New Law Aims to Reduce Financial Risk of Developing Biothreat Tools for US Gov't
A little-known bill enacted into law at the end of last year could be a boon to biotech companies, including those using genomic technologies, developing diagnostics for pathogens and other biosecurity-related products and services.
The Pandemic and All-Hazards Preparedness Act creates a new way for the federal government to contract out its biosecurity programs for biothreat responses, among other provisions.
It aims to reduce some of the risks faced by companies developing bio-threat technologies for the federal government.
Specifically, it will try to cover R&D costs for companies developing biothreat tools as NIH funding runs out but before Project BioShield kicks in, which can take between three and five years.
“The government is finally getting it,” David Persing, a vice president at Cepheid, told ProteoMonitor sister publication GenomeWeb News. “They’re finally understanding what companies need and how companies work.”
The Pandemic Act creates a new scaffold of powers, called the Biomedical Advanced Research and Development Authority, through which federal agencies are given more freedom to offer companies enticements to develop biothreat responses.
BARDA, which is slated to receive a $1.07 billion funding budget for fiscal years 2006-2008, will be used to supplement Project BioShield, which includes the Departments of Homeland Security, Agriculture, Energy, Health and Human Services, and the National Science Foundation, among other organizations.
HHS spokesman Bill Hall said there are inherent and novel risks to developing biothreat products, and BARDA “will help some of these companies … get through that valley.”
Hall said all drug- and disease-related research is risky, but biothreat programs are doubly so. “There is a tremendous amount of money spent on biotech on cancer,” Hall explained, “but there have been many dead ends. The same is true for biotech or biosecurity. But [in biosecurity] you’re dealing with issues [such as terrorist attacks] which may not come to fruition.
“And there is not a built-in delivery system in place,” Hall continued. “For a cancer drug, there is a delivery system: hospitals, doctors, etcetera."
Hill stressed that because the project is new, it is not yet clear where its funding will come from, how it will be overseen, or how it will be implemented.
As a contractor making a diagnostic for avian flu, for example, Persing said Cepheid might be likely to shy away from a restrictive contract.
“If [the government] had come up with a proposal and restricted it to avian flu, we’d say, ‘Well, why do we want to do that? We don’t even know if we’re ever even going to need'” the tests. “Nobody is excited about that kind of business model. Everybody gets discouraged and interest starts to wane.”
Supreme Court's Genentech Patent Ruling May Hinder IP Deals; Academia, Biotech Vulnerable
A recent ruling by the US Supreme Court allowing MedImmune to challenge a fundamental Genentech patent while Genentech continues to out-license the IP may hinder future technology licensing deals, the Licensing Executives Society said this week.
The Court’s decision may be particularly detrimental to future deals in the biotechnology industry and in academic technology-transfer offices, according to the LES, a 30-year-old tech-transfer professional society comprising more than 6,000 members. The ruling, handed down on Jan. 9, allows MedImmune to sue Genentech over the validity of a patent that covers techniques for making monoclonal antibodies.
According to the LES, 80 percent of a 186-participant survey said that the Court’s ruling would “hold large implications for the [IP] licensing profession.” The survey, released yesterday at the LES winter meeting in San Francisco, also found that 79 percent of participants said that licensees would be either “somewhat” or “much more” likely to challenge patents even after striking a licensing agreement, and that 57 percent thought that licensors would be “somewhat” or “much more” likely to seek higher upfront payments to offset the risk of losing out on future royalties.
“Historically, once you did a [licensing] deal, for the most part you stopped thinking about whether the patent you licensed was really valid,” Allen Baum, president of the LES and a partner with Raleigh, NC-based Hutchison Law Group, told GenomeWeb News yesterday. As a result of the ruling, licensees “are going to think about whether they need the relationship and whether they need the rights; or whether they should roll the dice and challenge the patent.”
Before the ruling, a patent licensee would have to breach a license agreement in order to challenge the patent in court. “Now you don’t have to do that,” Baum said.
“Under the old rules, if you decided to go ahead and breach, you exposed yourself to the potential of enhanced damages, up to triple,” he said. “Now, because you can keep paying royalties and challenge the patent, there is really no downside risk to the licensee other than … legal expenses if they ultimately lose.”
In addition, according to Baum, “biotechnology is an obvious place where [challenging a patent] is likely to happen because you’ve got such big dollar values — where you’ve got large amounts of money changing hands for enabling technologies.
“If you start thinking about the patents that are going to be most affected by this decision, [then] what you’re talking about typically are sort of fundamental, enabling technologies,” he added.
Academic tech-transfer offices could be particularly vulnerable. “This case will particularly hurt academic institutions, which cannot afford litigation costs and have relied on licensing fees to pay for their technology transfer efforts,” an unnamed survey respondent said, according to the LES.
Some experts believe that the decision may also spur university tech-transfer offices to add language to license contracts that would prohibit licensees from challenging the validity of a patent, which in turn could further hamper future tech-transfer efforts.
In a live online discussion held last week by The Chronicle of Higher Education, Jonathan Soderstrom, managing director of the Yale University Office of Cooperative Research, wrote: “My guess is that it will have a bigger impact in non-exclusive licenses than in exclusive licenses. I think obtaining contractual prohibitions will be very difficult to negotiate into license agreements.”
However, Soderstrom also wrote that it is still too early to judge exactly how the court ruling will change university licensing practices.
ABI/MDS Sciex, Pfizer, Sound Analytics to Develop ADME Software
ABI/MDS Sciex is collaborating with Sound Analytics and Pfizer to develop software aimed at helping drug manufacturers identify the viability of new drugs earlier in the development pipeline, the companies said this week.
The goal of the collaboration is improve the timeliness and accuracy of information generated during testing of the absorption, distribution, metabolism, and excretion of the drug candidates.
ABI/MDS Sciex will provide expertise in drug research tools and software-based automation. Sound Analytics will provide ADME software development expertise to the project, and Pfizer will guide its parteners in shaping requirements for the new ADME software applications, the companies said in a statement.
ABI/MDS Sciex's approach is to increase the automation of the analytical process "and [to] create a more intuitive method for managing the screening of compounds. At the same time, the approach emphasizes the acquisition of quantitative results on mass spectrometry instruments for deeper molecular analysis tailored for drug discovery laboratories," the company said.
Financial terms of the deal were not disclosed.
Proteomics Programs to be Offered by GenNext, Select
GenNext Technologies and Select Biosciences plan to co-produce meetings and educational programs that combine their experience in microarrays, proteomics, translational medicine, clinical genomics, and bioinformatics, among other disciplines, the firms said last week.
Select Bio said that by combining their knowledge the companies plan to offer professional development classes that will help researchers "enhance their careers."
GenNext said the courses will blend "theory" with "how-to information."
Select Bio has run meetings and courses covering topics such as proteomics, molecular diagnostics, drug/target screening, microarrays, and RNAi biomarkers.
GenNext, meantime, has created educational programs in proteomics, translational medicine, clinical genomics, and bioinformatics research.
Eksigent Separations Analytical Ink New Deals
Eksigent said this week it has a new distribution agreements with Separations Analytical Instruments, based in The Netherlands, and with French company Serlabo Technologies.
Financial details of both deals were not disclosed.
The deal with Separations Analytical covers sales of Eksigent's NanoLC HPLC products in the Benelux region, while its agreement with Serlabo covers sales and services of the NanoLC product line in France.
Separations Analytical was founded in 1989 and serves the pharmaceutical, life sciences and environment industries with special emphasis on high-throughput applications. The company specializes in HPLC and online SPE sales and services.
Serlabo specializes in the sales, application support and maintenance of chromatograpy, spectroscopy, and other biotech instruments.
Agilent Compliance Program Now Compatible with LC/MS
Agilent Technologies announced this week its Enterprise Edition qualification program is now compatible with mass spectrometers, liquid chromatography, and gas chromatography.
The program allows customers in highly regulated environments to use a single protocol to meet compliance requirements.
In a statement, the company said Enterprise Edition reduces the cost for instrument compliance by "streamlining compliance procedures across an entire company," and combined with electronic reporting and approval the program has cut the overall qualification down-time of instruments by half.
Oxford Takes Delivery of Waters' Synapt HDMS
Waters announced this week that Oxford University has taken delivery of the Synapt HDMS. The university's chemistry department will use the mass spectrometer to study interactions between proteins and other bio-macromolecules and between proteins and small molecules, the company said in a statement.
The university will also use the Synapt to do research on multi-component protein complexes. A major part of his work will be on gaining a chemical understanding of how cells sense oxygen.