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At California Central District Court Juno Therapeutics, Inc. et al v. Kite Pharma, Inc. – Multi-party Patent Infringement

Curator and Reporter: Aviva Lev-Ari, PhD, RN

 

Infringement of Patent: US7446190B2 – which is exclusively licensed to Juno Therapeutics, Inc.

United States

Inventor
Michel Sadelain
Renier Brentjens
John Maher
Current Assignee
Sloan-Kettering Institute for Cancer Research

Worldwide applications
2003  US

Application US10/448,256 events
2002-05-28
Priority to US38387202P
2008-11-04
Application granted
Application status is Active
Adjusted expiration
Show all events

 

SUMMARY OF INVENTION

The present invention provides chimeric TCR’s, nucleic acid polymer encoding the chimeric TCR’s and methods of using the chimeric TCR’s to facilitate T cell response to a specific target. The chimeric TCR’s of the invention combine, in a single chimeric species, the intracellular domain of CD3 ζ-chain (“zeta chain portion”), a signaling region from a costimulatory protein such as CD28 and a binding element that specifically interacts with a selected target. Thus, in accordance with a first aspect of the invention, there is provided a nucleic acid encoding a chimeric T cell receptor, said chimeric T cell receptor comprising a zeta chain, a CD28 signaling region and a binding element that specifically interacts with a selected target. In accordance with a second aspect of the invention, there is provided a chimeric T cell receptor comprising a zeta chain portion, a CD28 signaling region and a binding element.

In accordance with the method of the invention a chimeric TCR is provided which comprises a zeta chain portion, a co-stimulatory signaling element and a binding element which specifically interacts with a cellular marker associated with target cells. T-lymphocytes from the individual to be treated, for example a human individual, are transduced with the chimeric TCR. This transduction may occur ex vivo, after which the transduced cells are reintroduced into the individual. As a result, T cell immune response is stimulated in the individual to the target cells.

SOURCE

https://patents.google.com/patent/US7446190B2/en

  • Prior Art Search results: (cells) (nucleic acid) (acid polymer) (cell) (cd28) before:priority:2002-05-28

Assignees Inventors include:

C12P21
C12P21/00
C12P
C12P21/02
C07K14/52
C07K14/715
C07K14/54
C07K14/521
C07K14/47
C07K14/46
C12N9/6432
C12Y304/21006
C07K14/47
C07K14/46
C07K14/475
C07K14/435
A01K2217
A01K2217/00
A01K
A01K2217/075
C12N2533/00
C12N2533/14
C12N2533/18
C12N2533/30
G01N33/502
G01N33/5041
Y10S435/973
G01N33/5008
B01J2219/00648
B01J2219/00306
B82Y15/00
B01J2219/00646
C07K14/70532
C07K14/70503
C07K16/2827
A61K2039/5158
A61K38/1774
A61K31/33
A61K45
A61K45/06
C07K14/70532
C12N2795
C12N2795/00
C12N2795/00011
C07K14/47
C07K14/46
A61K48/00
C07K14/435
C12N2510/00
C12N2502/99
C12N2501/515
C12N2501/51
C07K14/70503
A61K38/00
A61K
C07K14/705
G01N33/6878
G01N33/68
C07K1/047
C07K1/04
C07K14/70503
A01K2217/05
C07K14/705
A01K2217
Y02A50/38
A61K2039/6068
A61K2039/6025
C07K2319/21
C07K14/47
C07K14/46
A61K48/00
C07K14/435
C07K14/4747
C07K14/70575
A61K45/06
A61K45

SOURCE

https://patents.google.com/?q=cells&q=nucleic+acid&q=acid+polymer&q=cell&q=cd28&before=priority:20020528&scholar

 

IRELL & MANELLA LLP Morgan Chu (SBN 70446) Alan J. Heinrich (SBN 212782) Elizabeth C. Tuan (SBN 295020) 1800 Avenue of the Stars, Suite 900 Los Angeles, California 90067-4276 Telephone: (310) 277-1010 Facsimile: (310) 203-7199 Attorneys for

Plaintiffs JUNO THERAPEUTICS, INC., MEMORIAL SLOAN KETTERING CANCER CENTER, and SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, and Sloan Kettering Institute for Cancer Research,,

Plaintiffs, v. Kite Pharma, Inc., Defendant. ) ) ) ) ) ) ) ) ) ) ) )

CASE NO.: 2:17-CV-07639

COMPLAINT FOR PATENT INFRINGEMENT

DEMAND FOR JURY TRIAL

Case 2:17-cv-07639 Document 1 Filed 10/18/17 Page 1 of 14 Page ID #:1

Knowing that it infringes the ’190 Patent, Kite challenged the validity of all claims of the ’190 Patent in an inter partes review (“IPR”) in the United States Patent and Trademark Office (“PTO” or “Office”) before the Patent Trial and Appeal Board (“PTAB” or “Board”). The PTAB instituted the IPR and then upheld all claims of the ’190 Patent in a Final Written Decision issued December 16, 2016. The PTAB concluded that Kite did not even show “by a preponderance of the evidence”—the lower standard applicable to validity challenges in an IPR—that any claim of the ’190 Patent was unpatentable.

Kite recently received marketing approval from the Food and Drug Administration (“FDA”) for its Yescarta™ product (axicabtagene ciloleucel) (“axicel” or “Yescarta,” also known as “KTE-C19”) on October 18, 2017. Plaintiffs accordingly bring suit against Kite for infringement based on Kite’s making, using, offering to sell, and selling of its chimeric antigen receptor products that comprise the claimed nucleic acid polymers of the ’190 Patent. 35 U.S.C. § 271(a). Plaintiffs hereby allege for their Complaint against Defendant Kite, on personal knowledge as to their own actions and on information and belief as to the actions of others,

26. Indeed, the DNA sequence of Kite’s retroviral vector demonstrates that Kite’s anti-CD19 chimeric TCR falls within the scope of the ’190 Patent claims. In a document Kite filed with the Recombinant DNA Advisory Committee (“RAC”), a federal committee that reviews clinical trial protocols that are either directly funded by the National Institutes of Health (“NIH”) or conducted at institutions that receive NIH funding, Kite provided the DNA sequence of KTE-C19’s anti-CD19 chimeric TCR vector. Exhibit 10 (KTE-C19 DNA Sequence). The RAC filing described the retroviral vector used as

encoding a chimeric antigen receptor directed against the B cell antigen, CD19 . . . The retroviral vector utilizes the MSGV1 (murine stem cell virus-based splice-gag vector 1) retroviral vector backbone and consists of 7026 bps including the 5’ long terminal repeat (LTR) from the murine stem cell virus (promoter), packaging signal including the splicing donor (SD) and splicing acceptor sites, FMC63- based (anti-CD19 FMC63-28) CAR protein containing a signal peptide (human GM-CSF receptor), FMC63 light chain variable region (FMC63 VL), linker peptide, FMC63 heavy chain variable region (FMC63 VH), CD28 (hinge, transmembrane and cytoplasmic region), and TCR-zeta (cytoplasmic region), followed by the murine stem cell virus 3’LTR. This particular vector was provided by Dr. Steven A. Rosenberg from the Surgery Branch/NCI and is the same vector used in an ongoing RAC-approved clinical trial of which Dr. Stephen A. Rosenberg is the Principal Investigator (OBA/RAC submission 0809-940). . . . [T]he complete nucleotide sequence as determined by the standard nucleotide sequencing protocol is shown in Appendix 2 of this application.

27. During the IPR Kite initiated against the ’190 Patent, Sloan Kettering’s expert, Prof. Thomas Brocker, the Director of the Institute for Immunology at the Ludwig-Maximilians University in Munich, Germany, compared the chimeric TCR used by Kite’s scientific collaborators to the claims of the ’190 Patent, demonstrating that Kite’s collaborators’ chimeric TCR construct, and thus, Kite’s own KTE-C19 product, falls within the scope of at least claims 1-3 and 5 of the ’190 Patent. Exhibit 12 (Brocker Declaration), ¶ 224. The NCI chimeric TCR analyzed by Prof. Brocker contains the same nucleotide sequence as KTE-C19’s chimeric TCR. See Exhibit 11 (RAC Filing).

28. On October 18, 2017, Kite received approval for the FDA to market and sell Yescarta (axicabtagene ciloleucel) in the United States.

COUNT 1:

INFRINGEMENT OF THE ’190 PATENT UNDER 35 U.S.C. § 271(a)

29. Plaintiffs re-allege and incorporate by reference the allegations contained in paragraphs 1-28 above.

30. to 40. are Plaintiffs’ description of Defendant Infringement on claims of the Patent

MAIN SOURCE for Filings by Plaintiffs

http://litigationtools.maxval-ip.com/UnifiedPatentViewDocument/home/index?caseid=128416

 

 

Plaintiffs:

  • Juno Therapeutics, Inc.,
  • Memorial Sloan Kettering Cancer Center,
  • Sloan Kettering Institute for Cancer Research

Defendant and Counterclaimant

  • Kite Pharma, Inc.

 

Effective April 17, 2018, Magistrate Judge Rozella A. Oliver will be located at the Edward R. Roybal Federal Building and U.S. Courthouse, COURTROOM 590 on the 5th floor, located at 255 East Temple Street, Los Angeles, California 90012. All Court appearances shall be made in Courtroom 590 of the Roybal Federal Building,

100

Oct 9, 2018

MINUTE IN CHAMBERS CLAIM CONSTRUCTION ORDER by Judge S. James Otero: The Court finds that a POSITA encountering the 190 Patent prior to the CoC would have understood SEQ ID NO:6 to begin with nucleotide 336 of the CD28 protein. The Court construes the disputed claim terms as follows: 1. The amino acid sequence encoded by SEQ ID NO:6 before the Certificate of Correction means Amino Acids 113-220 of CD28 (starting with lysine (K)) and after the Certificate of Correction means Amino Acids 114-220 of CD28 (starting with isoleucine (I)). 2. nucleic acid polymer encoding… a binding element that specifically interacts with a selected target is given its plain and ordinary meaning. (shb) (Entered: 10/10/2018)

 

Main Doc

 

Juno Therapeutics, Inc. et al v. Kite Pharma, Inc. (2:17-cv-07639), California Central District Court

California Central District Court
Judge: S James Otero
Referred: Jacqueline Chooljian
Case #: 2:17-cv-07639
Nature of Suit 830 Property Rights – Patent
Cause 35:271 Patent Infringement
Case Filed: Oct 18, 2017
Docket last updated: 03/08/2019 11:59 PM PST 

Thursday, March 07, 2019
150 order For Order Thu 12:50 PM 
ORDER GRANTING DEFENDANT KITE PHARMA, INC.S EX PARTE APPLICATION FOR AN EXTENSION OF TIME FOR THE MAGISTRATE JUDGE TO HEAR MOTIONS TO COMPEL PRODUCTION OF DOCUMENTS AND WITNESSES144 by Judge S. James Otero: 1. Time is extended until April 17, 2019, for the Magistrate Judge to hear (a) any motions to compel Plaintiffs to produce documents that Kite has already identified as deficient in Plaintiffs production and Plaintiffs have not yet produced, and (b) a motion to compel Bristol-Myers Squibb Company to produce documents in response to Kites subpoena; and 2. Time is extended until May 10, 2019, for the Magistrate Judge to hear a motion to compel deposition testimony regarding the documents described in paragraph 1 above. (lc) Modified on 3/7/2019 (lc)
Wednesday, March 06, 2019
149 transcript -Transcript Order Form (G-120) Wed 2:56 PM 
TRANSCRIPT ORDER as to Defendant Kite Pharma, Inc. for Court Smart (CS). Court will contact Adam R. Lawton at adam.lawton@mto.com with further instructions regarding this order. Transcript preparation will not begin until payment has been satisfied with the transcription company. (Lawton, Adam)
Tuesday, March 05, 2019
147 respm Reply (Motion related) Tue 5:31 PM 
REPLY in support of EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144 filed by Defendant Kite Pharma, Inc..(Lawton, Adam)
Att: 1 Reply Declaration of Adam R. Lawton
146 respm Objection/Opposition (Motion related) Tue 12:26 PM 
OPPOSITION Ex Parte Application re: EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144Opposition filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research.(Wells, Crawford)
Att: 1 Declaration,
Att: 2 Exhibit 1
Monday, March 04, 2019
148 minutes Telephone Conference For Order re Discovery Matter Wed 9:27 AM 
MINUTES OF CONTINUED PRE-MOTION TELEPHONIC DISCOVERY CONFERENCE settling139 Motion re: Informal Discovery Dispute held before Magistrate Judge Karen L. Stevenson. Should Judge Otero grant Kite’s Ex Parte Application, Kite may file a motion to compel. In the interim, at the request of counsel for non-party BMS, who does not receive the CM/ECF notifications in this case, the Court ORDERS Defendant Kite, to provide copies to BMS counsel of the following: (1) Minutes of Pre-Motion Telephonic Discovery Conference held on February 26, 2019, (Dkt. No. 138) (see document for further details). Court Recorder: XTR 03-04-19. (hr)
145 respm Declaration (Motion related) Mon 12:52 PM 
DECLARATION of Adam R. Lawton (Corrected) in support of EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144 filed by Defendant Kite Pharma, Inc.. (Lawton, Adam)
144 17 pgs motion Order Mon 11:50 AM 
EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses filed by Defendant Kite Pharma, Inc.. (Lawton, Adam)
Att: 1 Proposed Order,
Att: 2 Declaration of Adam R. Lawton,
Att: 3 Exhibit 1,
Att: 4 Exhibit 2,
Att: 5 Exhibit 3,
Att: 6 Exhibit 4,
Att: 7 Exhibit 5,
Att: 8 Exhibit 6,
Att: 9 Exhibit 7,
Att: 10 Exhibit 8,
Att: 11 Exhibit 9,
Att: 12 Exhibit 10,
Att: 13 Exhibit 11,
Att: 14 Exhibit 12,
Att: 15 Exhibit 13,
Att: 16 Exhibit 14,
Att: 17 Exhibit 15,
Att: 18 Exhibit 16
Thursday, February 28, 2019
143 order Leave to File Excess Pages Thu 10:50 AM 
ORDER GRANTING-IN-PART DEFENDANT KITE PHARMA, INC.’S APPLICATION FOR LEAVE TO FILE A 10-PAGE REPLY BRIEF IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT140 by Judge S. James Otero. It is hereby ordered that Defendant Kite Pharma, Inc. may file a reply brief of no more than 10 pages in support of its motion for summary judgment of noninfringement. Plaintiffs are permitted to file a sur-reply, not to exceed 7 pages, addressing the admissibility of the expert declarations submitted in support of its opposition to Defendant’s motion for summary judgment of noninfringement. The sur-reply shall be filed no later than 5 days from Defendant’s reply. IT IS SO ORDERED. (lom)

Juno Therapeutics, Inc. v. Kite Pharma, Inc. (2:17-cv-07639)

District Court, C.D. California

 

 

 

 

 

 

 

Recorded here ONLY if PDF is Downloadable

Oct 18, 2017

COMPLAINT Receipt No: 0973-20685642 – Fee: $400, filed by Plaintiffs Juno Therapeutics, Inc., Sloan Kettering Institute for Cancer Research, Memorial Sloan Kettering Cancer Center. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10, # 11 Exhibit 11, # 12 Exhibit 12, # 13 Exhibit 13, # 14 Exhibit 14) (Attorney Morgan Chu added to party Juno Therapeutics, Inc.(pty:pla), Attorney Morgan Chu added to party Memorial Sloan Kettering Cancer Center(pty:pla), Attorney Morgan Chu added to party Sloan Kettering Institute for Cancer Research(pty:pla))(Chu, Morgan) (Entered: 10/18/2017)

Main Doc

3

Oct 18, 2017

Request for Clerk to Issue Summons on Complaint (Attorney Civil Case Opening),, 1 filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Chu, Morgan) (Entered: 10/18/2017)

SKIPPED

46

Jan 29, 2018

JOINT REPORT Rule 26(f) Discovery Plan ; estimated length of trial 5-12 days, filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research.. (Attachments: # 1 Appendix 2)(Chu, Morgan) (Entered: 01/29/2018)

SKIPPED

66

Mar 29, 2018

AMENDED ANSWER and AMENDED COUNTERCLAIM to Complaint (Attorney Civil Case Opening),, 1 filed by Defendant and Counterclaimant Kite Pharma, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Appendix (redline version of amended pleading))(Lawton, Adam) (Entered: 03/29/2018)

SKIPPED

74

May 11, 2018

STIPULATION for Protective Order filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Proposed Order)(Tuan, Elizabeth) (Entered: 05/11/2018)

75

May 14, 2018

ORDER GRANTING PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver re Stipulation for Protective Order 74 (dml) (Entered: 05/14/2018)

Protective Order

SKIPPED

85

Aug 13, 2018

DECLARATION of Alan J. Heinrich re Brief (non-motion non-appeal), 84 ISO Juno’s Claim Construction Brief filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research, Counter Defendants Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Exhibit Exhibit 1, # 2 Exhibit Exhibit 2, # 3 Exhibit Exhibit 3, # 4 Exhibit Exhibit 4, # 5 Exhibit Exhibit 5, # 6 Exhibit Exhibit 6, # 7 Exhibit Exhibit 7, # 8 Exhibit Exhibit 8, # 9 Exhibit Exhibit 9, # 10 Exhibit Exhibit 10, # 11 Exhibit Exhibit 11)(Heinrich, Alan) (Entered: 08/13/2018)

Main Doc

Declaration

115

Dec 3, 2018

SEALED DECLARATION IN SUPPORT OF APPLICATION to file document (Reply in Support of Motion to Dismiss and Exhibits J-M) under seal 114 filed by Defendant Kite Pharma, Inc.. (Attachments: # 1 Unredacted Document Reply in Support of Motion to Dismiss, # 2 Unredacted Document Exhibit J, # 3 Unredacted Document Exhibit K, # 4 Unredacted Document Exhibit L, # 5 Unredacted Document Exhibit M)(Lawton, Adam) (Entered: 12/03/2018)

Main Doc

117

Jan 4, 2019

STIPULATION to AMEND Protective Order 75 filed by Defendant Kite Pharma, Inc.. (Attachments: # 1 Amended Protective Order, # 2 Proposed Order)(Lawton, Adam) (Entered: 01/04/2019)

118

Jan 7, 2019

ORDER GRANTING AMENDED PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver, re Stipulation to Amend Protective Order 117 (dml) (Entered: 01/07/2019)

119

Jan 7, 2019

AMENDED PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver, re Order Granting 118 (dml) (Entered: 01/07/2019)

122

Jan 24, 2019

Joint STIPULATION to Extend Discovery Cut-Off Date to March 29, 2019 filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Proposed Order)(Heinrich, Alan) (Entered: 01/24/2019)

Main Doc

SOURCE

https://www.courtlistener.com/docket/6175992/juno-therapeutics-inc-v-kite-pharma-inc/

Other related sources

35 U.S.C. 271 – Infringement of patent

Other related articles published in this Online Open Access Scientific Journal, include the following:

Economic Potential of a Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent) versus a Cancer Drug in Clinical Trials: CAR-T as a Case in Point, developed by Kite Pharma, under Arie Belldegrun, CEO, acquired by Gilead for $11.9 billion, 8/2017.

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/10/04/economic-potential-of-a-drug-invention-prof-zelig-eshhar-weitzman-institute-registered-the-patent-versus-a-cancer-drug-in-clinical-trials-car-t-as-a-case-in-point-developed-by-kite-pharma-unde/

 

Read Full Post »


Will the Supreme Court accept a UC Berkeley Appeal of the Sep. 10th, US Court of Appeals for the Federal Circuit decision to uphold the patent filed by the Broad Institute on CRISPR/Cas9 gene editing?

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on June 6, 2019

Several companies were founded on the initial CRISPR IP rights granted to various individuals and institutions. These companies include Intellia Therapeutics and its parent company, Caribou Biosciences (Berkeley), CRISPR Therapeutics and ERS Genomics (Emmanuelle Charpentier), and Editas Medicine (Broad) as well as the Broad Institute itself. Anyone aiming to commercialize CRISPR technology must obtain licenses from one or more of these companies. However, Broad and Berkeley have followed the long-standing recommendations that federally funded academic institutions grant non-exclusive licenses to university researchers and nonprofits.

ERS Genomics also offers non-exclusive licenses for research purposes and the commercialization of certain services and products, including, specifically, synthetic biology. Additionally, the Broad Institute offers non-exclusive licenses for companies selling reagents and other genome editing tools and for in-house commercial research. But they are clear they only offer exclusive licenses for human therapeutics. Editas holds most of the Broad’s IP rights for therapeutics but companies can potentially obtain licenses through what the Broad calls their “inclusive innovation” model.

If all of that weren’t complex enough, there are certain overlaps between the patents. For example, Editas, CRISPR Therapeutics, and Intellia all offer licenses to treat human diseases. But ERS Genomics specifically excludes a therapeutics option. Meanwhile, both Editas and Intellia offer licenses for stem cells, CAR-T cells, and Alpha-1 antitrypsin while Caribou Biosciences and the Broad Institute do not. In short, navigating the CRISPR IP thicket can be extremely confusing. And, unfortunately, it is likely to become even more so.

CRISPR

Image credit: Labiotech  and Science News.

While Berkeley’s notice of allowance does help put out the flames, until recently, most of the fights have centered on the Cas9 protein. But, in the last several years, research has shown that the CRISPR-Cpf1 protein, also known as Cas12a, is potentially more effective than Cas9. Companies like Mammoth Biosciences have already been founded off of Cas12a technology. Patents involving the Cas12a-RNA complex are already pending on behalf of Berkeley and the Broad Institute.

SOURCE

https://synbiobeta.com/with-the-recent-patent-news-who-owns-crispr-now/

 

On 2018, Sep. 10th, the US Court of Appeals for the Federal Circuit agreed to uphold the patent filed by the Broad Institute on CRISPR/Cas9 gene editing in organisms with complex cells – UC Berkeley team can appeal this decision to the US Supreme Court, it is unclear whether the Supreme Court will accept this case.

According to Appeal and Interference Statistics 11/30/2016

https://www.uspto.gov/sites/default/files/documents/Appeal%20and%20Interference%20Statistics%20November%202016.pdf

In recent years, more than half of PTAB’s decisions have been upheld. “The Federal Circuit heard three appeals of interferences in 2016,” said intellectual property expert Jacob Sherkow of New York Law School. “All three were at least affirmed in part. It’s completely unclear whether that’s meaningful — it’s an N of 3–but there you go.” Overall, on 155 appeals since PTAB was created in 2012, the Federal Circuit affirmed 120 on every issue, dismissed or reversed 21 on every issue, and issued partial decisions (that is, upholding parts of a PTAB decision and reversing others) in the other 14.

SOURCE

Disputed CRISPR Patents Stay with Broad Institute, U.S. Panel Rules

Three judges have released their decision

https://www.scientificamerican.com/article/disputed-crispr-patents-stay-with-broad-institute-u-s-panel-rules/

 

Based on

Appeal and Interference Statistics 11/30/2016

https://www.uspto.gov/sites/default/files/documents/Appeal%20and%20Interference%20Statistics%20November%202016.pdf

I recommend UC, Berkeley to Appeal to the Supreme Court the Sept 10th Decision.

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On June 12, 2018 – Berkeley was granted a patent on using CRISPR/Cas9 to edit single-stranded RNA. On June 19, 2018 – Berkeley was granted a second patent, covering the use of CRISPR-Cas9 gene editing with formats that will be particularly useful in developing human therapeutics and improvements in food security.

Reporter and Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 6/6/2019

What is the future of CRISPR IP rights?

Most likely, a complex one. Genomic breakthroughs are on the rise as CRISPR unlocks the secrets of the human genome. The CRISPR-Cas9 IP battle seems settled for now. And there is no indication that Cas12a will kick up nearly the same kinds of patent fights. But that is no guarantee for the future. With a potential worth of billions of dollars, CRISPR has the capability to break scientific partnerships as easily as it does DNA.

The best way to stay out of the IP rabbit hole is to use CRISPR for research or non-profit purposes. But even commercial companies looking to build CRISPR-based platforms should carefully review the relevant licenses from each institution, especially as there are often non-exclusive options for certain kinds of CRISPR products and services. Unsurprisingly, the most complex CRISPR IP rights seem to center around therapeutics. But other industries including agriculture should be clear on their licensing options as well.

We are still in the early days of CRISPR technology and there is a lot to learn both in and out of the lab. The hope is that licensing CRISPR will become more straightforward or at least clearer and more organized. Synthego CSO Rich Stoner spoke with SynBioBeta’s Kevin Costa about the current atmosphere surrounding CRISPR IP rights. “Yes, there’s a lot of litigation and contention around the core patents. But the pace of innovation to create new nucleases, new ways to edit and more predictability means that we’re very optimistic about the future of the technologies we’re deploying now as well as over the next few years.”

But that future remains a little way off—the dust is still settling.

 

UPDATED on 3/2/2019

 

U.S. patent office indicates it will issue third CRISPR patent to UC

Patent involved in interference proceedings will add to university’s gene-editing portfolio

The U.S. Patent and Trademark Office has issued a notice of allowance for a University of California patent application covering systems and methods for using single molecule guide RNAs that, when combined with the Cas9 protein, create more efficient and effective ways for scientists to target and edit genes. U.S. patent application number 13/842,859, which had notably been examined in advance of a prior interference proceeding involving the Broad Institute, specifically focuses on methods and systems for modifying a target DNA molecule in any setting, both in vitro and within live cells, using one or multiple single guide RNAs, across every cell type. The associated patent is expected to issue in the next 6-9 weeks.

This CRISPR-Cas9 DNA-targeting technology, invented by Jennifer Doudna and Martin Jinek of the University of California, Berkeley, along with Emmanuelle Charpentier at Umea University and Krzystof Chylinski at the University of Vienna, is a fundamental molecular tool for editing genes. Together, this patent application and prior U.S. Patent Numbers 10,000,772 and 10,113,167, cover CRISPR-Cas9 methods and compositions useful as gene-editing scissors in any setting, including in vitro, as well as within live plant, animal and human cells.

“We are pleased the patent application is now allowed and that the issued patent will encompass the use of CRISPR-Cas9 technology in any cellular or non-cellular environment. We expect to see continued momentum in the expansion of UC’s CRISPR patent portfolio in the coming months,” said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR matters for the University of California and a director at Sterne, Kessler, Goldstein & Fox. “The steadfast protection of the CRISPR intellectual property pioneered by the Doudna-Charpentier team is wholly focused on the improvement of human welfare.”

https://news.berkeley.edu/2019/02/08/u-s-patent-office-indicates-it-will-issue-third-crispr-patent-to-uc/

 

The patent covers methods of using optimized guide RNA formats (including single guide and dual guide formats) in certain environments, including eukaryotic cells (such as human, animal and plant cells). The optimized formats modify the part of a guide RNA that interacts with the CRISPR/Cas9 nuclease.

 

Who is it that deserves credit for turning a bacterial immune system into a revolutionary gene editing tool?

We suggest that it is as follows: Two owners of IP in Red

Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decision ruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.

https://pharmaceuticalintelligence.com/2017/04/13/gene-editing-consortium-of-biotech-companies-crispr-therapeutics-crsp-intellia-therapeutics-ntla-caribou-biosciences-and-ers-genomics-uc-berkeley-doudnas-ip-and-university-of-vienna-charpe/

Patents for the wide use of CRISPR-Cas9 for gene editing all types of cells have already been issued to the Doudna-Charpentier team by the European Patent Office (representing more than 30 countries), the United Kingdom, China, Japan, Australia, New Zealand, Mexico and other countries. The scope of the United States patent issued today broadly includes the use of a CRISPR-Cas9 compound that is specially engineered to be more easily employed inside any type of plant or animal cell, or outside a cell, in order to modify a gene or the expression of a gene.

CRISPR Therapeutics, Intellia Therapeutics and Caribou Biosciences issued the following joint statement on the grant of the ‘772 patent:

“We believe that the U.S. patent ‘772 granted today covers the use of CRISPR/Cas9 genome editing with the RNA guide formats that are widely used throughout the industry. We anticipate this is the first of many patents that will be granted to UC on this foundational CRISPR/Cas9 intellectual property.”

In addition to this granted U.S. patent, applications from this patent estate have been found allowable in the United States and also have issued in Europe, the United Kingdom, China, Japan and various other countries worldwide. These patents cover the dual- and single-guide RNA compositions of the widely adopted CRISPR/Cas9 genome editing technology and their uses in all environments, including plant, animal and human cells as well as for use in human therapeutics.

SOURCE

http://ir.intelliatx.com/news-releases/news-release-details/crispr-therapeutics-intellia-therapeutics-and-caribou

https://pharmaceuticalintelligence.com/2017/04/28/doudna-and-charpentier-and-their-teams-to-receive-wide-ranging-patents-in-many-countries-european-patent-office-epo-and-uk-intellectual-property-office-broad-patent-for-crispr-cas9-gene-editing/

Schematic representation of the CRISPR-Cas9 system. The Cas9 enzyme (orange) cuts the DNA (blue) in the location selected by the RNA (red). Image courtesy of Carlos Clarivan/Science Photo Library/NTB Scanpix

 

“Today’s patent is one of many we anticipate will be awarded to these inventors for their CRISPR-Cas9 invention,” said Edward Penhoet, special advisor to the UC Berkeley chancellor and special assistant to the University of California president. “Six years ago, the Doudna-Charpentier team was the first to file a patent application and publish on the necessary and sufficient components that enable CRISPR-Cas9 to be employed in all environments, including plant and animal cells. Their remarkable research has only accelerated since then, creating new jobs and opening up new possibilities to improve life.”

The U.S. patent granted today (10,000,772) is not involved in any interference proceeding before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, or any appeal before the U.S. Court of Appeals for the Federal Circuit. The ‘772 patent is not impacted by the USPTO’s decision to terminate an interference between a separate UC patent application and a patent application owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology without reaching a decision on which inventors were the first to invent the use of CRISPR/Cas9 technology for genome editing. UC’s appeal of that decision was heard on April 30, 2018 by the U.S. Court of Appeals for the Federal Circuit, which will issue a decision in the future.

RELATED INFORMATION

SOURCE

http://news.berkeley.edu/2018/06/19/doudna-charpentier-team-awarded-u-s-patent-for-crispr-cas9/

Comments made on On June 12, 2018 – Berkeley was granted a patent on using CRISPR/Cas9 to edit single-stranded RNA. On June 19, 2018 – Berkeley was granted a second patent, covering the use of CRISPR-Cas9 gene editing with formats

There have also been others commenting on the decision, including Jacob Sherkow, who’s an associate professor from the New York Law School. He said that he expected the second patent, in particular, to have “pretty minimal commercial value”. While former molecular biologist and biotech patent lawyer, Dr. Kevin Noonan have reportedly said he thinks UC Berkeley “is just happy to get a patent”.

SOURCE

http://www.frontlinegenomics.com/news/23997/finally-a-win-for-uc-berkeley-two-crispr-patents-awarded/

 

The University of California will finally be granted a key CRISPR patent

Other related 140 articles on CRISPR and on the Legal dispute, published in this Open Access Online Scientific Journal, include the following:

https://pharmaceuticalintelligence.com/?s=CRISPR

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Developments in CRISPR Patent Dispute: EPO Revokes Broad’s CRISPR Patent

Curator: Aviva Lev-Ari, PhD, RN

 

 

Mixed views on Broad’s fate after EPO revokes CRISPR patent

https://www.lifesciencesipreview.com/news/mixed-views-on-broad-s-fate-after-epo-revokes-crispr-patent-2671

 

EPO Revokes Broad’s CRISPR Patent

The Broad Institute of MIT and Harvard University is at risk of losing its dominant position over the intellectual property covering CRISPR gene-editing technology in Europe, after the European Patent Office (EPO) ruled today (January 17) that a foundational patent is revoked because the Broad did not meet EPO requirements to establish that its researchers were the first to use CRISPR in eukaryotes.

In addition to the highly publicized patent dispute between the Broad and the University of California over the rights to CRISPR gene editing in the U.S., the Broad has been fighting to maintain a number of patents over the technology in Europe. The issue revolves around a disagreement between the Broad and Rockefeller University over who should be named as inventors. The majority of patent applications filed by the Broad in Europe failed to name Rockefeller University itself, as well as Rockefeller researcher Luciano Marraffini, both of which were named on several of the documents filed to establish a priority date for the patent as early as December 2012. Changing the listed inventors goes against the EPO’s formal requirements for priority, leading the agency to rule this morning that the priority documents with the full list of inventors did not count toward establishing priority of the more-limited European filings.

“If you’ve got more than one person on a priority document, they are a singular legal unity,” explains Catherine Coombes, a senior patent attorney with HGF Limited in the U.K. “If you’re going to drop numbers . . . you need to transfer priority from everybody on the first.” Given the ongoing arbitration between the Broad and Rockefeller, it’s not surprising that the Broad did not procure this transfer, she adds.

Today’s decision is the first opposition heard in Europe, but at least 10 other Broad patents have been challenged, many of which have the same issue of leaving out certain inventors from those listed on the documents filed to establish priority. The EPO had put those other proceedings on hold while it looked into this first patent, Coombes says, but now it can apply its ruling to the other cases. “What we will expect to see over the next year or so is a number of the other Broad’s patents in Europe either being completely revoked or being severely limited in Europe.”

The Broad has announced that it will be appealing the EPO’s decision, but “I personally think it’s unlikely that we’ll see a change in direction,” Coombes says. She adds, however, that the institution does have one patent application that does name Rockefeller and Marraffini. “What I would suspect their patent attorneys would be doing is looking over the patent that doesn’t have this [priority] issue and trying to get more claims in that one.”

SOURCE

https://www.the-scientist.com/?articles.view/articleNo/51395/title/EPO-Revokes-Broad-s-CRISPR-Patent/

PRESS RELEASES / 01.15.18

The Rockefeller University and Broad Institute of MIT and Harvard announce update to CRISPR-Cas9 portfolio filed by Broad

An update regarding inventorship and ownership of certain Broad filings relating to the use of the CRISPR-Cas9 system in eukaryotic cells

New York, NY, and Cambridge, Mass., January 15th, 2018

— The Rockefeller University and the Broad Institute of MIT and Harvard have settled their disagreement regarding inventorship and ownership of certain Broad filings relating to the use of the CRISPR-Cas9 system in eukaryotic cells. Rockefeller believed that its faculty member Dr. Luciano Marraffini, co-author with Broad’s Dr. Feng Zhang, on a seminal paper published in Science in 2013, Multiplex Genome Engineering Using CRISPR/Cas Systems, should have been maintained in these Broad eukaryote filings.

SOURCE

https://www.broadinstitute.org/news/rockefeller-university-and-broad-institute-mit-and-harvard-announce-update-crispr-cas9

 

That Other CRISPR Patent Dispute

It’s possible the Rockefeller dispute may work its way in to the interference proceedings involving the Broad and UC Berkeley. Earlier this summer, the patent examiner on the Rockefeller’s application gave an initial rejection to some of the claims because they overlap with UC Berkeley’s patent application. Sherkow said it’s possible the examiner’s decision could be used as evidence to persuade the patent judges that Berkeley was first to develop CRISPR as a gene-editing tool.

SEE

Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decisionruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.

https://pharmaceuticalintelligence.com/2017/04/13/gene-editing-consortium-of-biotech-companies-crispr-therapeutics-crsp-intellia-therapeutics-ntla-caribou-biosciences-and-ers-genomics-uc-berkeley-doudnas-ip-and-university-of-vienna-charpe/

Other potential casualties of the Rockefeller dispute are some of the Broad’s patents overseas, as Catherine Coombs describes today (August 31) in an opinion article. In a nutshell, patents abroad may be compromised if the applicants on US patents are not the same as those listed on corresponding international patents, Coombs explains.

Rockefeller, Marraffini, and Zhang all declined to comment on the ongoing dispute. The Broad offered a statement acknowledging that Rockefeller has been an important collaborator on CRISPR, and that the institutions share a couple of patent applications related to the tool’s application in prokaryotic cells. “Rockefeller has raised the question of whether its interests are more general,” the statement reads. “We appreciate that Rockefeller has raised this question and expect it will be resolved amicably between our institutions. This resolution will likely take some time.”

The disagreement between Rockefeller and the Broad concerns just one of hundreds of CRISPR-related patent families, noted Corinne Le Buhan, the CEO of IPStudies, a Switzerland-based firm that tracks CRISPR patents. Le Buhan said it’s likely more patent fights will arise. “There are lots of very close patents signed by different inventors,” she told The Scientist. “Based on what we’ve seen on the technology side we can anticipate there will be more disputes.”

SOURCE

https://www.the-scientist.com/?articles.view/articleNo/46921/title/That-Other-CRISPR-Patent-Dispute/

CLASHES OVER THE FUTURE OF GENE THERAPY AT THE US’ BIGGEST BIOTECH MEETING, JP Morgan, SF, January 9-12, 2018

Role of Immune system in gene therapy using CRISPR Cas9

https://www.wired.com/story/clashes-over-the-future-of-gene-therapy-at-the-uss-biggest-biotech-meeting/

 

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Appellate Brief Seeking Reversal of U.S. Patent Board Decision on CRISPR/Cas9 Gene Editing

Reporter: Aviva Lev-Ari, PhD, RN

[Boldface added]

  • Appeal seeks reversal of Patent Trial and Appeal Board decision terminating interference without determining priority of inventorship of CRISPR/Cas9 gene editing
  • Brief asserts that the Board failed to properly apply controlling U.S. Supreme Court and Federal Circuit precedents, and ignored evidence of multiple groups readily applying CRISPR/Cas9 gene editing to eukaryotic cells following teachings of Charpentier-Doudna team

As explained in UC’s brief, application of the correct legal standards to the case is believed to require reversal of the PTAB’s decision. For these reasons, UC requests that the Federal Circuit instruct the PTAB to reinstate the interference proceeding so that it can properly determine priority of inventorship, as previously requested by UC. The PTAB’s failures to consider pertinent evidence and apply appropriate legal standards should at the very least require the matter to be remanded so that the PTAB can properly consider the evidence related to obviousness and Broad’s no-interference-in-fact motion using appropriate legal standards.
In the PTAB’s February decision terminating the interference proceeding prematurely, it had not yet considered the teachings of UC’s own prior-filed patent application with respect to using CRISPR/Cas9 in eukaryotic cells. Instead, the PTAB only addressed the threshold question of whether use in eukaryotic cells can be separately patentable from use in all settings as covered by UC’s claims. However, determinations on the underlying substantive matters have recently been made in parallel prosecution before the U.S. Patent & Trademark Office (“USPTO”). The USPTO has rejected a series of patent applications filed by Broad that are directed to uses of CRISPR/Cas9 technology in eukaryotic cells as being non-novel in view of UC’s prior-filed patent application, which the USPTO examiners considered to have effectively taught use of the CRISPR/Cas9 technology in eukaryotic cells. In addition, patent applications filed by Sigma-Aldrich and Toolgen that similarly claim use of CRISPR/Cas9 in eukaryotic cells (both of which filed applications before Broad’s application) have likewise recently been rejected as being either non-novel or obvious in view of the prior-filed UC patent application with specific respect to its teachings regarding application of the invention to use in eukaryotic cells.

SOURCES

On 7/25/2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics Announce Appellate Brief Seeking Reversal of U.S. Patent Board Decision on CRISPR/Cas9 Gene Editing

https://globenewswire.com/news-release/2017/07/25/1058142/0/en/CRISPR-Therapeutics-Intellia-Therapeutics-Caribou-Biosciences-and-ERS-Genomics-Announce-Appellate-Brief-Seeking-Reversal-of-U-S-Patent-Board-Decision-on-CRISPR-Cas9-Gene-Editing.html

On 4/13/2017:

Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decisionruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/04/13/gene-editing-consortium-of-biotech-companies-crispr-therapeutics-crsp-intellia-therapeutics-ntla-caribou-biosciences-and-ers-genomics-uc-berkeley-doudnas-ip-and-university-of-vienna-charpe/

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UPDATED – Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decision ruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.

 

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 8/1/2019

Unpatentable claims

In its newest brief, UC identified a list of motions it would like permission to file with the PTAB. Among these motions, UC has asked the PTAB to judge all the Broad’s claims involved in the interference unpatentable.

First, UC alleges that the Broad’s patents fall under the provisions of AIA’s “first to file” system. All of the Broad’s involved cases issued from applications with a filing date on or after March 16, 2013 when the AIA took effect, but claim priority benefit to one or more applications filed before that date, the motion said. However, the Broad’s involved cases and/or the applications involved in the cases “contains or contained at one time at least one claim that was not supported by Broad’s applications filed before March 16, 2013,” the university added. “Thus, Broad’s involved cases, the application from which each of Broad’s involved patents issued, and/or a parent application to which each of Broad’s involved cases claims benefit, contains or contained at one time at least one claim to subject matter having an effective filing date on or after March 16, 2013 — thereby subjecting each of Broad’s involved cases to AIA prior art provisions.”

In its filing, UC noted that this motion should be enough for the PTAB to decide the unpatentability of the Broad’s claims. However, the filing adds, if this argument isn’t enough, there are other provisions that would render the Broad’s claims unpatentable.

Misidentified inventors

In the next motion, UC claims that “Broad deliberately misidentified the inventors on its involved patents and application, as demonstrated by the fact that its own prosecuting attorney’s sworn declaration contradicts the inventive entities named during prosecution of the involved applications.”

The Broad’s patents name either Zhang as the sole inventor or Zhang in combination with Le Cong, Fei Ran, Randall Platt, Patrick Hsu, and/or Sanjana. However, UC claims, Broad attorney Thomas Kowalski identified “a substantially different set of inventors” in a declaration provided to the European Patent Office.” Specifically, Kowalski’s declaration attests that several individuals who weren’t listed on the official patents “had contributed in a not insubstantial manner” to various CRISPR inventions, including Cong, Ran, Shuailiang Lin, Platt, Ophir Shalem, Matthias Heidenreich, and Lukasz Swiech.

“As one example, Broad’s attorney determined that Dr. Cong contributed to the invention of ‘the CRISPR-Cas9 system adapted in for [sic] uses in eukaryotic cells,’ a critical feature of every involved claim in the Interference. But Dr. Cong is not named on 8 of the 14 patents/application involved,” UC’s motion notes. “If all inventors are not named, then a patent or application is unpatentable unless it is corrected.”

“Inequitable… untrue… materially false”

UC’s next motion, alleging the Broad engaged in “inequitable conduct” is the most explosive, however.

The university said that the Broad’s claims are unpatentable because it made “at least one affirmative material misstatement” in each of its applications. Specifically, UC alleges that Zhang made statements he knew to be “untrue” at the time he made them, and that Sanjana had made a “materially false declaration.”

Zhang alleged in his declaration that he had a complete conception and reduction to practice of the technology he’d claimed he’d invented, USC said. But the university alleges that the evidence shows Zhang’s experiments failed to include tracrRNA, which is a required component of a functional CRISPR-Cas9 cleavage complex.

“The evidence shows that Dr. Zhang did not include tracrRNA in his experiments to form a CRISPR-Cas9 complex at that time and therefore could not have had a complete conception, much less a reduction to practice, of a functional CRISPR-Cas9 system for cleaving DNA,” UC wrote.

The university also claimed that Zhang didn’t include tracrRNA in his CRISPR-Cas9 complex until after he’d read a 2012 Science paper co-authored by Doudna, Charpentier, and Martin Jinek, which showed that tracrRNA is essential for cleavage of target DNA.

“Dr. Zhang was aware of the Jinek paper, and cited it in his own publications before he signed his declaration and before his counsel submitted it to the [USPTO],” UC said.

UC also accused Zhang of omitting unfavorable data and context from a summary panel the Broad showed the patent office. The full data would have showed the experimental failure of not including tracrRNA, as well as Zhang’s “failure to understand the criticality of tracrRNA at the time he conducted the experiments,” UC said.

“The Broad’s affirmative mischaracterization of data… is part of a larger pattern of deception,” the university added. In filing a claim for one of the involved patents, the Broad submitted a declaration from Sanjana, stating that the researchers had achieved successful cleavage of target DNA in eukaryotic cells by a CRISPR-Cas9 system comprising a single-guide RNA. As evidence, the team included a copy of an experimental gel. But UC said that gel was misrepresented, and clearly shows that Zhang and Sanjana’s experiment was “a failure.”

By presenting the gel as proof of a successful experiment, UC added, “Sanjana materially misstated facts in an attempt to prove an even earlier date of invention. Those acts evidence Broad’s pattern of deceptive behavior in its dealings with the patent office.”

In its supporting documents, UC submitted a February 2015 email from Shuailiang Lin, a researcher who had worked in Zhang’s lab from 2011 to 2012 and who was listed as an inventor on the Broad’s provisional applications.

“The 15-page declaration of [Feng Zhang] and Le Cong’s luciferase data is mis- and overstated to change the examiner’s decision, which seems to be a joke. After seeing your in virto [sic, in vitro] paper, Feng Zhang and Le Cong quickly jumped to the project without letting me know. My lab notebooks, emails and other files like dropbox or gel pictures recorded every step of the lab’s failure process. I am willing to give more details and records if you are interested or whoever is interested to clear the truth. We did not work it out before seeing your paper, it’s really a pity,” the e-mail said, according to UC’s filing.

The bottom line, UC concluded, is that the Broad’s patents should be canceled.

SOURCE

https://www.genomeweb.com/business-news/crispr-patent-fight-turns-ugly-uc-accuses-broad-researchers-lying-about-claims#.XUNJBJNKggo

https://www.statnews.com/2019/07/31/latest-crispr-patent-fight-mudslinging/

https://acts.uspto.gov/ifiling/PublicView.jsp?identifier=106115&identifier2=null&tabSel=4&action=filecontent&replyTo=PublicView.jsp

 

UPDATED on 3/2/2019

U.S. patent office indicates it will issue third CRISPR patent to UC

Patent involved in interference proceedings will add to university’s gene-editing portfolio

The U.S. Patent and Trademark Office has issued a notice of allowance for a University of California patent application covering systems and methods for using single molecule guide RNAs that, when combined with the Cas9 protein, create more efficient and effective ways for scientists to target and edit genes. U.S. patent application number 13/842,859, which had notably been examined in advance of a prior interference proceeding involving the Broad Institute, specifically focuses on methods and systems for modifying a target DNA molecule in any setting, both in vitro and within live cells, using one or multiple single guide RNAs, across every cell type. The associated patent is expected to issue in the next 6-9 weeks.

This CRISPR-Cas9 DNA-targeting technology, invented by Jennifer Doudna and Martin Jinek of the University of California, Berkeley, along with Emmanuelle Charpentier at Umea University and Krzystof Chylinski at the University of Vienna, is a fundamental molecular tool for editing genes. Together, this patent application and prior U.S. Patent Numbers 10,000,772 and 10,113,167, cover CRISPR-Cas9 methods and compositions useful as gene-editing scissors in any setting, including in vitro, as well as within live plant, animal and human cells.

“We are pleased the patent application is now allowed and that the issued patent will encompass the use of CRISPR-Cas9 technology in any cellular or non-cellular environment. We expect to see continued momentum in the expansion of UC’s CRISPR patent portfolio in the coming months,” said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR matters for the University of California and a director at Sterne, Kessler, Goldstein & Fox. “The steadfast protection of the CRISPR intellectual property pioneered by the Doudna-Charpentier team is wholly focused on the improvement of human welfare.”

SOURCE

https://news.berkeley.edu/2019/02/08/u-s-patent-office-indicates-it-will-issue-third-crispr-patent-to-uc/

UPDATED on 11/22/2017

John Leonard to helm Intellia

SOURCE

https://endpts.com/synergy-ceo-passes-torch-to-cco-troy-hamilton-president-steven-kafka-resigns-from-foundation-abbvie-vet-john-leonard-to-helm-intellia/?utm_medium=email&utm_campaign=376%20Friday%20122217%20Year-end%20biotech%20bash%20FDA%20approves%20record%2046th%20drug%20Roche%20triggers%2017B%20buyout%20JJ%20pays%20350M%20for%20BCMA%20pact&utm_content=376%20Friday%20122217%20Year-end%20biotech%20bash%20FDA%20approves%20record%2046th%20drug%20Roche%20triggers%2017B%20buyout%20JJ%20pays%20350M%20for%20BCMA%20pact+CID_1bdfc3dd8fa117ef7d943125e8d312d8&utm_source=ENDPOINTS%20emails&utm_term=Synergy%20CEO%20passes%20torch%20to%20CCO%20Troy%20Hamilton%20President%20Steven%20Kafka%20resigns%20from%20Foundation%20AbbVie%20vet%20John%20Leonard%20to%20helm%20Intellia

See Background:

UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century

 

|
Source: Intellia Therapeutics, Inc.
  • Appeal to the U.S. Court of Appeals for the Federal Circuit seeks review and reversal of the Patent Trial and Appeals Board’s (PTAB) decision to terminate CRISPR/Cas9 interference
  • In parallel, the companies and their licensors plan to pursue additional patents in the U.S. and worldwide covering the CRISPR/Cas9 technology and its use in cellular and non-cellular settings, including eukaryotic cells

BASEL, Switzerland;

CAMBRIDGE, Massachusetts;

BERKELEY, California;

DUBLIN, Ireland,

April 13, 2017

(GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP), Intellia Therapeutics (NASDAQ:NTLA), Caribou Biosciences and ERS Genomics announced today that The Regents of the University of California, the University of Vienna, and Dr. Emmanuelle Charpentier (collectively “UC”), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, have appealed to the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”) the decision by the Patent Trial and Appeal Board (“PTAB”) to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, “Broad”).

In the appeal, UC is seeking review and reversal of the PTAB’s February 15, 2017 decision, which terminated the interference without determining which inventors actually invented the use of the CRISPR/Cas9 genome editing technology in eukaryotic cells. In its decision, the PTAB concluded that, although the claims overlap, the respective scope of UC and Broad’s claim sets as presented did not define the same patentable invention and, accordingly, terminated the interference without deciding which party first invented the use of the CRISPR/Cas9 technology in eukaryotic cells. UC is asking the Federal Circuit to review and reverse the PTAB’s decision.

In parallel with the appeal, UC is pursuing applications in the U.S. and other jurisdictions worldwide to obtain patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted in the United Kingdom, and the European Patent Office is also granting a patent to UC, which will issue on May 10, 2017. UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed more than six months later, on December 12, 2012.

The law firm of Munger, Tolles & Olson LLP will be handling the appeal, with Don Verrilli, former Solicitor General of the United States, as lead counsel.

SOURCE

https://globenewswire.com/news-release/2017/04/13/960152/0/en/CRISPR-Therapeutics-Intellia-Therapeutics-Caribou-Biosciences-and-ERS-Genomics-Announce-Appeal-of-CRISPR-Cas9-U-S-Patent-Board-Decision.html

 

Editas’ rivals appeal a recent setback on patent fight, mapping a global war for CRISPR supremacy

They say they are “pursuing applications in the U.S. and other jurisdictions worldwide to obtain patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted in the United Kingdom, and the European Patent Office is also granting a patent to UC, which will issue on May 10, 2017. UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed more than six months later, on December 12, 2012.”

The group said today it is also waging a global patent battle for CRISPR/Cas9 supremacy over Editas and its scientific founder, Feng Zhang, who patented the rival technology at The Broad.

SOURCE

https://endpts.com/editas-rivals-appeal-a-recent-setback-on-patent-fight-mapping-a-global-war-for-crispr-supremacy/?utm_medium=email&utm_campaign=201%20Thursday%2041317%20Biogen%20Roche%20forge%2011B%20in%20deals%20for%20Bristol%20drugs%20Busy%20week%20for%20the%20biotech%20jobs%20scene&utm_content=201%20Thursday%2041317%20Biogen%20Roche%20forge%2011B%20in%20deals%20for%20Bristol%20drugs%20Busy%20week%20for%20the%20biotech%20jobs%20scene+CID_1d65272f5e757d7ae0245395295e6e12&utm_source=ENDPOINTS%20emails&utm_term=Editas%20rivals%20appeal%20a%20recent%20setback%20on%20patent%20fight%20mapping%20a%20global%20war%20for%20CRISPR%20supremacy

 

REFERENCES

Other press releases by Intellia Therapeutics, Inc.

Read Full Post »


CRISPR Patent Battle Determined on 2/15/2017 – USPTO issues a verdict in legal tussle over rights to genome-editing technology

Curator: Aviva Lev-Ari, PhD, RN

Broad Institute prevails in heated dispute over CRISPR patents

Sharon Begley sharon.begley@statnews.com
@sxbegle

In a one-sentence judgment by the Patent Trial and Appeal Board, the three judges decided that there is “no interference in fact.” In other words, key CRISPR patents awarded to the Broad beginning in 2014 are sufficiently different from patents applied for by UC that they can stand. The judges’ full 51-page decision explaining their reasoning stated that the Broad had persuaded them “that the parties claim patentably distinct subject matter.”

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

MIT

The Broad said in a statement that the decision “confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other.”

UC, Berkeley

In a statement, the University of California said it was pleased that its patent application, which it described as covering “the invention and use of CRISPR gene editing in all cells,” can move forward. “We continue to maintain that the evidence overwhelmingly supports our position that the Doudna/Charpentier team was the first group to invent this technology for use in all settings and all cell types,” it said, “and that the Broad Institute’s patents directed toward use of the CRISPR-Cas9 system in particular cell types are not patentably distinct from the Doudna/Charpentier invention.”

UC said it is considering its legal options, including the possibility of an appeal, but it contended that anyone who wants to develop CRISPR-based treatments for human diseases would have to license not only the Broad’s patents but also those that UC expects to be awarded. “Ours,” Doudna told reporters, “is for the use [of CRISPR] in all cells,” including human ones.

PTAB appeals are heard by the US Court of Appeals for the Federal Circuit, which sits in Washington. In recent years, more than half of PTAB’s decisions have been upheld.

“The Federal Circuit heard three appeals of interferences in 2016,” said Sherkow. “All three were at least affirmed in part. It’s completely unclear whether that’s meaningful — it’s an N of 3–but there you go.” Overall, on 155 appeals since PTAB was created in 2012, the Federal Circuit affirmed 120 on every issue, dismissed or reversed 21 on every issue, and issued partial decisions (that is, upholding parts of a PTAB decision and reversing others) in the other 14.

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Said UC attorney Lynn Pasahow:

For “all tennis balls,” read “all cells.” For “green tennis balls,” read “eukaryotic cells.”

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

 

What will that mean for licensees of CRISPR patents?

Stanford University Voice

UC believes that any company that wants to use CRISPR to develop human therapies — we’re looking at you, Editas Medicine — will need to license not only the Broad’s patents on eukaryotic cells but also those UC expects to receive on all kinds of cells. “It looks to me as if someone wanting to use the Broad patent would also have to license the UC patent,” agreed law professor Hank Greely of Stanford University. “The UC patent (if granted) would be on any use; the Broad would be on use in eukaryotes. I think someone who wanted to do this in eukaryotes would need to have licenses to both.”

CRISPR-Cas9 is unlikely to be the last genome-editing technology ever discovered. In 2015, Zhang and his colleagues discovered a version called Cpf1, which they’ve now patented and licensed to Editas. “I continue to think the possibility of inventing around the [CRISPR] patents seems very likely,” said Stanford’s Greely. Bacteria “have certainly come up with other ways to reach the same end [of genome editing], ways that aren’t covered by UC’s or the Broad’s claims. That could make either of these patents ultimately of little importance … especially if the licensing conditions give people a strong incentive to come up with invent-arounds.” Science will march on.

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

What does the CRISPR ruling mean for biotech?

By DAMIAN GARDE @damiangarde

FEBRUARY 15, 2017

Editas Medicine, which has aligned with the winning Broad, saw its share price rise more than 25 percent on Wednesday. Intellia Therapeutics, affiliated with UC, fell about 11 percent, while compatriot CRISPR Therapeutics dipped 24 percent.

https://www.statnews.com/2017/02/15/what-does-the-crispr-ruling-mean-for-biotech/

 

Broad Institute wins bitter battle over CRISPR patents

The US Patent and Trademark Office issues a verdict in legal tussle over rights to genome-editing technology.

15 February 2017 Updated:In December 2016, lawyers representing the University of California and the Broad Institute participated in oral arguments before a trio of patent-court judges. University of California attorney Lynn Pasahow said that the team had not yet decided whether it would appeal the verdict on 2/15/2017.

Lawyers representing the University of California filed for an ‘interference’ proceeding, in an effort to have the Broad’s patents thrown out. But on 15 February, patent judges determined that there was no interference, meaning that the Broad’s invention is distinct from that of the University of California, and the Broad patents will stand. The University of California’s patent application will now be referred back to an examiner, but legal challenges could continue.

molecular biologist Jennifer Doudna of the University of California in Berkeley, likened the situation to licensing permission to someone who wants to use green tennis balls. “They will have a patent on the green tennis balls,” she said, referring to the Broad patents. “We will have a patent on all tennis balls.” ”Doudna argued at the press conference that the patent battle had not hampered research, given the speed with which researchers had taken up the technique and companies had rushed to commercialize it.”

The University of California’s invention would cover the design of the RNA molecule that guides the key step in CRISPR–Cas9 gene editing, directing the Cas9 enzyme to a specific site in the genome. But getting that system to work in eukaryotes was an additional inventive step, Coombes says, a patent lawyer at intellectual-property specialists HGF in York, UK.

SOURCE

Nature doi:10.1038/nature.2017.21502

http://www.nature.com/news/broad-institute-wins-bitter-battle-over-crispr-patents-1.21502?WT.ec_id=NEWSDAILY-20170216%20

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Related articles from nature.com

Other related articles published in this Open Acceaa Online Scientific Journal include the following:

UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century: UC, Berkeley and Broad Institute @MIT

Reporter: Aviva Lev-Ari, PhD, RN

 

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