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« Court Report | Main | Efficient Delivery of siRNA »

August 02, 2009


"the possibility exists for a generic competitor to use the innovator's safety and efficacy data to obtain approval of a biosimilar drug that does not infringe the innovator's patent protection."

Okay. Next question: so what? Three possibilities:

1) Generic biosimilar does not infringe and it is not as effective or has unwanted side effects. Less people use it. Maybe some people buy it instead of the trademarked drug because it's cheaper. Where Does the public benefit overall? Yes. Is there any unfairness to the "innovator" drug company? I don't see it.

2) Generic biosimilar does not infringe and it's equally effective (how long would it take to prove this?). Innovator drug company loses sales. Does the public benefit? Yes. Is there any unfairness to the "innovator" drug company? It still has the patent on its drug and should still be able to compete, assuming it knows how to advertise.

3) Generic similar does not infringe and it's more effective than the patented drug or has less side effects. Does the public benefit? Yes. Is there any unfairness to the "innovator" drug company? No, it claimed the wrong drug.

On balance, shorter data exclusivity periods are better for the public and are not unfair to "innovator" companies. The only argument for extending data exclusivity is the tired old argument about these companies refusing to innovate because they can't make big profits for their shareholders. These companies have plenty of protection already. They have the Hatch-Waxman provisions and they have the patent system. If we want to encourage innovation, why would we want to give companies the opportunity to milk excessive profits from narrow discoveries when there are so many more discoveries to be made?

Dear Keep:

Well, the point is that the follow-on biologics bills will be for drugs that don't fall under the Hatch-Waxman regime, so I'm not sure I would chalk H-W as something on the "advantage" side of the ledger.

Here's another way of looking at it. Right now, the data exclusivity period is infinity - there is no way for a biogeneric to get or use the innovator's data. The biotech industry has said that it needs 12 years of data exclusivity, a number supported by (actually lower than) the only peer-reviewed study in the mix. Maybe they are right about the 12 year number, maybe they are wrong. But 12 is much less than infinity, and if it turns out that 12 years is too long, Congress will be able to adjust it downward.

Seems to me we should stop worrying about this issue, and focus on the criteria the FDA will use to decide whether the biogeneric is similar enough to warrant using the safety and efficacy data in the first place.

Thanks for the comment.

Dear Keep:

Sorry I missed this last night.

Here's another way to look at it. Right now, the data exclusivity period is infinity, since there is no pathway for a follow-on biologic to be approved. The biotech industry has asserted that 12 years is the right term for data exclusivity, and this number is supported by (actually, it is significantly less than) the only peer-reviewed study on data exclusivity that is part of the debate.

So why doesn't Congress pass a bill with a 12-year data exclusivity term, which is vastly better than what we have now, and then see how that works out? After all, while there may be an initial 5-year delay in when a particular biogeneric comes to market, once it is there it will be there for good. And if the term is too long, Congress can amend the law once we have some actual data to consider.

This approach has the advantage that it will encourage lawmakers to begin focusing on the other important aspect of the data exclusivity issue that has gotten lost in the debate over term: how similar does a biosimilar have to be in order to be entitled to rely upon an innovator's data for evidence of safety and efficacy in the first place?

Thanks for the comment.

There are some websites (e.g., http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3886) claim that if 12-year data exclusivity gets implemented in the US legislation, the first biosimilar in the US will not appear until 2020. They don't explain how they arrived at this number. Aren't several drugs (Epo, GCSF, Insulin, Interferon, HGH) losing patent protection in a few years and will also have been well beyond 12 years since first approval at that time? So why would it take until 2020 for them to come to the market?

Also, do you know if FDA is prevented from reviewing an application before data exclusivity or approving it before data exclusivity?

Your help is appreciated.


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