Class Notes

From Cyberlaw

3.6.06

(As always, pls edit if mistakes, add links, etc.)

Can create an anonymous user name on wiki

Nesson showed us the Wireless Philly page – might make 2 credit paper into wiki debate

Bruce’s lecture (can someone add a link to his PPT [here]??):

• Players: academic scientists, biotech companies, pharma companies, TTO
• Motivations:

- Saving patient’s lives

- Money

- Advancing science

- Winning

- All of the above

• IP is king; development is the devil: w/o IP rights, you won’t raise the money to develop anything
• Control Mechanisms: contracts, litigation, regulation
• Key academic contract issues:

- How do I make sure patent rights enforced?

- How do I make sure biotech is diligent in development?

- What happens if drug turns out to have other benefits?

• Key biotech objectives:

- Flexibility -- make sure I can sublicense

- Make sure scientist doesn’t also create a competing product

- Not too much cash in beginning

- Ability to control patent prosecution

• Two kinds of clients: ppl who know how to deal w/ biotech partnering and ppl who are frustrated dealing w/ technical lawyering
• Liability issue: purpose is to deal w/ who has the ability to make sure things are done appropriately

- University wants indemnification for toxicology experiments, makes sense

- Clinical trials: if dr doesn’t follow rules of the experiment, fair for biotech to tell university that it’s responsible

• NIH’s role: access to govt resources, validates legitimacy of technology is NIH will work w/ person

- CRADAs (coop research and development agreements) – clients often want to enter into these agreements w/ NIH

- Statutory, little room for negotiation

- Option price is not set

- Govt can force you to license invention – is it worth it getting the work done for free and then losing out to competitors if you don’t get the license?

- Govt can license rights for govt purposes – only happened w/ AZT in pharma, happens in defense industry

- MTAs (material transfer agreements) – like a confid agreement for transfer of matl, not really doing research at same time

- Note: pre-Bayh-Dole, ppl just sat on their research, BD made things accessible to industry; BD created biotech, before there was just pharma, which looked a lot like NIH does now

- Govt has the authority now to do both exclusive and non-exclusive license agreements

- NIH has right to approve sublicenses, too (can only force them into time limit for decision)

- Must patent the inventions, otherwise goes into public domain

- Short time period if collaboration (3 yrs)

- Govt gets first right to sue

- Requires reports

- Most manufacturing supposed to occur in U.S. (can get waivers)

- Question ab using academic settings for churning out products – unlikely to ever get a university to get into this business outside of a clinical trial

• Take-away points:

- First question to ask the client: do you need the rights?

- Weigh the benefits of govt participation and costs of govt terms – how will govt entanglement influence negotiations w/ pharma?

- Lot of terms aren’t negotiable

Notes on negotiations:

• First milestone is v imp – most small molecs don’t get that far
• Don’t necessarily have to be adversarial
• Big tenured faculty have pull in getting deals done – shows how everything’s dependent on context
• W/ indemnity, focus on who is best able to control the problem
• There’s room for innovation in the licensing (e.g. options if new things discovered)
• Most times ppl like working w/ what’s familiar, so if university has an established licensing office, you’ll end up working off their form
• Biotech has an advantage on big pharma bc of speed of drafting

Belee 22:11, 7 March 2006 (EST)