Facilitating Collaborations to Develop Combination Investigational Cancer Therapies Workshop Summary (2012) / Chapter Skim
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5 Legal Issues in Collaborations
5 Legal Issues in Collaborations
Pages 43-52
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From page 43... ...
Suggestions from Various Workshop Participants to Address Legal Issues in Collaborations • G iving patients more autonomy in deciding how much risk they are willing to take with experimental therapies • B eginning conversations about collaboration and IP at an earlier stage of development • R eserving IP protections for direct drug candidates, and embrace precompetitive collaborations for work upstream of specific candidates • D eveloping standardized material transfer agreements, perhaps modeled on those used by the National Cancer Institute's Pediatric Preclinical Testing Program • S pecifying upfront those aspects of an agreement that are negotiable and those that cannot be changed • R estricting collaborations to research and development to avoid antitrust violations 43
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From page 44... ...
Dr. Schlom pointed out that a major impediment to companies sharing their cell lines and drug candidates preclinically is intellectual property issues, while others stressed that intellectual property rights impede clinical trials of combination cancer therapies.
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From page 45... ...
for indi vidual agents to "provide a platform to allow for combination studies." Dr. Jason Cristofaro, intellectual property advisor at the NCI Division of Cancer Treatment and Diagnosis, expanded on CTEP's efforts to foster collaborative, multisite cancer research.
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From page 46... ...
The IP provision also grants a label license that enables the companies to use the data and information they receive on the invention in their label for the drug or drug combination. This limited commercial label license does not grant the right to make and sell the assay or invention that has been created, so the academic testing sites can still partner with small diagnostic companies to develop diagnostics using the biomarker data collected in a clinical trial, and the diagnostic companies can still sell, make, and profit from the diagnostics, with the understanding that the original collaborator will still have the right to put the information
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From page 47... ...
Dr. Sherry Ansher, associate branch chief of the Agreement Coordination Group at NCI, stressed the importance of that biomarker language in the new IP option by pointing out that of all the new clinical trials entailing treatment studies done under INDs, 80–85 percent of them for 2010 included embedded correlative biomarker studies.
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From page 48... ...
But having core principles really makes the process much quicker because everyone is starting at the same place, and just minor tweaking is needed for the specific situation." Mr. Blakeslee added that it can be expedient to identify the appropriate person to contact in the company about a material transfer or other intellectual property agreement, and that often time is wasted waiting for the right person to respond.
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From page 49... ...
ANTITRUST LEGISLATION Although some drug companies have expressed reluctance to conduct collaborative R&D on investigational drugs with other companies because of concerns about violating antitrust laws, Mr. Robert Leibenluft, partner at Hogan Lovells, explained that these laws should not restrict such collaborations.
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From page 50... ...
Leibenluft stressed that antitrust rules prohibit companies from collaborating to fix their prices and restrain trade such that together they have a larger market share and market power. "If you had collaborators that together were the only entities doing research in a certain area, that would raise antitrust issues.
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From page 51... ...
Leibenluft. "A collaboration involving everybody in the pharma industry would raise more serious antitrust concerns obviously than if it's a few players, and there's others out there who have their own collaboration in competition," he said.
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From page 52... ...
Mr. Leibenluft noted that it is possible to obtain prior guidance with the FTC or the DOJ, both of which oversee antitrust laws.
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