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

Embryo and stem cell research: Views from the USA

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ABSTRACT: Presents a study that examined the history, ethical debates and religious views regarding embryo and stem cell research in the U.S. Effect of the abortion debate on embryo research in the U.S.; Reason behind the reluctance of the federal government to fund therapeutic research; Role of the private sector in the development of embryo and stem cell research.

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.

My maiden guest post for the Biotechblog last focused on the global impact of reduced funding for innovative bio-pharma development on clinical research and the threat to the global clinical research enterprise.   At that point the clinical research sector in India looked like an outlier with year-on-year increases in clinical trials and revenues projected to grow from $450 million in 2011 to $1b by 2016.  Now as we approach the end of 2013, that rosy scenario appears increasingly unrealistic.  India’s clinical research sector faces an uncertain future, with allegations including lack of informed consent and poor treatment of illiterate Indian patients.

Responding to civil society allegations of corruption and fraud, the Indian Supreme Court has intervened directly in the conduct of clinical research in India, suspending or freezing hundreds of clinical trials.  While it is tempting to put the blame for lax enforcement of standards on the recent influx to India of MNC clinical trials, India’s Parliamentary Standing Committee on Health and Family Welfare identified similar shortcomings in oversight of both domestic Indian companies and MNCs alike, going back several years in time.

Well ahead of the Indian Supreme Court decisions in 2013, the Parliamentary Standing Committee reported in May of 2012 that  the Central Drugs Standards Control Organization (CDSC) – the primary watchdog responsible for drug safety and related clinical research – had long since been captured by the industry it was charged with regulating:

The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured. p. 9  

The Parliamentary Standing Committee cited systematic fraud, for example, in the case of Cipla’s application for approval of cancer drug Pirfenidone.  The Committee concludes that Cipla never undertook the required Phase III clinical trial in India, and yet the company received marketing approval nonetheless.

Not only the regulators, but Indian academics and specialist hospital physicians are also compromised in the process.  The Committee’s report to the both chambers of Parliament continues, documenting that the company coordinated or otherwise controlled simultaneous submission 4 separate letters of recommendation of approval from institutions located in Delhi, Mumbai, Chandighargh and Secunderabad – all received exactly on the same day 2-7 2010 and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880.” (p. 34)

(In October of 2010, Cipla issued a glowing press release announcing the launch of the “World’s First Generic Pirfenidone in India, Giving Hope to Suffers of IPF (Idiopathic Pulmonary Fibrosis)”  Despite the strong documentation presented to both Houses of Parliament supporting the contention that the Cipla did not conduct any clinical trials at all prior to approval of this first generic copy of a serious cancer drug, it remains on the market in India and internationally via Canadian online pharmacies – caveat emptor.)

Now the India Supreme Court process has taken matters to the other extreme, creating onerous and unrealistic new clinical research requirements and freezing clinical research in India, far exceeding requirements under the  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, known as ICH. These include mandatory compensation requirements for patients, and use of audio and visual recordings of informed consent, among others.  Paradoxically, by imposing more stringent obligations than exceed ICH standards, the Indian Supreme Court rulings further reduces the likelihood that India can build needed capacities for ethical clinical research in compliance with international compliance.

In this context,  a clinical research advocacy group known as: People for the Advancement of Clinical Research – India, has lodged an online petition at Change.org and petitioning Supreme Court of India: “Allow the Review and Approval Process for Clinical Trial Applications to Resume.” The Change.org petition provides compelling reasons for the continuation of clinical trials in India – identifying the existing standards and the extraordinary new measures now required under the recent Indian Supreme Court decisions.  Everything in the petition is both true and  yet sadly irrelevant given what we know to be the unfortunate ground realities documented by the 2012 Parliamentary Standing Committee report.

The Change.org petition seeks to reinstate the status quo ante without any serious reflection on how things have gone wrong, or suggestions on how to change a drugs development culture that tolerates cutting of corners and even outright fraud.  All good intentions aside, Indian academics, industry and government agencies together have shown remarkable effectiveness at evading and undermining India’s compliance with ICH standards.

The Indian Supreme Court may have got it wrong, but the Change.org petition does not get it right.

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 November 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
SAMSCAOtsuka America Pharmtolvaptan5,258,510Nov 2, 2013
PROPECIAMerckfinasteride5,571,817Nov 5, 2013
ACIPHEX SPRINKLEEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
ACIPHEXEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
TECHNESCAN MAG3Mallinckrodttechnetium tc-99m mertiatide kit5,573,748Nov 12, 2013
EXPARELPacira Pharms Incbupivacaine6,132,766Nov 16, 2013
SURFAXINDiscovery Labslucinactant5,407,914Nov 17, 2013
SUSTIVABristol Myers Squibbefavirenz5,519,021*PEDNov 21, 2013
ATRIPLAGileadefavirenz; emtricitabine; tenofovir disoproxil fumarate5,519,021*PEDNov 21, 2013
JEVTANA KITSanofi Aventis Uscabazitaxel5,438,072Nov 22, 2013
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALINIARomarknitazoxanide5,578,621Nov 26, 2013
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALLEGRASanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ZOLINZAMerckvorinostatRE38506Nov 29, 2013
*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.

With prior BiotechBlog intern Fintan Burke moving on to some exciting new projects, I have time to train a few more aspiring writers.

(Professionals seeking to submit guest posts to BiotechBlog or to the Journal of Commercial Biotechnology should visit the Publishing Opportunities page).

Prospective interns are advised to see Fintan’s contributions and the other guest content. The schedule and deliverables are flexible, to accommodate your school schedule.
To apply for a BiotechBlog internship please send me writing samples, your resume, and a statement of interests to info@thinkbiotech.com.

Ananda Chakrabarty is the holder of the first patent on a genetically-modified organism. Lately he’s turned his sights to a revolutionary new approach to cancer treatment — utilizing proteins from naturally-occuring symbiotic bacteria. These exploits are described in his new book, Bugging Cancer.

For centuries mankind has been intimidated by cancer, and research has been going on for many decades as to how to address or attack the disease meaningfully so as to eradicate it. But the causes of cancer are so diverse in nature that it is extremely difficult to predict or to control the conditions, let alone fully cure it.

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, any anyone else interested in healthcare and scientific innovation.

Interested media outlets should contact me for a review copy, and readers can fill out the form below for notification on publication (due February 2014):

Notify me when the book is published


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

Cancer remains the dominant disease target for biotech through to 2010

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ABSTRACT: The two leading therapeutic areas for biological products, in terms of current sales and pipeline focus, are oncology and AIID (arthritis, immune and inflammatory disorders). Datamonitor's biotechnology strategic market analysis team recently analysed the AIID market, since this sector is currently powering biotechnology market growth, owing to high demand for biologicals to treat rheumatoid arthritis and psoriasis (Belsey, M...

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

The fourth edition of Building Biotechnology, the premier biotechnology industry primer, is slated for publication in December and is ready for reviewers.

Building Biotechnology has been adopted by dozens of educational programs, and is on the nightstands of many biotech CEOs. The book covers a broad range of essential knowledge in business, regulations, patents, law, policy, and science.

This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

Interested media outlets should contact me for a review copy, and readers can fill out the form below for notification on publication (due December 2013):

Notify me when the book is published


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 Finston

In what can only be described as a slow news period for pharma IP policy, the arcane yet important issue of patent linkage has resurfaced in not once but twice in the last week – relating to the recently completed EU/Canada FTA and in the ongoing cut and thrust of Indian pharma IP policies. These mentions – in both cases implying that the policy unfairly prejudices generic producers –  shed more heat than light on a topic critical to the innovative bio-pharma industry.  So this posting will attempt to clarify the concept of patent linkage: what it is, why it matters as an IP norm,  and how patent linkage has been implemented across regions.

First to define patent linkage: when a company receives a patent for a pharmaceutical invention that is found to be novel, non-obvious and to have a commercial application, the conventional bundle of rights that goes along with the patent includes the right to exclude others from commercializing the patented invention. To ensure that outcome for highly regulated products requiring marketing approval by government agencies, patent linkage connects the marketing approval process for a product to its patent status, ensuring return on investment by preventing entry of infringing products during the limited patent period.

In effect, without patent linkage, the grant of patents for pharmaceutical products cannot assure any exclusivity in the market, and so advanced developing and developed countries with well-functioning patent systems have also made an effort to implement patent linkage.

Among the BRICS, perhaps the most predictable system is found in South Africa, where the Medicines Control Council (MCC) accepts generic manufacturing applications prior to the expiration of patent protection, consistent with the country’s ‘early working’ exception to patent protection that does not permit manufacturing or warehousing of products for launch of infringing generic products during the period of patent protection. At the time of WTO accession, Russia also committed to providing notifications to innovators of generic applications for marketing approval, for any subsequent applications lodged during the six-year period of data exclusivity in force in the Russian Federation. (Implementation of the Russian policy remains to be seen, however.) Although similar in design to the US approach, the Chinese Patent Linkage policy has been characterized by information gaps relating to registration applications and patent databases, so it has been helpful at times, yet inconsistent.  While there is no formal patent linkage in Brazil, injunctive relief for patent holders is widely available in the country’s judicial system. Accordingly, stakeholders have opportunities for redressal through access to the courts, either before or after the entry into the market of infringing products, though still suffering substantial injury from patent infringement in the process. India famously has neither a patent linkage system nor a work-around in terms of timely access to the courts to prevent market entry for openly infringing product.

The US Patent Linkage system seeks to promote a high level of transparency through publicly accessible online databases that list existing patents. The system also requires that marketing approval applications include a declaration relating to the patent status to the patent holder to enable timely private enforcement of patent rights.  The US Food and Drug Administration (FDA) maintains an online database of pharmaceutical products under patents – Approved Drug Products with Therapeutic Evaluation Equivalents, known familiarly as “the Orange Book.” (The Electronic Orange Book is available via the internet at: http://www.fda.gov/cder/ob/)

The EU also provides a very high degree of predictability for right holders through the effective operation of up to 11 years of data exclusivity that provides patent linkage by proxy across the EU. Both early working and expanded data exclusivity periods were introduced under the Future of Medicines Law (FML), where the 10 – 11 year data exclusivity term may be co-extensive with the remaining patent protection period at the time of product launch. Accordingly, data exclusivity operates as a proxy for formal patent linkage for patent holders, and innovators enjoy effective protection against registration of potentially infringing pharmaceutical products during the patent period.

Canada’s Patent Register, generally equivalent to the U.S. “Orange Book,” lists patents relevant to approved pharmaceutical products. Under the Patented Medicines (Notice of Compliance) Regulations, Health Canada requires that applicants seeking marketing authorization for a generic product address the status of all listed patents for that particular product, and provides an expeditious legal process for review of claims of potential infringement. In addition, following Canada’s loss before the tribunal in the 2000 WTO dispute settlement panel decision barring advance manufacturing and ‘stockpiling’ of generic versions of patent-protected products, Canada amended its patent law to bar commercial scale manufacturing of any generic product during the period of patent protection, providing another safety valve to prevent infringement of innovative products during the period of patent protection.

All in all,  patent linkage has become an IP norm, adopted in one fashion or another by most of the BRICS, the US, EU and Canada, among others.  Given its fundamental importance to prevent routine infringement of patent rights, and the validation by  the WTO’s 2000 panel ruling against Canada (stockpiling), how weird is that?

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

Forecasting new product revenues

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ABSTRACT: This paper discusses real-life experiences in developing revenue forecasts for biopharmaceutical clients. The importance of forecasts based on emerging information about the product, market conditions and the competitive landscape is emphasised.

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 October 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
OMNISCANGe Healthcaregadodiamide5,560,903Oct 1, 2013
ELOXATINSanofi Aventis Usoxaliplatin5,338,874*PEDOct 7, 2013
LYRICAPf Prismpregabalin5,563,175Oct 8, 2013
RESCRIPTORViiv Hlthcaredelavirdine mesylate5,563,142Oct 8, 2013
RAXAROtsukagrepafloxacin hydrochloride5,563,138Oct 8, 2013
JENLOGAConcordia Pharms Incclonidine hydrochloride5,869,100Oct 13, 2013
KAPVAYConcordia Pharms Incclonidine hydrochloride5,869,100Oct 13, 2013
PROPECIAMerckfinasteride5,547,957Oct 15, 2013
STALEVO 100Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
STALEVO 150Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
COMTANOrion Pharmaentacapone5,446,194Oct 19, 2013
STALEVO 50Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
STALEVO 125Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
STALEVO 200Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
STALEVO 75Orion Pharmacarbidopa; entacapone; levodopa5,446,194Oct 19, 2013
LOTEMAXPharmosloteprednol etabonate5,540,930Oct 25, 2013
MACUGENValeant Pharms Llcpegaptanib sodium6,113,906Oct 27, 2013
MACUGENValeant Pharms Llcpegaptanib sodium5,919,455Oct 27, 2013
BACTROBANGlaxosmithklinemupirocin calcium5,569,672Oct 29, 2013
YAZBayer Hlthcaredrospirenone; ethinyl estradiol5,569,652Oct 29, 2013
YASMINBayer Hlthcaredrospirenone; ethinyl estradiol5,569,652Oct 29, 2013
*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.