Should a New Technology Change the Patent System? 159
linuxizer writes "Congress seems poised to turn an effort to create a pathway for generic biotech drugs, such as Remicade, into the exact opposite. Instead of the 5-year protection that traditional pharmaceuticals get, or the 0-year protection that the FTC recommends, the bill offers 12-year exclusivity with renewability for minor changes. The issue is highly charged, with activists waging a campaign to change the bill. Yet it also raises interesting questions for other technologies. To what extent do the traditional contours of patent law need to change in response to new technologies with a different set of market realities (biotech drugs are 22 times more expensive on average, and development costs for generics will be substantially higher) and in what direction? Need every new technological category get its own patent rules, and how do those rules get decided?"
Re:All the same (Score:3, Informative)
Huh? That makes no sense,
If "it's complicated enough that others won't be able to easily copy the idea and compete," then you don't need a patent-- you can use a trade secret.
The original idea of patents was that the inventor gets a period of exclusivity in exchange for writing out a complete description that allows anybody skilled in the relevant art to replicate the invention. Patents and trade secrets are, in a sense, opposites.
(However, there's very little that can't be reverse engineered these days. I'm not sure that there's anything that can't be copied for a few million dollars worth of analytical work.)
20 years not 5 (Score:3, Informative)
Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
Traditional pharmaceutical patents last for 20 years.
This Is About Regulatory Exclusivity, Not Patents (Score:3, Informative)
Even a cursory reading of the linked articles would show that this has almost nothing to do with patent protection, which lasts for 20 years from the date of filing regardless of the subject matter. This is all about regulatory exclusivity from the FDA. An example of regulatory exclusivity is new drug product exclusivity [fda.gov], which generally lasts for 5 years for completely new drugs and 3 years for new formulations of existing drugs. Another kind is the 180 day generic exclusivity [fda.gov] for the first generic to market, which encourages generics to be made by giving them a small window of high profitability.
The issue here is whether biologic drugs [wikipedia.org] should be given a longer than usual regulatory exclusivity period given that (so the argument goes) they are a new, experimental technology that is harder to develop than traditional small molecule drugs.
You might ask "if a drug is patented, then why is a (shorter) period of exclusivity even necessary?" Here's an example: inventor discovers a new compound that might be a useful drug. A patent is filed in 2000. Then 10 years go by while the inventor struggles to find the optimal dose and delivery mechanism. Now in 2010 the inventor's startup starts looking for a partner to bring it through trials and into production. 5 years later, human trials start. 3 years later the drug is approved by the FDA for sale. Now it's 2018 and the patent only has two years left. If the manufacturer has to recoup all of its costs in just 2 years, the price will have to be extremely high, which will limit the drug's availability. So the regulatory exclusivity period gives drug makers a guaranteed 5 years in which to recoup their costs.
So that's the argument for having an exclusivity period. There are also arguments against it, of course, but the main point is that all of this is only tangentially related to patent protection and has nothing whatever to do with a special patent rule for biologics.