IP and Gender: The Unmapped Connections: Eileen Kane

Kane's topic was one women’s health issue, breast cancer, and how the IP landscape affects it. An examination of four important molecules might help us see when patents are a help or a hindrance.

There’s been lots of activism on breast cancer over the past 10-15 years, partly inspired by the successes of the AIDS community in lobbying, activism, and recruitment of high profile public figures. Forty-five thousand women a year die of breast cancer, though heart disease is still the leading killer of women.

First, Taxol: Back in the 1960s-70s, people observed in the lab, under the auspices of the National Cancer Institute that taxol caused cells to stop dividing. Though it was a promising compound, the feds aren’t in the business of getting drugs to market. Using a series of laws about tech transfer, NIH signed a deal with Bristol Myers Squibb; BMS got exclusive rights to use NIH’s clinical trial data. The FDA approved taxol in 1992. The compound wasn’t patentable, but BMS got five years of market exclusivity as the first to file on the drug. It generated $1 billion per year in sales; as the end of exclusivity approached, a nervous BMS got a series of patents on methods of treating with taxol. BMS was also able to use the Hatch-Waxman act, which was designed to accelerate generic entry into the market, to slow down competition: by law, BMS got an automatic 30-month stay of any generic application merely by filing suit. BMS’s patents were weak and ultimately invalidated. Then BMS entered into an agreement with a generic company that had a patent of its own and tried to do the same thing. This caught the FTC’s attention, and in 2002 the FTC brought an enforcement action.

Courts have started to look with disfavor on attempts to game the marketplace with patents. Taxol also illustrates issues with drugs developed by the federal government, for which the government ends up paying private entities through Medicare and Medicaid – is that sensible?

Second, Tamoxifen: Breast cancer is accelerated by female hormones, and tamoxifen is an antiestrogen. There was a 1985 patent; a generic company succeeded in invalidating it in 1992, but the brand name company struck a deal with the generic company and paid the generic to stay out of the market. Consumer groups started to pay attention to what looked like a conspiracy to restrain trade. The Second Circuit, though, recently endorsed the idea that nothing was wrong with such agreements. The Supreme Court may well reach the issue.

Third, Herceptin: This drug comes from molecular biology, targeting a protein found on the surface of breast cancer cells. Genentech had patents, and there’s a huge issue about how to get generic biotech drugs to market, since all our experience with this deals with classic chemicals. There’s no regulatory apparatus for approving generic biotech drugs – and branded Herceptin costs $48,000 a year.

Fourth, BRCA1 and BRCA2, genes associated with a high risk of breast cancer. Companies have gotten many patents on pieces of DNA, including these, which were discovered in the mid-90s by academics and licensed to a private company, Myriad, which refuses to license other labs to test women for the presence of the genes. Testing is important so women know whether they’re at high risk and can take various prophylactic measures. This testing exclusivity leads to concerns over pricing and quality: a big study in JAMA showed definitively that Myriad’s test has technical limits and misses a number of high-risk cases. Europe has allowed somewhat successful oppositions to Myriad’s exclusivity, but here no other test is possible because of the patents.

Overall, for legitimate developments by commercial companies, patents helped. But BMS’s weak patents on something it didn’t develop hurt patients. Likewise, with BRCA1 and 2, there were no big clinical trials, so patent monopoly returns weren’t necessary to recoup development costs.