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Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

How DanioLabs has evolved its relationship with the CIMR

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ABSTRACT: The commonest interaction of industry with academia is as the passive recipient of intellectual property. A much deeper and productive interaction is possible with the creation of closely knit collaborations. Here the barriers to achieving this and how they may be overcome are explored.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

I have posted a series of free biotechnology training videos at BiotechU.com .

biotechu_white_webThe course is derived from my textbook, Building Biotechnology, and covers the following topics:

  • Biotechnology Industry Introduction
  • The Development of Biotechnology
  • Preface: The Science of Biotechnology
  • Introduction to Molecular Biology
  • Drug Development
  • Tools and Techniques
  • Applications
  • Preface: Laws, Regulations, and Politics
  • Intellectual Property Regulation
  • Politics
  • Preface: The Business of Biotechnology
  • Biotechnology Company Fundamentals
  • Finance
  • Research and Development
  • Marketing
  • Licensing, Alliances, and Mergers
  • Managing Biotechnology
  • International Biotechnology
  • Final Words

I invite you to check out this free resource. Customized onsite bootcamps are also available — contact me for more information.

This spring has been a busy one for book launches — I have one final book to announce: The Success Matrix.

The Success Matrix: Winning in Business and in Life takes a slightly different approach than most business books.the-success-matrix_150px

A typical business book guides the reader through its prescribed methods and tools, using various real world examples to support its concepts and conclusions. In fact, the central chapters of The Success Matrix do just that. But The Success Matrix is atypical in the opening and closing chapters. In these chapters the author conveys the basic concepts of the book in a format that should be more accessible and recognizable to readers who are themselves executives, managers, entrepreneurs or individual contributors: a fictional account of one executive’s exposure to The Success Matrix, as explained to him by his friend and mentor.

Bracketing deep management insights with a fictional story to illustrate the power of the concepts within, The Success Matrix demonstrates how, by focusing on the balance across three areas — Vision, Process, and Output, you can improve your business performance as well as satisfaction in your world outside of work. It’s a fun, easy read, but with serious impact in your business, your career and your personal life.

See more details, and buy the book at Amazon.com

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

A maturing industry: Strategic patenting trends, US and academic dominance, and the global biotechnology landscape

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ABSTRACT: Patent analytical data has proved itself a key enabler in measuring the commercial focus and activity taking place within highly research and development (R&D) intensive industries such as biotechnology. Marks & Clerk has assessed biotechnology patent application and grant records from a range of international patent office and proprietary databases, with a view to gauging the industry's commitment to R&D and the particular areas of biotechnology that are attracting investment...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

A maturing industry: Strategic patenting trends, US and academic dominance, and the global biotechnology landscape

Go to paper

ABSTRACT: Patent analytical data has proved itself a key enabler in measuring the commercial focus and activity taking place within highly research and development (R&D) intensive industries such as biotechnology. Marks & Clerk has assessed biotechnology patent application and grant records from a range of international patent office and proprietary databases, with a view to gauging the industry's commitment to R&D and the particular areas of biotechnology that are attracting investment...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Susan Kling FinstonThis is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Looking at the increasing therapeutic importance of peptide therapies,  you may be surprised to learn that these (literal) building blocks of proteins have been defined away under the The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and don’t get twelve (12) year period of data exclusivity for biologics and protein products.  To learn more, read on.

Over the past decade, peptide therapies have crossed over into the mainstream with over 60 approved products, 140 therapies in the clinic and an estimated 500 – 600 in preclinical development. Indications for peptide drugs also are broadening, ranging from infectious disease, to metabolic disorders and advanced cancer therapies. With less toxicity and fewer side effects, naturally occurring peptide drugs have an approval rate that is double that of small molecules (new chemical entities or NCEs).

Why are peptide drugs so important?

“Evolution has been honing the specificity of polypeptides for millions of years. Amino Acid sequences – whether in peptides or proteins – control and direct all aspects of cellular functioning and coordinate most intercellular communication. No other class of biological molecules offers the range of chemical diversity … they are nature’s toolkit and the more we can use native peptides or closely related analogs , the safe and more specific the drugs at the physician’s disposal.” (Source: Rodney Lax)

With emerging nanotechnologies, we are seeing breakthrough products like oral insulin, along with a range of critical new therapeutic approaches including peptide cancer therapies for oral delivery and on an out-patient basis, up to and including anticipation of effective cancer prophylaxis for patients with BRCA mutations. Convergence of nanotechnologies with increased understanding of peptides makes everything possible.

Understanding the greater development and manufacturing challenges associated with biologics, the FDA’s understandable preference is for shorter, truncated, peptides that can be manufactured through chemical synthesis. This entails a time-consuming and painstaking process of optimizing and abbreviating peptide drugs to reduce the size from 50, 40, or 30 peptides to a smaller size can be synthesized chemically for hospital use (IV delivery) or as oral formulations (nanotechnology).

So while avoiding the risks and challenges of biologics, peptide therapies are inherently more complex than typical small chemical entities. Months or even years of additional development time may be needed to fully optimize a truncated peptide that will retain safety and effectiveness as a drug, comprising smallest possible amino acid chain for submission to the FDA.

Given lengthier product development cycles, increased patent litigation, greater complexity of clinical trial requirements and the new regulatory pathway for biosimilars, the U.S. Government mandated an increased data exclusivity period for biotech drugs generally. The BCPI Act included a 12 year period of exclusivity for regulatory dossiers associated with biologicals and protein products.

You may think that this includes peptide drugs – that would be logical. In fact, the opposite is true. Based on the (revised) definition and FDA guidance to the BPCI Act, peptide drugs that navigate the Scylla and Charybdus of biologics and small molecule development and gain FDA approval expressly are excluded from the 12 year period of exclusivity available for biologics.

This brings to mind President Lincoln’s famous riddle:

“If you call the tail a leg, how many legs does a horse have?

Four – calling a tail a leg does not make it a leg.”

As the building blocks of proteins, technology-intensive peptide therapies are essentially biologic in nature – and well deserving of 12 years of data exclusivity.

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Drug Patent Expirations for February 2014

TradenameApplicantGeneric NamePatent NumberPatent Expiration
LEVEMIR INNOLETNovo Nordisk Incinsulin detemir recombinant6,869,930Feb 2, 2014
LEVEMIR PENFILLNovo Nordisk Incinsulin detemir recombinant6,869,930Feb 2, 2014
LEVEMIRNovo Nordisk Incinsulin detemir recombinant6,011,007Feb 2, 2014
LEVEMIR FLEXPENNovo Nordisk Incinsulin detemir recombinant6,011,007Feb 2, 2014
LEVEMIR INNOLETNovo Nordisk Incinsulin detemir recombinant6,011,007Feb 2, 2014
LEVEMIR PENFILLNovo Nordisk Incinsulin detemir recombinant6,011,007Feb 2, 2014
LEVEMIRNovo Nordisk Incinsulin detemir recombinant6,869,930Feb 2, 2014
LEVEMIR FLEXPENNovo Nordisk Incinsulin detemir recombinant6,869,930Feb 2, 2014
CEDAXPernix Therapceftibuten dihydrate5,599,557Feb 4, 2014
ELIGARDTolmar Therapleuprolide acetate5,599,552Feb 4, 2014
TEMODARMerck Sharp Dohmetemozolomide5,260,291*PEDFeb 11, 2014
EXELONNovartisrivastigmine tartrate5,602,176Feb 11, 2014
HECTOROLGenzyme Corpdoxercalciferol5,602,116Feb 11, 2014
EXELONNovartisrivastigmine5,602,176Feb 11, 2014
ARTHROTECGd Searle Llcdiclofenac sodium; misoprostol5,601,843Feb 11, 2014
TRITECGlaxosmithklineranitidine bismuth citrate5,601,848Feb 11, 2014
NIASPANAbbvieniacin6,818,229Feb 15, 2014
DUACStiefelbenzoyl peroxide; clindamycin phosphate5,466,446Feb 16, 2014
GILENYANovartisfingolimod5,604,229Feb 18, 2014
CETROTIDEEmd Serono Inccetrorelix7,605,121Feb 22, 2014
CETROTIDEEmd Serono Inccetrorelix6,863,891Feb 22, 2014
ALVESCOTakeda Gmbhciclesonide5,605,674Feb 25, 2014
PROVENTIL-HFA3malbuterol sulfate5,605,674Feb 25, 2014
IMAGENTImcor Pharms Codimyristoyl lecithin; perflexane5,605,673Feb 25, 2014
QVAR 80Teva Branded Pharmbeclomethasone dipropionate5,605,674Feb 25, 2014
QNASLTeva Branded Pharmbeclomethasone dipropionate5,605,674Feb 25, 2014
PROAIR HFATeva Branded Pharmalbuterol sulfate5,605,674Feb 25, 2014
MYLOTARGWyeth Pharms Incgemtuzumab ozogamicin5,606,040Feb 25, 2014
QVAR 40Teva Branded Pharmbeclomethasone dipropionate5,605,674Feb 25, 2014
XOPENEX HFASunovionlevalbuterol tartrate5,605,674Feb 25, 2014
ZETONNATakeda Gmbhciclesonide5,605,674Feb 25, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
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  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
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worldview-5-yearsSix years ago I built a global biotechnology innovation index, and I have been using it since tracking global biotechnology innovation in Scientific American’s Worldview. It has been a very rewarding project, and I have enjoyed the opportunity to present my research data at international conferences, business schools, and even National Defense University.

Some of the issues I am focusing on this year are economic recovery, agricultural biotechnology, and global biotechnology workforce intensity and mobility.

I am always looking for feedback on the index and new data sets to help expand it. I invite you to visit the scorecard at http://www.saworldview.com/wv/scorecard/ and send me your suggestions and feedback.

Ananda-Chakrabarty-Bugging-Cancer_300x477The 1980 Supreme Court case of Diamond v. Chakrabarty was transformative for the biotechnology industry. It saw the Supreme Court allow Ananda Chakrabarty’s patents on living organisms, and paved the way for commercial biotechnology.

Decades later, Chakrabarty is still an active researcher, and he is now working to develop cancer therapeutics based on symbiotic bacteria. In Bugging Cancer, Chakrabarty and his colleagues at the Chicago Oncogroup have written a compelling dramatic thriller that portrays a fictional story based on this real-life work.

Bugging Cancer is a fictional book, based on real scientific progress in using bacteria and bacterial proteins to attack malignant tumor cells. Scientific results are extended in a fictional way to describe the cancer-fighting power of an imaginary bacterial protein termed neelazin. The book also mirrors present-day issues, including international competition for scientific talent, issues in patent law, research ethics, and financing.

Written by a team of seasoned scientific and business professionals, Bugging Cancer is sure to appeal to scientific researchers, patent attorneys, physicians, and any anyone else interested in healthcare and scientific innovation.

See more details at the book’s homepage, or buy it at Amazon.com

In a recent post at In the Pipeline, Derek Lowe answers a reader’s question about how best to promote drug discover in India. Given my research on the matter, I figured I would try and provide an answer as well.

In Scientific American’s Worldview, I have been ranking national biotechnology industries for the past five years. When I was recently in New Delhi I presented the Indian innovation figures and asked the audience to guess where they ranked. Much to their amazement, India was ranked with the bottom five of the 50+ countries assessed. The issues are myriad — poor patent protection, infrastructure problems, an insufficient quantity (not quality!) of skilled workers, etc.

Compounding this issue, I also refer back to my study on pharmaceutical globalization (see also peer-reviewed publication). When studying the locations of pharmaceutical patent inventors since 2000, I was surprised to find that it had essentially never moved — The US, Western Europe, and Japan have and still do dominate pharmaceutical invention. This is a sobering finding for any region (either a country or even a province/state within one) seeking to improve their drug discovery output. It is notoriously hard to seed new locations.

So, where does that leave India and every other country that doesn’t have strong drug discovery? Should they simply give up? Clearly that is not a good plan, and it is also not practical because of the strong social, economic and political benefits that come from drug discovery. Rather, I think that countries seeking to develop drug discovery capacity should focus first on building foundations for drug discovery, and this is often best done by not working on drugs!

One of the problems with providing stimulus to foster novel drug development firms is that, if successful, the talent, products, and profits often move to one of the established drug development hubs. It is akin to trying to build an broadcast entertainment industry outside Hollywood or developing a sports team in a new city — if you do develop talent, much of it will be drawn to the existing hubs.

So, given that successfully developing drugs outside of existing hubs has been shown to be rare, and that any products and talent developed outside of existing hubs is also likely to relocate to existing hubs, what can be done? I think that a better approach is to focus on uniquely domestic needs, which can be later adapted to serve broader problems.

Brazil is a world leader in bioethanol production. This capacity was developed with the initial help of tax subsidies, but it also followed a natural path — sugarcane processing. In Brazil bioethanol is produced by fermentation of bagasse, which is the pulpy sugarcane plant mass left behind after sugar extraction. Because bagasse was already collected at sugar processing plants, biomass producers simply had to set up shop at the collection points. Furthermore, because bagasse is expensive to ship, it means that the bioethanol companies are likely to stay local.

To come back to the Indian example, it is important to recognize that drugs are but one way to improve health. Another way is to prevent disease. When I was in New Delhi, holidays were providing a respite from smog as farmers upwind from Delhi had temporarily stopped burning crop residues. Investments in industrial or agricultural biotechnology applications to provide alternatives to burning crop residues can improve rural employment while reducing pollution and pollution-borne illnesses. These domestic solutions are unlikely to relocate, and can build a foundation for further development in other areas, such therapeutic biotechnology.