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bioentrepreneurship-bootcampThe Journal of Commercial Biotechnology announces the publication of the July 2013 issue, featuring new papers on biotechnology management and commercialization.

Journal of Commercial Biotechnology Vol 19, Issue 3 (2013)

Patenting human genes and mutations: A personal perspective
Ananda Mohan Chakrabarty
Full details at the Journal of Commercial Biotechnology

The polyvalent scientist: the added value of management training
Maria Theodosiou, Arsia Amir-Aslani
The PhD is becoming more and more prevalent as a degree. However, PhD students are not adequately prepared for careers outside academia and most of them have trouble translating their skills to the job market. The biotech sector is a science-driven industry that is now mature and flourishing and requires business leaders that are technically trained…
Full details at the Journal of Commercial Biotechnology

A Role for Virtual Biotechnology Companies in Drug Discovery and Development?
Dianne Nicol, Johnathon Liddicoat, Christine Critchley
The orthodox business model of many drug discovery and development companies centres on adding value to early-stage discoveries prior to engaging with large pharmaceutical companies to bring products to market. Anecdotal observations suggest some companies are moving to a ‘virtual’ business model – instead of employing in-house scientists, a skeletal management team runs the company and out-sources all research and development…
Full details at the Journal of Commercial Biotechnology

The role of specialization in mutual fund investment strategies: An exploratory study of the life sciences industry.
Osne Frans Kirzner, Lorraine Marie Uhlaner
This paper explores possible differences in investment strategies between specialty and non-specialty funds in the life sciences industry…
Full details at the Journal of Commercial Biotechnology

Culture and the Principles of Biomedical Ethics
Kola Abimbola
This paper examines the roles of culture in the principles of biomedical ethics.  Drawing on examples from African, Navajo and Western cultures, the paper maintains that various elements of culture are indispensable to the application of the principles of biomedical ethics. Full details at the

The relevance and importance of business development and licensing in the biopharmaceutical industry.
Roger Davies
The importance of the business development and licensing (BD&L) function in the global biopharmaceutical industry has grown significantly over the past 20 years as pharmaceutical companies have sought to supplement their internal R&D with innovative products and technologies sourced from biotechnology and drug delivery companies…
Full details at the Journal of Commercial Biotechnology

Patent Licensing Considerations for Biologics under the BPCIA
Sheila Swaroop, Carol Pitzel Cruz
Full details at the Journal of Commercial Biotechnology

Evergreening patents: The Indian Supreme Court rejects patenting of incremental improvements
Joanna Brougher
On April 1, 2013, the Supreme Court in India handed down its decision to dismiss Swiss drug maker Novartis AG’s attempt to win patent protection for its cancer drug Glivec…
Full details at the Journal of Commercial Biotechnology

The life sciences industry and the changing IP landscape
Gareth Williams
This article looks at the findings of Marks & Clerk’s 2013 Life Sciences Report, launched in April 2013. Of interest to both R&D/IP experts and professionals in strategic positions within biotechnology companies, it explores many of the issues facing the biotechnology industry and is informed by an industry survey of over 330 international life sciences professionals…
Full details at the Journal of Commercial Biotechnology

EU Legal & Regulatory Update
Ewan Grist
Full details at the Journal of Commercial Biotechnology

Book Review: The crowdfunding revolution: How to raise venture capital using social media
Steven S. Ma
Full details at the Journal of Commercial Biotechnology

DrugChatter - How do people like their drugs?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 6th 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 .

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

Legal and regulatory update

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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.

Susan Kling FinstonIn 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.

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

The evolving concept of value add in university commercialisation

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ABSTRACT: Universities have been challenged to assess what value creation means to them against a complex backdrop of changing markets and funding priorities. In response, universities and their partners are creating new paradigms in value creation. This paper seeks to demonstrate and to celebrate the flexibility and cutting-edge approaches that have been adopted within the UK university sector.

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 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.

While the dust has settled on the oral hearings of Association for Molecular Pathology (AMP) v Myriad (read our report here), the Supreme Court has yet to deliver its verdict in light of those hearings on April 15th. AMP’s argument against Myriad’s claim on the BRCA gene for its cancer diagnostic test was heavily reported, with amicus briefs by James Watson and the US Solicitor General  emphasising the gravity given by the US government and scientific communities alike. The case is notable by many in regards to both the fundamental question posed (“Are genes patentable?”) and its implications for the commercial future of personalised medicine.

The case comes in light of two previous cases that addressed diagnostic claims head on. In re Bilski was a US Federal Circuit Court of Appeals decision backed by the US Supreme Court which reiterated that if you need a machine to do some process, or doing that process changes one thing into another, then the process is patentable under Section 101 of the Patent Act (the “Machine or Transformation Test”). The second case, Mayo v Prometheus, gave the controversial decision that a newly discovered law of nature is unpatentable, with its application in a process also unpatentable if there is nothing new introduced into the art.

Dr Eli Loots, a partner in the San Francisco IP law firm Knobbe Martens, does not consider the Prometheus case beneficial to this one.

The court had a variety of reasons for disliking those claims. The claims defined a method but it didn’t require, necessarily, the invention itself in that particular scenario. You could definitely see many people struggling with the fairness of that issue. That can happen any time you have a litigation where one side is being very aggressive on their claim interpretation. This follow-on case is in my mind – and I think in many more practitioners’ minds – are much more telling of the future; of diagnostics in particular and biotech generally.

One source of difficulty for this case, says Loots, is the idea of defining invention in the science world.

At some level you just can’t see a lot of these inventions. You need years of training to understand what these building blocks are made out of. Are they actually there? You can get an expert up there and say ‘well these electrons are distributed on a probability function’ and everybody’s going to fall asleep! Because of that, what biotech has done in the past is to define things functionally… what ends up happening is it appears from the functional language that you have a new, non-obvious invention, but it also appears that you have some really broad claims that may encompass more than people originally envisioned.

From a legal point of view, the biggest cause of concern is the attack on the patent under Section 101, which sets out what is and is not patentable subject matter. During the oral hearing itself, Chief Justice Roberts was heard to ask whether the whole case would not be better off examined under the ‘previously non-obvious’ clause that makes up Section 103. One attorney of a high profile Californian firm (who did not wish to be named) agreed with this suggestion. “They were really just saying ‘you isolated the gene out of the body and you did some things to it but all those steps you did were not novel. They were obvious. They’ve been done before, so you shouldn’t get a patent.’ And a lot of the commentators said ‘well that’s a 103 argument, that’s not a 101 argument.’”

He also explains lifting the patent could damage investment and innovation in the field, though could also lower the price for consumers and offer second opinions. Friend-of-the-court briefs from both sides of the argument echo the ramifications of ruling whether or not genes are patentable. The Biotechnology Industry Organisation stated that “The PTO has been granting patents on isolated DNA molecules for thirty years” and that “modern biotechnology industry has developed and flourished under this regime of consistent protection.” A lift in genetic IP protection may see generic gene diagnostics flooding the market, making the field undesirable for investors. Meanwhile an amicus filed by The Nation Woman’s Health Network et al states “Because Myriad’s patents give them a monopoly on genetic testing for breast and ovarian cancer in the United States … physicians in our country cannot give second opinions regarding a diagnosis for the disease.”

The attorney also considers the previous Mayo v Prometheus case, which got several mentions in this case’s oral hearings, to have underperformed in clearing up patentability matters. “A lot of us in the field think that the Supreme Court sort of muddled the Prometheus opinion. If you read it you’ll see there’s an awful lot of references to obviousness and 103 and that’s probably how they really decided it. Under the guise of ‘you can’t patent mental operations’ is what Prometheus essentially said. But really they were saying ‘and everything else that was part of that was obvious.’”

“Every disinterested observer I talked to thought the Prometheus patent was really, really crappy—outrageous, and a huge mistake by the USPTO” says John Conley, Kenan Professor of law at the University of North Carolina when contacted. “In Myriad, I suppose it’s possible that the court will say, let obviousness handle it, but I think they’ll make a decision under 101.” Continuing his comment on his blog at genomicslawreport.com he notes “What difference will it make? If the Supreme Court invalidates genomic DNA patents, it will be seen as a win by the growing personalized medicine industry. Companies using isolated genomic DNA to screen patients at multiple gene loci will no longer have to worry about whether the genes they are testing are patented—though the industry hasn’t seemed terribly worried about that problem thus far.”

The court is expected to give its decision within the next month.

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 .

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

Strategies for improving communication between scientists and the public

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ABSTRACT: It is believed that a scientifically literate society benefits the national economy by improving the workforce and raising consumer awareness by helping people appreciate and support scientific advancement. Traditionally, communication between scientists and the public has been viewed as unidirectional, with an 'expert' scientist bestowing information on a recipient perceived to be largely passive and unquestioning...

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