Tuesday, July 23, 2013

One Hell of a Birthday Present

Anybody have any constructive ideas/specific industry practice insights on what Mike can do about this?
Posted by David Codrea at 7/23/2013 08:51:00 AM

2 comments:

Anonymous said...

From Wikipedia:

"In 2013, more than 100 cancer specialists published a letter in Blood saying that the prices of many new cancer drugs, including imatinib, is so high that U.S. patients couldn't afford them, and that the level of prices, and profits, was so high as to be immoral. Signatories of the letter included Brian Drucker, Carlo Gambacorti-Asserini, and John Goldman, developers of imatinib. In 2001, imatinib was priced at $30,000 a year, which was based on the price of interferon, then the standard treatment, and would have recouped the development costs in 2 years. After unexpectedly becoming a blockbuster, its price was increased to $92,000 per year in 2012, with annual revenues of $4.7 billion. All its research and development costs were covered in the first $1 billion, and everything else was profit.[39][40] Other doctors have complained about the cost.[41][42][43] For GIST the cost is $64,800 a year.[44]

Prices for a 100 mg pill of Gleevec internationally range from $20 to $30,[45] although generic imatinib is cheaper, as low as $2 per pill.[46]...

...The active pharmaceutical ingredient of Glivec/Gleevec is a specific chemical form of imatinib, namely, the beta polymorph of imatinib mesylate, which exhibits greater stability and bioavailability than the alpha polymorph. A patent for the free base of imatinib was first granted in 1996; Novartis later filed and obtained separate patents for the specific formulation used as the active ingredient of Glivec/Gleevec in several countries.[47] In India, however, such a patent application was rejected in 2005 for a variety of reasons, including lack of novelty and lack of enhanced efficacy; under Section 3(d) of the Indian Patent Act, alternative forms of a chemical compound (including its salts, isomers and crystal polymorphs) are not eligible for patent protection unless they exhibit a difference in efficacy as compared with the parent compound.[47]

In 2007, this rejection of the imatinib patent claim became a test case through which Novartis challenged India's patent laws. A win for Novartis would make it harder for Indian companies to produce generic versions of drugs still manufactured under patent elsewhere in the world. Doctors Without Borders argues a change in law would make it impossible for Indian companies to produce cheap generic antiretrovirals (anti-HIV medication), thus making it impossible for developing countries to buy these essential medicines.[48] On 6 August 2007, the Madras High Court dismissed the writ petition filed by Novartis challenging the constitutionality of Section 3(d) of Indian Patent Act, and deferred to the World Trade Organization (WTO) forum to resolve the TRIPS compliance question. In 2009 Novartis filed a case with the Supreme Court of India challenging the patent denial and the Section 3(d) of Indian Patent Act on the basis that it defined innovation too narrowly. On 1 April 2013, Novartis lost the case.[5] The court cited that the chemical form of imatinib that Novartis wanted to repatent in India is not significantly different from imatinib free base, which had patents that have already expired; hence, Novartis' claim to the patent was considered invalid, as there was no change in efficacy with the new compound that Novartis was trying to patent. This process of repatenting modified formulations of a drug after the original composition of matter patent has expired is an example of evergreening, which is prohibited under Indian patent law. Novartis responded by indicating that it will continue to refrain from research and development activities in India.[
"

Sounds like the generic is available in India...sigh...

7/23/2013 9:30 AM
Mama Liberty said...

I hope he can find some help at the GIST support group. http://www.gistsupport.org/

Many of these groups form specifically because of drug cost, availability problems.

(I posted this at Sipsey St. already. )

7/23/2013 10:18 AM

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