by UCB in support of their request to file a request for authorization to seek additional discovery in response to Broad oppositions 3 and 4.

This order is available as document 792 on the PTAB interference website

August 24, 2016: Broad requested authorization to file a motion seeking additional discovery relating to the legal team representing the Regents of the University of California. This request was not granted.

This order is available as document 791 on the PTAB interference website

August 16, 2016: Broad filed opposition to UCB motions 3 and 4. UCB motion 3, filed May 23, requests that PTAB replace Count 1 with a new Count 2 that removes the limitation to eukaryotic cells and instead concerns a method for use of a CRISPR-Cas9 system that has a covalently linked, single molecule DNA-targeting RNA. UCB motion 4, also filed May 23, requests that PTAB recognize three UCB provisional applications, filed May 25, 2012; October 19, 2012; and January 28, 2013 as providing an example within the scope of Count 1.

These oppositions are available as documents 725 and 726 on the PTAB interference website.

UCB filed opposition to Broad motions 2, 3, 5, and contingent motion 6. Broad motion 2, filed May 23, requested PTAB end this Interference because all of the claims of Broad’s patents and application have a eukaryotic limitation and, thus, do not interfere with the claims of UCB which do not have this requirement. Broad motion 3 requested benefit of December 12, 2012 priority application, contending that from this first provisional, Broad successfully demonstrated how to adapt and use an engineered CRISPR-Cas9 system in methods, in eukaryotic cells, such as to edit genomic DNA targets. Broad motion 5 asked PTAB to remove S. aureus Cas9 and other Broad patents from this Interference. Contingent motion 6 asks that in the event the judges grant UCB’s proposal to change the count, the PTAB recognize Broad’s December 2012 priority application in parallel.

These oppositions are available as documents 652, 653, 655, and 689 on the PTAB interference website.

As required by PTAB, Broad provided a list of its current exhibits to opposing counsel.

This list of exhibits is available as document 724 on the PTAB interference website.

As required by PTAB, UCB provided a list of its current exhibits to opposing counsel.

This list of exhibits is available as document 654 on the PTAB interference website.

August 11, 2016: Attorneys for both parties agreed to extend the current deadline to file motions from August 12 to August 15.

This notice is available as document 580 on the PTAB interference website.

Broad filed a request for teleconference about further discovery and an additional extension. This request was not granted; rather the PTAB requested further briefing to be filed by August 16th.

This order is available as document 581 on the PTAB interference website

July 6, 2016: The parties conducted a good-faith discussion over a possible settlement. These discussions are a required element of the interference process. To date these conversations have not resulted in a resolution.

This notice is available as document 576 on the PTAB interference website.

UCB notified PTAB of its intent to depose Paul Simons on July 18, 2016. This deposition will be video-recorded.

This notification is available as document 577 on the PTAB interference website.

Broad notified PTAB of its intent to video-record the cross-examinations of Carol Greider and Dana Carroll, set to take place on July 20 and July 21, respectively.

This notification is available as document 578 on the PTAB interference website.

June 29, 2016: PTAB granted Broad’s motion to add a legal team member.

This order is available as document 575 on the PTAB interference website.  

June 22, 2016: Broad Institute filed a contingent motion in response to UCB’s proposal to change the count (UCB Motion 3). This motion asks that in the event the judges grant UCB’s proposal to change the count, the PTAB recognize Broad’s December 2012 priority application in parallel.

This motion is available as document 570 on the PTAB interference website.

In addition, Broad also moved to add an additional team member to its legal team.

This motion is available as document 571 on the PTAB interference website

June 14, 2016: Judge Katz issued an order addressing requests made by Broad in response to UCB’s proposal to change the count (UCB Motion 3). Specifically, Broad requested authorization to raise additional points should the judges decide to consider UCB’s proposal to change the count. Judge Katz authorized Broad to proceed with this contingent motion and its related positions in opposition to UCB’s Motion 3, which is currently due August 3.

This order is available as document 569 on the PTAB interference website.

June 10, 2016: Attorneys for both parties agreed to extend the due date for motions to June 22.

This notice is available as document 568 on the PTAB interference website.

May 23, 2016: On May 23 attorneys for UCB and the Broad Institute filed authorized motions:

UCB: Motion 3, for new Count (document 56). The PTAB has set up this Interference with a single Count: the use of CRISPR-Cas9 system in a method in a eukaryotic cell (for example, gene editing in a mammalian cell using CRISPR-Cas9 system). UCB requests that the PTAB replace Count 1 with a new Count 2 that removes the limitation to eukaryotic cells and instead concerns a method for use of a CRISPR-Cas9 system that has a covalently linked, single molecule DNA-targeting RNA. NOTE: In this motion, UCB states “All of Junior Party's [Broad’s] claims have a eukaryotic limitation. None of Senior Party's [UCB’s] claims do. If the method in eukaryotic cells is separately patentable, there is no interference-in-fact.” (See Broad Motion 2, below, in which Broad also argues there should be no-interference-in-fact between claims with a eukaryotic limitation and those without.)

UCB: Motion 4 for benefit of each of three UCB provisional applications, filed May 25, 2012; October 19, 2012; and January 28, 2013 (document 57). UCB contends that each of these applications describes at least one example within the scope of Count 1.

Broad: Motion 2, for judgment of no-interference-in-fact (document 77). Broad requests judgment to end this Interference because all of the claims of Broad’s patents and application have a eukaryotic limitation and, thus, do not interfere with the claims of UCB which do not have this requirement. The methods in the UCB patent applications are environment-free (such as cutting DNA in a test tube), whereas the methods in the Broad patents describe CRISPR gene editing methods in eukaryotic cells, whose success was not obvious based on prior studies of CRISPR, such as biochemical characterization in a test tube.

Broad: Motion 3, for benefit of December 12, 2012 priority application (document 66). Broad contends that from this first provisional, Broad successfully demonstrated how to adapt and use an engineered CRISPR-Cas9 system in methods, in eukaryotic cells, such as to edit genomic DNA targets.

Broad: Motion 5, to remove S. aureus Cas9 and other Broad patents from this Interference (document 67). This motion argues that the inventions described are separately patentable and distinct from the generic Cas9 in Count 1 and should not be included in the interference. Broad argues that S. aureus Cas9 has unique properties as compared to other Cas9s, like S. pyogenes Cas9.

These motions are available on the PTAB website. In addition, parties have filed lists of exhibits, including references and declarations. The lists of exhibits are available as documents 54, 55 and 120.

May 17, 2016: Judge Katz issued an order detailing the submission of exhibits.

This order is available as document 51 on the PTAB interference website

May 11, 2016: Judges Schafer, Lane, and Katz together issued an order following the May 6th telephone call with the parties. The key decision in the Order is that UCB was not authorized to file a motion seeking to add a claim to this Interference. In addition, the judges set the page limits for both parties for the authorized motions at 40 pages.

This order is available as document 48 on the PTAB interference website

May 6, 2016: Judge Katz hosted a conference call with attorneys from both parties to discuss requests to extend page length limits for motions that will be filed later this month. These motions were authorized on March 18, 2016 (see PTAB document 33). Judge Katz was joined on the call by her colleague Judge Schafer.

During the call, an attorney for UCB said “the interference was declared in a way that we did not expect.” Specifically, the UCB attorney was referring to the “count,” which is the definition of what the invention in question is. The judges have set the count as the use of CRISPR-Cas9 in a method in an eukaryotic cell (such as, gene editing in a mammalian cell using CRISPR).

The attorney said UCB intends to request a substitute count, which would cover CRISPR systems more broadly. UCB also indicated that in its request for a new count, UCB will seek to add different claims, from a newer patent application that it has filed, but which has not yet been examined by the USPTO, or included as part of the current interference process.

The PTAB authorized the requests for higher page limits and took UCB’s requests for further motions under advisement.

A transcript of this call is available as document 45 on the PTAB interference website

April 27, 2016: Attorneys for both parties agreed to revise the schedule for a second time. This revision extends the current deadline to file motions from May 6 to May 13.

This notice is available as document 44 on the PTAB interference website.

April 15, 2016: PTAB rejected UCB’s request (filed April 1) for the court to reconsider its decision to defer a proposed motion questioning the validity of Broad’s patent claims. UCB wished to argue that, even though the Broad/MIT patent application was begun under “first to invent” rules, the case should be heard under the later “first to file” rules. On March 17, Judge Katz and her colleagues had deferred UCB’s initial motion, stating that the filing dates were not relevant because the purpose of the interference was to determine priority—meaning, which party was “first to invent” a method of using CRISPR-Cas9 in eukaryotic cells (e.g., such as for mammalian genome editing).

This order is available as document 42 on the PTAB interference website.

April 11, 2016: The parties conducted a good-faith discussion over a possible settlement. These discussions are a required element of the interference process. To date these conversations have not resulted in a resolution. 

The notice of this discussion is available as document 41 on the PTAB interference website

April 5, 2016: Emmanuelle Charpentier changed her representation. Judge Katz had granted Charpentier permission to seek new counsel on March 31.

This order is available as document 40 on the PTAB interference website.  

April 1, 2016: On March 17, the PTAB deferred UCB’s request to file a motion to question whether Broad’s patent claims are valid. UCB is now asking the PTAB to reconsider this deferral. Briefly, UCB wishes to argue that, even though the Broad/MIT patent application was begun under “first to invent” rules, the case should be heard under the later “first to file” rules. On March 17, Judge Katz and her colleagues had deferred UCB’s motion, stating that the filing dates were not relevant because the purpose of the interference was to determine priority—meaning, which party was “first to invent” a method of using CRISPR-Cas9 in eukaryotic cells (e.g., such as for mammalian genome editing). See UCB proposed motion 1, document 33.

UCB also requested authorization to file a motion to change the claims in its patent applications.

This miscellaneous motion is available as document 39 on the PTAB interference website.

March 31, 2016: Judge Katz issued an order stating that the court will reconsider the date for the oral argument—initially scheduled for November 17, 2016. In addition, Emmanuelle Charpentier was given permission to seek to change her representation. Charpentier is not represented by the same legal team as the Regents of the University of California and the University of Vienna.

This order is available as document 37 on the PTAB interference website.

Attorneys for both parties also agreed to revise the schedule—extending the next deadline to file motions from April 22 to May 6.

This notice is available as document 38 on the PTAB interference website

March 18, 2016: Patent Trial and Appeal Board denies a UCB motion that alleged Broad's patents were obtained through inequitable conduct. UCB argued that Zhang did not demonstrate he possessed methods to use tracrRNA even though, in patent applications, he indicated he used tracrRNA to achieve mammalian genome editing. The PTAB rejected this inequitable conduct claim as “without sufficient basis” (pages 12-13 of document 33, available on the PTAB website).

The PTAB authorized other motions, which means it has invited the parties to present briefs about the following points. The motions concern:

  1. Filing dates. When an interference is first declared, the parties are temporarily designated as “Senior” or “Junior” parties according to the date of a particular filing date designated by the Patent Office (in this case, March, 2013 for UCB and October, 2013 and December, 2013 for Broad/MIT). The judge has said that both Broad and UCB can request that its priority date be pushed back to the first patent filing that is pertinent to the question before the administrative law judge--in this case, the use of CRISPR in a eukaryotic cell. In this case, Broad/MIT’s first filing demonstrating the use of CRISPR to achieve genome editing in a eukaryotic cell considerably predates the Berkeley filing. (For more, see “what does Senior or Junior party status mean,” below)
  2. The count. In any patent interference the judges set “the count,” which is the definition of what the invention in question is. In this case, the judges have set the count as the use of CRISPR in a method in an eukaryotic cell. UCB asked to argue that this decision should be revisited. The judge invited UCB to prepare a motion arguing this point.
  3. Actual interference. Broad presented an argument that its patents do not interfere with the involved claims of the UCB application. The judge has agreed to hear this argument.
  4. Lack of written description. Broad has argued that UCB’s patent application does not provide written support for their involved claims, such as, for example, demonstrating a Cas9 protein with a domain for traversal of an organelle membrane. The patent judge invited Broad to prepare motions arguing this point.

Motions on these points are due April 22. The PTAB has scheduled an oral hearing for November 17.

March 10, 2016: Judge Katz hosted a conference call with attorneys from both parties. Judge Katz was joined on the call by two colleagues, Judge Lane and Judge Schafer.

A transcript of this call is available as document 30 on the PTAB interference website.

March 3, 2016: Attorneys for both parties filed their required lists of proposed motions. These lists set forth motions each party is requesting to file and streamline initial conference call. 

The list of motions proposed by UCB is available as document 27 on the PTAB interference website.

The list of motions proposed by Broad is available as document 26 on the PTAB interference website.

January 11, 2016: The US Patent and Trademark Office (USPTO) announced an interference proceeding with respect to certain CRISPR patents held by the Broad Institute, MIT, and President and Fellows of Harvard College (collectively “Broad”) and the claims of the Regents of the University of California, University of Vienna and Emmanuelle Charpentier (collectively “UCB”). Administrative Patent Judge Deborah Katz will oversee the proceedings styled as Patent Interference No. 106,048 (DK).

UCB’s annotated claims are available as document 22 on the PTAB interference website.

Broad’s annotated claims are available as document 21 on the PTAB interference website.

The Notice to Declare Interference—including the counts and claims of the parties—is available as document 1 on the PTAB interference website.