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Archive for the ‘Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough’ Category


Real Time @BIOConvention #BIO2019:#Bitcoin Your Data! From Trusted Pharma Silos to Trustless Community-Owned Blockchain-Based Precision Medicine Data Trials

Reporter: Stephen J Williams, PhD @StephenJWillia2
Speakers

As care for lifestyle-driven chronic diseases expands in scope, prevention and recovery are becoming the new areas of focus. Building a precision medicine foundation that will promote ownership of individuals’ health data and allow for sharing and trading of this data could prove a great blockchain.

At its core, blockchain may offer the potential of a shared platform that decentralizes healthcare interactions ensuring access control, authenticity and integrity, while presenting the industry with radical possibilities for value-based care and reimbursement models. Panelists will explore these new discoveries as well as look to answer lingering questions, such as: are we off to a “trustless” information model underpinned by Bitcoin cryptocurrency, where no central authority validates the transactions in the ledger, and anyone whose computers can do the required math can join to mine and add blocks to your data? Would smart contracts begin to incentivize “rational” behaviors where consumers respond in a manner that makes their data interesting?

Moderator:  Cybersecurity is extremely important in the minds of healthcare CEOs.  CEO of Kaiser Permenente has listed this as one of main concerns for his company.

Sanjeey of Singularity: There are Very few companies in this space.  Singularity have collected thousands of patient data.  They wanted to do predictive health care, where a patient will know beforehand what health problems and issues to expect.  Created a program called Virtual Assistant. As data is dynamic, the goal was to provide Virtual Assistant to everyone.

Benefits of blockchain: secure, simple to update, decentralized data; patient can control their own data, who sees it and monetize it.

Nebular Genetics: Company was founded by Dr. George Church, who had pioneered the next generation sequencing (NGS) methodology.  The company goal is to make genomics available to all but this currently is not the case as NGS is not being used as frequently.

The problem is a data problem:

  • data not organized
  • data too parsed
  • data not accessible

Blockchain may be able to alleviate the accessibiltiy problem.  Pharma is very interested in the data but expensive to collect.  In addition many companies just do large scale but low depth sequencing.  For example 23andme (which had recently made a big deal with Lilly for data) only sequences about 1% of genome.

There are two types of genome sequencing companies

  1.  large scale and low depth – like 23andme
  2. smaller scale but higher depth – like DECODE and some of the EU EXOME sequencing efforts like the 1000 Project

Simply Vital Health: Harnesses blockchain to combat ineffeciencies in hospital records. They tackle the costs after acute care so increase the value based care.  Most of healthcare is concentrated on the top earners and little is concentrated on the majority less affluent and poor.  On addressing HIPAA compliance issues: they decided to work with HIPAA and comply but will wait for this industry to catch up so the industry as a whole can lobby to affect policy change required for blockchain technology to work efficiently in this arena.  They will only work with known vendors: VERY Important to know where the data is kept and who are controlling the servers you are using.  With other blockchain like Etherium or Bitcoin, the servers are anonymous.

Encrypgen: generates new blockchain for genomic data and NGS companies.

 

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

#blockchain
#bitcoin
#clinicaltrials

 

 

 

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Proprietary IP Asset Sale Opportunity of SeraSeal® Global Rights Purchase with the CE License

Guest Author: Dr. Jukka Karjalainen, MD, PhD

 

IP Asset Sale Opportunity by Dr. Jukka Karjalainen, IP and Asset Agent to Leon Wortham Owner of IP and CEO of Wortham Laboratories, Tennessee, USA including the intellectual property of SeraSeal® with the CE license.

The value proposition of purchase of IP of SeraSeal® is available for global rights purchase. The proprietary IP of SeraSeal® is protected from replication and has no lifetime limits.

 

 

Dr. Jukka Karjalainen, MD, PhD

SeraSeal Intellectual Property Agent

Pharma Consulting Services (PCS) Inc.

Toronto, Ontario, Canada

Cell: + 1 (416) 258 4495

Email: jukan_koti@hotmail.com

 

TO SENIOR BUSINESS EXECUTIVE, CEO, President , CBO, CMO, CTO, CSO PRESENTING THE OPPORTUNITY:

SeraSeal®

A PRIMARY HEMOSTATIC AGENT CAPABLE OF:

  • control all forms of bleeding quickly without destroying tissue
  • to use immediately without any preparation time
  • get the product to any part of body, even to closed systems with multiple delivery systems
  • be extremely effective in the presence of anticoagulant drugs and coagulopathies (bleeding disorders)

Problem and Challenge

All of the hemostatic agents on the market are adjunct or secondary products, which are added after the bleeding is controlled and their use is limited to surgical procedures. This suboptimal treatment puts patients at risk of dying of injuries and surgical procedures.

All competitor hemostatic and tissue sealing products are only able to arrest bleed in minutes as compared to ONLY SECONDS with SeraSeal®.

Industry and Market Overview

The market size of global hemostasis and tissue sealing products was valued at $5.35 Billion (USD) in 2018. It is anticipated to expand at a CAGR of 8.7% annual rate during the 7-year forecast period. Out of the 15+ competitors, four companies dominate 98% of the total market: Baxter, J&J, Ethicon US, LLC., C. R. Bard, Inc., B. Braun Melsungen AG, Pfizer Inc., Z-Medica, LLC., CryoLife, Inc., Integra LifeSciences, Advanced Medical Solutions Group plc, GELITA AG.

The lucrative market growth over the next seven years is due to increase in demand from increasing surgery volumes, resulting from growth in geriatric population and prevalence of chronic conditions (Grand View Research: Hemostasis & Tissue Sealing Agents Market Size Report, 2019-2026).

The major competitors are the fibrin glues, which are a two-component hemostatic agent, delivered by a double barrel syringe, forming a physical barrier over the wound. This method of approach will stop venous bleeds in 1-3 minutes and capillary arteries in 5-10 minutes. SeraSeal®, however is a one component agent that interacts with the patient’s own blood, acting as a catalyst to form a clot in 1-2 seconds for most bleeds, and less than 60 seconds for large arterial hemorrhages, even in the presence of anticoagulant therapy or coagulation disorders.

The fibrin glues are primarily in the cardio-vascular market, with some applications in liver and gastro surgeries. SeraSeal® having many delivery systems and achieving hemostasis in seconds, can be applied to any part of the body, which opens a broad market. Unlike hemostatic agents on the market, SeraSeal® can be used in all surgical departments, hospital departments, emergency/trauma centers, medical and surgical clinics, private practice, dentistry, paramedics, veterinary medicine, military, law enforcement, and the consumer market in the form of first-aid products for the home, business, recreational and sporting events.

SeraSeal® is Ultimate and Only Solution

SeraSeal® is a the only CE licensed primary hemostatic agent registered in 47 countries as the first line of defense to arrest bleeding in in closed wounds, such as gunshots, stabbings, or impaled wounds, and open large gaping wounds, and surgical bleeding and used in military, by paramedics, emergency/trauma center personnel, and law enforcement for immediate stopping of venous or arterial bleedings, even in the presence of anticoagulant therapy drugs and in patients with bleeding disorders. Efficacy vs competitors are discussed in the Journal of Gastroenterology, July 2015, and Journal of Cranio-Maxillo-Facial Surgery, June 2016.

SeraSeal® is capable of reducing surgical time by 50%, eliminates blood transfusion by 90%, and reduces anesthetic and pain medication. Efforts to reduce health care costs are actively pursued worldwide by government health care agencies, private hospitals, medical and surgical clinics, and insurance companies. Other cost savings are available.

SeraSeal® can be delivered to any part of the body through multiple delivery systems.

–   Syringe for deep wounds and arterial bleeds: Used for treatment of the visceral organs, particularly the spleen. Also used for lacerations, incisions, dissections, biopsies, resections, and fiber optic and catheter delivery.

–   SeraSeal® Foam is designed to arrest bleeding in closed wounds, such as gunshot, stabbing, or impaled wounds, and open large gaping wounds. The Foam can be applied by a medic, a buddy in the field, or can be self-applied.

–   Spray, scope, trochar, catheter, trauma dressing, battlefield dressing, surgical sponges, dental compresses, swab, bandage strip.

–   Fiber optics, where SeraSeal® can be delivered semi-invasively through scopes, such as an endoscope for a bleeding ulcer.

–   All products are stable with long shelf lives, require no preparation, and are immediately applicable to the patient.

–   SeraSeal® does not create chemical burns, but rather, accelerates healing for the patient. By contrast, all competing products on the market are secondary hemostatic agents, effective only for minor bleeds requiring direct pressure, cauterization, and some are limited to external use only.

With SeraSeal® Hemostasis occurs in seconds:

–  Venous bleeds: 1-3 seconds / Small artery: 5-10 seconds / Medium artery: 15-30 seconds / Large artery:   <60 seconds

 

 

FOAM                                                 BANDAGE STRIPS                                                     HEMOSTATIC SEALAND

VIALS                                     BATTLEFIELD DRESSING                                                     SERASEAL® SWAB

 

How It Works

BANDAGE STRIPS

 

SERASEAL® SWAB

VIALS

FOAM


HEMOSTATIC SEALAND

 

 

BATTLEFIELD DRESSING

 

SeraSeal® is derived from proprietary bovine hemostatic factors and specifically formulated for its applications. It is the World’s ONLY Primary Hemostatic Agent, meaning that it stops major hemorrhages in seconds, even in the presence of anticoagulant therapy or factor deficiencies, without the need for ANY of the traditional applications of pressure, elevation, tourniquets or cauterization.

Current Market Position
Market position is shared with companies who are interested in asset purchase evaluation in detail and have signed an NDA.
IP Asset Sale Opportunity
Dr. Jukka Karjalainen, IP and Asset Agent to Leon Wortham Owner of IP and CEO of Wortham Laboratories, Tennessee, USA (http://worthamlabs.com/secure_landing ), presents herein an asset purchase opportunity to global pharmaceutical companies, including the intellectual property with the CE license.

The value proposition of purchase of IP of SeraSeal® is available for global rights purchase. The proprietary IP of SeraSeal® is protected from replication and has no lifetime limits.

 

To further discuss your interest to purchase the IP assets and certification transfer, please contact me

 

Jukka Karjalainen, MSc, MD, PhD, Docent, Professor

Board Certified in Pharmaceutical Medicine, Pediatrics, General Medicine, Immunology and Diabetes

CEO, President and Director, Pharma Consulting Services (PCS) Inc.

 

 

 

Email: jukan_koti@hotmail.com

Main:

+1 (416) 358-4495

 

SOURCE

On 5/27/19, 11:21 AM, “Jukka K” <jukan_koti@hotmail.com> wrote:

Attached.

Jukka

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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/

 

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Patent on Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription was awarded to UC, Berkeley on October 30, 2018

  •  site-specific modification of a target DNA and/or a polypeptide associated with the target DNA, a DNA-targeting RNA
  •  genetically modified cells that produce Cas9; and Cas9 transgenic non-human multicellular organisms.

Reporter: Aviva Lev-Ari, PhD, RN

 

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United States Patent 10,113,167
Doudna ,   et al. October 30, 2018

Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription 

AbstractThe present disclosure provides a DNA-targeting RNA that comprises a targeting sequence and, together with a modifying polypeptide, provides for site-specific modification of a target DNA and/or a polypeptide associated with the target DNA. The present disclosure further provides site-specific modifying polypeptides. The present disclosure further provides methods of site-specific modification of a target DNA and/or a polypeptide associated with the target DNA The present disclosure provides methods of modulating transcription of a target nucleic acid in a target cell, generally involving contacting the target nucleic acid with an enzymatically inactive Cas9 polypeptide and a DNA-targeting RNA. Kits and compositions for carrying out the methods are also provided. The present disclosure provides genetically modified cells that produce Cas9; and Cas9 transgenic non-human multicellular organisms.


Inventors: Doudna; Jennifer A. (Berkeley, CA), Jinek; Martin (Berkeley, CA), Chylinski; Krzysztof (Vienna, AT), Charpentier; Emmanuelle (Braunschweig, DE)
Applicant:
Name City State Country Type

The Regents of the University of California
University of Vienna
Charpentier; Emmanuelle
Oakland
Vienna
Braunschweig
CA
N/A
N/A
US
AT
DE
Assignee: The Regents of the University of California (Oakland, CA)
University of Vienna (Vienna, AT)
Charpentier; Emmanuelle (Braunschweig, DE)
Family ID: 1000003617643
Appl. No.: 15/138,604
Filed: April 26, 2016

SOURCE

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10113167.PN.&OS=PN/10113167&RS=PN/10113167

SAVE

UC Berkeley team awarded second CRISPR-Cas9 patent

 

“Today’s news … represents yet another validation of the historic and field-changing breakthrough invented by scientists Jennifer Doudna, Emmanuelle Charpentier, and their team… The patent announced today specifically highlights the CRISPR-Cas9 invention’s ability to edit DNA in any setting, including within animal and human cells. It also highlights its utility in several formats across both dual-RNA and single-RNA configurations, useful for therapy for genetic diseases and for improving food security.”
— Edward Penhoet, special adviser to the UC Berkeley chancellor, tells Axios

The details: According to the patent, the compositions can be used in animal or human cells, and can work as either 2 separate pieces of RNA or a single piece of RNA.

  • Penhoet says the new patent covers 2 RNA components that together form the “DNA-targeting-RNA,” with one that targets the particular sequence of DNA needed to be edited and the other that binds with the Cas9 protein.
  • This follows another patent given to UC Berkeley in June on methods to use CRISPR-cas9.
  • The patents cover the composites used by CRISPR-Cas9 within human, plant, animal and bacteria cells.
  • Both allow the use of strands of RNA “that can be shorter than naturally-occurring RNA components. This allows them to be more easily used and, therefore, is a form often preferred,” Penhoet says.

Go deeper:

SOURCE

https://www.axios.com/uc-berkeley-awarded-crispr-cas9-gene-edit-patent-5a533f22-929d-4e7d-83fe-0a73ebeb4538.html

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HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future

Reporter: Aviva Lev-Ari, PhD, RN

 

HUBweek 2018

Hi Aviva,

 

At HUBweek and in this community, we believe a brighter future is built together. In these times of division, particularly when many are feeling excluded from the benefits brought forth by rapid technological development, there is critical importance in the act of coming together, of breaking down barriers, of convening across disciplinary lines to shape our future.

That’s why this year’s theme for HUBweek is We the Future. It is a call to action and an invitation. Throughout the week, we’ll bring together innovators, artists, and curious minds to explore the ways in which we can shape a more inclusive and equitable future for all.

Today, HUBweek kicks off with dozens of events taking place across the city–from public art tours, a drone zoo, and discussions on nuclear weapons and the impact of emerging technologies on people with disabilities, to a policy hackathon hosted by MIT and the first ever Change Maker Conference.

There are 225+ more experiences to take part in throughout HUBweek–a three-day Forum and a documentary film festival; open dialogues with leading thinkers; a robot block party; and collaborative and participatory art. And we’ve got a little fun in store for you, too–make sure you sign up and stop by The HUB later this week to check it all out.

At its core, HUBweek is a collaboration. If not for our partners and the unwavering support of this community, this would not be a reality. A big thank you to our presenting partners Blue Cross Blue Shield of Massachusetts, Liberty Mutual Insurance, and Merck KGaA, to our sponsors, and to the hundreds of collaborating organizations, speakers, artists, and creative minds that are behind this year’s festival.

On behalf of the HUBweek team and our founders The Boston Globe, Harvard University, Mass. General Hospital, and MIT, we’re thrilled to invite you to join us at HUBweek 2018.

 

Linda Pizzuti Henry

SOURCE

 

From: Linda Pizzuti Henry <hello@hubweek.org>

Reply-To: <hello@hubweek.org>

Date: Monday, October 8, 2018 at 9:38 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Welcome to HUBweek

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NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Stephen J. Williams PhD, Reporter

Penn Center for Innovation (Pennovation) sponsored a “Meet with NCI SBIR” program directors at University of Pennsylvania Medicine Smilow Center for Translational Research with a presentation on advice on preparing a successful SBIR/STTR application to the NCI as well as discussion of NCI SBIR current funding opportunities.   Time was allotted in the afternoon for one-on-one discussions with NCI SBIR program directors.

To find similar presentations and one-on-one discussions with NCI/SBIR program directors in an area nearest to you please go to their page at:

https://sbir.cancer.gov/newsevents/events

For more complete information on the NCI SBIR and STTR programs please go to their web page at: https://sbir.cancer.gov/about

A few notes from the meeting are given below:

  • In 2016 the SBIR/STTR 2016 funded $2.5 billion (US) of early stage companies; this is compared to the $6.6 billion invested in early  stage ventures by venture capital firms so the NCI program is very competitive with alternate sources of funding
  • It was stressed that the SBIR programs are flexible as far as ownership of a company; SBIR allows now that >50% of the sponsoring company can be owned by other ventures;  In addition they are looking more favorably on using outside contractors and giving leeway on budgetary constraints so AS THEY SUGGEST ALWAYS talk to the program director about any questions you may have well before (at least 1 month) you submit. More on eligibility criteria is found at: https://sbir.cancer.gov/about/eligibilitycriteria
  • STTR should have strong preliminary data since more competitive; if don’t have enough go for  an R21 emerging technologies grant which usually does not require preliminary data
  • For entities outside the US need a STRONG reason for needing to do work outside the US

Budget levels were discussed as well as  the waiver program, which allows for additional funds to be requested based on criteria set by NCI (usually for work that is deemed high priority or of a specialized nature which could not be covered sufficiently under the standard funding limits) as below:

Phase I: 150K standard but you can get waivers for certain work up to 300K

Phase II: 1M with waiver up to 2M

Phase IIB waiver up to 4M

You don’t need to apply for the waiver but grant offices may suggest citing a statement requesting a waiver as review panels will ask for this information

Fast Track was not discussed in the presentation but for more information of the Fast Track program please visit the website  

NCI is working hard to cut review times to 7 months between initial review to funding however at beginning of the year they set pay lines and hope to fund 50% of the well scored grants

NCI SBIR is a Centralized system with center director and then program director with specific areas of expertise: Reach out to them

IMAT Program and Low-Resource Setting new programs more suitable for initial studies and also can have non US entities

Phase IIB Bridge funding to cross “valley of death” providing up to 4M for 2-3 years: most were for drug/biological but good amount for device and diagnostics

 

Also they have announced administrative supplements for promoting diversity within a project: can add to the budget

FY18 Contracts Areas

3 on biotherapies

2 imaging related

2 on health IT

4 on radiation therapy related: NOTE They spent alot of time discussing the contracts centered on radiation therapy and seems to be an area of emphasis of the NCI SBIR program this year

4 other varied topics

 

Breakdown of funding

>70% of NCI SBIR budget went to grants (for instance Omnibus grants); about 20-30% for contracts; 16% for phase I and 34 % for phase II ;

ALSO the success rate considerably higher for companies that talk to the program director BEFORE applying than not talking to them; also contracts more successful than Omnibus applications

Take Advantage of these useful Assistance Programs through the NIH SBIR Program (Available to all SBIR grantees)

NICHE ASSESSMENT Program

From the NCI SBIR website:

The Niche Assessment Program is designed to help small businesses “jump start” their commercialization efforts. All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply. Registration is on a first-come, first-serve basis!

The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners. Services are provided by Foresight Science & Technology of Providence, RI.

Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and seventy-five (175), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:

  1. Needs and concerns of end-users;
  2. Competing technologies and competing products;
  3. Competitive advantage of the SBIR/STTR-developed technology;
  4. Market size and potential market share (may include national and/or global markets);
  5. Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
  6. Market drivers;
  7. Status of market and industry trends;
  8. Potential customers, licensees, investors, or other commercialization partners; and,
  9. The price customers are likely to pay.

Commercialization Acceleration Program  (CAP)

From the NIH SBIR website:

NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

I-Corps Program

The I-Corps program provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

Program benefits include:

  • Funding up to $50,000 to cover direct program costs
  • Training from biotech sector experts
  • Expanding your professional network
  • Building the confidence and skills to create a comprehensive business model
  • Gaining years of entrepreneurial skills in only weeks.

 

ICORPS is an Entrepreneurial Program (8 week course) to go out talk to customers, get assistance with business models, useful resource which can guide the new company where they should focus on for the commercialization aspect

THE NCI Applicant Assistance Program (AAP)

The SBIR/STTR Applicant Assistance Program (AAP) is aimed at helping eligible small R&D businesses and individuals successfully apply for Phase I SBIR/STTR funding from the National Cancer Institute (NCI), National Institute for Neurological Disorders and Stroke (NINDS), National Heart, Lung and Blood Institute (NHLBI). Participation in the AAP will be funded by the NCI, NINDS, and NHLBI with NO COST TO PARTICIPANTS. The program will include the following services:

  • Needs Assessment/Small Business Mentoring
  • Phase I Application Preparation Support
  • Application Review
  • Team/Facilities Development
  • Market Research
  • Intellectual Property Consultation

For more details about the program, please refer to NIH Notice NOT-CA-18-072.

 

These programs are free for first time grant applicants and must not have been awarded previous SBIR

Peer Learning Webinar Series goal to improve peer learning .Also they are starting to provide Regulatory Assistance (see below)

NIH also provides Mentoring programs for CEOS and C level

Application tips

  1. Start early: and obtain letters of collaboration
  2. Build a great team: PI multi PI, consider other partners to fill gaps (academic, consultants, seasoned entrepreneurs (don’t need to be paid)
  3. They will pre review 1 month before due date, use NIH Project Reporter to view previous funded grants
  4. Specify study section in SF to specify areas of expertise for review
  5. Specific aims are very important; some of the 20 reviewers focus on this page (describes goals and milestones as well; spend as much time on this page as the rest of the application
  6. Letters of support from KOLs are important to have; necessary from consultants and collaborators; helpful from clinicians
  7. Have a phase II commercialization plan
  8. Note for non US clinical trials:  They will not fund nonUS clinical trials; the company must have a FWA
  9. SBIR budgets defined by direct costs; can request a 7% fee as an indirect cost; and they have a 5,000 $ technical assistance program like regulatory consultants but if requested can’t participate in NIH technical assistance programs so most people don’t apply for TAP

 

  • They are trying to change the definition of innovation as also using innovative methods (previously reviewers liked tried and true methodology)

10.  before you submit solicit independent readers

NCI SBIR can be found on Twitter @NCIsbir ‏

Discussion with Monique Pond, Ph.D. on Establishment of a Regulatory Assistance Program for NCI SBIR

I was able to sit down with Dr. Monique Pond,  AAAS Science & Technology Policy Fellow, Health Scientist within the NCI SBIR Development Center to discuss the new assistance program in regulatory affairs she is developing for the NCI SBIR program.  Dr Pond had received her PhD in chemistry from the Pennsylvania State University, completed a postdoctoral fellow at NIST and then spent many years as a regulatory writer and consultant in the private sector.  She applied through the AAAS for this fellowship and will bring her experience and expertise in regulatory affairs from the private sector to the SBIR program. Dr. Pond discussed the difficulties that new ventures have in formulating regulatory procedures for their companies, the difficulties in getting face time with FDA regulators and helping young companies start thinking about regulatory issues such as pharmacovigilence, oversight, compliance, and navigating the complex regulatory landscape.

In addition Dr. Pond discussed the AAAS fellowship program and alternative career paths for PhD scientists.

 

A formal interview will follow on this same post.

 

Other articles on this OPEN ACCESS JOURNAL on Funding for Startups and Early Ventures are given below:

 

Mapping Medical Device Startups Across The Globe per Funding Criteria

Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

 

Funding Opportunities for Cancer Research

 

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

 

A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding; From the Fung Institute at Berkeley

 

PROTOCOL for Drug Screening of 3rd Party Intellectual Property Presented for Funding Representation

 

Foundations as a Funding Source

 

The Bioscience Crowdfunding Environment: The Bigger Better VC?

 

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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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