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

Patenting human genes and mutations: A personal perspective

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ABSTRACT:

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 December 2014

Tradename Applicant Generic Name Patent Number Patent Expiration
TRAVATAN Alcon Pharms Ltd travoprost 5,889,052 Dec 2, 2014
TRAVATAN Z Alcon Pharms Ltd travoprost 5,889,052 Dec 2, 2014
MYLOTARG Wyeth Pharms Inc gemtuzumab ozogamicin 5,693,762 Dec 2, 2014
NORVIR Abbott ritonavir 5,635,523*PED Dec 3, 2014
NOVOLOG FLEXPEN Novo Nordisk Inc insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG INNOLET Novo Nordisk Inc insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG MIX 70/30 Novo Nordisk Inc insulin aspart protamine recombinant; insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG MIX 70/30 PENFILL Novo Nordisk Inc insulin aspart protamine recombinant; insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG Novo Nordisk Inc insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG FLEXTOUCH Novo Nordisk Inc insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG MIX 50/50 Novo Nordisk Inc insulin aspart protamine recombinant; insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG MIX 70/30 FLEXPEN Novo Nordisk Inc insulin aspart protamine recombinant; insulin aspart recombinant 5,618,913*PED Dec 7, 2014
NOVOLOG PENFILL Novo Nordisk Inc insulin aspart recombinant 5,618,913*PED Dec 7, 2014
IMAGENT Imcor Pharms Co dimyristoyl lecithin; perflexane 5,695,741 Dec 9, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 5,919,832*PED Dec 10, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 6,433,026*PED Dec 10, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 5,607,669*PED Dec 10, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 6,066,678*PED Dec 10, 2014
OFEV Boehringer Ingelheim nintedanib 6,762,180 Dec 10, 2014
RELENZA Glaxosmithkline zanamivir 6,294,572 Dec 15, 2014
IONSYS Incline Therap fentanyl hydrochloride 5,697,896 Dec 16, 2014
SANDOSTATIN LAR Novartis octreotide acetate 5,639,480*PED Dec 17, 2014
TRAVATAN Alcon Pharms Ltd travoprost 5,631,287 Dec 22, 2014
TRAVATAN Alcon Pharms Ltd travoprost 5,849,792 Dec 22, 2014
TRAVATAN Alcon Pharms Ltd travoprost 6,011,062 Dec 22, 2014
LETAIRIS Gilead ambrisentan 5,703,017 Dec 30, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
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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

Tradename Applicant Generic Name Patent Number Patent Expiration
ATROVENT HFA Boehringer Ingelheim ipratropium bromide 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,335,033 Nov 4, 2014
QVAR 80 Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 5,958,452 Nov 4, 2014
ZETONNA Takeda Gmbh ciclesonide 5,683,677 Nov 4, 2014
ALVESCO Takeda Gmbh ciclesonide 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 5,965,161 Nov 4, 2014
QVAR 40 Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,706,281 Nov 4, 2014
QNASL Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,743,442 Nov 4, 2014
NOVOLOG PENFILL Novo Nordisk Inc insulin aspart recombinant 5,626,566*PED Nov 6, 2014
APTIVUS Boehringer Ingelheim tipranavir 6,169,181*PED Nov 6, 2014
INTEGRILIN Schering eptifibatide 5,686,570 Nov 11, 2014
INTEGRILIN Schering eptifibatide 5,756,451 Nov 11, 2014
DICLOFENAC SODIUM Falcon Pharms diclofenac sodium 5,653,972 Nov 16, 2014
DICLOFENAC SODIUM Falcon Pharms diclofenac sodium 5,603,929 Nov 16, 2014
FOSAMAX Merck alendronate sodium 5,462,932*PED Nov 17, 2014
SURFAXIN Discovery Labs lucinactant 5,407,914 Nov 17, 2014
FUZEON Roche enfuvirtide 6,133,418 Nov 17, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,138,524*PED Nov 18, 2014
CELLCEPT Roche Palo mycophenolate mofetil 5,688,529 Nov 18, 2014
ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,138,524*PED Nov 18, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
PRILOSEC Astrazeneca omeprazole magnesium 5,690,960 Nov 25, 2014
VELTIN Stiefel Gsk clindamycin phosphate; tretinoin 5,690,923 Nov 25, 2014
PRILOSEC OTC Astrazeneca omeprazole magnesium 5,690,960 Nov 25, 2014
NEXIUM 24HR Astrazeneca Lp esomeprazole magnesium 5,690,960 Nov 25, 2014
NEXIUM IV Astrazeneca esomeprazole sodium 5,877,192*PED Nov 27, 2014
NEXIUM Astrazeneca esomeprazole magnesium 6,875,872*PED Nov 27, 2014
VIMOVO Horizon Pharma esomeprazole magnesium; naproxen 6,875,872*PED Nov 27, 2014
NEXIUM Astrazeneca esomeprazole magnesium 5,877,192*PED Nov 27, 2014
SULAR Shionogi Inc nisoldipine 5,626,874 Nov 30, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

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