Friday, February 16, 2007

Waxman writes Novartis chairman

As background, Novartis has been refused a patent for a cancer medicine, Gleevec, on the grounds that the medicine was simply a new form of an old medicine with a trivial change, something which cannot be patented under Indian law. Novartis is not only seeking to overturn this decision but also to challenge the law itself and the way in which India has implemented international trade rules on intellectual property. (see Indian Catholic).

According to a post in business-standard, Henry Waxman wrote Novartis about its patent actions in India:

Waxman, in a letter to Novartis Chairman Daniel Vasella, said that while he did not dispute Novartis’s right to apply for a patent or appeal against patent denial, he was concerned about the company’s attempt to influence a domestic Indian law that could have a severe impact on world-wide access to medicines.

"India’s robust generics market supplies affordable, essential drugs to its citizens as well as to poor nations around the world. Its law contains safeguards designed to preserve a balance between protecting innovation and promoting public health.

"If India is pressured to make its patent laws more stringent than its obligations under the International Trade Law, this crucial supply of medicines could be threatened," he said.

Novartis has reiterated that the company was denied a patent on its anti-cancer drug Glivec [Gleevec] in India because its laws do not comply with the intellectual property rights standards drafted by the World Trade Organisation.


About one year ago (February 28, 2006), Merrill Goozner published "Innovation in Biomedicine: Can Stem Cell Research Lead the Way to Affordability?" in
PLoS Med 3(5).

The second sentence in the paper stated: "Campaign organizers also claimed the state would receive royalties from new therapies, economic development in the form of jobs and taxes, and access to cheaper medicines." and referenced Baker L, Deal B (2004) Economic impact analysis: Proposition 71 California Stem Cell Research and Cures Initiative. New York: Analysis Group. Available:

Of course, the Baker - Deal report has come under recent criticism. One curious angle was that any new stem cell based treatments might raise (not lower) health care costs.

Among other things, the Goozner paper recommended a patent pool for stem cell patents arising from funding under Proposition 71:

CIRM and other stem cell funders can become catalysts for cutting through this patent thicket. They can require that all grant recipients agree to donate the exclusive license to any insights, materials, and technologies that they patent to a common patent pool supervised by a new, nonprofit organization set up for that purpose. A patent pool serves as a one-stop shop where investigators can obtain no-cost or low-cost licenses for subsequent research. Patent pools have been successfully used in other high-technology industries such as consumer electronics and software to facilitate the development of new technologies that either require common standards or rest on a common base of basic research. Several patent law firms and close observers of medical research have suggested that patent pools can work in biomedicine.

Can anyone say 35 USC 271(e)(1)? See 88 JPTOS 239, published in March 2006 concerning stem cell research and 35 USC 271(e)(1).


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