Computer program that could bypass patents to produce synthetic drugs

https://www.europeanpharmaceuticalreview.com/news/83106/intellectual-property-patent/

by zhamisen • 8 years ago

125 54 8 years ago

zhamisen• 8 years ago

Link to the paper: https://www.cell.com/chem/fulltext/S2451-9294(18)30567-9

234dfgdgdf• 8 years ago

It could bypass patents, but instead it is owned by Merck, Giant Pharma so they can now bypass all the patents for themselves

refurb• 8 years ago

Exactly! I’m sure the first customers of this software will be the big pharma patent departments who will use it to further expand their patent space.

jordigh3• 8 years ago

In the global industry, some of the best kept secrets are those necessary to make life-saving medication and other pharmaceutical products.

What? Patents are not secret. Patents are the opposite of secret. The very word "patent" means "open". Are drug patents some kind of trick to do the opposite of what a patent is supposed to do?

However, when the researchers designated some atoms and bond as untouchable, the program proposed plans that avoided the patented ones.

Can someone explain just exactly how do drug patents work? Can this legally work? I understand that normally patents cover processes or working inventions. I didn't think that the precise chemical bonds were required to be produced in the final output of a patent.

Also, since apparently the researchers have read the patents in question and designed their software to produce drugs that avoid those patents, have they willfully infringed? Since they were aware of the patent and the process by which the drug worked, so using this knowledge they produced similar drugs that do the same thing?

I assume that the researchers know drug patent law well enough and are confident that their method avoids patents, so there's obviously a lot I don't understand.

sp527• 8 years ago

Yea it’s important to note these guys are risking breaking the industry. If for some reason pharma companies were unable to at least recoup the cost of their (expensive) R&D efforts, it would disincentive new drug development.

drieddust4• 8 years ago

Book Bad Pharma thoroughly debunks this idea. These companies spend more time and money in lobbying, marketing, and rehashing the old research.

beautifulfreak• 8 years ago

Pharma companies don't do their own R&D anymore, for the most part. The documentary, Drug$ (2018) does a tough takedown of the industry. Pharma companies acquire drugs from indie or academic researchers. What pharma companies do is get the drugs FDA approved then market them, and at the highest price the market will bear (meaning that some people can't afford them). In other words, there are no R&D expenses. https://www.imdb.com/title/tt7394770/

geofft6• 8 years ago

If for some reason pharma companies were unable to at least recoup the cost of their (expensive) R&D efforts, it would disincentive new drug development.

I'd like to see any evidence at all for this.

The closest thing we have to a controlled experiment is the software industry, where patents are a) difficult to obtain, at least in a way analogous to patenting a molecule and b) not culturally common among large portions of the R&D community. There is a huge amount of R&D into better databases, better operating systems, better distributed systems, better UIs, better programming languages, better compilers, etc. etc. that happens with no patent protection, and often with no license fees or other direct monetary compensation at all. Microsoft being willing to keep their source code secret and patent their techniques didn't help NT defeat Linux one bit, and certainly has caused no loss of people willing to work on Linux.

exmadscientist• 8 years ago

Can someone explain just exactly how do drug patents work? Can this legally work? I understand that normally patents cover processes or working inventions. I didn't think that the precise chemical bonds were required to be produced in the final output of a patent.

A big part of it is that drug patents cover the process of production that gives the final molecule with viable yields. Pharmaceutical companies try to write patents broadly enough, or just file enough different patents, that there's no way to get to the final product without infringing one or more of their patents. The idea here is to come up with a sufficiently novel synthesis pathway that the original patents don't cover it, and thereby don't apply.

Derek Lowe has a good discussion: http://blogs.sciencemag.org/pipeline/archives/2019/01/18/aut...

onetimemanytime• 8 years ago

>Pharmaceutical companies try to write patents broadly enough, or just file enough different patents, that there's no way to get to the final product without infringing one or more of their patents.

The patent can also be thrown out if it's to broad, no? The broader it is , the better the chances that there's prior art. Sure it costs money, but then there's money to be made so someone will sue

sigstoat• 8 years ago

I understand that normally patents cover processes...
since apparently the researchers have read the patents in question and designed their software to produce drugs that avoid those patents, have they willfully infringed?

the patents cover process, not the resultant molecule. the program finds a different process to make the same thing.

adamzk2• 8 years ago

I'm a patent holder for a pharmaceutically relevant class of compounds. There are two types of patents typically seen in pharma. One is procedural (how the drug is synthesized, isolated, formulated or administered) and another is composition of matter (the atoms in the molecule, their relative coordinates and the lengths and types of bonds that connect them). This program takes a target compound and does two things. 1) produces a library of similar compounds by structural diversification (making substitutions of atoms or small groups of atoms in the target compound with other atoms or groups which are known to behave similarly) with restrictions based on what has been patented under composition of matter. 2) It then takes each molecule and looks for ways it can be synthesized. It does this by breaking apart the molecule piece by piece until it obtains commercially available building blocks. These piecewise separations correspond to synthetic a steps in the other direction, which the program screens for literature precedence. It does this for every possible combination of piecewise separations until it finds a set of viable pathways from available compounds to the target. This is called retro synthesis. It then filters the potential synthetic routes for those that are covered by procedural patents until it has a list of non patented, commercially viable synthesis plans.

As you can imagine there are thousands of ways a moderately complex molecule could be deconstructed and the bank of known reactions is more than any one person can really grasp. That and the myriad patent literature and how cryptic and dense it can be make the problem particularly suited for algorithmic treatment. This is only being done now because cataloging all the research and patent literature (which goes back to the late 1800s) and digitally formatting in a way that allows it to be computationally analyzed and processed requires manual translation of each report by a human being. Not many people have the expertise required for this and those that do usually prefer less menial work. So it has taken this long to amass a digital library of sufficient size to give one confidence that the answers it provides are comprehensive and that further searching would be pointless.

yholio• 8 years ago

The research team hope that their software could help pharmaceutical companies in the protection of their intellectual property, and to hasten research into organic chemistry.

It seems what they are attempting to sell is a IP protection service: let us show you other molecules and synesis routes you should also patent defensively, without actually attempting them in practice. Pretty soon you will have algorithmically defined patents.

It's IP anti-science at it's worst.

jordigh3• 8 years ago

One thing I don't get: if you're trying to avoid patents, why go back to the 1800s? Don't you just need to look at recent patents that haven't expired?

Symmetry• 8 years ago

The very word "patent" means "open".

I was really surprised by that. So when Elizabeth I sold a patent for the monopoly of salt to some duke in order to raise gold for the crown the word "patent" meant that it was a public rather than a secret decree.

https://en.wikipedia.org/wiki/Letters_patent

User23• 8 years ago

More on this: https://blogs.sciencemag.org/pipeline/archives/2019/01/18/au...

bentona• 8 years ago

I love it when sci fi and sci fact seem to merge https://www.npr.org/2017/09/20/548664924/in-a-future-ruled-b...

fernly• 8 years ago

But isn't a modified molecule a reformulation, which cannot be assumed to have the same effect, or dose-response, or even safety, as the original molecule? Say if you can synthesize something _like_ garblezolib or whatever, aren't you then faced with all the safety and effectiveness trials that were so expensive for the OEMs?

jamiek88• 8 years ago

The end molecule is not patented, the process and pathway to creating it is.

If this software can come up with sufficiently novel pathways other processes can be used to come up with the same drug.

This is the idea anyway.

monochromatic• 8 years ago

Some commentary from my favorite chem-blogger: https://blogs.sciencemag.org/pipeline/archives/2019/01/18/au...

Sounds like this is for finding different synthetic routes to the same molecule. So it might help avoid method claims, but not claims for the product itself.

sachindhar• 8 years ago

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• 8 years ago

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• 8 years ago

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• 8 years ago

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.

laughingman2• 8 years ago

Information wants to be free.

leoh• 8 years ago

This article is not complete. In order for a drug to be approved by the FDA for a particular condition, it must demonstrate (through expensive clinical trials) superior efficacy to existing treatments unless the drug is considered a generic. It's hard to say if a drug with slight molecular modifications could be said to be a "generic" form of another. There's a good chance the answer would be no, because slight molecular modifications can cause significant differences in efficacy.

Computer program that could bypass patents to produce synthetic drugs

Related Stories