In a teleconference chat yesterday afternoon with a few bloggers, Jim Greenwood spent some time sharing the BIO point of view on the pressing matters of the day - follow-on biologics legislation, patent reform legislation and the FDA reform bill, which is otherwise known as PDUFA. Here are some excerpts….

Follow-on Biologics: This is “a critical, critical issue…(Ideally, legislation) would leave interchangeability to physicians (as opposed to insurers)…The Senate version (of the current legislation) has 12 years of data exclusivity; we still think 14 is the right number. If you make that number small enough, you’ll save some money (in healthcare costs), but innovators will have to shelve research products, and their investors won’t invest hundreds of millions of dollars if data exclusivity is too short…” And the chances of legislation passing in the current Congress? “We won’t take a bad deal for fear of the outcome of a presidential election…But we’d like to see the job get done, if it can get done right…I think before the ‘08 election, you’ll see a bill.” (To read the Senate bill, go to this site and type in S1695)

Patent Reform: As expected, Jim criticized the House bill, arguing it was “largely inspired” by high-tech companies “who roll out iPods, MP3 players and cellphones in rapid order, and feel threatened by patent trolls…It’s good for them, but not good for us…Anything that erodes IP (intellectual property) and makes it easier to infringe and less costly to infringe is dangerous for biotech…There’s a big problem with apportionment of damages.” (To read the House bill, go to this site and type in H1908).

The House bill includes an apportionment provision for assessming infringement damages, which would have courts calculate a reasonable royalty based on the economic value of an individual patent’s contribution to the invention, instead of the value the patent creates for the overall product. Biotechs and drug and device makers say this would lowball damages in infringement suits.

FDA Reform: We think we’ve done pretty well…We’re not happy that Congress included $250 million in PDUFA fees after we spent last year negotiating with Congress…But PDUFA expires in 12 days and morale at the FDA is not good. If Congress doesn’t grant a temporary extension, it’ll be another morale killer. They (FDA staffers) really do start thinking about other offers, since government doesn’t pay.”

For more insights, see The Orange Book Blog, Patent Baristas and Patent Docs, who also sat in on the call.