Posts Tagged: "bio"

Richard M. Marsh, Executive Vice President and General Counsel for Myriad Genetics is on the panel. He started off his presentation explaining that he really wants to talk about the case and the issues, but given that the case is ongoing and the future is uncertain regarding whether it will continue to be appealed, go back to trial or be dismissed altogether he might be unable to answer all questions. He did say clearly that the biotechnology industry “is under attack.” Marsh explained that the industry needs to be proactive because “if we sit back and idly do nothing there could be grave consequences.” Marsh explained that Myriad was able to do what it did thanks to the patents by giving it the time, money and incentive to innovate. I couldn’t agree with him more.

This morning the first panel discussion is focusing on Stanford v. Roche, titled Who’s Rights Are They Anyway? The first speaker, Maggie Shafmaster, Ph.D., Vice President and Chief Patent Counsel, Genzyme Corporation, lead off by pointing out something that everyone largely seems to agree with, namely that the facts of the case are still largely in dispute, which makes me wonder why would the Supreme Court take such a case. Be that as it may, Shafmaster went on to say that this case is one that makes in-house attorneys and those representing Universities lay awake at night. She characterized the case as “an academic/industry collaboration gone wrong.” And we are off to the races!

BIO also is concerned about the inclusion of broader prior user rights in the House bill, and believes that this issue, coupled with the harmful inter partes review changes, could set back efforts to pass meaningful patent reform this year by undermining the broad coalition of American innovators currently supporting patent reform.

What becomes clear in reading these briefs (and the excerpts below) is that despite what you might have heard to the contrary the Supreme Court has already previously addressed this issue and has done so in support of a standard appreciably higher than the mere preponderance supported by Microsoft. The argument of those in support of Microsoft has been that at least some Circuit Courts of Appeal had a lower presumption of validity prior to when the Federal Circuit announced the clear and convincing standard of proof and thereby settled patent law. While that may be true it seems abundantly clear that law setting a preponderance standard was directly in conflict with the clear and unambiguous Supreme Court precedent directly on point. In fact, there is even Supreme Court precedent directly on point saying that more than a mere preponderance is necessary even when the prior art has not been previously considered. So perhaps i4i and the amici, including the U.S. government by and through the Solicitor General and the USPTO General Counsel Bernie Knight can convince the Supreme Court not to overrule its own prior decisions and keep an appropriately high standard.

The Humanitarian Award honors work that aims to reduce human suffering significantly or enhance the human experience in a way that has a clear and direct benefit to society. Additional consideration will be given to approaches that are at a turning point and may potentially have immeasurable influence. The Award and a prize of $10,000 will be presented at the 2011 BIO International Convention, in Washington, DC on June 27-30, 2011.

As a prelude to his presentation at BIO Mr. Iverson agreed to go on the record with me. Part 1 of my interview with Mr. Iverson was published last week, and what appears below is the final segment of our discussion. We pick up with discussion of crowd sourcing techniques to enhance innovation and the humanitarian work of the Gates Foundation, as well as the humanitarian work of all those engaged in the life sciences, which Iverson says is “all about helping people and saving lives.”

Erik Iverson is Associate General Counsel with the Bill & Melinda Gates Foundation, working exclusively with Foundation’s Global Health initiate. Mr. Iverson works with grantees in the development of intellectual property management plans, collaboration agreements and global access strategies with respect to the health solutions being funded by the Foundation. During our conversation Iverson and I talked about how the Gates Foundation seeks to incentivize innovators, as well as foster and respect intellectual property rights while at the same time engaging in what by its very nature is a humanitarian effort.

Carrier goes on to detail the comprehensive research of Professor John Walsh who in 2007 surveyed 1125 biomedical researchers in universities, government labs and nonprofit institutions. Walsh received 414 responses and the responses were overwhelmingly clear. Carrier explains that only 3% of respondents indicated that they stopped pursuit of a research agenda based on an excess of patents present in the space. Furthermore, Carrier explained that a mere 5% of respondents even regularly checked for patents related to their research and “no respondents reported that they had abandoned a line of research because of a patent.”

Congress is at it once again, with the Senate Judiciary Committee reporting out a bill last week that remarkably resembles the bill that has been unable to gain any traction in the Senate for the last several years. That would suggest that the same fate is in store for this legislation. Not so fast! I have a suspicion that this year things are different and that we really could be on the cusp of patent reform. Whether that is for better or for worse will largely be in the eye of the beholder, but what is emerging feels different and I think we are closer to change, and perhaps an end to fee diversion, than we have been at any point over the last 6 years.

While New Mexico is not the only institution fostering growth, they do on average participate in the start up of 5 to 8 new companies a year. Kuutilla said that STC.UNM has participated in licensing technology to start-up companies that have created multiple hundreds of jobs at an average annual salary of $80,000 per job, which is $30,000 higher than the average private sector salary in the United States. There is no doubt that jobs in the innovation economy are high paying and exactly the type of jobs we need to be fostering.

On Monday evening, November 1, 2010, David Kappos, Undersecretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, told the Dow Jones news service: “The USPTO at the present time is maintaining the status quo. We’re continuing with current procedures as they are.” This could set up a contentious and public policy battle between the United States Department of Commerce and the United States Department of Justice. This battle of agency titans — DOJ v. DOC — comes as a result of the Department of Justice filing an amicus brief in The Association of Molecular Pathology v. The United States Patent and Trademark Office, which actually does not take the side of the USPTO, but rather says that what the USPTO is doing is wrong. Thus, in an extremely odd twist the DOJ is supporting the plaintiffs’ against the United States Patent Office.

Like it or not, the patent system is a great motivator, and used appropriately to incentivize the type of behavior we want to encourage it is a powerful tool in the government arsenal. To fundamentally alter what is considered patentable subject matter will not only negatively impact cutting edge biotechnology research, but it will also have a chilling effect. Uncertainty causes business paralysis and forces investors to the sidelines. The uncertainty that would be created by the curtailing of patentability would not be isolated to the biotechnology sector, and is exactly the opposite of what our economy presently needs.

On Friday, October 29, 2010, practically on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general, the Department of Justice filed an amicus brief at the United States Court of Appeals for the Federal Circuit that would destroy the U.S. biotechnology sector. In an astonishing and irresponsible policy shift that directly contradicts the long-standing policy of the United States federal government and a variety of agencies, the Department of Justice is promoting the dialing back of what is considered patentable subject matter and is urging the Federal Circuit to rule that “isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”

In this edition of News, Notes & Announcements, the USPTO announces it has signed an agreement with the Russian Patent Office to act as an International Searching Authority; the USPTO announces expansion of the Patent Prosecution Highway; PLI’s Patent Litigation 2010 starts next week and will travel across the US with stops in Virigina, Atlanta, Chicago and New York; BIO is hosting a Technology Transfer Symposium next week in San Francisco; Howard University will hold an IP Empowerment Summit on November 5, 2010, aimed at trying to help indigent inventors — USPTO Director David Kappos will participate; and BlackWeb Technologies sues two computer giants — IBM and HP — on patents covering methods for transmitting information between a remote network and a local computer.

In this edition of News, Notes & Announcements, the mother of all patent trolls, Acacia Research Corporation, scores two more licensing agreements, one with IBM the other with US Cellular. Samsung Electronics and Stanford Law School are combining forced to co-sponsor a patent prize for excellent writing about patent law, with real money awarded to the winner and runners-up; $10,000 and $5,000 respectively. AIPLA announced that David Kappos will give the keynote speech at the annual meeting on Thursday, October 21, and Judge Gajarsa will speak on Friday and Chief Judge Rader will participate in a panel on the amicus process. The Wall Street Journal is reporting about new challenges to cookies tracking our every move online, and BIO is the charter sponsor of a new weekly public affairs television program called BioCentury This Week, which premiered yesterday and is available on the web.