DNA patenting down

The number of DNA-related patents issued by the US Patent and Trademark Office declined in 2004. So says the Washington, DC-based intellectual property law firm Finnegan Henderson, which conducted a DNA patent study published June 20. According to the 2005 Biotechnology Innovation Report, about 9% fewer patents with the word “DNA” in the specification were issued in 2004 than in 2003. US patents, writ large, declined 3%. The slump was most notable at universities and research institutes. The patenting decline extends a downward trend in DNA patenting that started in 2000; last year, authors of the Finnegan report observed a drop of 11% between 2001 and 2003 (Nat. Biotechnol. 22, 930–931, 2004). Interestingly, in 2004 the number of new DNA patent applications also fell, reversing a sharply increasing trend. Notable exceptions were fields like RNA interference (RNAi) and kinase-related agbiotech research, where patent activity went up. Top DNA related US patent holder University of California added 14 patents to its portfolio of 118 and the US government held on to second place with 94 patents, up from 87 in 2003. Private companies Applera (78 patents) and Genentech (55 patents) captured third and fourth place. About two-thirds of DNA patents are privately held. PV

Pfizer pays top dollar for biotech firm

In an unusually high takeover bid, on June 16 pharmaceutical giant Pfizer (New York) offered $1.9 billion for all shares of Vicuron Pharmaceuticals, a biotech drug discovery firm headquartered in King of Prussia, Pennsylvania. The $29.10 per share offer was 90% more than Vicuron's 52-week average closing price. Vicuron, which has two anti-infectives under review for market approval at the US Food and Drug Administration, had already been collaborating with Pfizer, as well as with Sanofi-Aventis, Bayer, Schering-Plough and Salt Lake city, Utah-based Myriad Genetics. This takeover could replenish Pfizer's portfolio of antifungals and antibiotics under patent protection, which last year lost Diflucas (fluconazole) and will soon also lose top-selling Zithromax (azithromycin). Other factors influenced the premium offer price, says Scott Henry, healthcare analyst at Oppenheimer, an asset management firm in New York City. “Everybody has empty pipelines, so it's really a seller's market,” he says. “Also, because of new tax laws, US firms are repatriating a lot of cash from abroad. Thirdly, there's fear of generic competition.” Might this confluence of factors bode well for biotech? Most certainly, if biotechs can deliver the products. Henry says the answer remains to be seen. PV

Pharmacogenomics moves in on patients

On June 21, New Haven, Connecticut-based pharmacogenomics company Genaissance Pharmaceuticals announced it will be acquired later this year by Newton, Massachusetts-based Clinical Data, a worldwide supplier of services and diagnostic equipment to hospitals and doctors. The move will bring genetic testing for drug safety and efficacy one step closer to physician's offices, says Kevin Rakin, a cofounder and CEO of Genaissance, who will join the board of the combined firm. At present, Genaissance only markets genetic tests to biotech and pharmaceutical companies as well as research institutions, helping them to determine drugs' efficacy. Recently, however, the company initiated plans to market drugs targeted at genetically typed patient populations to maximize effect or reduce adverse events. It licensed an exclusive right to develop and commercialize vilazodone, a selective serotonin re-uptake inhibitor, hoping to find single nucleotide-polymorphism markers that can identify patients who will respond well to the drug. According to Rakin, the takeover will lead to an even stronger focus on genetic tests that can be distributed through the channel of physician's offices. “This deal means pharmacogenomics is growing up,” he says. “In the next two to three years, tests will be coming out that can be marketed to end users.” PV

NASA relaunches biotech space plans

Credit: NASA

On June 21 and 22, NASA scientists and space service providers met to develop a plan for opening up the International Space Station (ISS) for commercial biotech research. Participants identified three areas in which research in a microgravity setting could have commercial health applications: infectivity, genetics and aging. They also discussed how to interest the biotech community and venture capitalists in space research. NASA has long voiced intent to open the ISS to entrepreneurial ventures, and in 1998 the US Congress passed the Commercial Space Act to seek commercial avenues for ISS use. But recent attempts to entice the nanotechnology and high-strength materials industry, for example, never got off the ground, says Phil Smith, CEO of the California Space Grant Program. Smith adds that the Columbia and Challenger accidents derailed the biological research that was already underway. Alan Marty, an executive in residence at JP Morgan Partners in San Francisco, was initially skeptical about the worth of the program. He reconsidered after attending the ISS meeting. “From a VC [venture capitalist] perspective,” he says, “I came away thinking it's not a matter of whether, but when” this project will bear fruit. What's changed the picture is a booming interest in commercial space flight by entrepreneurs such as Burt Rutan, which could lead to the possibility for cheap frequent flights in the next decade. Still, says Marty, “NASA has to make the decision to do what it takes to accelerate commercial space launch.” AK

Table 1 New product table

US slouches toward regulatory streamlining

Some critics complain that US regulations governing field tests of genetically engineered crops are onerous. When officials of the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued permits in June to field-test crops engineered to produce pharmaceuticals, it seemed to some that regulators might be easing restrictions when they agreed to locate plots near commercial plantings of similar crops. The permits were issued to Ventria of Sacramento, California, (Nat. Biotechnol. 23, 636, 2005) and SemBioSys Genetics of Calgary, Alberta, Canada. Skeptics, however, are withholding judgment until later this year when APHIS officials are expected to issue a comprehensive environmental impact statement (EIS) that former USDA Secretary Ann Veneman requested in early 2004. Many in the biotech industry hope that the EIS will, in fact, lead to a substantive update of current rules and include a move to a tiered system for issuing permits, whereby plants engineered with familiar genetic modifications could be spared detailed reviews. “That's a modest step in the right direction,” says Gregory Conko of the Competitive Enterprise Institute in Washington, D.C Conko, a vocal critic of existing protocols, who believes more extensive reform is needed but warns that little is expected to change. Likewise, little is expected to change in how the US Food and Drug Administration and the US Environmental Protection Agency contribute to such reviews, though officials at each have promised to continue making interagency efforts more “seamless.” JF

Report maps biodefense industry market

A little-noticed report published in May has detailed all 162 companies, universities, government labs and international organizations worldwide that are working on the 323 prophylactic vaccines and therapeutic drugs targeting agents of bioterror (see Supplementary Table 1 online). Mark Dibner, president of Bioability, a strategic research company in Research Triangle Park, North Carolina, which conducted the study, says that he was surprised by the sheer quantity of products in the pipeline. “There usually aren't that many competitors in most fields we analyze,” he says. All told, there are 60 products in development against anthrax, 37 for smallpox and 20 for dengue fever. That's a lot of products vying for the same market: the government. Typically, in the commercial biotech arena, competition is determined by market size. In biodefense, Dibner says “it's much harder to say”. Another surprising finding, says Dibner, was that of all 323 products in development, only three are in phase 3 clinical trials. With such a large percentage of biodefense still in early stages of development, he says, “I think many companies would be interested to know what the competition is doing.” The report, published and sold by BioWorld Today, also details funding sources for all research entities covered. BioAbility is now working on updating another book outlining the biodefense funding opportunities that are available, to be published in late 2005. AK

News in Brief written by Peter Vermij, Alla Katsnelson & Jeffrey L. Fox

Table 2 Select research collaborations