In the last weeks, India has seen serious setbacks to its life sciences industry. The NIH recently announced that they were cancelling 40 clinical trials in India due to an ‘unstable regulatory environment’. Earlier, the UK Medicines and Healthcare products Regulatory Agency (MHRA) recalled 16 Indian drugs, citing deficiencies in manufacturing procedures.

These recent occurrences compound prior concerns over the patentability of medicines (here and here), and low drug innovation rates. Furthermore, in the recent issue of Scientific American Worldview I showed how the sum of India’s API production revenues were exceeded by the the top-selling patented drug. So, even having a focus on generic drugs is not generating substantial revenues for India.

These developments lead one to question — does India present a postive environment for biotechnology?

I am off to Taiwan for the “Asian Food and Agribusiness Conference 2013″ and then a brief stopover in Korea.

I look forward to learning more about agricultural biotechnology in the region and meeting readers while there. If you would like to meet, please contact me.

Five years ago I built a biotechnology innovation index and I have been using it since tracking global biotechnology innovation in Scientific American’s Worldview. It has been a very rewarding project, and I have enjoyed the opportunity to present my research data at international conferences, business schools, and even National Defense University.

Now, Worldview’s editor Mike May has compared my innovation scores with the Venture Capital and Private Equity Country Attractiveness (VCPECA) index. I was quite pleased to see a relatively strong correlation between my innovation index and the VCPECA index.

I am always looking for feedback on the index and opportunities to expand it. I invite you to visit the scorecard at http://www.saworldview.com/wv/scorecard/ and send me your suggestions and feedback.

Image courtesy of Biswarup Ganguly, via Wikimedia Commons

The 1980 Supreme Court decision in Diamond v. Chakrabarty established the patentability of human modifications to bacteria, and arguably laid the foundation for the biotechnology industry.

Professor Chakrabarty remains an active researcher, and is currently pursing a promising anti-cancer therapy. Given his unique perspective on patenting in biotechnology, I asked him to provide a personal perspective on the recent Myriad ruling. His commentary on patenting human genes and mutations appears as an open access paper in the latest issue of the Journal of Commercial Biotechnology.

I invite you to read Professor Chakrabarty’s commentary and sound off in the comments below.

A common challenge faced pharmaceutical industry analysts, pharmacists, and other healthcare professionals is obtaining objective information on recently approved drugs. Often the only source of information in the first months after a drug’s launch is from sales representatives who may not have access to raw clinical data.

DrugChatter fills this gap by tapping into the DrugPatentWatch database and mining social media to bring you public opinions on recently-approved drugs . DrugChatter also provides details on the most discussed drugs, and can supplement focus groups with its profiles of pharmaceutical drug ads.

I invite you to take a look at this new site in development, and let me know what you think.

This guest post is from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

Earlier this year the International Service for the Acquisition of Agri-biotech Applications (ISAAA) reported that for the first time the developing world has taken over responsibility for producing over half (52%) the commercially available Genetically Modified (GM) crops worldwide. While the majority of these seeds can be traced to Western companies, the current state of native GM research in both the African and Asia-Pacific regions are both growing and have noticeable similarities; in both areas only a handful of countries serve as the growth poles for a region with scattered levels of GM policies and research institutions.

In Sub Saharan Africa, both South Africa and Burkina Faso have been recognised in a UNDP paper as instigating modern commercial biotechnology in the region. Similarly India, China and The Philippines are credited with the quick adoption of GM crops in their regions with cotton, maize and canola being the leading crops. While social debates over GM crops echo many of the issues in the developed world, a unique complaint in the African region is the involvement of the dominant seed companies in native biotech agriculture development projects by controlling the supply of seeds, these companies can be seen to be taking over the traditionally held role of the farmer in creating the best possible crop variety. In effect, what sovereign genetic engineering there was (via breeding) in the region is being removed. In Asia problems seem to stem from the sheer variety of GM legislation levels for each country. A 2008 list compiled by APCoAB illustrates the varying extent of legislation established by governments; from India’s extensive policies covering trade and biosafety to Mongolia only offering a 2005 framework for development.

The African Panel on Biotechnology has recommended a “co-evolutionary” approach to developing biotech legislation. As Dr Adrian Ely – head of Impact and Engagement at Social Technological & Environmental Pathways to Sustainability (STEPS) Centre – explains the agricultural research group CIMMYT were “working within a regulatory vacuum” when it came to their recent efforts in Kenya. “They obviously have been working with the authorities and everything they’ve been doing is in the full knowledge of the authorities and where they’ve required licences they’ve had them. That’s an example where even in the absence of an actual law … legally sanctioned biosafety research was able to continue.”

For Africa a major factor hindering research development is the highly volatile nature of investment. In 2011 the Agricultural, Science and Technology Indicators held a conference in an attempt to pin down reasons for the low investment in Africa’s agricultural R&D. The financial culture of one-off donations and deals with development banks tend to leave research institutions nearing bankruptcy once the donor-funded project is finished was pointed out as one major factor. It was also illustrated using the “Volatility Coefficient” (the standard deviation of growth in R&D spending over a course of time) that Sub-Saharan Africa’s scattered R&D investment amongst countries created a far more volatile environment compared to the Asia-Pacific region. Two main sources of funding – government grants and the region’s remarkably higher level of donor contribution – were also found to be incredibly volatile, with the lack of transparency and income security in government and in particular the short term, ad hoc attitude to donor funding being the main factors in volatility.

In the Asia-Pacific region, both government policies and public opinion tend to provide the main difficulties in fostering a competitive R&D capacity. When discussing the challenges with BiotechBlog Dr Tom Burns, director of the Asia and Pacific Seed Association, notes that while India has had a history of success with GM cotton crops, the vocal anti-GM lobby is being successful in preventing edible GM crop research from being developed further. These protests may then prevent funding at a government level in response to the negativity. This approach manifested itself most clearly in 2004, when Bayer announced it was giving up on its efforts on commercialising crops in India, following several protests which included Greenpeace activists chaining themselves to their Indian headquarters.

Another, more pressing issue involves the restrictions on commercialising research due to the prohibitive cost of intellectual property licensing. Licensing out previous traits to include in a new GM crop strain under westernised intellectual property (IP) policies often mean that those crops developed in the African and Asian-Pacific region can be too expensive to compete in the market.

Such problems are less prevalent in India and China, the two emerging R&D centres of the region. China is less stringent on its IP policies and has benefited from constantly revising their seed policy to ensure that even small seed companies are able to flourish, curtailing the practice of a black market for seeds that bypass lengthy legislation and are grown without approval (the so-called “Stealth Seeds” that have been found in India and Argentina, among others). Active support from the Chinese government and self-tailored polices have meant that the country is now the 6^th largest producer of GM crops in the world. India’s success with GM crops (in particular GM cotton) has lead to a more commercial achievement. As stated in an ISAAA report last year, India was transformed from a net importer to net exporter of cotton since its commercial approval in 2002, and quotes a Barnes and Barfoot estimate of GM cotton adding $9.4bn to agricultural income in the 2002-2010 period alone. This seems to have encouraged regional governments in India to pursue field trials with other crops, though this has been met with the aforementioned controversy. Nonetheless India’s recent confidence in its GM crop potential has lead to a quickened pace in research centres, increased acceptance among the farming community and just this month the introduction of a bill in government aiming to quell disinformation from anti-GM groups.

Though only in its infancy, GM crop research in these countries has nontheless already produced world-class success stories. Calestous Juma, Professor of International development at Harvard University, recently illustrated the success Nigeria’s Institute for Agricultural Research in addressing a regional challenge to the black-eyed pea crop by developing their own transgenic variety. Larger-scope institutions such as the International Treaty on Plant Genetic Resources are helping to harmonise the intellectual property and biopiracy concerns to help encourage commercialisation, while the Strengthening Capacity for Safe Biotechnology Management (SABIMA) project offers support for those countries who decide to develop their biotechnology capacity. Though it may still be too early to tell in many of these cases it appears that for the countries experiencing the greatest growth in the regions, a certain degree of autonomy and relaxed intellectual property laws have helped GM research create localised solutions to crop challenges and economic strength.

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

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

Legal and regulatory update

Go to paper

ABSTRACT: The European Commission has launched a public consultation on its proposed amendments to the Medical Devices Directive (MDD) (Dir 93/42/EEC). The aim of the European Commission's proposals is to improve the coherence, transparency and effectiveness of the legislation governing medical devices in line with the recommendations of the report produced in 2002 by the European Commission's Medical Device Experts Group...

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.

In a 9-0 decision (with brief concurrence by Justice Scalia) in Association for Molecular Pathology v. Myriad (‘Myriad’), argued April 15, 2013 and decided June 13, 2013, the U.S. Supreme Court both strikes down and upholds selected gene patents. Delivered by Justice Clarence Thomas, the Court’s decision:

1. Invalidates gene patents relating to the isolated BRCA1 and BRCA2 genes on the basis that they are naturally occurring, and
2. Allows gene patents for synthetic DNA created in the laboratory and known as complementary or cDNA given that it is not identical to DNA in its natural state.

With regard to the BRCA1 and BRCA2 gene patents, Myriad patent claims identified the location and sequence of these genes in the human body and claimed the isolated DNA coding itself as the invention without any further inventive step. The holding of the Court explains why these claims fail meet the statutory requirements for patentability under the Patents Act (35 USC §101):

Myriad’s DNA claim falls within the law of nature exception. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new “with markedly different characteristics from any found in nature,” id., at 310. Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf

The Myriad decision distinguishes the BRCA1 and BRCA2 patent claims from those relating to cDNA, upholding as permissible the patenting of genetic inventions that “create or alter” genetic information, including synthetic DNA created in the laboratory and known as complementary or cDNA. The Court notes that cDNA “contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.”

The Court emphasizes the role of human agency, noting that “the lab technician unquestionably creates something new when cDNA is made.” cDNA production, though, may take place without human agency. (For example, retroviruses like HIV-1 and HIV-2 produce cDNA for integration in the host genome, a fun fact that the Myriad decision does not address.)

All in all, the Myriad decision should not adversely affect the patentability of a broad swath of gene-based inventions. The ability of a patent applicant to avoid the law of nature exception, i.e, to “create or alter” DNA – whether via cDNA or through use of plasmids – limits the prospective impact of the case.

And, while referencing USPTO past practice in issuing the BRCA1 and BRCA2 gene patents, the Court skirts the issue USPTO practice with regard to utility or inventive step. In fact, the USPTO implemented heightened utility requirements that disallowed patent applications for a newly discovered gene without a clearly demonstrated and specific use, effective January 5, 2001. This heightened utility requirement should narrow considerably the universe of gene patents affected by the Myriad decision.

Finally, Justice Scalia’s brief concurring opinion states that he is unable join in the entirety of the Court’s opinion due to lack of personal knowledge of, or belief relating to, “fine details of molecular biology.” While his candor is praiseworthy, it also underscores the clear need for continuing judicial dialogue on biotechnology, other advanced technologies and the intersection of science and commerce.

Susan K. Finston is President of Finston Consulting LLC, and, together with biotechnology pioneer Ananda Chakrabarty, is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivoresearch. She is currently preparing to launch her first Crowd Funding campaign for Amrita Therapeutics first-ever therapeutic oncology medical device. For more information see AmritaTherapeutics.com or FinstonConsulting.com.

The Nasonex Drug Ad analysis at DrugChatter.com is pretty close to even, with 40/60 split between people not liking and liking the ads. Some people find the bee ‘sexy’ and like its voice, whereas others think the bee is creepy.

What’s your opinion? Post your thoughts to twitter and get counted!

For more drug sentiment analysis, see the listings at DrugChatter.com .