Bio Lex Tech

This Blog is No longer in service....calls are being taken at...

2004-10-27T07:51:00.000-07:00

I know this is flip flopping at its worst, and confusing, but I have decided to bite the bullet and close down this blog in favor of resuming the Life Science Lawyer blog covering the same material. I believe the title more clearly relates what the blog is about. Please accept my apologies for any confusion and inconvenience.

Scientists Warn of Bioweapons Threat

2004-10-26T11:21:00.000-07:00

From Europe AP via Yahoo! News:

"The threat from biological weapons has outstripped that from chemical and nuclear arms because of the 'riotous' progress of biotechnology, according to a British report.

If those advances of biotechnology remain unchecked, they could be abused by terrorists to target specific ethnic groups and recreate devastating diseases such as the 1918 Spanish flu, according to the author of the report for the British Medical Association, or BMA.

Genetically-engineered anthrax and a synthetic version of the polio virus are among the potential biological weapons that could cause havoc..."

Biometrics In The Mainstream

2004-10-25T09:54:00.000-07:00

From industryclick:

"Not so long ago, biometric suppliers tended to provide uncustomized “black boxes” with unchanging components. Now, more biometric suppliers are scrapping the mystery box approach for a two-tier structure, with some companies providing specialized components and others devising complete systems from these targeted elements...

Providers say the biometric industry is following a traditional — and reassuring — path toward maturity, with a few atypical accelerators. Use of biometric systems by government agencies, and in core industries such as banking, healthcare and even travel, has led to more acceptance of the concept of biometrics...

More severe motivators such as domestic terrorism and widespread identity theft have also pushed the issue of identity to the forefront and reemphasized the importance of protective measures to the general public as well as to the corporate world..."

Open Source Good Match for Pharma?

2004-10-23T17:27:00.000-07:00

From MSNBC

"Pharmaceuticals represent one new and surprising area where freely shared innovation is catching on. Most industry profits have been made from expensive patented drugs. But now the BioBricks project at MIT is trying to establish standardized tools and processes for research. That way, researchers from everywhere can contribute.

Open innovation also makes sense in industries where patents aren't relevant—for example, finding new uses for existing drugs. Eric Von Hippel, MIT's head of innovation and entrepreneurship, is studying FDA applications since 1998 for these so-called off-label uses of patented drugs to see whether, as he suspects, they come mostly from independent researchers rather than the big drugmakers holding the original patents. If they do, it means open-source innovation is already well underway."

Door Open to U.S. India Collaboration

2004-10-22T08:47:00.000-07:00

From gulfnews.com:

"A senior US official met Indian foreign ministry officials yesterday to discuss cooperation in advanced technology, nearly a month after Washington lifted curbs on high-tech defence exports to India, a US official said.

The two countries have identified four sectors for potential collaboration: biotechnology, nanotechnology, advanced information technology and defence technology."

India, China in Biotech Race

2004-10-21T13:54:00.000-07:00

From BusinessWorld Online:

"Asian giants India and China are accelerating investment in biotechnology research to fight the odds in agriculture and feed their teeming millions, say scientists and officials.

Scientists at a workshop in one of Indias biggest gene research centres in Patencheru in southern Andhra Pradesh state said China and India accounted for more than half the developing world's expenditure on plant biotechnology.

Margarita Escaler of the United States-based International Service for the Acquisition of Agri-Biotech Applications said the Asian giants were putting the emphasis on genetically modified (GM) seeds and technology to ensure their billion-plus populations have enough to eat. "

Advice for partnering with pharma

2004-10-21T09:45:00.000-07:00

From Bioentrepreneur:

"As big pharmas fall over each other to proclaim themselves the 'partner of choice' for biotechs, there are still some lessons the younger sibling can learn.

A brief survey of the world's largest pharmaceutical companies reveals their changing attitude towards collaborating with biotech firms. At recent conferences and meetings, it seems that pharmas have been fighting to position themselves as the most biotech-friendly.

This change in pharma's attitude reflects a shift in the dynamic between the old giants and the younger biotech sector. Pharmas are becoming increasingly more reliant on licensing products from biotechs to fill their pipelines, and the terms of deals are becoming more complicated and, in some cases, more favorable to the biotech partner. But as more and more biotech companies emerge to sell their wares, there are some things a startup should note to rise above the din."

Greenpeace Challenges Stem Cell Patent

2004-10-21T07:53:00.000-07:00

From The Scientist:

"The German arm of the environmental lobby group Greenpeace is disputing a patent awarded earlier this year to a leading researcher on the grounds that it allows the commercial exploitation of human stem cells.

The organization filed a notice of opposition with the German Patent Office on Wednesday (October 20) against a patent granted in May to Oliver Brustle from the University of Bonn. The patent covers a cell culture method related to a process for deriving neural cells from embryonic stem cells."

Privacy Concerns Raised over FDA’s Approval of Medical Data Chip

2004-10-21T07:39:00.000-07:00

From Lawsof.comreferrring to an article from MercuryNews.com:

"The United States Food and Drug Administration (“FDA”) approved last week a small computer chip for implantation in a patient’s arm that can store a patient’s medical history. When a scanner passes over the chip, the dormant chip can release the patient-specific information to doctors and hospitals and therefore speed care. Despite the benefits of this device, FDA’s approval of the chip has raised privacy concerns. Privacy rights advocates argue that privacy protection measures should be put in place at the outset in order to avoid harmful consequences to patients. One such measure is to ensure that the devices reveal only vital medical information."

Do drug patents can stifle innovation in poor nations?

2004-10-18T11:39:00.000-07:00

From SciDev.Net:

"Most drug discoveries are made by public institutions. Private pharmaceutical companies, however, generally take over the development and commercialisation of the drugs, filing numerous patents in the process. In recent years, cumulative innovation — the development of products based on earlier discoveries — has meant that more and more patents are being registered.

This "privatisation of science" has been accelerated by shortcomings in the patent system, says Carlos María Correa, director of the Centre of Interdisciplinary Studies of Industrial and Economic Law at the University of Buenos Aires. Writing in the Bulletin of the World Health Organisation, Correa says large drug companies have exploited the patent system using strategies he calls 'blanketing', 'fencing', 'surrounding' and 'flooding'. All of these involve the registration of large numbers of patents.

By using patents "offensively" to block potential competitors, drug companies can inhibit innovation, says Correa. He says this is especially worrying in developing countries where competition laws are weak or poorly enforced. Developing nations need to design and implement patent laws that prevent strategic patenting and which promote competition and access to medicines, Correa concludes."

Painful Withdrawal for Merck, Maker of Vioxx

2004-10-18T09:48:00.000-07:00

From the washingtonpost.com (free registration required).

"...On Sept. 30, the company would take the dramatic step of withdrawing the drug, sending the price of its stock into a steep slide that wiped out a quarter of the company's value, a slide from which it has not yet recovered.

An examination of how and why Merck reacted offers an unusual look at how safety issues are handled in clinical trials once a drug is on the market and the complex business of weighing risks against benefits. Even as Merck was deciding to withdraw the drug, there were medical experts arguing that it should not. It also shows that federal regulators often rely on drug companies to tell them that a product is dangerous.

The whole saga, industry experts said, raises unsettling questions about aggressive consumer marketing of drugs before their long-term safety has been proven…"

GM Corn Peacefully Co-exists in Spain

2004-10-18T09:34:00.000-07:00

From CORDIS: News service:

"Having strengthened its regulations on the traceability and labelling of genetically modified organisms (GMOs), the Commission has recently lifted the EU's de facto moratorium on the technology and begun authorising new varieties for sale in Europe.

Despite this clear political endorsement of GM food and feed products, however, many consumers and retailers remain opposed to the technology, and while millions of tonnes of genetically modified crops are grown and consumed in other areas of the world, Europe's countryside remains virtually GM free.

That is why the biotechnology industry in Europe is so keen to promote the example being set by maize farmers in Spain, where GM corn varieties have been grown alongside conventional crops for the last seven years. This year, some 60,000 hectares of Bt maize are being cultivated commercially around the country, representing around 12 per cent of Spain's total maize harvest."

Biometrics Aids Law Enforcement Agencies

2004-10-18T09:29:00.000-07:00

An article by Thomas Fitzgerald of the New York Times New Service reports:

"Biometrics, the science of using measurable physical characteristics to identify people, has added new weapons to the arsenals of law enforcement agencies, and as some of these new tools are connected to high-speed wireless communications they could become widely available to officers in the field, not just those back at headquarters.

Hand-held devices that can be used to digitally scan fingerprints and match the results against large databases are being tested by several law enforcement agencies nationwide, with officials at some saying that the benefits of biometrics are already clear."

Anti-Biotech Vote in CA has Global Implications

2004-10-18T07:13:00.000-07:00

"Californians who think they are voting for safer food by banning biotech may in fact be unintentionally denying proven safer foods to people in developing countries. " So contend, Bruce Chassy, professor of food, microbiology and nutritional sciences and executive associate director of the Biotechnology Center at the University of Illinois, Urbana-Champaign and Drew Kershen, professor of law at the University of Oklahoma, Norman.

They explain, "an anti-biotech trend in a major agricultural state like California can reverberate in nations unfamiliar with the safety record of biotech crops. Consider what has taken place in Africa in recent months. Leaders of some African nations, misled by anti-biotech activists, have refused to accept shipments of U.S. corn sent to feed millions of starving people. If they won't accept free grain to feed their people, they certainly won't allow their countrymen to plant improved seeds that could reduce the risk of birth defects."

Read the rest of the story in this article from Checkbiotech.org.

U.S. Bioterror Plan Frustrates Industry

2004-10-17T13:02:00.000-07:00

From eweek.com:

"Project BioShield was supposed to jump-start a national security renaissance in the biotechnology and pharmaceutical industries by guaranteeing contracts to make drugs for combatting potential bioweapons.

But all the law has done so far is to generate indifference or frustration among biodefense contractors, industry executives and experts say. Most are snubbing the program because of liability and intellectual property issues and confusion over what the government wants.

The corporate response to BioShield is summed up in a new study, by the Center for Biosecurity at the University of Pittsburgh, that criticizes the government's fuzzy mandate and concludes that the nation remains highly vulnerable to a biological attack."

Indigenous Knowledge Poses Justice Issues

2004-10-16T16:00:00.000-07:00

This article form allAfrica.com poses interesting questions about the dilemma faced by less developed nations regarding the commercial exploitation of indigenous knowledge by developed countries for the "good of mankind."

Indigenous knowledge of, say the medicinal properties of plants, does not readily fit within the western tradition of intellectual property right protections. Problems stem in part from the fact that indigenous 'prior art' is not usually documented.

"It only exists in the oral traditions of the people and is passed on from generation to generation. Standard legal practice relating to intellectual property rights requires that documentary evidence of 'prior art' be furnished. This means that claims by indigenous or local communities over certain discoveries are rendered futile owing to this requirement."

In response, some "legal scholars have innovated what is referred to as the sui generis intellectual property rights model, a legal framework that actively recognises community rights to indigenous knowledge of plant species. They argue that once community-based IPRs are recognised, it becomes possible to secure equitably the benefits that accrue from the commercial exploitation of indigenous knowledge in areas such as the development of novel drugs and therapies."

Does HIPPA Block Research?

2004-10-16T10:42:00.000-07:00

From Eurekalert:

"The Privacy Rule implemented as part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 is constraining researchers in the United States and slowing the progress of a wide range of clinical studies and biomedical research. Unless fundamental rule changes are addressed, many studies may simply move offshore, warns Roberta Ness, M.D., M.P.H., professor and chair of the department of epidemiology at the University of Pittsburgh's Graduate School of Public Health (GSPH). "

NIH Bans Outside Collaborations

2004-10-16T10:38:00.000-07:00

From the Washington Post (free registration required):

"All scientists at the National Institutes of Health will be banned from any new outside collaborations with pharmaceutical or biotechnology companies for at least one year -- and all existing collaborations will have to be discontinued -- under a surprise shift in policy released...by agency officials.

The blanket moratorium represents a much more radical policy change than NIH officials recently said they would invoke, and one that could shake already flagging morale at the beleaguered agency. But its need became apparent after the agency's own conflict-of-interest investigation turned up more problems than had been anticipated, said Raynard S. Kington, NIH's deputy director and ethics chief. "

NeuroInformatics Market Potential

2004-10-16T10:32:00.000-07:00

From Brain Waves:

" While bioinformatics isn't likely to create any new software stars, neuroinformatics will. The reason is simple: complexity. As I mentioned recently, the data about a person's genome can already fit on an ipod, yet the data about one's brain will require petabytes, if not exabytes, of storage capacity.

How much is a petabyte? One example is the Internet Archive Wayback Machine that contains approximately 1 petabyte of data and it has been archiving almost every webpage created since 1993. "

Top Ten Biotechnologies

2004-10-16T10:31:00.000-07:00

From eurekalert:

"The 10 most promising cutting-edge technologies for health in developing countries:

1. Easy-to-use molecular diagnostic tests for TB, hepatitis C, HIV-AIDS, malaria and other diseases, which detect the presence or absence of pathogen-associated molecules, such as DNA or protein, in a patient's blood or tissues;

2. Recombinant vaccines against infectious diseases, produced through genetic engineering, which promise to be safer, cheaper and possibly easier to store and transport than traditional vaccines;

3. Reducing pollution and making water safe to drink through bioremediation -- the potential exploitation of micro-organisms with remarkable biochemical properties;

4. Creating microbicides for female-controlled protection against sexually transmitted disease like HIV, both with and without contraceptive effect;

5. Better drug and vaccine delivery methods that avoid the use of needles and reduce cross contamination;

6. Bioinformatics to identify drug targets and to examine pathogen-host interactions;

7. Nutrition-enriched crops to counter specific deficiencies, such as vitamin A-rich 'Golden Rice' to improve health for millions without a balanced diet;

8. Sequencing pathogen genomes to understand their biology and identify new antimicrobials;

9. Recombinant technology to make therapeutic products (e.g. insulin, interferons) more affordable to help fight such diseases as diabetes, now emerging as a major public health problem throughout the world;

10. Combinatorial chemistry for drug discovery. "

Start-Up How-To Articles

2004-10-16T10:28:00.000-07:00

Follow this link to the following collection of how-to start-up articles:

"Effectively Sourcing Commercialization Grant Opportunities for Technology Companies
By Julie Seward Nagel, Ph.D.

Tips on Collecting Market Intelligence
By Michael Kurek, Ph.D.

Everything the Academic Entrepreneur Needs to Know About Market Research
By Mickey Katz-Pek

Lessons Learned
By William Fry, M.D.

Working Successfully with Your Technology Transfer Office
By Ken Nisbet"

Does Public Policy Deter Vaccine Research?

2004-10-16T09:40:00.000-07:00

From cantonrep.com (free registration required):

"American drug and biotech companies should be burning the midnight oil working on vaccines to prevent ... diseases, but flawed public policy has discouraged vaccine development to the point that supplies of lifesaving vaccines are in jeopardy.

The fundamental problem is that government policies discourage companies from investing aggressively to develop new vaccines. Producers have abandoned the field in droves, leaving only four major producers and a few dozen products.

As a result, the United States has experienced dangerous shortages of several essential vaccines, and some school systems have been forced to waive immunization requirements."

Agricultural Biotechnology Patent Database

2004-10-15T10:36:00.000-07:00

From Navigating the patent maze:

"The Economic Research Service has a newly available online-searchable database on agricultural biotechnology patents. The database is freely available for use by all. This database identifies and describes U.S. utility patents on inventions in biotechnology and other biological processes with issue dates between 1976 and 2000*that are used in food and agriculture. The database also provides information about the ownership of these patents, whether patents are held in the public or private sector, and changes in patent ownership due to firm mergers, acquisitions, and spinoffs. The database can be accessed at www.ers.usda.gov/data/AgBiotechIP. The attached PDF file provides a brief summary of information contained in the data. "

UK Govt biometric ID cards vulnerable to fraud?

2004-10-15T08:13:00.000-07:00

From computerweekly.com:

"A leading biometrics expert has warned the [UK] government that biometric ID cards, due to be rolled out from 2007, could be vulnerable to fraud unless it invests in more sophisticated iris recognition technology.

Professor John Daugman, who pioneered the developed of iris recognition at Cambridge University said that the biometric systems under test by the government were not sophisticated enough to distinguish between real and fake eye images."

Open-Source Initiative Aims to Save Biotech

2004-10-15T08:09:00.000-07:00

From bio-itworld:

"This month, an international movement was quietly born — one that aims to loosen the grip of the world’s biggest life science corporations on key enabling technologies and patents for biotechnology R&D.

The Biological Innovation for an Open Society (BIOS) initiative is the creation of U.S.-born molecular geneticist Dr. Richard Jefferson, founder and CEO of the CAMBIA (Centre for the Application of Molecular Biology to International Agriculture) in Canberra.

BIOS is an attempt to establish an open-source technology movement in the biotechnology industry, similar to the computing industry’s open-source software movement. An editorial in the flagship journal Nature earlier this month said the BIOS intellectual property database and associated informatics “promise to bring more transparency to the opaque patent web and to provide tools to guide decision-making when choosing technologies”.

In practice, BIOS provides biotechnology with its own free ‘operating system’: a public-domain toolkit and associated patents, aimed at freeing researchers worldwide to innovate without restriction, and without being forced into partnerships or unfavorable royalty agreements with the big corporations that currently dominate the pharmaceutical and agbiotech industries."