Friday, October 23, 2015

Anti-patent polemic in the American Spectator by Mytheos Holt exploded

Talk about bad timing! The anti-patent rant by Mytheos Holt titled THE HIGH PRICE OF OUR MEDICAL PATENT SYSTEM focuses on the recent price high for the drug Daraprim (which drug is not on patent and which price hike had nothing to do with the patent system) and which price hike has been rendered nugatory by actions of the pharma company Imprimis, which is planning to sell a variant for $99 for a 100-count bottle.

See USA Today post Drug company attempts $1 alternative to Daraprim

The American Spectator should be ashamed.

Statements such as

Worse, as the Left’s rapid railing about Daraprim shows, that patent system is a boon to the supporters of socialized medicine, because it gives them an ever-increasing cost of care to rail against with zero opposition from Big Pharma so long as they leave the patent system intact


Yet because of the perverse incentives created by a patent system that grants ten years of exclusive rights to price gouge drugs on the flimsiest pretexts, that is exactly what American taxpayers are subsidizing, particularly with the money they spend on Obamacare-approved insurance plans.


But it doesn’t have to be that way, and if patent reform can get past the obstacles created by anticapitalist big business, it won’t

have nothing to do with Turing's price hike on Daraprim, which would not have been remedied by any currently proposed patent reform.

Additionally, Holt mentions only the opposition to patent reform by pharma, but neglects to mention "why" universities and small inventors also oppose reforms such as the Goodlatte bill.

***Details of the issues with Daraprim are included in an article in Law360:

Daraprim was first approved by the FDA on Jan. 23, 1953.[3] Through a chain of title that included GlaxoSmithKline PLC, Amedra Pharmaceuticals LLC and Impax Laboratories Inc., Turing acquired the rights of Daraprim in August 2015. Daraprim is a reference listed drug in the FDA’s Orange Book[4] and no generic version of the drug is currently available.[5]

One reason no generic may be available is the small number of patients who take Daraprim. The U.S. market for Daraprim is estimated to be about 2,000 patients. The relatively small number of patients, coupled with a modest price of $17.50 per pill for the brand product (which a generic would likely lower), do not create a significant financial incentive for a generic market entry.

Another potential reason why a generic is not currently available is the presence of a restricted distribution program.[6] According to press coverage, Turing, the sole U.S. supplier of Daraprim, acquired exclusive rights from Impax Laboratories in August 2015. Prior to the acquisition, Impax subsidiary Amedra Pharmaceuticals LLC, the then-manufacturer of Daraprim, implemented a restricted distribution program.[7] Restricted distribution programs are often put in place when required by the FDA as part of a risk evaluation and mitigation strategy ("REMS"). REMS help to mitigate a drug’s risk profile by various means, including controlling drug access to ensure that only educated physicians prescribe the drug to patients that actually need it.

Amedra’s restricted distribution program does not appear to be associated with an approved REMS, and therefore it appears to have been a self-implemented restricted distribution.[8] While restricted distribution can make drugs safer, restricted distribution programs in some circumstances could also make it tougher for generics to enter the market. In order to receive FDA approval, a generic manufacturer must show that its drug is bioequivalent to the marketed drug.

Restricted distribution programs potentially could make it more difficult to get sufficient quantities of the marketed drug to perform these bioequivalence studies. Thus, as a result of the restricted distribution program, a generic competitor — seeing the opportunity to make profits by entering the marketplace after Turing’s price hike — might have a harder time developing the required data package to support approval. Restricted distribution programs in the context of REMS have been evaluated under the antitrust laws,[9] and restricted distribution absent a REMS likewise potentially could raise antitrust issues.


One notes that there is no mention of a patent blocking generics from providing a bioequivalent form of Daraprim.

One note that Forbes wrote:

But unless you’ve been offline or away from the news for the last month, you’ll know that’s exactly what happened when Turing Pharmaceuticals’ CEO Martin Shkreli announced a price increase for Daraprim, a patented formulation of the antiprotozoal drug, pyrimethamine.



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