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Yearly Archives: 2014

2013 and 2014 have been very good for biotechnology public markets. 35 biotechnology companies went public in 2013, and well over a dozen have gone public in the first few months of 2014.

nasdaq-biotech-index-1m

Figure 1: Nasdaq Biotech Index since February 1 2014

With the surge in public launches, one must ask the question: “How long can it last?”

Just a few days ago Barrons’s cautioned about a potential bubble, and as Figure 1 (courtesy of MSN Money) shows, recent drops have effectively wiped out NASDAQ biotechnology industry gains since February 1st of this year.

While this quick rise and fall of value may be sobering, long-term value investors should take some comfort in the bigger picture. The recent IPOs enabled many companies which had been sitting on the sidelines for years to raise public cash and to offer exit opportunities to investors — both of which will support future growth in the sector, and the NASDAQ biotechnology index has generally been on a tear for the past five years (Figure 2).

Nasdaq biotechnology index March 2004 - March 2014

Figure 2: Nasdaq biotechnology index March 2004 – March 2014

So, the short-term question remains — is this a short-term correction, a closing of the IPO window, or the start of a larger correction?

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for March 13 2014

TradenameApplicantGeneric NamePatent Expiration
KALETRA
Abbvie
lopinavir; ritonavir
Mar 13, 2014
NORVIR
Abbott
ritonavir
Mar 13, 2014
NORVIR
Abbvie
ritonavir
Mar 13, 2014

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for March 10 2014

TradenameApplicantGeneric NamePatent Expiration
IMITREX
Glaxosmithkline
sumatriptan
Mar 10, 2014

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for March 7 2014

TradenameApplicantGeneric NamePatent Expiration
EXUBERA
Pfizer
insulin recombinant human
Mar 7, 2014

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

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.

Have you heard the urban legend about Egypt’s compulsory license for Viagra, following declaration of a national emergency for erectile dysfunction?  Its a whale of a tale, combining crony capitalism, low-quality generics, and a fun therapeutic category.

Just one problem – it never actually happened.

The facts are these:

  • In early October 2002, the New York Times published an article highlighting the recent passage of Egypt’s new intellectual property law, including updated patent law provisions intended to bring Egypt into compliance with its World Trade Organization (WTO) patent obligations by 2005.
  • The same article went on to say that an identified MOH official had issued a statement to the effect that it would soon authorize copy-cat products for Pfizer’s recently approved Viagra, noting that the patent law was not yet in place.
  • As rejoinder, the NYT also quotes Egyptian IP expert (and my friend) Karem el-Helaly, who stated that while the patent amendments were not yet in place, “Viagra is entitled to data exclusivity protection under Egyptian law for five years after its market authorization.”

What does this mean?

There was no pharmaceutical compulsory licensing in Egypt – then or now.

In fact, by mid-2002 Egypt had implemented data exclusivity to protect the commercially valuable clinical dossiers lodged by companies with any application for marketing approval.  The IP Amendments included a number of lacunae and compulsory licensing provisions that gave industry heartburn, to be sure, but were passed more than 3 years ahead of the deadline.

While Egypt’s early implementation of its data protection obligations suffered from occasional  (and not uncommon) backsliding, in this case it turned out the MOH official had spoken out of turn, and was not expressing official Egyptian policy.  Following consultations between the Egyptian Ministry of Commerce, the Pharmaceutical Research & Manufacturers of America (PhRMA), and the two governments, the Government of Egypt renewed its commitment to provide the required  protection for pharmaceutical clinical dossiers.

Recognizing the progress made in Egypt through passage of the IP Amendments in 2002, the PhRMA 2003 “Special 301” submission to the US Trade Representative recommended that Egypt be promoted from the “Special 301” Priority Watch List to the Watch List, and supported continuing U.S. technical assistance to ensure implementation of the patent amendments and full exclusivity for clinical dossiers.

However, the New York Times article spawned an enduring urban legend. The tale of Viagra compulsory licensing has become a world traveler, lately cited in an Indian Op-Ed taking comfort that at least India’s compulsory license issued against Bayer was for Nexavar (cancer therapy) and not for Viagra, like in Egypt.   As Mark Twain wrote, “A lie can travel half way around the world while the truth is putting on its shoes.”

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.

bioentrepreneurship-bootcampThe back-issues of the Journal of Commercial Biotechnology more than five years old are now free. For complete access, see the  archives at http://commercialbiotechnology.com/issue/archive.

The Journal of Commercial Biotechnology, in print since 1994, is the definitive international quarterly publication for bioscience business professionals. The Journal is designed specifically for those professionals who need to enhance their knowledge of biotechnology business strategy and management, improve and advance their product development or want to keep up-to-date with current issues and industry trends. It has been described as a “Harvard Business Review for biotechnology companies.”

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

At the time of this posting, volume 15 number 1 and older are free. Check them out at http://commercialbiotechnology.com/issue/archive .

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

Go to paper

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

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for March 2 2014

TradenameApplicantGeneric NamePatent Expiration
EVISTA
Lilly
raloxifene hydrochloride
Mar 2, 2014

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

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.