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Archive for February, 2006

Report on Bioscience Alliances in Silicon Valley

Written by on Tuesday, February 28th, 2006

Report on Bioscience Alliances in Silicon Valley will be held on June 7, 2006 at Crowne Plaza Caba

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Settlement Reached in University of California Case Against Monsanto

Written by on Tuesday, February 28th, 2006

St. Louis-based Monsanto Company agreed today to pay the University of California more than $100 million to settle a claim that the company infringed on a University of California patent related to a hormone that makes cows produce more milk.

According to AP Business Writer Christopher Leonard, Monsanto agreed to pay the University of California $100 million in upfront royalties and 15 cents a dose, or at least $5 million annually, to license the patented technology, commonly called BST. The University’s patent rights expire in 2023.

Leonard describes the issues at the heart of this dispute as follows:

At issue is the genetically engineered bovine somatotropin hormone, sold under the brand name Posilac. Monsanto says injections of the hormone help dairy cows produce 10 percent to 15 percent more milk.

The university alleges in its lawsuit that three researchers at UC-San Francisco first isolated the DNA that is used to make the hormone. The lawsuit said that Monsanto knew about the research as early as 1985, but sold the product anyway.

Under the settlement agreement reached today, Monsanto will receive an exclusive commercial license to use the university’s patented hormone, while the University of California will have the right to use the hormone in noncommercial research and the U.S. government will also retain some rights.

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Stem Cell Plaintiffs Described As “Fumbling” on First Day of Trial

Written by on Tuesday, February 28th, 2006

The Stem Cell Trial opened today in Alameda County, California–apparently without any fireworks.

California Stem Cell Report
Blogger David Jensen, who is closely following the proceedings, wrote of the day’s events:

The case of the CIRM foes moved slowly on Monday with fumbling over exhibits and evidence, tedious readings of long and short documents and a lengthy opening statement that tested the patience of Alameda Superior Court Judge Bonnie Lewman Sabraw. . . . CIRM’s opponents did seem ill-prepared and poorly organized. But this was day one in the nonjury trial, which is certain to be appealed and ultimately not resolved for another 12 months or so. And a fumbling, country-boy routine may be part of the strategy.

Clearly, Jensen’s characterization of CIRM opponents on this first day of trial was not a favorable one. Based on his commentary, one would think that CIRM opponents did a good job today of reinforcing themselves as the archetypical stereotype of conservative, right-wing Christian, country bumpkins. As a transplanted Southerner from a part of the country that is often viewed by my fellow Californians as mere “Flyover Country,” I cringe a bit at the imagery. It goes without saying that Southerners are often seen through a similar light.

Having said that, there is little doubt that serious religious and political value questions are fundamentally entangled in this stem cell debate, and perhaps even at the heart of this legal dispute, as suggested by Jensen through his remarks. The question for the court of law and of public opinion is whether there is anything more to this legal dispute than mere politics and religious issues. It doesn’t sound as though Plaintiffs got off to a very good start today in proving their case.

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Biotech Response to Proposed USPTO changes

Written by on Monday, February 27th, 2006

Peter Zura’s Two-Seventy-One Patent Blog recently examined the Biotech Community’s response to the USPTO’s proposed changes to US patent practice, including the proposed change aimed at curtailing the number of continuations that could be filed from a disclosure.

According to Zura, the response from the patent community was “befuddled outrage.” Zura writes:

The USPTO has no overt authority to limit continuations, yet is requiring applicants to explain why amendments, arguments, or evidence could not have been previously submitted? Aside from the fact that such a requirement injects subjective elements to an apparently objective process, this heavy-handed approach unduly restricts a valuable procedure for practitioners.

Zura reports that biotech companies are complaining that the proposed continuation rules are the wrong approach, since

[i]n this industry, product development timelines can reach 10 to 15 years and can cost upwards of $500 million. Accordingly, continuing applications are needed to protect technologies that can take more than a decade to bring to market. The biotech patent process not only covers product itself but also the process to make the product. As the 12 to 15 year cycle continues, different matters about the product, process, and its ultimate application are learned. All of this would require applicants to revisit applications and provide updates on any new developments.

Thus, restricting continuing applications will result in overly broad biotech patents, according to Todd Gillenwater, vice president of public policy at the California Healthcare Institute, a life sciences trade group in La Jolla, California.

Of course, from very early in the debate, the biotech community has been vocal on its views regarding the proposed patent reform rules. The Biotechnology Industry Organization (“BIO”) testified before the U.S. House of Representatives on September 15, 2005 on the proposed patent reforms, and has posted a transcript. An earlier letter to the U.S. House of Representatives is also posted on the website.

Likewise, in his recent President’s Desk column, the BayBio President wrote about the many flaws in the USPTO’s proposed direction, which was intended to address and remedy the existing three to five year USPTO backlog, highlighting the following:

First and foremost, the 2005 hiring trend at USPTO suggests that the agency of the Department of Commerce is aware of its human resource problems. Among the primary elements of reform that will not be proposed in the present comment period is the addition of hundreds – or thousands – of new examiner positions. Retention of new hires may also be an issue, but not in these proposed reforms.

Second, this collaborative approach asserts a fundamentally flawed view of governance in the public interest. Can John Q. Public realistically expect that Corporation X will act in the public’s interest in previewing materials and attachments filed by Corporation X in a working relationship with the Patent Office?

Third, the approach misses the mark on the responsibility of the USPTO. The backlog in the system is not the shared responsibility of innovators and the Government. The responsibility of innovators is to innovate – and in our industry, to continue the work of discovering life-saving products that shape and change people’s lives every day. It is the responsibility of the Patent Office to receive and review patent filings.

Finally, presuming that this proposition: Innovator: Control Thyself became USPTO policy, this reform does not accurately imagine the lawsuits that may result in the system – lawsuits by both innovators who face the unintended consequences of the priority of brevity, as well as by challengers who will have less material by which one discovery may be differentiated from another.

The BayBio President writes that the comment period will soon begin on these reforms and encourages members to participate in that debate and voice their views on the proposed reforms.

Clearly, this is sound advice to all of us in the biotech community.

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Opening Statements in Stem Cell Case Set to Begin

Written by on Monday, February 27th, 2006

Arguments in the trial addressing the constitutionality of the California Institute for Regenerative Medicine (“CIRM”) are set to begin on Monday, February 27, 2006 in an Alameda County Courtroom. The trial is expected to last about two weeks.

According to InsideBayArea, Plaintiffs, who include the People’s Advocate, the National Tax Limitation Foundation, and the California Family Bioethics Council, will argue that the committee is unconstitutional because the group operates outside of the exclusive management control of the state, since members of the committee serve terms longer than those who appoint them–six to eight years–and cannot be removed except under extreme circumstances by the state attorney general, such as committing a felony.

InsideBayArea reports that Nicole Pagano, spokewoman for the CIRM, argued in an email that the committee is accountable by the fact that most members are appointed by elected state officials and that they are subject to an annual financial audit to be reviewed by the state controller.

Paul Elias of the Associated Press wrote in an article today titled “$3 Billion California Stem Cell Agency Fights for Life in Court” :

The future of embroynic stem cell research could be shaped in a sleepy suburban courtroom where two taxypayer groups are challenging the legality of California’s new agency dedicated to the controversial field. . . .

Even some of the agency’s harshest critics believe the institute will prevail. Recent actions such as ensuring the state will share any potential profits gleaned from state grants, show it is starting to function as a government agency.

Californians in all walks of life will be watching this trial closely to see what the fate will ultimately be of California’s CIRM. While there seems to be a consensus throughout the state that government needs to be accountable to the people on the CIRM as well as other issues, the voters who said yes to Proposition 71, which created the CIRM, are definitely starting to be concerned that the CIRM will never be the successful institution that was originally promised to California. The outcome of this trial will likely signal the fate of both the CIRM and stem cell research in California.

For more information on the Proposition 71 controversy, you should check out the California Stem Cell Report, which has been reporting on the controversy extensively. The authors promise to be in attendance at the trial and say that they will file a report at least by early evening on Monday, perhaps sooner, depending on time constraints and Internet accessibility. We look forward to hear what they have to report on tomorrow’s proceedings.

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Intellectual Property Owners Association

Written by on Sunday, February 19th, 2006

http://www.ipo.org/

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BioImmersion

Written by on Sunday, February 19th, 2006

The conference BioImmersion will be held from June 28-30th, 2006 at the Embassy Suites, 150 Anza Blvd, Burlingame, CA 94010. The course introduces and explains the basic biological concepts that are the basis for biotechnology.

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The 2006 Venture Forum

Written by on Sunday, February 19th, 2006

The 2006 Venture Forum will be held on June 28-29, 2006 at the San Jose Hilton & Convention Center. The event is heralded as the nation’s largest showcase of seed and early-stage companies.

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Assay Development & High Throughput Screening

Written by on Sunday, February 19th, 2006

The conference Assay Development & High Throughput Screening will take place on June 22-23, 2006 at the Marines’ Memorial Club & Hotel in San Francisco, CA. The event will focus on new development in Cell Based Assays and HTS Screenings (New reporter systems, High contents screening, Channels, Yeast: genetic and enzymatic), In vitro Assays and Screening, Applications in Drug Discovery (Target identification and validation, Biomarkers and Diagnostics application), and Data collection and management. Presentations will be given from organizations such as Merck, Eli Lilly, Roche, Pfizer, AstraZeneCa, Amgen, Chiron, GE Global Research Center, Serono and many more. For more information contact Rania Hafez at raniah@gtcbio.com

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Bioscience Business Development: Building Value

Written by on Sunday, February 19th, 2006

UCSC Extension in Silicon Valley will teach a course on Bioscience Business Development: Building Value, which begins June 22-23, 2006. This is an exciting array of intensive courses covering the breadth of the bioscience field. From discovery to clinical to market and beyond, the organization helps busy professionals rapidly gain the knowledge they need to keep pace with the dynamic industry. The speakers for this year’s event will include: Ginger Dreger , J.D., M.S., who heads the biotechnology patent prosecution group in the Silicon Valley office of Heller Ehrman; Harold (Hal) Etterman, MBA, who has over 25 years of experience in Finance, Operations and Information Technology, including over ten years serving as a CFO, COO and interim CEO; Carolyn Feamster , MBA, Vice President, Business Strategy & Analysis at Clearview Projects; Thomas L. Gutshall , Chairman as well as Co-Founder of Cepheid in 1996; Michael G. McCully , M.S., Director at Recombinant Capital (Recap); and Herwig von Morze , Ph.D., an international patent consultant with 27 years of corporate patent experience in Europe and the United States.

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