Thursday, December 23

Got Patential?

"If, on the night before Christmas, you still don't know what to give that biotechnology giant or budding lawyer-scientist, San Diego inventor Richard Warburg has a suggestion.

The intellectual property attorney's latest creation, 'Patential' promises not to cure any diseases or facilitate medical procedures of any kind. It's a board game that attempts to unravel the mysteries of the drug patenting and licensing process...

Game players are entrepreneurs with cash flow and choices to make. Buy or license a drug patent. Apply for a patent. Enter clinical trials. Or sit tight and raise more money from investors.

The road ahead is printed with all the myriad contingencies and successes one might find in the real world of drug development. An eerie illustration of cold hard cash and pills on the box cover depicts what awaits game players inside. Sometimes the Food and Drug Administration (news - web sites) expedites its review and you find yourself ahead. Other times, it's hard to find enough volunteers to test your drug on, and you have to hold off. Sometimes patients die, or the government passes a new law and you've got to have your attorney look things over."

Tuesday, December 21

Biotech Crops Pose Legal Issues

"A farmer whose pollen drifts on the wind from his cornfield to a neighbor's could face a lawsuit from a multinational corporation.

A farmer who saves his own seed and plants it the next year, as many have done for generations, could also be sued.

These are real risks for the thousands of North Carolina farmers growing genetically modified crops, such as soybeans, corn and cotton plants that have been bred to withstand weed killers, according to a new report from farm advocacy groups."

From newsobserver.com.

How to Shop Around Your Most Valuable Asset

"With an almost non-existent IPO market and reduced venture capital investments, many Biopharma companies are looking for alternative sources for capital infusion to fund their R&D and clinical operations. Out-licensing is one of the available options that gains importance in recent years. Emerging Biotech companies that are able to sign an out-licensing agreement with a credible licensee are better positioned to survive the long proof-of-concept stage in the product lifecycle. In addition to the immediate capital infusion, the licensee benefits from increased technological credibility and investor confidence. This often translates into enhanced capability to raise further capital in the private or public market, usually at higher valuation. Although attuned to the importance of out-licensing, many companies are struggling to execute an effective out-licensing strategy and some fail to maximize the value of their most valuable assets. "

Read the rest of this article at about.com.

Monday, December 20

Biotech Research Tool Patents: The Good, The Bad, and Freely Available?

"Recent patent appeals court cases have strengthened the protection afforded by research tool patents. This article from Testa, Hurwitz & Thibeault LLP's Michael H. Brodowski reviews recent case law in research tool patents and strategies to maintain the value of these assets."

From about.com.

Saturday, December 18

Management Issues Challenge Biotech Startups

"Emerging biotechs and pharmaceuticals companies... often struggle with the transition from being primarily research-oriented to focusing on product development and commercialization.

Many biotech companies fail to make the leap from the lab to clinical trials and beyond, winding up on the scrap heap or getting bought well before investors would have liked to see that happen. Why such companies fail has often been a real head-scratcher for those in the industry and its analysts.

A recent study of biotech management practices, however, suggests that a primary reason for such failures is an ongoing conflict, at many companies, between the collegial, informal, creativity-based management model common to scientific endeavors and one that has more discipline, structure and predictability. As part of that conflict, biotechs tend to hire managers whose expertise is in the science end without management experience, and that can be fatal..."

Management Issues Challenge Biotech Startups December 15, 2004 - News:

Democratic Transhumanists Unite

"Biopolitics is emerging as an axis of modern politics alongside economic politics and cultural politics. Transhumanists, people who embrace technologies that extend and enhance regardless of their effect on “natural” life spans, limitations or social institutions, are the progressive end of the new biopolitical continuum. BioLuddites, who call for bans on technologies that threaten the “natural,” are conservative end of the new biopolitics.

But biopolitics only complicates the preexisting political landscape, they doesn’t supplant it. There are Christian fundamentalists, centrists and socialist-feminists forming alliances to to oppose human genetic engineering and nanotechnology. But the transhumanists are, so far, much less diverse, mostly adhering to one or another flavor of libertarianism. Democratic transhumanists, pro-scitech social democrats or Left technoutopians are conspicuously absent from their theoretical niche in this new political landscape. This essay is an attempt to identify democratic transhumanists and urge their coalescence."

From linkfilter.net




Wednesday, December 15

Biotech IPO's Analyzed

"Since the fall of 2003, 33 young biotechnology and specialty pharma companies have entered the public domain. Together, they embody the new generation of drug discovery and development firms, whose fledgling product candidates could ultimately become breakthrough therapies for everything from ocular diseases to psychiatric disorders. But do these newer drug candidates - or the technologies used to create them -- differ from those already on the market or under development by more mature firms? And if so, how?"

From about.com

ASX enforces draft biotech code

"The Australian Stock Exchange appears to have toughened its stance on announcements from the biotechnology sector, with at least one company being asked to water down comments about a new licensing deal.

Prima BioMed was yesterday delayed from releasing a statement to the market because it was told by an ASX officer that information provided about the value of the deal did not comply with an industry code of conduct for reporting.

The code, developed by the exchange in conjunction with industry peak body AusBiotech, is still in draft form and companies have no legal obligation to follow it."

From www.theage.com.au.

Tuesday, December 14

Angel investors shy away from biotech

"Angel investors often avoid biotech startups because of long and costly development times of biotech products, as well as a tendency for venture capitalists (VCs) to set over-diluting terms when entering in follow-on financing rounds. These trends are exacerbating an early-stage funding gap in the biotech sector..."

From Bioentrepreneur:

Friday, December 10

In the Beginning, There is a License

From Testa, Hurwitz & Thibeault via Mondaq (free registration required):

" While this article is not a primer in technology licensing, it does address some recurring issues in biotechnology licensing transactions, namely, reservation of rights, sublicensing, and royalty stacking. "

Plant Variety Registration is Not a Bar to Trade Secret Protection

From Navigating the patent maze:

"One form of legal protection for biotechnology inventions, which is not often used, is trade secrecy. This right, in contrast to patents and copyrights, is not registered and is of unlimited duration, as long as the holder of the trade secret makes reasonable efforts to maintain secrecy. With regard to keeping parental lines of hybrid seed as a trade secret, for example, identification by private code of fields of inbred parent lines of corn has been deemed, in the 1994 Iowa case Pioneer Hi-Bred v. Holden Foundation Seeds, sufficient to constitute a reasonable effort to maintain secrecy, even though the corn was grown outdoors and subject to misappropriation by informed "flashlight breeders."

Furthermore, acquisition of the viable parent seeds that occasionally appear in bags of hybrid seeds is not antithetical to trade secrecy. But what if the parental lines are protected by Plant Variety Certificates (akin to plant breeder's rights)? One might think that the disclosure requirement to register a plant variety would destroy the secrecy necessary for maintaining the lines as trade secrets.

The short answer from the District Court of the Western District of Wisconsin is NO, registration does not extinguish trade secrecy."

Thursday, December 9

Recent Cases Strengthen Research Tool Patents.

"Biotech research tools come in many forms. Examples of such research tools include screening techniques, rational drug design schemes, and chemical or biological compounds having useful physiological properties such as specific receptor binding. These research tools can assist in the discovery, identification, characterization, and development of commercial products, e.g., pharmaceuticals and biologics, but are not themselves readily marketable.

Consequently, a company or university that creates research tools should be aware of the recent developments for protecting and exploiting them."

From about.com:

A Primer on Stem Cells


stem-cell-5
Originally uploaded by TigerTigerTiger.
From Howstuffworks:

"Inside an embryo no bigger than the period at the end of this sentence are dozens of stem cells. Initially, these cells are blank slates, meaning that their fate is undecided. But they have great potential. Stem cells are pluripotent, which means that they can develop into every cell, every tissue and every organ in the human body.

Their almost limitless potential has made stem cells a significant focus of medical research. Imagine having the ability to return memory to an Alzheimer's patient, replace skin that was lost during a terrible accident or enable a wheelchair-bound person to walk again.

But before scientists can use stem cells for medical purposes, they must first learn how to harness their power. They can't treat disease until they learn how to manipulate stem cells to get them to develop into specific tissues or organs."

This article explains stem cell basics and is an excellent primer to allow you to better understand the fierce debate surrounding their research and use.

Carnegie Mellon scientist develops way to deliver promising genetic tool into living cells

From EurekAlert:

"By exploiting an HIV protein that readily traverses cell membranes, Carnegie Mellon University scientists have developed a new way to introduce a gene-like molecule called a peptide nucleic acid (PNA) directly into live mammalian cells, including human embryonic stem (ES) cells. The work, published online December 2 in Chemical Communications, holds considerable promise in genetic engineering, diagnostics and therapeutics. "

Collaborations and Licensing - Key Legal Issues

This article from Pharmalicensing.com "gives an overview of two of the principal types of relationship in which a company in the biotechnology sector is likely to be involved at some point in its lifecycle. It begins with a discussion of the reasons why a biotech company might benefit from entering into a licensing or collaborative arrangement, and then considers the principal legal terms which each type of agreement should contain."

Wednesday, December 8

The Ethics of Biotechnology: Bigger, Faster, Stronger

Event Horizon: Bigger, Faster, Sronger:

"I came across this article (Baseball's Bioethical Dilemma) by accident, but it is probably one of the best pieces on bioethics that I've read in a long time. The article grounds the subject in the latest controversy over the use of steroids in baseball, and then goes on to assess the broader implications of biotechnology and encourages us to have a public debate about the potential uses and misuses of the technology. Brave new world indeed."

Life Science Insights Top Ten List for 2005

From Bio-It World

"The outlook for 2005 is one of “cautious optimism,” with an increased emphasis on issues of compliance, pharmacovigilance, outsourcing, and the pharma CIO. Those were some of the key takeaways of the first annual Life Science Insights (LSI) Predictions for the life sciences industry, delivered today by Jim Golden, vice president for research....

And so with apologies to David Letterman, the LSI Top Ten list for 2005:

1. Technology growth later in the value chain...
2. Disaggregation happens...
3. Innovation will happen - somewhere else...
4. The line between IT and drug discovery . . . will continue to blur...
5. Thus, the rise of the Pharma CIO...
6. Data standards will drive a fragmented industry...
7. The curse of Eliot Spitzer...
8. Pharmacovigilance...
9. Lost on the NIH Roadmap...
10. Venture capital is back"

Tuesday, December 7

Are States Equipped to Oversee Biotech Trials?

From UPI via MENAFN:

"The field testing of genetically modified crops is growing across the country, but questions are being raised about whether state regulators are equipped to oversee the trials.

The federal and state governments have an important role in supervising agricultural biotechnology, but a report released Thursday questions whether some states have the critical tools necessary to hold up their end of the role.

The survey conducted by the Pew Initiative on Food and Biotechnology found a common concern about whether state governments have the legal authority, financial resources and trained staff to properly regulate the testing."

Monday, December 6

link to Electronic Journal of Biotechnology

Electronic Journal of Biotechnology

The Cuban Biotech Revolution

From Wired 12.12:

"Embargo or no, Castro's socialist paradise has quietly become a pharmaceutical powerhouse. (They're still working on the capitalism thing.)"

Efforts to clone primates move forward

From EurekAlert:

"Using newer cloning techniques, including the 'gentle squeeze' method described by South Korean researchers who earlier this year reported creating the first cloned human embryonic stem cell line, University of Pittsburgh scientists have taken a significant step toward successful therapeutic cloning of nonhuman primate embryos.

It is the first time researchers have applied methods developed in the Seoul laboratory to nonhuman primate eggs. Resulting cloned embryos progressed to the blastocyst stage, a developmental step in which the embryo resembles a hollow, fluid-filled cavity surrounded by a single layer of cells. Called the inner cell mass, this layer contains embryonic stem cells. Growth of a cloned nonhuman primate egg to the blastocyst stage is farther along the developmental spectrum than ever achieved before..."

Patenting Nature's Bounties

From sciencebase.com:

"Attempts to patent and commercialise the fruits, figuratively speaking, of the developing world, those natural pesticides, revitalising potions and grubby microbes, have been causing a major headache for those who take their ethical dilemmas seriously.

Meanwhile, the potential for boosting the indigenous governments' coffers has not gone unnoticed and now upfront return on their countries' resources are being demanded. Cash would be nice but a return in kind might suffice, especially if the added value provided by Western science is enough to turn what might be a 'primitive' remedy into a fully functioning, safe and more effective antimalarial, for instance."

Saturday, December 4

New Methods Could Bridge Stem Cell Ethical Divide

From Beliefnet.com:

"A Stanford University biology professor and two Columbia University physicians told a presidential advisory council Friday (Dec. 3) that new approaches could resolve the thorny ethical problems swirling around embryonic stem cell research.

Several members of the President's Council on Bioethics reacted with enthusiasm, but some conservative religious groups remain skeptical. "

Crisis Management in Biotechnology

From About.com Biotechnology:

"Biotechnology product development faces significant internal and external challenges. While scientific setbacks may be difficult to predict, many external problems can be anticipated and prepared for. Read on for strategic guidance to anticipating and managing biotechnology crises. "

Get in the First Punch, Recover with a Plan

From Small Business Success, Marketing & Entrepreneurship:

"My favorite way to learn about effective small business growth and entrepreneurship is to look beyond small business and entrepreneurship. Experts are all too often incestuous regurgitators. New ways of processing things are found outside of the same-old, same-old. I'll throw out some of these lessons-from-beyond in this feature from time to time.

From Bare Knuckles And Back Rooms by Ed Rollins, a terrific and entertaining book if I ever read one:

Mike Denton [boxing coach for Rollins in his early years] taught me two invaluable lessons, in the ring and out. Number one: 'The guy who lands the first good punch usually wins.' To help me be that guy, he taught me th throw a left hook. Executed well, the left hook is the most deadly punch there is. It's especially valuable when some idiot tries to hit you with a lead overhand right. The counter left hook will always beat him to the punch.

Number two: 'Every fighter gets knocked down. A bad fighter doesn't get up. A good fighter jumps right back up and starts swinging. A great fighter gets up on one knee, takes an eight count, clears his head, things about what he's going to do next, then stands up and starts fighting again with a plan to survive.'"

WorldChanging: Another World Is Here: Generic Biomedicine

From WorldChanging:

"The American patent on Human Growth Hormone -- useful for fighting wasting diseases associated with AIDS -- expired in 2003. So why isn't there a far-less-expensive 'generic' version available in the US? Because HGH is a protein 'biologic' drug, and protein drugs are far more difficult to produce than 'small molecule' drugs, and the FDA says it can't be certain that the generic versions are identical to the originals.

So goes the story in the December Technology Review. Biotech companies have made substantial sums on life-saving complex protein drugs, and now the patents are starting to expire. With 'small molecule' drugs (the kind regularly advertised on television and in the hundreds of pieces of spam you got today), the process of duplicating the molecule in order to create a generic version is straightforward, as are the tools for confirming that the drugs are identical. But proteins are big, complicated molecules, with varying properties depending on how they fold. Biomedical proteins aren't just conjured up in test tubes, but are often produced by reengineered bacteria. Duplication is difficult. But help is on the way..."

Wednesday, December 1

Biotechnology Information Directory

The Biotechnology Information Directory - A Public Service of Cato Research contains over 3000 links to companies, research institutes, universities, sources of information and other directories specific to biotechnology, pharmaceutical development and related fields. It places emphasis on product development and the delivery of products and services.

Biotechnology Benefits Biodiversity

From Globetechnology:

"There are three certainties: the population will continue to rise for decades to come, people will be fed, and all agriculture has some impact. If we want to save biodiversity, we must save the remaining wilderness.

Without a doubt the largest threat to biodiversity is converting wilderness to farmland. Agricultural biotechnology has shown that it can reduce the impact on the environment while maintaining or increasing yields. Therefore its incorporation into world agriculture will help protect biodiversity."