User talk:Mac/Interviews

Basic questions

What is the basic business model in the In-Vitro Diagnostic (IVD) industry?*

What are the stages of the development pipeline for an IVD? (i.e. innovation, validation, regulatory approval, clinical utility, marketing?)

At which of these stages is there IP activity?

What is the mode of control? (patent, trade secrets, NDAs, Non-compete, non-solicitation, confidentiality, etc.)

What are the component parts of diagnositc kit creation. Of those parts, what is being protected using intellectual property rights or trade secret and what remains in the public domain? (i.e. measurement techniques, analytes, algorithms, trials data?)

What is the effect of increased co-development, or bundling, of diagnostic kits with theraputics (PGx)?

Have you seen the industry trend towards consolidation effect patent behavoir? (Labcorp of America, Corning, and Beecham)

What are the key institutions where early stage development occurs?

Collaboration / Commons-building questions

Commons can be classified with two parameters: access and regulation. What, if any, examples of commons exist in the IVD industry?

Are there any commons-based diagnostic chassis or platforms shared amongst many IVDs?

What phases of IVD development do you envision could benefit from commons-based resources?

What forces inhibit the formation of commons-based resources? Conversely, what (potential) incentives would drive their adoption?

Licensing Questions

Are there industry norms for licensing of IVD patents?

Do these norms favor exclusive or nonexclusive licensing?

Do these norms differ significantly for acedemic use as compared to commercial use?

Are patent clearing-house or patent pool models feasible in today's market?

Would they cause more problems than they solve (ie. antitrust, high maintainence costs associated with administration)?

In the case of clearinghouses, would standardizd license use be possible? Our research ahs shown that there are efficencies involved in a common licensing scheme but is this a good fit for the IVD industry?

Is confusion over patent ownership or enforcment a significant barrier to IVD research and development?

some firms innovate through aquisition, this seems to frustrate downstream licensees. Is there a need for better reporting of patent assignment/licesning agreements?