Skip to comments.Solving The Drug Patent Problem (Old but interesting article)
Posted on 02/13/2018 3:24:32 AM PST by RoosterRedux
Drug companies may be suffering from a research slump but their problems run deeper--to the U.S. intellectual property laws on which they rely for their heavy profits. Fortunately, there is a solution which we presented a year ago: Give a new drug's inventor the exclusive right to sell the drug for 15 years after the day the drug is approved by regulators. (See: Perennial Patents.)
Sounds simple. But it is very different from the way the system currently works. Now, patents protect drugs from copycat versions for 20 years after the drug is invented. This is a bitter pill for pharmaceutical companies because it can take eight years or more after invention to accumulate enough data to get a drug past the U.S. Food and Drug Administration. Once the patent expires, 80% of the brand name sales can vanish within a year as generic competitors reach the market.
Worse, the current system becomes complicated as drug companies file patent upon patent to try to extend the life of a single drug--turning to litigation to try to stifle generics. Big pharma's biggest loophole: When a generic drug is challenged in court, the FDA is forced by law to freeze its approval for 30 months unless the case is settled before that. As a result, generic companies are constantly suing to invalidate extra patents and brand name drugmakers sue to keep generic versions off the market.
Such patent shenanigans slow medical innovation. The knowledge that current drugs will go off patent should in theory help spur big pharmaceutical companies to license or develop new and better drugs. In theory, we pay more for branded drugs to finance the massive research needed to develop them. But long battles over dozens of patents can simply distract pharmaceutical companies from their job: making new medicines.
(Excerpt) Read more at forbes.com ...
This article gives us a glimpse of the opportunities that Trump has to make U.S. drugs/pharmaceuticals cheaper.
The FDA currently plays two roles: Safe, Effective.
As soon as the Drug is established to be safe, it should be available for sale with accurate advertising as to effectiveness.
Safe (should) come in several levels: Safe over the counter. Safe behind the counter at the pharmacy. Safe prescribed by the doctor for external pharmacy fill. Safe when administered by a medical professional.
The accuracy of the advertising should take into consideration that it always informs both the patient ... and the professionals.
Many drugs which currently must be prescribed by a doctor are in fact so safe that there is no logical reason for a prescription. Going to a doctor for the sole reason of getting a prescription adds hundreds of dollars to the cost of the drug.
For example, a skin cream benefits me. That skin cream should not be taken internally. Well already I have access to thousands of things that should not be taken internally. What makes the FDA so worried that I would take this skin cream internally that they will allow it only be sold under prescription?
Yes, the laws should be revised.
And helps the doctor keep customers coming through his doors....
> What makes the FDA so worried that I would take this skin cream internally that they will allow it only be sold under prescription?
Tide capsules come to mind.
Shorten the length of a patent?
How about reverting copyright law to 28 years and one extension?
This hundred year BS only feeds the wealth of Big Media which has 100 years of product to sell and insulate itself from boycott and modern productions’ poor performance.
And one day the nation’s cultural history could be sold to China the Saudis who could torch the mater tapes/negatives in an act of cultural revolution. China has done this to its own history, US works would not be respected.
I’d like to see ‘qualifications’ that the generic is the same strength per mg/mcg as the Name Brand be made. Many are NOT. My thyroid med is Name Brand as the generic verison is 30% LESS hormone and has nasty side effects the Name Brand Synthroid dosen’t have. ENDO won’t script Generic for that reason, the difference in cost isn’t much $8.00 a month between the 2.
Safe and effective is NOT a role they do well, or we’d not have drugs that cause various forms of Cancer, GI, heart disease, neurological, Suicide or addictions like Lyrica, Neurotin, Cymbalta, Xanax, Prozac, Humeria, Lunesta causes extreme Rage, Reglan, OA/OP drugs. Which they keep putting on off label use. Many of them have Black Box warnings on them. Just look at the lawsuits over that surgical mesh for bladder or hernia repair. Not all lawsuits are friouluos. Gardasil has a ton of them, deaths pay out is at last count $6M with hundreds of thousands of girls on the lawsuit list for lefe time health damages. https://medium.com/@jbhandley/hpv-gardasil-injury-scandals-worldwide-why-is-u-s-media-silent-parents-beware-86b416691f5b
A bunch of new drug ads with horrible side effects, and lawyer ads suing them.
Patents and copyright are two separate things. Fortunately, patent holders haven't been able to bribe congresscritters as easily as copyright holders have. Both Patent and Copyright are artificial constructs of the state that wouldn't exist absent the application of government force. They are supposed to be a trade off. The public benefits from new inventions, and the patentee benefits by having a period of time that his work is protected from being copied. SO, what is it that the public if going to receive in compensation for extending patent terms? I could certainly hope it wouldn't be the promise of the possibility of cheaper drugs at some point in the future, because we all know how effective that promise will be.
Similarly, it is way past time we claw back the massive extensions of copyright terms that were allowed to happen over the last century. The public gained nothing from these extensions. I'd like to see copyright returned to its original terms of 14 years with the possibility of a one-time extension to 28. That would make the entirety of the Beatles catalog finally enter the public domain, as it should have a decade ago.
It is not true of all laws. Some legal concepts and rights transcend the existence of government and the threatened use of force on its behalf. For instance, the rights enumerated in the 1st and 2nd Amendments to the U.S. Constitution exist regardless of their presence in the document itself. You have the right to speak and defend yourself by virtue of your being a human being. It's not a right granted you by the Constitution or any other legal document.
On the other hand, Patents, Copyrights, and Letters of Marque exist wholly as creations of law and other legislated instruments. All three of these concepts entirely consistent with the Constitution, and in fact are listed specifically as such in the document, but none of them are actual rights. They are legal fictions created because we, as a society deem there to be societal benefit of their existence. If we, through our legislatures decide to alter or abolish those concepts, it is perfectly legal for us to do so.
In any case, I'm not certain what your point is relative to the OP in question.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.