You are correct on your first point; I was typing on my phone (which is a very tedious process) and didn’t notice my glaring misrepresentation. Drug companies do not and cannot “extend patents” by reformulating; the original patent over the original formulation will always expire once it runs its course.

Your second point is completely absurd. No where in reading my comment could you possibly come up with idea that I am “trying to say that once a patent on a drug is expired then there should be no future patents on innovative (i.e., new and non-obvious) improvements,” and it is completely intellectually dishonest of you to characterize my arguments as such.

In my comment I state that a) these reformulations often are not innovative (“minor and inconsequential); and b) that an easy solution to the antitrust issue would be simply to force the inventing company to call the new reformulation by a different name than the old one. Nowhere in there did I come remotely close to saying that drug companies should not receive patents on innovative drug formulations, whether or not that reformulation is entirely new or a reformulation of an older drug.

You accuse the FTC, myself and “so many others” of missing the point, but it is you who is missing the *real* point, which does not have so much to do with patents as it does with the way these drugs are regulated.

As I already stated in my comment, if you bothered reading it, doctors write prescriptions for a brand name of drug. When that drug is reformulated under the same name, most doctors are unaware either of the fact that the drug has changed or of the fact that the doctor must now write the name of the generic equivalent (if he or she even knows what it is called) in order to enable the patient to actually purchase the generic equivalent (either because it is equivalent to what the patient has been taking all along or because the patient cannot afford the brand name). If the inventing company was forced to call the reformulation something else (e.g., “Valium RX” instead of just plain “Valium” then that would be an easy solution to the problem. Note that this solution has nothing to do with denying patent protection for innovative reformulations.

To unpack this further, note that the FTC, in its amicus brief and according to your own words, says that drug companies are hurting competition by introducing “minor, non-therapeutic” changes which is antithetical to your argument that the FTC wants to stop patents for “innovative” reformulations (unless you believe that minor, non-therapeutic reformulations are in fact innovative). Regardless, in my opinion, if the drug company was forced to release reformulations under different names I don’t think it would matter as much that the USPTO continues to issue patents on useless modifications to existing formulations.

“Under what circumstances would a non-therapeutic reformulation make it harder for a patient to switch?”

Bobby explained it at 9:46pm, but I’ll try elaborating further.

Let’s take a concrete example. Provigil, generic name modafinil. Both brand name and generic available. If my doctor writes me a prescription for Provigil, I can get brand or generic at my discretion at the pharmacy.

If my doctor writes me a Nuvigil prescription (R-enantiomer of modafinil, no generic available), I can’t switch that to Provigil. If for the purpose of this discussion we accept the claim that the L–enantiomer of modafinil is minimally bioactive, the effects of both medications are the same.

However, if my doctor wrote me a Nuvigil prescription and I wish to switch to generic modafinil, I have to have the prescription re-written – I can’t merely have the pharmacist fill the generic.

Thus, it’s harder to switch from Nuvigil to modafinil. You’re making the patient and doctor have to decide on generic vs. brand at the time of prescription writing, when there isn’t nearly as much time to do research into the differences.

So, no, not counterfactual. Entirely consistent with the facts. Can you answer my hypothetical, please?

“What this is all about is the brand name drug provider offering a different formulation that has no additional benefits. They market it and the consumer believes that it is somehow better than the generic and wants that rather than what the generic is selling because the generic is selling something different.”

If they’re coming up with a different name for functionally the same thing to mislead their customers, isn’t that dishonest?

“The FTC must be arguing that people don’t want something different no matter how much cheaper.”

I thought that the FTC was arguing that the companies are making things appear more different than they are in order to mislead customers.

You know full well that “is identical to” is worth more than “is nearly as good as.” Misleading people into believing that an identical product is, in fact, different is a dishonest lie.

“That is rather absurd. The entire generic market is based on people wanting therapeutic drugs off-brand for a fraction of the cost.”

Yes, and it’s also based on the assertion that the generics are the exact same material with the exact same standards, rules and regulations. Misleading people into believing that there isn’t a true, identical generic available distorts the market and is misleading.

Your hypothetical is counterfactual.

Under what circumstances would a non-therapeutic reformulation make it harder for a patient to switch?

What this is all about is the brand name drug provider offering a different formulation that has no additional benefits. They market it and the consumer believes that it is somehow better than the generic and wants that rather than what the generic is selling because the generic is selling something different. The FTC must be arguing that people don’t want something different no matter how much cheaper. That is rather absurd. The entire generic market is based on people wanting therapeutic drugs off-brand for a fraction of the cost.

-Gene

I get your point. I just think that you’re skipping some important details.

“The generic CAN copy the off-patent drug. There is no delay in generics entering the market.”

Let me ask this directly: If a reformulation is done expressly for the purpose of making it harder for a patient to switch from a brand to a generic, do you think that is right? If it’s not right, should it be illegal?

This is a hypothetical – I’m assuming for the purposes of the question that everybody involved agrees that there isn’t a pharmacological difference.

You write: “Drug companies often make minor and inconsequential variations on drugs merely to extend the patent.”

What you say is 100% false. A patent will expire when the patent expires. These type of formulation changes will not under any circumstances extend the life of the patent.

I think what you are trying to say is that once a patent on a drug is expired then there should be no future patents on innovative (i.e., new and non-obvious) improvements. That is quite a different matter. I find it quite ridiculous to cut off innovation simply so a generic could copy the latest patented formulation. Let the copy-cat, non-innovator copy the off-patent drug. Not the newest version of the drug.

You and so many others, including the FTC, are missing the entire point. The generic CAN copy the off-patent drug. There is no delay in generics entering the market.

-Gene

You write: “as the brief states, prescription drugs have rules associated with them, and this product hopping is being used as a means to take advantage of those rules to delay generics from taking over the market.”

The problem is it is incorrect. There will be absolutely no delay of entry of a generic into the marketplace with respect to the previous formulation. That is exactly why the FTC is completely wrong here and will ultimately fail. The generics can enter the marketplace upon the expiration of the patent and the approval of an ANDA. What they seem to not want to do, however, is have to file another ANDA relating to the new formulation.

So you (and the FTC) can try and pretend that this is exactly what the antitrust laws are supposed to prevent, but that is inaccurate. The antitrust laws have never been used in this way and there is no rational basis for ordering a company to not proceed to market with something that is legal and approved for distribution by the FDA.

-Gene

The simple solution would be to force companies to use a different name on the reformulation. For example, the inventing company could use “Valium rx” as the name for reformulated Valium, that way a patient prescribed “Valium” by a doctor who always writes the same prescription for that patient’s ailment could still get the generic, while at the same time the doctor could always write the prescription for “Valium rx” if he thinks the reformulation would be better for that particular patient.

Of course you want to change the debate to suit you, that is what you normally do.

The reality is that there is no right for a generic to exist in the first place. When drugs are patented the doctor faces the same situation you describe, which is they can’t prescribe a generic. If no generic manufacturer has filed an ANDA the doctor is in the same place even after a patent expires.

There is absolutely no justification for the government or anyone else telling a company that is safe and approved by the FDA that they cannot sell the product. The generic companies don’t have a right to force drug companies to only sell what they have a right to sell as a generic. The generic companies can file another ANDA if they want to sell the reformulated composition of the drug.

-Gene

In all fainess, it appears that this non-equivalence isn’t totally one-sided, though. The doctor could still prescibe the gelcap form generic, and then the brand name drug would be excluded. However, we aren’t going to see direct competition until the generic has a legally recognized equivalent on the market, which will take more time. The brief makes comparisons to Microsoft and changes they made that served no purpose other than to lock out competitors. It seems like quite an apt comparison. Put simply, product hopping is a means of eliminating prescription compatibility.

I will agree that the ideal solution is probably not antitrust, at least not as a first choice, but rather, expansion of recognized equivalency substitutions. I’m not sure how broadly this could safely be done (if it’s unsafe, there’s obviously serious drawbacks), and it appears to be an issue primarily dealt with in state law, so even if it were a simple change to make, it would require action from a lot of legislatures before it is effective.