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« Court Report | Main | Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015) »

May 18, 2015

Comments

Excuse me Senators, but ALL pharma is built on this model of "abuse of monopoly power" - certainly not just Sovaldi.

The "logic" of this thrust is not contained by the present objective, good sir.

High prices for pharmaceuticals are justified by high research and development costs including the cost of obtaining regulatory approval.

However, it is not self-evident from the Wikipedia entry for Sovaldi that an unusually high price would be justified since the main patent WO 2010/135569 was published in 2010, a New Drug Application for sofosbuvir was submitted on April 8, 2013, and received the FDA's Breakthrough Therapy Designation, which grants priority review status to drug candidates that may offer major treatment advantages over existing options and in December 2013, the FDA approved sofosbuvir for the treatment of chronic hepatitis C. Development and approval seem in this instance to have been unusually short.

It will be interesting to see what the company says in reply.

I am SO relieved to know that communism is alive and well in Vermont.

Don,

With all due respect, Senator Sanders request to Secretary McDonald "to break the patents on" Gilead's Hepatitis C drugs is misguided. This request is on par with that made by our Ohio Senator Sherrod Brown (then a Congressman) to have NIH assert march-in-rights under Bayh-Dole with respect to Xalatan and Novicir. I most heartedly support our Vets, but this request by Senator Sanders to essentially give away these drugs for free "or else" is beyond the pale, and would set an ugly precedent that will most certainly be abused.

Great post. Historically we seem to be in the same antitrust / anti-corporation mindset that led to the Sherman Antitrust Act in the 1890s! History does have a habit of repeating itself.

Mr. Cole,

I would take issue with your statement and blind acceptance of "High prices for pharmaceuticals are justified by high research and development costs including the cost of obtaining regulatory approval."

When you build into the development process the "ability" to absorb high prices, you remove from that very process the impetus to improve and make the process more efficient (cost, time or otherwise).

Spare the rod...

Just wondering what the VA spends, per patient, when providing the prior standard of care for HepC. Ribavirin + PEG-interferon, last time I looked, was not cheap, and the treatments could go on for years. I would bet that Gilead took this into account when calculating the market value of an actual cure for the disease. (Although they may well have multiplied it by 3.)

I'm not sure how Sanders expects §1498 to be of any help. The "reasonable and entire compensation" recited in §1498 isn't a normal patent infringement award, it's the Fifth Amendment "just compensation" for government takings by eminent domain. And in a case brought under §1498, "the profits that the plaintiff would have made are a proper measure of the damages suffered."
Waite v. United States, 282 U.S. 508, 509 (1931)

James,

But that cost will be paid for by all the taxpayers.

Nothing against veterans (God bless them), but please tell me why I (the royal "I") have to pay more in taxes AND pay my own medical bills?

This is in fact nothing more than an exercise in social engineering (yes, you can read that as socialism if you like, albeit it's an odd form in that "The Right" still get theirs, while "The Left" think that they are getting theirs too). In other words, the big picture here is one of ultimate non-sustainability while the Politicians can pretend that they have done something noble.

Its is disturbing to all patients in the world to know that a treatment exists and due to certain limitations (finance) they may not afford the cost of these medicines.
Agreed, lot of efforts has been done by the MNCs to bring novel, innovative medicines into market and deserve monopoly & rewards. However when the situation is beyond normal persons limits, the government of any country needs to step in and provide a balancing solution. Provide MNCs with incentives in other forms and reduce the price of drugs to benefit patients.

Rajesh G,

Would you then support a model of removing from the private sector ALL such medicinal subjects?

After all, the actual pricing is driven purely by profit models, and since - as it appears - you believe that Government has this over arching duty to its citizens, the question arises as to the primal propriety of even allowing a profit-driven model to exist in the first place.

I find deeply troubling the phrase and even the notion of "when the situation is beyond normal persons limits." What does that even mean? Who decides? Even if you choose a median value, you are choosing to deny this "essential" benefit to half of the population. IF this is SO essential so as to impose absolute governmental control (and I am particularly NOT arguing whether or not this is the case), then how can you turn around and let ANY part of the population be denied access based on affordability?

You cannot be "a little bit pregnant" with the logical argument you appear to want to use.

The comments to this entry are closed.

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