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

Biogenerics 2007: How far have we come?

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ABSTRACT: The recent approval of a follow-on version of Pfizer's Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent ‘biogenerics’ industry and the evolving regulatory framework that will shape its competition with innovator companies...

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

Kinik: Raising the stakes for importing products derived from US patented processes practised abroad

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ABSTRACT: This paper analyses the recent ruling in Kinik Co. v. Int'l Trade Comm'n, 362 F.3d 1359 (Fed. Cir. 2004), and the impact that decision may have on proceedings before the US International Trade Commission under the Tariff Act of 1930 (19 USC §1337(a)) – particularly those concerning the importation of products derived from practising US patented processes abroad.

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

The regulatory system in the EU and further afield

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ABSTRACT: The regulation of modern biotechnology began almost as soon as the potential benefits and risks became clear. In some countries a decision was made to use current law to address the new technologies, arguing that the changes that are able to be introduced into new products are not substantially different from those introduced by other techniques...

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

This 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.

Susan Kling FinstonIn the “Mystery of Capital,” Peruvian economist Hernando de Soto famously writes about the need to convert assets into capital for creation of social and economic value in developing countries and economies in transition, noting:  “Any asset whose economic and social aspects are not fixed in a formal property system is extremely hard to move in the market.”  While de Soto is describing the need to legalize informal property systems, this is equally true with respect to BRICS and other countries seeking to unlock capital resources for R&D intensive start-ups, also known as Micro, Small and Medium Enterprises (MSMEs).

The importance of creating incentives for Angel investors has been recognized as a critical factor for development of biotechnology.  As articulated by Life Sciences policy expert Michael Tremblay, PhD in describing the needs of smaller (or less developed) biotech markets:  “you’ll need to consider the economic developments that come with building a life sciences sector as you’ll need to energise high net worth individuals as angel investors to help start and run the small businesses ….”

The United States provides investment tax credits at the state and federal level that create an immediate benefit to High Net Worth Individuals (HNWIs), also known as Angel Investors, from the moment of investment in a biotechnology start-up or other high-risk technology company.  These Angels have made a huge difference for biotech entrepreneurs in recent years, pitching in where VCs increasingly fear to tread.

In contrast, the challenge of private financing for innovation remains a continuing challenge for the BRICS, in part due to the absence of similar tax credit programs to provide immediate investment incentives for HNWIs:

Angel investors are virtually absent and there remain concerns relating to tax and exchange control regulations that may impact on the risk management strategies of local fund managers.

To take the case of India, for example, the government seeks to provide incentives for R&D investment both through grant / soft loan programs (with matching requirements) and by allowing deduction of R&D expenses against revenues.  Both of these policies provide significant benefits for larger companies with established product lines, however these are not the companies that generally create market disturbing bio-pharma innovation.

Conversely, these policies do not provide as much benefit for R&D intensive MSMES, both due to the challenge of meeting stringent matching requirements, and the absence of incentives for HNWIs to invest in high-risk / high-reward start-up companies. This may be one important reason why India’s life sciences sector has been described as “Biotech without Startups,” something that sounds paradoxical to Western ears, accustomed to how biotechnology evolved from start-ups to global operations, as in recent years with Celgene and Alexion, and in the early days of the biotechnology revolution with Biogen-Idec, Genentech and Amgen.

Amgen began as a biotech start-up more than 30 years ago, with a focus on commercialization of  innovative cancer therapies that save and improve people’s lives.  including oncology therapies are effective against blood cancers, solid tumors, supportive care and more in the pipeline. In financial terms, Amgen ’s valuation exceeds $100 billion –  more than India’s pharmaceutical and biotechnology sectors combined.

With the right incentives for High Net Worth Individuals, imagine the how much social and economic value could be created in any of the BRICS by just one home-grown Amgen!

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.

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

EU Financial accounts reports

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ABSTRACT: Presents updates on the 2000 financial results of several biotechnology and pharmaceutical firms in Europe. Celltech Group Plc; ML Laboratories plc; Pharmagene plc.

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

Drug Patent Expirations for November 2014

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ATROVENT HFABoehringer Ingelheimipratropium bromide5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,335,033Nov 4, 2014
QVAR 80Teva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride5,958,452Nov 4, 2014
ZETONNATakeda Gmbhciclesonide5,683,677Nov 4, 2014
ALVESCOTakeda Gmbhciclesonide5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride5,965,161Nov 4, 2014
QVAR 40Teva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,706,281Nov 4, 2014
QNASLTeva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,743,442Nov 4, 2014
NOVOLOG PENFILLNovo Nordisk Incinsulin aspart recombinant5,626,566*PEDNov 6, 2014
APTIVUSBoehringer Ingelheimtipranavir6,169,181*PEDNov 6, 2014
INTEGRILINScheringeptifibatide5,686,570Nov 11, 2014
INTEGRILINScheringeptifibatide5,756,451Nov 11, 2014
DICLOFENAC SODIUMFalcon Pharmsdiclofenac sodium5,653,972Nov 16, 2014
DICLOFENAC SODIUMFalcon Pharmsdiclofenac sodium5,603,929Nov 16, 2014
FOSAMAXMerckalendronate sodium5,462,932*PEDNov 17, 2014
SURFAXINDiscovery Labslucinactant5,407,914Nov 17, 2014
FUZEONRocheenfuvirtide6,133,418Nov 17, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,138,524*PEDNov 18, 2014
CELLCEPTRoche Palomycophenolate mofetil5,688,529Nov 18, 2014
ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRASanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,138,524*PEDNov 18, 2014
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRASanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
PRILOSECAstrazenecaomeprazole magnesium5,690,960Nov 25, 2014
VELTINStiefel Gskclindamycin phosphate; tretinoin5,690,923Nov 25, 2014
PRILOSEC OTCAstrazenecaomeprazole magnesium5,690,960Nov 25, 2014
NEXIUM 24HRAstrazeneca Lpesomeprazole magnesium5,690,960Nov 25, 2014
NEXIUM IVAstrazenecaesomeprazole sodium5,877,192*PEDNov 27, 2014
NEXIUMAstrazenecaesomeprazole magnesium6,875,872*PEDNov 27, 2014
VIMOVOHorizon Pharmaesomeprazole magnesium; naproxen6,875,872*PEDNov 27, 2014
NEXIUMAstrazenecaesomeprazole magnesium5,877,192*PEDNov 27, 2014
SULARShionogi Incnisoldipine5,626,874Nov 30, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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

Conflict of interest in academic research

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ABSTRACT: The potential for conflict of interest in research can occur whenever a faculty member's financial interest in an industrial sponsor is sufficient to affect his or her impartiality in interpreting the results of the sponsored project. Owing, in large part, to the role of public funding of research, the appearance of a conflict of interest can be as damaging to the reputation of the investigator and/or university as an actual conflict...

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 new season for biotechnology in Europe

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ABSTRACT: Comments on the status of the biotechnology industry in Europe as of March 2002. Research system for life sciences in Europe; Changes in the European Union's (EU) policy toward biotechnology; Plans of EU for the biotechnology industry.

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

Welcome to Biotech Nation

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ABSTRACT: Welcome to Biotech NationMoira A. Gunn, PhDAMACOM, New York, NY;ISBN: 978 0814409237; 2007; 258pp; hardback

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