[sachindhar]

Lots of misinformation in these comments. Both the process and end product are patentable, but some companies do not disclose their processes and opt to keep them as trade secrets.

As for the article, changing the molecule can have unpredictable effects on how the compound acts in the body. Even changing one bond/atom can result in dramatically different properties. The article doesn't address that.

[philipkglass]

The Cell article and the In the Pipeline post explain more clearly: this system plans synthesis of the same final molecule by different pathways. The only patents it can detour around are process patents. Since the final product is the same, its properties also remain the same.

[sbierwagen]

More relevantly, this scheme doesn't address the prescription side at all.

Doctor: I judge you to have [medical condition]. Here is a prescription for [expensive on-patent drug].

Patient: I would prefer to take this less expensive drug, which a computer program thinks might be equivalent.

Doctor: Hmm. Doesn't look like there are any clinical studies for this analogue drug. Since I don't want to risk a malpractice lawsuit, I'm not going to prescribe it. Without a prescription, your insurance won't pay for the analogue drug either, so it'll have to be cheaper than your copay in order for it to make sense for you.

[riahi]

The conversation goes more like this:

DOCTOR: You have [medical condition]. We can manage it with [medication which is on the appropriate tiered formulary for the patient’s pharmacy benefits manager].

PATIENT: I would prefer to take this medication they advertised to me during the last football game.

DOCTOR: This medication is only a slight incremental improvement over the generic one approved by your insurance. If you want the newer one, it may have higher copays and will have more paperwork hassle as we try to get the insurance to cover it. In the end, it may not be covered. Do you still want it?

PATIENT: Yes. [Leaves angry Yelp review over how the physician wouldn’t prescribe them X medication].

END SCENE

As for the final point, if there are no clinical studies (at all) for a given drug, then it is not FDA approved and would be illegal to prescribe unless under the auspices of a registered clinical trial with a filed IND with the FDA.

If it is FDA approved but not for that specific indication, then it depends on the clinical practice patterns at large whether this is a reasonable course of action vs malpractice. Case in point: Avastin is way cheaper than Lucentis for macular degeneration and works via similar mechanism, but was never tested or approved for that indication. Many Retinologists will inject Avastin anyway because some trials have shown benefit for cost conscious patients or patients from whom insurance will not cover Lucentis. This is not malpractice.

Using another drug from another class entirely without any clinical evidence to back up its use outside of a trial could be considered malpractice, but only provable if there is a bad outcome.

Without a prescription, they aren’t getting the drug legally. With a prescription without insurance/PBM approval, then yes, it could be very expensive for unconventional treatments.