Thursday, June 30

Setting a Patent Stategy

"To add the most value, [biotechnology] companies need to do more than file applications early and often...Patents provide potential leverage for obtaining cash, technology, and desired collaborations through licensing. They are also attractive assets to potential investors, collaborators, and acquiring companies. And they can help remove roadblocks set by third-party patents through cross-licensing...

Consider the case of a startup biotechnology company. Frequently, the company begins by obtaining a license for its initial core technology from a university and then develops and enhances that technology through its own research and development efforts. Eventually, the company seeks to partner with a large pharmaceutical company for further research, development, regulatory approvals, and marketing...

The first step in the patent strategy comes when the company begins negotiations to license its core technology from the university. It starts with a strategic analysis of the patent rights supporting that technology, typically through a due diligence process...The patent rights need to be examined to assess their realistic scope and significance... Patent counsel should conduct a "freedom to operate" assessment of the technology. Any third-party patent rights that might be infringed by the use of the technology must be identified and analyzed...

Beyond the initial results of the due diligence, a strategic plan represents an ongoing process that evolves as the company's business plan evolves.

One basic issue is what to patent... The plan should also set decision-making criteria for each point in the process of obtaining a patent... In addition, the plan should provide a long-term approach for identifying and neutralizing third-party patent rights that may block research, development, or marketing of the biotech's products...

If a biotech company has developed and implemented an intelligent patent strategy and has successfully done the many other tasks necessary to develop its products, then the company is ready for its collaboration with big pharma."

Read more in this Cooley Godward LLP article from Mondaq.

Monday, June 27

Tech Transfer Offices Can Facilitate Business Startups

"There exists in some quarters a long-standing belief that, in terms of starting biotech companies, university technology transfer offices are staffed with highly educated order takers who do not understand business. If the lawyers and scientists in these offices are not actual impediments to getting business done, then at best they are bureaucrats frozen in idleness until an entrepreneur spies a technology worth millions and thaws them out long enough to strike a deal.

The truth is somewhat different. Tech transfer offices can indeed wait passively for entrepreneurs to walk in the door and license something. But sometimes startup formation begins at the universities, which in their excitement about their technologies do not wait for entrepreneurs. Instead, they spin off companies and seek CEOs to manage them. This happens not just at Stanford and MIT, which benefit mightily from flourishing venture capital activity nearby. Other universities also do startups very well -- or are getting better -- even where VC activity is less intense, or is mainly devoted to other industries, or where spinoffs lack a tradition of encouragement."

Read more in this article from Signals Magazine.

Saturday, June 25

Stem Cell Breakthrough in Pittsburgh

"Hailed as a ground-breaking study, scientists in Pittsburgh say they've discovered that adult stem cells have the same ability as embryonic stem cells to multiply.

The previously unknown characteristic indicates post-natal stem cells may play an important therapeutic role, according to the researchers at the city's Children's Hospital."

Read more in this WorldNetDaily article.

Sunday, June 19

The National Agricultural Law Center

In 1987, Congress recognized the University of Arkansas School of Law for its "unique expertise in the area of agricultural law" and called for the creation of the The National Agricultural Law Center at the Law Schooll. Since then, the National AgLaw Center has been funded with federal appropriations through the National Agricultural Library, an entity within the USDA Agricultural Research Service. The National AgLaw Center is the only agricultural and food law research and information facility that is independent, national in scope, and directly connected to the national agricultural information network.

The Center conducts objective legal research and provides timely, accurate, and non-partisan agricultural and food law information to those in the agricultural community.

Biotech grant to create jobs in Southwestern Pa.

"Five Pennsylvania biotechnology companies will split $5 million in state funding, a move that will create about 100 jobs in Allegheny County.

The funding, announced Monday by the Pennsylvania Department of Community and Economic Development, comes from Gov. Ed. Rendell's Governor Action Team plan.

Read more in this article from the Pittsburgh Business Times.

Aborted babies used in Russian anti-ageing fad

"WEALTHY Russians are switching from investing their roubles in luxury yachts and designer jewellery to stem cell therapies in an attempt to maintain the vitality of youth into their old age.

The treatments, in which stem cells extracted from aborted or miscarried foetuses are injected into the body, is the latest anti-ageing weapon, following Botox injections and facelifts, to keep Moscow's youth-obsessed high society looking young.

And those who have admitted visiting the clinics now springing up across the Russian capital claim it works and has wiped years off their age."

Read more in this Scotsman.com article.

State bid to end cloning ban

"A PUSH to relax Australia's legal restrictions on stem cell research was launched yesterday by the Victorian Government, as fears grow that Australia could fall behind other countries if it maintains its ban on therapeutic cloning.

Victorian Treasurer John Brumby warned yesterday Australia could 'lose our competitive edge and ... our best people' if a legislative review announced by the federal Government on Friday did not allow the present laws to be relaxed. "

Read more in this article from The Australian.

Tuesday, June 14

Merck v. Integra LifeSciences Decision Boon to Big Pharma

"While the U.S. Supreme Court's opinion did not extend the statutory research use exemption to patented research tools under 35 U.S.C. ss.271 (e)(1) in Merck KGaA v. Integra LifeSciences I, Ltd . (2005 WL 1386324 (U.S.)), the Court unanimously ruled for a broader interpretation of the exemption from patent infringement for use of a patented invention 'solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.' The Court specifically noted that patented 'research tools' were not part of that interpretation."

Read more in this Patent Baristas post.

Seed Shrinkwrap License Does Not Implicate Plant Variety Protection Act

"Illinois farmer, Edward Showmaker, filed suit against Advanta USA, claiming that the language of the shrinkwrap license agreement on Advanta's soybean seed violated the misbranding provision of the Plant Variety Protection Act (PVPA). The Advanta's Garst Brand Seed D445N, Variety 57004 purchased by Mr.. Showmaker was neither patented or PVPA certified...

The United States District Court for the Southern District of Illinois dismissed the case for failure to state a claim upon which relief can be granted because the contractual language in the Agreement did not implicate the PVPA's misbranding provisions. "

Read more in this Patently-O post.

Friday, June 10

Business Week Biotech Issue

"Make sure to read this week's BusinessWeek -- devoted to the biotech sector. You can access many of the articles here."

From this Biotech Stock Blog post.

Saturday, June 4

A Prescription for Life Sciences - BetterManagement.com

"We have all read the press articles on the future of the Life Sciences industry and the pressures to become more cost effective. AMR Research recently talked to business and technology leaders in pharmaceutical, biotech, and generic manufacturing companies to crystallize the big picture. The result is the following set of core components that must be addressed in varying degrees in every company's business and operations strategy (this is also forming our research agenda):

Research and development...
Commercializing the product innovation pipeline...
Improving sales and marketing performance...
Predictable product supply...
Demand-Driven Supply Network (DDSN) transformation...
Integrated business and operations performance management...
Capitalizing on IT...
Using assets and investments and minimizing risks..."

Read more in this BetterManagement.com article.

Friday, June 3

Biotechnology at the Tipping Point?

"There has been a flurry of news reports this year showing the heightened awareness of the biotech industry and the concomitant growth.

Business Week recently published an article touting that Biotechnology has finally come of age after 30 years of biological research. Now, recent developments in gene and exotic chemical manipulation have brought a wave of biological drugs, many of them reengineered human proteins. These drugs represent real progress for a range of diseases all but untreatable just five years ago...

It's not all rosy, though.."

Read more in this Patent Baristas post.