SCOTUS case on patents could influence drug affordability

Pea-n-Me

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I thought this was a good article about why prescription drug costs are so high, and whether the results of a patent case (on a speedometer, of all things) may indirectly have an effect on whether manufacturers of prescription drugs will be able to continue to keep their prices high, or whether there will be a way to lower them - using generic drugs - via newer rules for patent challenges put into by Congress more recently.

It should be interesting to follow.

https://www.statnews.com/2016/04/22/supreme-court-patent-case-drugs/

“In patent law, much turns on the nitty-gritty details. There’s nothing grittier than the issue” raised in the Supreme Court case, Robin Feldman, a law professor at the University of California, Hastings, told STAT. “It matters a lot. It matters a lot for pharma.”

The consequences, for pharmaceuticals and any other industry that relies heavily on patents, could be huge.

Ronald Mann, a Columbia law professor writing for SCOTUSblog, said “the case has the potential to be a landmark, setting the practical boundaries of patent validity for decades to come.”

Patents are extremely important to brand-name drug companies because they allow those companies to exclusively sell the medicines they develop for a set period of time, before generics can enter the market offering a similar drug at a much lower price.

During that period, the companies can charge whatever price they want (or at least whatever the market will pay) and, therefore, they say, earn back the millions and millions of dollars they spent developing the drug. Then, the companies say, they reinvest that money into more research to find the next breakthrough treatment.

At stake in the Supreme Court case is a new process for challenging patents. In 2011, Congress passed a law that created a new procedure — called inter partes review — for patent challenges to be heard by an appeals board inside the US Patent and Trademark Office. Previously, patent challenges were typically addressed in costly and time-consuming litigation.

In court litigation, patents are presumed to be valid and understood by their “plain and ordinary meaning.” But in these inter partes reviews, as established by the administration, patents are interpreted more broadly.

For drug makers, that’s a problem. Patent holders want the standard for review to be narrow. The more specific their claim is considered to be, the harder it will be for competitors to argue that the claim is not novel and important. They also want the same standard to apply in both the courts and the appeals board.

It’s a subtle difference, but an important one."
 
My DH works in that industry. It's true that developing new medications is extremely costly. It takes a very long time to get through testing and audits and clinical trials (most of which is there for patient safety, so they can't just eliminate it). If they don't have a way to make that money back, I do believe that less research will be done. Universities may pick up some of the slack, but not all of it.
 
My DH works in that industry. It's true that developing new medications is extremely costly. It takes a very long time to get through testing and audits and clinical trials (most of which is there for patient safety, so they can't just eliminate it). If they don't have a way to make that money back, I do believe that less research will be done. Universities may pick up some of the slack, but not all of it.
And people that need new medications will lose out.
 
Interesting read and I do agree with the premise, however disappointed that the "intellectual property" of these drugs overseas was not addressed or maybe SCOTUS is trying to nail them to the wall?

The trend is that the USA manufacturers of these drugs, products, tech, etc.. places the "intellectual property" overseas where they make billions of which the USA does not reap the benefits.

In addition they may post a LOSS in the USA, like Pfizer, when it fact it is a lie.

I find it a bit disingenuous on the part of the drug companies.

My brother worked for a drug company as a chemist in a failing company, so I do understand how the "little guy" gets smashed in the business.
 
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It will be interesting to see if the court ruling makes a difference with drug costs. I've read there is a creative industry of attorneys that work to extend patent protection for pharmaceuticals.

Not that long ago i read a former New England Journal of Medicine editors book on the pharmaceutical industry. Dr. Marcia Angell didn't pull any punches. She took issue with a great deal, from how patents are extended, to the lack of new research done by the drug firms, and lack of transparency with research costs, etc. She felt most drugs that come to market these days are Me To drugs. She wished that similar drugs would be tested against each other, with approval only given if a newer drug is found to be superior to older established drugs. She felt that would help lower costs.

Interesting read. I didn't agree with everything mentioned but enjoyed her experience and point of view. Her book can be seen here:

The Truth About the Drug Companies: How They Deceive Us and What to Do About It

http://www.amazon.com/Truth-About-D...&qid=1461686956&sr=8-1&keywords=marcia+angell

During her two decades at TheNew England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change.

Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers....

...Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.

The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
 
I understand that they need to recoup their money, but they are pricing out the people who need the medication!

MarketWatch lists the most expensive drugs in America (per month):

1. Solvaldi (Hep C) $81000
2. Harvoni (Hep C) $79200
3. Cinryze (hereditary Angioedema) $72100
4. Daklinza (Hep C) $54300
5. HP Acthar (MS) $51600
6. Olysio (Hep C) $44800
7. Orkambi (Cystic Fibrosis) $44200
8. Cuprimine (Wilson's disease) $39800
9. Firazyr (Hereditary Angioedema) $35800
10. Viekira Pak (Hep C) $34600

http://www.marketwatch.com/story/this-is-the-most-expensive-drug-in-america-2016-04-09



Epogen. DH was on 20000U/mL twice a week while on dialysis. About $3300.00 per vial.

Valcyte is used for CMV retinitis in AIDS patients. however, it's also given to transplant patience for the prevention of CMV right after the transplant, usually for about 3 months. 60 pills (one month dose) runs $25+ a pill. The specialty pharmacy we used charged almost $1700 per month. Three months of that and we hit our deductible cap!
 





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