HIGHLIGHTS
PTO Rescinds Rule Allowing Multiple Nucleotide Sequences in Patents
The Patent and Trademark Office changes its policy regarding patent claims for pending applications related to inventions concerning nucleic acid sequences. The agency rescinds a 1996 policy that allowed patent applicants to claim up to ten independent and distinct nucleotide sequences in a single application, in part because of the exponential growth of nucleotide sequences now available in the prior art. Page 17 
Over $42 Billion Found Spent in 2005 on R&D at Universities, Colleges
More than $42 billion was spent on research and development at U.S. and Canadian colleges and universities in 2005, according to a survey by the Association of University Technology Managers. The survey also finds that 527 new products resulting from research and development by those surveyed were released in 2005, along with 628 spin-offs. Page 9
AAMC, 11 Universities Issue Technology Licensing Practice Guidelines
University researchers should be able to continue to work with intellectual property that has been licensed for commercial purposes, guidelines on technology transfer recommend. This and eight other recommendations are detailed in a white paper, "In the Public Interest: Nine Points to Consider in Licensing University Technology," issued by a consortium of 11 high-ranking universities and the Association of American Medical Colleges. Page 9
Insmed Settles All Litigation Over Iplex, Will Stop Selling Drug
Insmed Inc. will stop selling Iplex for treatment of children with short stature as part of a settlement of all litigation with Tercica Inc. and Genentech Inc., the companies announce in the wake of a jury award of $7.5 million plus royalties against Insmed for patent infringement. Insmed also will withdraw its marketing authorization application in the European Union, but still may develop and sell Iplex for certain other indications, subject to opt-in rights and royalty provisions for Tercica and Genentech. Page 5
Court Reinstates Permanent Injunction Against Abbott Over Hepatitis C
A federal appeals court reinstates a permanent injunction barring Abbott Laboratories from selling, using, or exporting products that make use of Innogenetics NV's hepatitis C genotyping technology. The permanent injunction affirms a ruling from a federal district court in Wisconsin that prevented Abbott from using a method of genotyping the hepatitis C virus patented by Innogenetics. Page 6
Analysis & Perspective
Regulatory Policy: Academician Francis Fukuyama and consultant Franco Furger describe their proposal to create a new independent commission to regulate reproductive medicine and biomedical research. Page 32
ALSO IN THE NEWS
VENTURE CAPITAL: An aging population and new techniques for less invasive surgery are two drivers behind the growing funding for biotechnology, a venture analyst says. Page 10
CALIFORNIA: A unanimous state appeal court upholds Proposition 71, creating a $3 billion pool to fund stem cell research over 10 years. Page 21
LICENSING: A survey of licensing executives finds the U.S. Supreme Court decision in MedImmune may end up chilling innovation. Page 11
NEVADA: State agency announces a third wave of advertisements and mailings urging New Jersey life sciences firms to consider moving west. Page 22
CONFERENCE REPORT
CALBIO: Speakers discuss FDA product review, pharma-biotech partnerships, and cost reimbursement at a conference sponsored by BIOCOM, a trade association. Pages 29, 30, and 30
BNA AUDIOCONFERENCE
CLINICAL TRIALS NCD: A CMS official and two compliance experts will discuss proposed changes to the clinical trials NCD during a BNA audioconference April 13. Page 20
Table of Contents
COURT PROCEEDINGS
COURT ACTIVITY
Recent court activity 8
LICENSING
Court says licensee owes royalties, but concludes agreement still valid 5
MERGERS AND ACQUISITIONS
Lawsuit charging omission of positive product data dismissed 6
PATENTS
Federal circuit reinstates permanent injunction against Abbott over Hepatitis C 6
Insmed settles all litigation over Iplex, will stop selling drug for growth treatment 5
INDUSTRY NEWS
DRUG DEVELOPMENT
Study of drug in lung disease patients terminated due to lack of benefit, FDA says 11
INTELLECTUAL PROPERTY
Race-based patenting of pharmaceuticals explored 12
LICENSING
MedImmune seen as chilling innovation in survey 11
TRANSACTIONS
A summary of recent life science transactions 13
STEM CELL RESEARCH
Meeting FDA early on, building in options called essential 13
TECHNOLOGY TRANSFER
Over $62 billion spent in 2005 on R&D at universities, colleges 9
White paper by AAMC, 11 universities sets practice guidelines for technology licensing 9
VENTURE CAPITAL
Biotechnology venture investment growing, fueled by aging population, tech advances 10
FEDERAL NEWS
ADVERTISING AND MARKETING
Waxman asks drug firms for documents on product marketing 17
BIOTECHNOLOGY
Plantings of genetically modified rice pose no environmental threat, USDA says 18
BNA AUDIOCONFERENCE
CMS clinical trial NCD is subject of upcoming BNA audioconference 20
EMPLOYMENT AND RECRUITING
Gates urges H-1b visa program change to help competitiveness 19
FDA
Draft industry guidance describes how to submit materials to advisory panels 18
PTO
Rule allowing multiple nucleotide sequences in patents rescinded 17
STATE NEWS
CALIFORNIA
Appeals court decision upholds stem cell research funds initiative 21
COLORADO
State House approves bill to expand grant program for bioscience research 24
EMPLOYMENT AND RECRUITING
States get federal grants for life sciences workforce development 23
MARYLAND
Legislature backs Gov. O'Malley's plan to create life sciences advisory board 23
MICHIGAN
State Democrats aim to repeal statute giving drug companies lawsuit immunity 25
NEVADA
Las Vegas steps up promotional campaign to lure life sciences firms from New Jersey 22
PENNSYLVANIA
May debut planned for online list of Philadelphia area life science firms 24
INTERNATIONAL NEWS
BRAZIL
Brazilian Senate approves legislation to streamline licensing of modified crops 27
GERMANY
Germany proposes rules on genetic plant research 28
NANOTECHNOLOGY
French bioethics commission urges EU-wide registration of nanomaterials 28
PATENTS
Legal experts debate enforcement of foreign patents after Voda ruling 26
CONFERENCE REPORT
COST REIMBURSEMENT
Drug developers should plan on eight years for coverage approval 30
DRUG REVIEW
Survey sees improved industry-FDA relations; static drug approval time 29
PARTNERSHIPS
Open approach encouraged by product development companies 30
ANALYSIS & PERSPECTIVE
REGULATORY POLICY
Modernizing the regulation of assisted reproductive technologies 32
JOURNAL
CONFERENCES & MEETINGS
Brief list of coming events 40
LEGISLATIVE CALENDAR
Committee actions, bills introduced 39
REGULATORY CALENDAR
Agency notices 39
TABLE OF CASES
California Family Bioethics Council v. Independent Citizen's Oversight Committee (Cal. Ct. App.) 21
EraGen Biosciences Inc. v. Nucleic Acids Licensing LLC (W.D. Wis.) 5
Innogenetics NV v. Abbott Laboratories (Fed. Cir.) 6
Little Gem Life Sciences LLC v. Orphan Medical Inc. (D. Minn.) 6
MedImmune Inc. v. Genentech Inc. (U.S.) 11
People's Advocate v. Independent Citizens Oversight Committee (Cal. Ct. App.) 21
Tercica Inc. v. Insmed Inc. (E.D. Va.) 5
Tercica Inc. v. Insmed Inc. (N.D. Calif.) 5
COMPANY NAMES INDEX
Abbott Laboratories 6
AstraZeneca Pharmaceuticals LP 17
Boston Scientific 17
Bristol-Myers Squibb 30
Cephalon Inc. 17
Cordis Corp., 17 , 26
Eli Lilly and Co. 17 , 30
EraGen Biosciences Inc. 5
Genentech Inc. 5 , 11
Innogenetics NV 6
Insmed Inc. 5
InterMune Inc. 11
Little Gem Life Sciences LLC 6
MedImmune Inc. 11
Merck Inc. 30
Metastatix Inc. 9
Neocure 30
NeuroMetrix 30
NeurOp Corp. 9
NitroMed Inc. 12
Nucleic Acids Licensing LLC 5
Orphan Medical Inc. 6
SiGen Pharmaceuticals 9
Tercica Inc. 5
Ventria Bioscience 18
Wyeth Pharmaceuticals Inc. 30
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