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Archive for the ‘Patent Law in Biotech’ Category


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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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

 

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

 

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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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

 

UPDATED on 1/23/2018

Two CARTs, Two Charts: Dissecting Returns From T-Cell Therapy M&A

Bruce Booth

1/22/2018 Celgene finalized its acquisition of Juno Therapeutics for $9B, only a few short months after Gilead bought Kite Pharma for $11.9B.

It’s also clear that public investors did quite well in these deals – unlike some outcomes, both private and public investors can only be happy with these deals. Kite’s IPO investors made over a whopping 10x, and Juno’s nearly a 3.6x (in 3 years, so still a very strong public market return). Even the follow-on financing participants made handsome returns: both Kite’s and Juno’s follow-on financings about 4-6 months prior to acquisition delivered a 2x return in a short period. What’s clear is that participating at any point only these price curves was a positive for investors. Obviously that doesn’t always happen, but great to see when it does.

A final takeaway is that there is “no one size fits all” for how to build business models that can work in biotech these days, even to get to similar product and patient outcomes. While Kite and Juno have remarkably similar products, similar platforms, and similar overall acquisition valuations, the stories were built quite differently when it comes to financing their growth.

https://www.forbes.com/sites/brucebooth/2018/01/23/two-carts-two-charts-dissecting-returns-from-t-cell-therapy-ma/#23f0b7a2459e

UPDATED on 10/18/2017

Kite Pharma, under Arie Belldegrun, CEO, acquired by Gilead for $11.9 billion, 8/2017.

Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy

— Manufacturing Success Rate of 99 Percent in ZUMA-1 Pivotal Trial with a Median 17 Day Turnaround Time —

CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek and destroy cancer cells. CAR T therapy is manufactured specifically for each individual patient.

“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” said Arie Belldegrun, MD, FACS, Founder of Kite. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”

“Today is an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer,” said John Milligan, PhD, President and Chief Executive Officer of Gilead Sciences. “With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”

The list price of Yescarta in the United States is $373,000.

Yescarta has been granted Priority Medicines (PRIME) regulatory support for DLBCL in the European Union. A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA) and potential approval is expected in the first half of 2018.

Yescarta (axicabtagene ciloleucel) Pivotal Trial Results

The approval of Yescarta is supported by data from the ZUMA-1 pivotal trial. In this study, 72 percent of patients treated with a single infusion of Yescarta (n=101) responded to therapy (overall response rate) including 51 percent of patients who had no detectable cancer remaining (complete remission; 95% CI: 41, 62). At a median follow-up of 7.9 months, patients who had achieved a complete remission had not reached the estimated median duration of response (95% CI: 8.1 months, not estimable [NE]).

In the study, 13 percent of patients experienced grade 3 or higher cytokine release syndrome (CRS) and 31 percent experienced neurologic toxicities. The most common (≥ 10%) Grade 3 or higher reactions include febrile neutropenia, fever, CRS, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia and lung infections. Serious adverse reactions occurred in 52% of patients and included CRS, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia and anemia), and serious infections. Fatal cases of CRS and neurologic toxicity occurred. FDA approved Yescarta with a Risk Evaluation and Mitigation Strategy.

Yescarta Indication

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases. In the United States each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR T therapy. Historically, when treated with the current standard of care, patients with refractory large B-cell lymphoma had a median overall survival of approximately six months, with only seven percent attaining a complete response. Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since nearly half of them either do not respond or relapse shortly after transplant.

“With CAR T therapy, we are reengineering a patient’s own immune system to detect and kill cancer cells, and the results have been impressive,” said Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “Many of the patients that received CAR T therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant. Now, thanks to this new therapy many patients are in remission for months.”

“This therapy is a new option for patients with relapsed or refractory large B-cell lymphoma who have run out of treatment options and face a dire prognosis,” said Louis J. DeGennaro, PhD, President and Chief Executive Officer of The Leukemia & Lymphoma Society (LLS). “Early on, LLS recognized the potential of CAR T therapy and we are proud to be part of making this historic approval possible.”

“Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients,” said David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite. “Together, Gilead and Kite will accelerate studies of CAR T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy.”

http://www.businesswire.com/news/home/20171018006639/en/Kite%E2%80%99s-Yescarta%E2%84%A2-Axicabtagene-Ciloleucel-CAR-Therapy-Approved

This article has the following structure:

  • ABOUT Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent)
  • ABOUT Gilead’s $12 billion buy of Kite Pharma
  • ABOUT  the Drug Development process and the COMMERCIALIZATION GENIUS of Arie Belldegrun – Interviewed by Globes
  • ABOUT the Perspective of Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent) following the Gilead’s $12 billion buy of Kite Pharma – Interviewed by Globes
  • ABOUT the Economic significance of Kite Pharma Acquisition for the Venture Capital Investment in Biotech in Israel
  • Key Opinion Leader’s View: Aviva Lev-Ari, PhD, RN

 

  1. I agree with Prof. Zelig Eshhar that this Case in Point is “one more invention, or parts of an invention, came from an Israeli laboratory (at the Weizmann Institute in this case) and fell into foreign hands. It is another enormous missed opportunity in the field of biomedicine and ethical drugs.”
  2. I agree with Prof. Zelig Eshhar that this Case in Point should have been a TEVA commercialization effort. It is a regrettable reality that the development and the manufacturing will not benefit the State of Israel, home of the Weitzman Institute where the Patentable invention took place by Prof. Zelig Eshhar.
  3. It is to be acknowledged that for CAR-T – the process of treatment using the drug – personalized genetic engineering of each patient’s cells – a grafting process with no precedent in the pharmaceutical industry (Juno has related process) – is bringing to the Oncology arena a NOVEL treatment for hematological malignancies cancer patients
  4. I agree with Prof. Zelig Eshhar that the Barriers in the pharmaceutical industry are especially high. Developing ethical drugs is a process requiring huge amounts of time, patience, money, and failures. It is exactly, therefore, all need to acknowledge that the Drug Development process and the COMMERCIALIZATION GENIUS of Arie Belldegrun is inseparable from the breakthrough invention of Prof. Zelig Eshhar to develop the drug from the Lab bench to the FDA accelerated process of Drug approval.
  5. The Biotech industry in Israel needs to develop more MDs, PhDs with the level of training of Arie Belldegrun and with his entrepreneur acumen, keenness and depth of perception, discernmentdiscrimination especially in practical aspects of Translation Medicine, Clinical Research, Clinical Trial Design and abilities to engage in innovating the FDA processes.
  6. The Biotech industry in US needs to develop more MDs, PhDs with the level of training of Prof. Zelig Eshhar to carry the scientific gravitas and the creativity to become inventors of novel drugs.

 

ABOUT Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent)

Pioneers of Cancer Cell Therapy:  Turbocharging the Immune System to Battle Cancer Cells — Success in Hematological Cancers vs. Solid Tumors

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/08/19/pioneers-of-cancer-cell-therapy-turbocharging-the-immune-system-to-battle-cancer-cells-success-in-hematological-cancers-vs-solid-tumors/

 

ABOUT Gilead’s $12 billion buy of Kite Pharma

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/08/30/fda-has-approved-the-worlds-first-car-t-therapy-novartis-for-kymriah-tisagenlecleucel-and-gileads-12-billion-buy-of-kite-pharma-no-approved-drug-and-canakinumab-for-lung-cancer-may-be/

 

ABOUT  the Drug Development process and the COMMERCIALIZATION GENIUS of Arie Belldegrun – Interviewed by Globes

“Chemotherapy will become just a bad memory”

More energetic than ever, Arie Belldegrun talks to “Globes” about Kite Pharma’s remarkable journey and the future of cancer treatment.

http://www.globes.co.il/en/article-chemotherapy-will-become-just-a-bad-memory-1001206978

 

ABOUT the Perspective of Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent) following the Gilead’s $12 billion buy of Kite Pharma – Interviewed by Globes

Kite Pharma was a $12b missed opportunity for Israel – Interview with Professor Zelig Eshhar

Some Israeli media headlines depicted Kite as an Israeli exit. But it is a US company that does no business in Israel and has no employees here.

Professor Zelig Eshhar is the man who registered the patent on the cancer treatment drug developed by Kite Pharma, recently acquired by Gilead for $11.9 billion.

“Globes”: Do you believe that any party in Israel could have financed the product and brought it where it is today?

Eshhar: “On the one hand, yes. The level of investment in the product before it reached Nasdaq was something that an Israeli concern could certainly have financed. On the other hand, Kite Pharma founder Professor Arie Belldegrun, with his energy and connections, brought it to a completely different place (Eshhar previously tried to interest various concerns in Israel in financing the drug, but all of them told him that it was too early, or that the product was not effective enough, E.T.).

Was the development already in its final form in the 1980s?

“Almost. I went to the National Institutes of Health (NIH), where I met for the first time Professor Steven Rosenberg, who later became the first doctor to conduct clinical trials with the technology. Rosenberg heard about my technology, and offered me exceptional conditions. We set up a team there, and had the best of everything. I only wish I had it now.”

They say that Belldegrun didn’t want the product at first. Today, he’s devoting all his efforts to it.

“When Arie founded Cougar Biotechnology, which developed a drug for prostate cancer, and was eventually sold to Johnson & Johnson for $1 billion, I contacted him and offered him the technology, but he was busy with Cougar’s product, and maybe didn’t think that he had enough capital for such a production. Only after he sold Cougar did he get back to me with an offer to buy the rights to my patent. At that time (2009-2010), the technology was already arousing great interest, and there were negotiations with several large companies.” (from an April 2015 “Globes” interview with Eshhar, who was awarded the Israel Prize).

Israelis can be very provincial. In at least some of the media headlines, Kite Pharma was portrayed as a “huge Israeli exit,” and the impression was given that it was an Israeli company. The truth is very different. Kite Pharma is not an Israeli company; it is a 100% US company. It does no business in Israel; its nearly $12 billion exit has no significance whatsoever for the Israeli economy, and will contribute nothing to it: no jobs, and the tax contribution will be marginal, and certainly not on the scale of Mobileye, for example. Let me say it again: Kite Pharma does not have even one employee in Israel (and has no reason to employ anyone here), and certainly does not pay taxes in Israel. There are no Israelis on the company’s management team or board of directors. This is a US company for all intents and purposes. The word “Israel” appears exactly once in the company’s full documents – where registration of the company’s patents is concerned. The fact that every story about the company mentions the small holdings of several Israeli financial institutions in it is a bad joke. Everyone should remember that Israeli financial institutions are of course entitled to invest in any foreign share, such as Google, Amazon, Facebook, Apple Computers, and so forth. Kite Pharma is one of those foreign shares, and nothing more.

Of course, there is cause for pride in the fact that Eshhar, owner of the patent for Kite Pharma’s drug is “one of ours,” i.e. an Israeli researcher at the Weizmann Institute of Science. Another source of pride is Kite Pharma founder and CEO Arie Belldegrun, a graduate of the Hebrew University Medical School who did his post-doctorate at the Weizmann Institute, where he met Eshhar, and Kite Pharma later bought his patent for the cancer drug. Belldegrun was also a director at Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) until recently, resigning at the peak of that company’s crisis. Beyond this Israeli connection, however, the Kite Pharma exit has no great significance for Israel. All it means is that one more invention, or parts of an invention, came from an Israeli laboratory (at the Weizmann Institute in this case) and fell into foreign hands. It is another enormous missed opportunity in the field of biomedicine and ethical drugs.

It is necessary to realize that while Belldegrun is indeed a big biomedical brain with many achievements in the field, he is a brain that has left Israel, and we all have to ask ourselves why he left, why Kite Pharma is not an Israeli company, and why its (as yet non-existent) product was not developed in Israel and will not be manufactured there. The headline in Israel for the Kite Pharma exit should ask why Israel lost out on it, even though the patent came from Israeli laboratories, albeit with US cooperation.

Belldegrun is likely to keep his experiences on the Teva board of directors to himself. Of all the directors in the company, what he has to say is the most interesting, but he is unlikely to divulge what happened there with the inflated deal with Allergan, and exactly what he said at the board of directors meeting that approved the deal that led Teva into its current major crisis. The Kite Pharma exit and his other exits only highlight the lost opportunity. Kite Pharma, still without a product and without approval for a product, was sold for $11.9 billion in cash. Teva yesterday hit another low point, with a market cap of $16 billion. It is simply inconceivable: a company with an enormous potential, but no product, is worth three quarters of a huge veteran company with at least dozens of products, including products in the ethical drug sector. Kite Pharma is actually one of the indirect reasons for Teva’s decline – for the fact that Teva, which could have been a hothouse for developments like Copaxone, chose a huge inflated gamble on the generics market – a gamble that is now jeopardizing Teva’s future and very existence.

It is true that developing drugs is a very long process, requires huge amounts of capital, and involves many failures, but Teva decided to neglect it, and when a major company like Teva neglects Israeli developments, there are enough competitors in the pharma industry ready to turn Israeli research into gold. Kite Pharma is one example of this research.

The Weizmann Institute is a fruitful source of biomedical research. According to previous estimates published in “Globes,” the Weizmann Institute gets NIS 1 billion each year in royalties on medical and other developments, amounting to half of its budget. Directly and indirectly, the Weizmann Institute, together with other universities in Israel, is responsible for tens of billions of pharmaceutical sales. Only a few billions of this, however, results from drugs developed in Israel, like Copaxone, and far less than that is also made in Israel. The reports by Yeda R&D Company Ltd., the technology transfer arm of the Weizmann Institute of Science, are top secret, and there is a good reason for that. Exposing them will only highlight the scale of the missed opportunities. Instead of these inventions providing a base for a major pharmaceutical industry here, the commercialization companies are benefiting only the inventors and the Weizmann Institute itself (that is certainly natural and legitimate, and they are entitled to it), even though the research infrastructure from which they sprung is Israeli know-how, as in the case of Eshhar.

Barriers in the pharmaceutical industry are especially high. Developing ethical drugs is a process requiring huge amounts of time, patience, money, and failures. When it succeeds, however, the profit is enormous – for the industry, the employees, and the state (provided that some tax is paid). For example, Pfizer’s peak sales of Lipitor, a very popular drug for reducing cholesterol and fat in the bloodstream, reached $11 billion, and its profit on the drug was $9 billion, before competition from a generic version began. In addition to money, a great deal of experience and marketing power is required, and that is the reason why most developments wind up in the hands of major companies like Pfizer, Merck, and others at some stage. After all these qualifying statements, everyone who celebrated Kite Pharma’s exit should weep over it – it is another part of the sale of Israeli know-how overseas for a mess of pottage. Instead of consolidating a splendid pharma industry here, Israel is selling the brains with their know-how to foreigners. More than anything else, Teva’s decline and the Kite Pharma exit epitomize this sad and dangerous trend.

Published by Globes [online], Israel Business News – www.globes-online.com – on August 30, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

http://www.globes.co.il/en/article-kite-pharma-the-huge-exit-that-israel-missed-1001203173

 

ABOUT the Economic significance of Kite Pharma Acquisition for the Venture Capital Investment in Biotech in Israel

Israeli investors profit from $11.9b Kite acquisition

Pontifax fund and Israeli institutional investors will profit from the US personalized cancer drug company’s huge sale.  Part of the technology was developed at the Weizmann Institute

Pharmaceutical company Gilead Sciences Inc. has announced that it will acquire US company Kite Pharma Inc., developer of personalized cancer treatment drugs, at a company value of $11.9 billion. This is one of the biggest ever acquisitions of a company whose products have not yet been approved for marketing. The company value for the acquisition reflects a 29% premium on the market price.

Kite Pharma has developed a new method for genetically engineering immune system cells, so that they will make a focused attack on the malignant tumor. The company was founded in the US by Israeli-American Professor Arie Belldegrun, who already has two exits to his credit. He is also a former director at Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) (whose current value is not much more than the value at which Kite Pharma, a company with no products approved for marketing yet, is being acquired).

A significant part of the technology on which the product is based was developed by Professor Zelig Eshhar of the Weizmann Institute of Science.

The main Israeli beneficiary of the acquisition is the Pontifax fund, which invested $3.8 million in Kite Pharma at an early stage, but which distributed Kite Pharma shares worth $120 million to its investors. Among the investors in Pontifax that received shares in Kite Pharma are Menorah Mivtachim Holdings Ltd. (TASE: MORA) (which also bought shares on the market, and whose stake in the company is now worth over $100 million), The Phoenix Holdings Ltd. (TASE: PHOE1;PHOE5), Altshuler Shaham Ltd.Meitav Dash Investments Ltd. (TASE:MTDS), Harel Insurance Investments and Financial Services Ltd. (TASE: HARL), and Mori Arkin.

Kite Pharma is waiting for marketing approval of its first product, following a successful trial on 100 patients on a very abbreviated track for innovative cancer products. The product was initially designed for treatment of blood cancer, but it is now hoped that its use can later be expanded to treatment of other types of cancer. Gilead is making a big gamble, first of all that the US Food and Drug Administration (FDA) will fulfill its commitment to approve the product, even though the development plan it devised, together with the company, was very short and limited. The second gamble involves the process of treatment using the drug – personalized genetic engineering of each patient’s cells – a grafting process with no precedent in the pharmaceutical industry.

Speaking about the talks to sell Kite, Prof. Arie Belldegrun told “Globes.” “We handled like in the IDF 669 unit. Nobody knew anything. Nobody heard anything. We held meetings in places where nobody would see us. And before we announced it only five employees knew about it.”

Published by Globes [online], Israel Business News – www.globes-online.com – on August 28, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

http://www.globes.co.il/en/article-israeli-investors-profit-from-119b-kite-acquisition-1001202841

 

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

Curators: Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

  • Cancer Biology & Genomics for Disease Diagnosis, on Amazon since 8/11/2015

http://www.amazon.com/dp/B013RVYR2K

  • Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery (Series C Book 2) – on Amazon since 5/18/2017

http://www.amazon.com/dp/B071VQ6YYK

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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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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 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.

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