Law under the Microscope

NIH Clears Most Researchers in Ethics Investigations

On Feb. 3, NIH Director Elias Zerhouni issued a moratorium on researchers receiving compensation for "extracurricular" activites, and forbade NIH employees from holding stock in biotech companies. This was in response to a brewing scandal about certain researchers who allegedly entered into contracts with pharma companies without notifying the NIH of their deals.

UN Committee Calls for Total Ban on Human Cloning

The UN has been debating how to address embryonic cloning and research for at least the last 4 years. Last fall, a UN committee was looking into two different proposals, one that would call on all members to ban such research, the other that would allow each member state to decide for itself.

Now, a UN general assembly committee has voted 71 to 35 (with 43 abstentions) to take the proposal for banning such research before the full UN assembly.

More Time to Comment on SBIR Business Size Requirement

As a follow-up to my post last Friday about SBIR tips (and to the comment about watching the requirements about ownership and size of the company), I wanted to point out that the Small Business Adminstration (SBA) has extended the time to comment on a proposal to change the way a business' size is calculated, particularly the participation of businesses majority-owned by Venture Capital Companies in the SBIR program.  The new deadline for providing a comment is April 3, 2005.

SBIR Applications - Watch the P's&Q's

A major source of funding for many bioscience companies is a government grant, including SBIR grants. Many companies look to receive this money when starting out because they are usually of a fairly decent size, with a possibility of receiving more money if the first phase of research goes well. Unfortunately, many companies don’t read the fine line in their grant proposals or they may not consider certain conditions that may be placed on their research beforehand. Here are a few tips to make sure your SBIR grant receives thorough consideration and to increase your chances at getting funding.

FDA to Implement New Oversight Board

It looks like the HHS and FDA is doing what it can right now to appease its critics within and outisde the government. This week, HHS Secretary Mike Leavitt announced that Lester Crawford, the Acting Commissioner, was being nominated as permanent Commissioner of the FDA. That is a great step, as it was necessary to get someone into the position (and, curiously, there were no other names bandied about as competition - makes me wonder why the administration didn't act on it sooner).

The FDA also announced, before 3 days of Congressional hearings, that it was going to implement a new independent Drug Safety Oversight Board. This board is something of a response to the recent scandals about drugs such as the Cox-2 inhibitors, Vioxx and Celebrex.

Open Source Biotechnology

Lately, there has been a lot in the press about open source software as there is a faction of folks who believe that most software should be open and available to whomever wishes to make improvements on it. But in recent weeks, "open source" biotechnology has been sending a buzz through laboratories.

Most recently, a group in Australia made headway in creating a method of making bioengineered crops that supposedly does not infringe on any existing patent rights. Even more, that group wants to make the technology available to anyone so long as they make any improvements available to others.

Biosciences in Idaho to be Highlighted at Legislative Dinner this Month

Just to put in a shameless plug, the Idaho Bioscience Association (BioIdaho - the state affiliate for BIO) is presenting a Legislative Dinner on Feb. 28th in Boise, Idaho to set out and define for legislators and other attendees the infrastructure in place in Idaho to support the biosciences and steps the state should consider to foster the growth of the industry. In addition to a spectacular roster of speakers from academia, government and the private sector in Idaho, Carl Feldbaum, Past President of BIO, and G. Steven Burrill, CEO of Burrill and Company and the author of the bible for stats on the industry each year, will be presenting their view of Idaho's future.

More details on the dinner may be found here.

Canada to Make Internet Pharmacy Sales to U.S. Illegal

The last two years or so have seen tremendous efforts by individual states, including Illinois and Wisconsin, among many, to provide prescription drugs to their citizens at lower costs. For most of these states, the solution was to work with Canadian internet pharmacies and other Canadian suppliers. It looks like Canada is bowing to pressure from either the US Government or the pharmaceutical companies.  Canada's Health Minister is strongly considering shutting down sales from Canadian internet pharmacies to U.S. (and possibly other countries) buyers.

New Biotechnology Centers Opening

I love to report on new centers that are opening up in the U.S. and around the world. So long as they're done right (adequate planning, good management, researchers who are committed to their craft, and realistic monetary goals, among other things), they bring tremendous promise to the region.

The first to report on, just because I love the name, is the new Dubai Biotechnology and Research Park, or DuBiotech. Sheikh Mohammed Bin Rashid Al Maktoum, the Crown Prince of Dubai and its Defense Minister, revealed the impressive new center with 30,000,000 square feet of built-up area. With Dubai's free trade zone and its unique location (sort of in the middle of everything for international businesses - a crossroads for Asia, Europe and Africa), and with the money that Dubai can pour into getting researchers and labs running, this will be an interesting development. And this should make the U.S. sit up and take notice - Dubai has promised companies establishing themselves there a 50 year exemption from all corporate and personal income tax, guarantees that companies will have 100% ownership of the business, and 100% repatriation of capital and profits.

California Court Sets Aside Genentech-City of Hope Verdict

A quick update on the dispute between City of Hope and Genentech. In a prior column (Dec. 2, 2004), I blogged about City of Hope's lawsuit against Genentech for non-payment of royalties for certain protein technology. The jury had awarded $500 million (that's not a typo) to City of Hope and the state appeals court upheld that verdict.

The California Supreme Court has just announced it will hear Genentech's appeal in the matter. It did not provide any further comment, and it sounds like the main issue on appeal will be the interpretation of the contract. Genentech asserts that the lower courts' interpretation of the contract was unreasonable. It's interesting that the CA Supreme Court took up the case, as they usually are looking for new issues of law, not contract interpretation. Maybe it was the money at stake that swayed them to look at the matter. I've been trying to find a copy of the writ asking for review. Guess I'll have to wait to see what the appellate briefs present as the issues.