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Biotech / Medical : Celera Genomics (CRA) -- Ignore unavailable to you. Want to Upgrade?

To: Rob Pierce who wrote (160)	3/14/2000 8:46:00 PM
From: Ilaine	Read Replies (1) \| Respond to of 746

One thing Celera has done that is absolutely stupid is change its story about its intentions, which makes public statements less than credible. As an example, here is an article from the Washington Post. The article describes how Celera misled Congress, by stating that it intended to file 100 to 300 patents on bits of the human gene sequence, while filing literally thousands. Venter said that the info would be put onto a DVD and "given" to any researcher who wants it, when in fact the company intends to charge thousands. There's nothing wrong with making a buck, obviously, otherwise there's no point in investing, but there's a big difference between patenting inventions (ok) and patenting things that occur in nature (not ok). >>Md. Gene Researcher Draws Fire On Filings By Justin Gillis Washington Post Staff Writer Tuesday, October 26, 1999; Page E01 A maverick gene researcher who told Congress last year that he expected to receive patents on "100 to 300" bits of human genetic material has filed preliminary applications on about 6,500 such gene sequences in the space of a month. J. Craig Venter, the Rockville scientist who has been a lightning rod for criticism since he announced plans to unravel all human genes as a commercial venture, is drawing fresh controversy with the announcement. But he said his plans have not really changed and his critics don't understand U.S. patent law. Celera Genomics Corp., Venter's Rockville company, says it has unraveled about a third of the human body's genetic instructions in one month and expects to publish a full gene map next year, five years before the original deadline set by the federal government. Mapping the genetic code promises to open up new possibilities for understanding and treating such ailments as cancer, AIDS and Alzheimer's disease. The potential profit and glory have set off intensive jockeying among researchers. To Celera's many critics, including academic researchers locked in a race with Venter to be first to publish a gene map, the disclosure that the company has already filed 6,500 patent applications comes as proof of their longstanding argument that Venter is out to profiteer at the expense of public welfare. "I think it's going to inhibit work on these genes," said Robert Waterston, director of a gene-sequencing center at Washington University. "I worry that both companies and people will not invest their time and effort into something if they think that things are tied up." In sworn testimony before Congress last year, Venter said he expected to obtain no more than 100 to 300 genetic patents, and then only after careful study of their potential usefulness as treatments. He said he would put most of his data in the public domain for free, making it difficult for any researcher to stake out big patent claims on the human genetic code. "Our actions will make the human genome unpatentable," Venter said then. The issue of gene patents has long been controversial. A clear body of law has developed in the United States and other Western countries that genes can be patented, but many academic researchers feel nonetheless that a sort of gold rush is underway to stake out excessively broad claims based on thin research. These critics fear that such broad, sloppy patents will slow medical progress. "It puts us in a situation where there is such a tangled meshwork of patents and licenses that downstream research is actually inhibited," said Francis Collins, director of the National Human Genome Research Institute, which is competing with Venter. "A situation where somebody with a good idea is actually prohibited from pursuing it is not the way the public will benefit." Some academic researchers have been excoriating Venter over the past two days after his patent statistics were reported in the Los Angeles Times and several British newspapers. They are accusing him of promising Congress one thing and doing another. But Venter said yesterday that his critics were misreading his intentions. The patent applications filed to date are "provisional" applications that establish the date of a discovery, Venter said. Such applications, permitted by U.S. law since 1995, can be filed cheaply and give a company one year to file a full patent application, which is more detailed and more expensive. The company's commercial interests are protected during that year. Many companies--particularly in fast-moving, competitive industries such as biotechnology--file provisional patents as soon as they believe they've found something useful, then spend the next year deciding whether the application is really worth pursuing. Many of these applications are subsequently abandoned, though few companies will disclose exact numbers on how many they abandon. Executives of these companies see the provisional applications as an essential competitive strategy--if they don't file first, they reason, somebody else will. "Everybody all over the world is working on the same thing," said Kenneth J. Burchfiel, a top patent lawyer in Washington who has no involvement with Celera or Venter. "Whoever plants that stake first potentially is going to get a patent on that [gene] sequence." Celera expects to keep filing provisional patent applications, possibly totaling 20,000 or 30,000 by the time all genes are mapped. But Venter said a great many of those applications will be abandoned as it becomes clear the gene sequences specified in them are not medically useful. When he's through, Venter said, he expects Celera to have roughly the number of patents he told Congress he would have--a few hundred, not several thousand. "There's a lot of people out there that want to make hay about anything we're doing," Venter said. "It's scare-mongering, and it's doing harm to the American public's ability to understand this complex field." One thing is clear: As fast as Celera may be moving, other companies are far ahead of it in filing patents on genetic information. One of them is Human Genome Sciences Inc. of Rockville, with which Venter was once associated. That company, using a different research method than Celera's, has filed patent applications far more detailed than Venter's on about 6,750 human genes that it believes to be medically useful. Venter said he had no ultimate control over how many gene patents will spring from Celera's research because big drug companies can subscribe to the company's database, use it to make their own discoveries and then file their own patent applications. Venter added, however, that he remained committed to handing out the complete human genetic sequence without charge by sometime next year. He said the gene map would be put on a high-capacity computer disk, known as a DVD, and given to any researcher who wants it.<<

To: Rob Pierce who wrote (160)	3/14/2000 9:54:00 PM
From: Susan G	Respond to of 746

Today's Real News: Government Supports Gene Patents How investors are misunderstanding biotech By Jeff Fischer (TMF Jeff) March 14, 2000 People fell all over themselves to sell biotech shares today, even though many of these same people had rushed to buy the shares only recently. Human Genome Sciences (Nasdaq: HGSI) , Celera (NYSE: CRA) , Millennium Pharmaceuticals (Nasdaq: MLNM) , Incyte (Nasdaq: INCY) and many other young, leading biotech stocks fell 20% or greater. The culprit? The media is pointing to Bill Clinton and the U.K.'s Tony Blair. The two men had the "audacity" to propose that raw human genome sequencing information should be shared with the public. That is not new information, however. The Human Genome Project was created long ago to do this very thing (share its information), and since its inception Celera stated that it would likely share its raw data for free or at very little cost to subscribers. So, in fact, the only novel news presented today was good news, thus it is baffling that biotech shares got stomped. This evening I spoke with Human Genome Science's President and CEO, Dr. William Haseltine, and he happily pointed out that today was the first time in history that the government publicly stated that it supports gene-related patents. Dr. Haseltine said, "Read the quote from Clinton," and then he read it aloud. Today Clinton said, "Intellectual property protection [i.e., patents] for gene-based inventions will... play an important role in stimulating the development of important new health care projects.' Dr. Haseltine said that if he wanted to, he could begin his next annual report with this monumental statement, and quote today as a monumental day. Investors apparently misunderstood the meaning and implications behind Clinton's statements, however, sending almost all biotech stocks sharply lower. How could Wall Street misunderstand so badly? Perhaps because today the government also stated that scientists cannot get patents for human genes themselves. This, however, should not be a surprise to the industry or to investors, either. Any biotech company with patent attorneys worth their salt would not attempt to randomly patent human genes. As Dr. Haseltine has said in the past, "Trying to patent a human gene is like trying to patent a tree. You can patent a table that you build from a tree, but you cannot patent the tree itself." With genes, you can patent specific uses that you discover regarding a gene, but you cannot patent the gene itself. (After all, you didn't create the gene. Just like you didn't create the tree.) Human Genome Sciences has been issued 117 patents on specific uses for genes in the body. These are the kinds of patents that have value and that should, almost without a doubt following today, stand up in a court of law. Dr. Haseltine said, "Raw genomic data is not patentable because it is not useful [or original]." His company, instead, has focused on isolating genes and turning them into forms that can be used to make a protein for the body. This practice is original and patentable. So, today the business of patenting information regarding the use of isolated genes was blessed by two key leaders of the Free World. Biotech companies such as Human Genome Sciences and Millennium Pharmaceuticals, both of which have been obtaining patents on this very premise for several years, have been vindicated, as has the entire gene-based drug industry of the future. Celera and Raw Genome Data "Part two" of today's news was that, according to Clinton and Blair, all raw human genome data should be shared with the public. From the start, Celera has planned to make much of this information widely available without cost or at very little cost. This month, Celera will publish the fruit fly genome free of charge. In the future, Celera will share sequencing data from the human genome as well. As today's detailed press release from Celera reminds, this has always been the plan. Celera is interested in sharing information with the world, not locking it away. Will all of Celera's information be freely shared? Well, most likely much of its "raw data" will be shared openly, and this raw data is what the government was naively clamoring for today -- "naively" because the value of the raw data (the genome itself) is limited anyway. When Celera adds additional expertise to its genomic information, however, it will almost certainly patent (when possible) and sell that value to subscribers. It is, after all, a business. Understand, though, that having the human genome sequenced alone will not answer many questions or create much value by itself. This is only the beginning of the work. Isolating and discovering what each gene does in the body is where actual medical solutions can be discovered. Companies that discover these solutions deserve rewards for their labor and expense, and they will be rewarded -- as the government stated today (although the message was lost in the noise). Admittedly, most of the potential reward for young information gathering companies lies far down the road, but that has always been the case. Celera is in "phase one" of its business plan. (Biotech companies that have patented uses for isolated genes for years are considerably further along.) So, the real culprit behind the tumble in biotech shares today was not Clinton or Blair, but investors who do not understand the business models that many young biotech companies are trying to create, and it was investors who may not understand how the patent process works and is enforced, either. These are complex topics and admittedly a great deal of uncertainty exists. However, companies such as Human Genome Sciences, Millennium Pharmaceuticals, and others that have filed patents for specific uses of isolated genes received excellent news from the government today, while genome sequencing companies, such as Celera, were merely reminded that leveraging raw genome data into dollars will meet much resistance. However, the real value has always been buried far beneath the raw genome data, and don't think that Celera didn't already know that. fool.com