Sure Todd. You determine which patent laws are weak, then expressing and purifying the protein, then setting up and running the trial, then submitting for regulatory approval, then marketing the drug (that seems like the easiest part - just go to the hospital pharmacy and say we make the exact same amino acid sequence and will charge 50% of the price so-and-so charges you). I’ll handle the, umm, rest.

I didn’t say it was easy. But there is an existing mechanism to bring competion to biologics. Profitable? Possibly. Cost-effective? Probably not.

Yes, you likely could do it if the patents have run out. Given that every pharma in the world is looking for new products, biotech, and revenue there must be something preventing this from happening. I will admit not the sharpest guys run the pharmas…. but I think they would have looked at this at some point - don’t you?

If no one is doing it and it is feasible - let’s get together and start one up. I would like to run a company instead of working, wouldn’t you?

Me: Right, but a significant amount of that cost boils down to the 90%+ failed clinical trials. This trial should be a slam dunk.

Brian: The whole point of a generic is to steal a discovery and sell it for just above it’s manufacturing cost.

Me: I work for a brand name pharmaceutical company. I still wouldn’t call making a generic drug “stealing.” Patents require vigilant protection while active (I’m looking at you Thailand), and they need to have an expiration date.

Todd: Except for the fact that companies also patent manufacturing and delivery technology - that’s why there are so many court cases. There is not 1 patent for every drug out there - there are up to 10 or so.

Me: But all patents expire eventually. A company patents the initial molecule, than all through the discovery process they patent parts of the manufacturing process. Let’s say a patent lasts 17 years (right?). Let’s say Antibody X is first discovered/synthesized in 1980 and the company patents it. This patent expires in 1997. All the regulatory processes, the manufacturing processes, the clinical trials, everything, that all takes 10 years for this antibody. Then at the last minute in 1990, just before marketing the drug, the company secures another patent. Wouldn’t all these patents still expire in 2007? So another company, Generic Biologics Inc. could then make the same antibody, run a trial, prove it works, and submit it to the FDA for approval.

Would this be legal? I can’t see why it wouldn’t - and it really means there’s already some mechanism for competing biologics to reach the market place. Yes, Generic Biologics Inc probably couldn’t charge the same price as the original innovator. Yes, Generic Biologics Inc couldn’t market the drug for any indications it didn’t prove, in it’s own trials, that Antibody X worked for. But the only two companies selling Antibody X are the original innovator and Generic Biologics Inc, so they wouldn’t need to drop their price to just above manufacturing costs. And yes, it would be expensive, but Generic Biologics already knows Antibody X works. They don’t need to test ten antibodies to find one that works. They just need to make the molecule and run the trial correctly (which really means mimicing the way the original company created it). On my rough timeline of when biologics first started to appear, I feel we’re right around the time a generic company could rerun a trial and get a copycat biologic to the market.

Paxil 329 ring a bell,…Maybe you can give us a better argument…

Look at the Mircera debate for proof that companies patent more than just a simple molecule. They are even getting patents for ideas. You can get into right or wrong, but those are the rules. You can challenge anything in court you want as long as you have the $$$$.

Also - if you just want a “generic” company come in and manufacture a molecule, they too will charge “what the market will bear”. Biologics would not go down to a dollar a day, they would be about a dollar a day cheaper. So you have a company who didn’t do any bench research taking away revenue from companies that are out there doing research for better treatments.

Bottom line - someone is going to make that profit, do you want a biologic doing groundbreaking work or a “me-too” company trying to profit off of someone’s ideas and hard work and large financial investment.

That being said, does you arguement still hold any water?

With small molecules, a generic company can synthesize the exact same active molecule, place it into its delivery form (usually a tablet or capsule), prove the kinetics fall between 80-125% of the brand name product and start marketing it.

I also understand that for biogenerics, you just can’t get generic approval this way.

But…

Everyone knows the active protein in the biotech product. And they must have patent life too, right? Let’s say a brand name company makes Antibody X for cancer. After 17 years (or whatever) could a generic company make Antibody X for cancer, test it in patients for EFFICACY, and then market it? It’s more expensive than just proving bioequivalence. But it’s also way less risky than testing a whole new drug (if you make the protein correctly, and run the trial correctly you already know the drug will work). Then the “generic biotech” company could drive down the price of the treatment AND also charge much more than they normally can for a generic small molecule (since presumably few generic companies would try this). Even if you only get 10-20% of the market, these biotech products could pay off big time.