Home Archives 2014

Yearly Archives: 2014

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.

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 4 2014

TradenameApplicantGeneric NamePatent Expiration
AVELOX
Bayer Hlthcare
moxifloxacin hydrochloride
Mar 4, 2014
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Bayer Hlthcare
moxifloxacin hydrochloride
Mar 4, 2014
EMEND
Merck And Co Inc
fosaprepitant dimeglumine
Mar 4, 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 February 25 2014

TradenameApplicantGeneric NamePatent Expiration
ALVESCO
Takeda Gmbh
ciclesonide
Feb 25, 2014
IMAGENT
Imcor Pharms Co
dimyristoyl lecithin; perflexane
Feb 25, 2014
MYLOTARG
Wyeth Pharms Inc
gemtuzumab ozogamicin
Feb 25, 2014
PROAIR HFA
Teva Branded Pharm
albuterol sulfate
Feb 25, 2014
PROVENTIL-HFA
3m
albuterol sulfate
Feb 25, 2014
QNASL
Teva Branded Pharm
beclomethasone dipropionate
Feb 25, 2014
QVAR 40
Teva Branded Pharm
beclomethasone dipropionate
Feb 25, 2014
QVAR 80
Teva Branded Pharm
beclomethasone dipropionate
Feb 25, 2014
XOPENEX HFA
Sunovion
levalbuterol tartrate
Feb 25, 2014
ZETONNA
Takeda Gmbh
ciclesonide
Feb 25, 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.

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