Do U.S. drug companies share all research?

[isochar]

I've been looking for this answer but haven't had much luck. Considering that a each company has 20 year patents on new drugs from the date of invention, it would permit them to share all their research w/o worrying about competitors. However, some of that research could be used for future drugs...

So, does anyone know for sure? With some supporting/contradictory evidence?

(PS. Never realized how large a mess the current system is. )

[Wombat]

No, they don't share. And sorry iso, but it looks like you don't quite understand patent-land.

You can patent something without showing everything about how you got there. Also, the more you reveal, the more you're helping your competitors.

For example, there's something called "patent fences." Suppose you research and patent object A. I can then figure out all sorts of things that can be done based on A. I can go out and patent A+B, A+C, A+B+C, D (which is based on A), etc. Now, I can't actually <I>use</I> these things because I don't have a licence for A, but you basically can't use A either, because I've got you hemmed in. It's time to cut a deal, to my advantage of course.

So, companies also don't want to help other people build fences.

[isochar]

I know I'm part of the uninformed, which is why I'm searching for answers .

So... the drug companies do not even release all their research to the FDA? It seems that drug companies only publicly disclose the list of ingredients of their approved drug...

[Dr Mordrid]

They DO have to release their research to the FDA for the review process and much of that info is public.

Dr. Mordrid

[Brian Ellis]

No company will reveal their research programmes. It would constitute "prior art" and invalidate their patent applications. Furthermore, if a company is researching a molecule which has a specific physiological action and a rival company gets to hear about it, the info could give them a hint about where to look for a slightly different molecule with a similar (or better) effect, which could come to the market that much sooner.

The disclosure in the patent application is the first info that a competitor can have of a new molecule, and that puts the patentee typically 5 years ahead. The application is made before disclosure to the FDA or any other body (otherwise, the info would be in the public domain).

The key date is the day that the patent application is filed. This is put off until after the basic studies have been terminated and the feasability of production has been determined. This ensures that the company has the longest priority. Until then everything is held top secret. In fact, the CIA, FBI, MI5/MI6, La Surité and other such organisations could learn a lot from the security practised by the drugs companies laboratories.

In the 1950s, I worked for a company manufacturing industrial instruments. Two of my direct customers were well-known pharma companies and I was involved with the manufacturing feasability stage that, in two cases, required custom instrumentation. My company and I were sworn to secrecy in front of a notary public and the information supplied to us was on a strict "need to know" base. In fact, we were given zero details on the process itself, only on the physical parameters that we had to measure and the chemical compatibility of the substances involved, so that we could design the sensors, using the right materials. Even so, disclosure of the materials we were permitted to use would have been a breach of confidence, as they were afraid that it could give rivals a clue by back-engineering (which was ridiculous, as they were mostly common alloys and polymers!). We were given no clues as to the composition of the proposed substance, not its effects. The word 'paranoid' almost comes to mind.

Other customers, working on military projects, for example, were much more open. In fact, I've had access to the UK Ministry of Defence Research Labs themselves on a number of occasions, including files of varying degrees of confidentiality, without any of the hassle of entering the labs of the pharma companies.

[Wombat]

Originally posted by Brian Ellis
The disclosure in the patent application is the first info that a competitor can have of a new molecule, and that puts the patentee typically 5 years ahead. The application is made before disclosure to the FDA or any other body (otherwise, the info would be in the public domain).

I don't know about the rest of your info, but this is outdated. Patents are now published 18 months after filing, I believe.

[Brian Ellis]

Originally posted by Wombat
I don't know about the rest of your info, but this is outdated. Patents are now published 18 months after filing, I believe.

Maybe this is the case in the US, I don't know, but I cannot believe it is the case elsewhere. Granted, I haven't filed a patent application for a few years (the last one was in 1993), but I can assure you that the patent specification was available from the following day.

How can a "prior art" opposition be filed by a third party against an application, if the latter is not published with the results of the applicant's attorney's search? It's ridiculous.

[Brian R.]

Re: Do U.S. drug companies share all research?

Originally posted by isochar
I've been looking for this answer but haven't had much luck. Considering that a each company has 20 year patents on new drugs from the date of invention, it would permit them to share all their research w/o worrying about competitors. However, some of that research could be used for future drugs...

So, does anyone know for sure? With some supporting/contradictory evidence?

They share very little with each other.

The Pharma companies (theoretically) share all their research with FDA. This information is confidential and is never revealed. FDA drug reviews are released from FOI (Freedom of Information office), but all proprietary information is (theoretically) redacted from the reviews.

The FDA FOI reading room is:

http://www.fda.gov/cder/foi/nda/index.htm

From this, you can get a handle on the amount of information FDA is permitted to divulge. The Medical Officer's review (clinical trials results) is much more complete in the FOI page than the Chemist's review. That is because the majority of the MO's review is reflected in the Physician's Package Insert. The Chemist's review is primarily specifications, characterization studies, developmental work, and production details which will never be made public. Much of this information is cross-product applicable and is the advantage one company has over another as far as production volume and costs.

The secrecy of alot of the chemistry information is due to the ability of other companies to create similar new drugs after marketing exclusivity expires, and generic drugs after the patent exclusivity expires. To market a generic drug, the ANDA application must have the same quantitative and qualitative formulation as the innovator product. Fot this very reason, this is another tightly-held secret in many cases. The generic drug must also be able to pass the same specifications as the innovator drug.

For details on new drug exclusivity, see Sections 505.b.1 and 505.b.2 of the FD&C Act.

With all these caveats in mind, there is alot of information on specifications exchanged between Pharma (innovator) companies. They use this information to keep FDA honest with regard to specifications for similar drugs. One company does not want to have a higher hurdle to pass a drug product batch, than that for a similar drug as marketed by another company. I do not know if the information is passed knowingly by management, or if employees who change companies provide that information to their new employer...

Feel free to e-mail me if you have specific questions.