All Journal Entries Journals

Gleevec patents - rethinking health care costs

Apr 02, 2013 - 0 comments
Tags:

gleevec

,

patent

,

Health

,

health care

,

cost

,

Cancer

,

drugs

,

Indian Supreme Court

,

Novartis



I'm a patent attorney.  In my profession, people make big money on inventions like those used in new drugs.  I'm also a cancer patient.  I routinely get invited to Stanford med school to listen to their talks on new cancer drugs in the pipeline and ongoing clinical trials.  The projected costs of these new drugs in the pipeline are quite shocking.  Even for people with my income, I'm not sure that I can afford them.

Today, India Supreme Court issued its decision in Novartis case (the full text of the decision can be found here - http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212) , refusing to issue a patent to Gleevec.  India court recognizes that its inventive step is a higher standard than that of different countries around the world – especially in the area of pharmaceuticals. And pushing in that direction is India's statute stating that:

"(3)(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. "

In reading the statute, the Indian Supreme Court found that section 3(d) "clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds."

The active ingredient in Gleevec is a beta crystal form of Imatinib Mesylate. It turns out that Imatinib was already known to be useful for inhibiting BCR-Abl tyrosine kinase (the function of Gleevec) and the court found that the difference between the two insufficient to allow the new patent.

It's a 112-page decision and the court laid out on the first page that "The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India."

It was heart shaken when I read these words.  The generic version of Gleevec costs $2,500 in India whereas the brand drug costs $70,000 elsewhere in the rest of the world.  The huge price difference speaks to the value of my day-to-day work, but at the same time, I think my fellow patent attorneys need to recognize signs that indicate when a technical area has been excessively patented, and when patent is used as an economic weapon that harms every living being in this society.


Post a Comment