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I'm not sure I've commented on this issue previously, so I thought now would be a good time, as legislation has now been proposed (see Medical News Today's Drug Industry Raises Concerns Over Potential Changes To Patent System), and presumably there will be some debate in Congress.

The issue of bringing US inventorship criteria more in line with the rest of the world has been around for some time. In most of the world, inventorship is determined in part by first-to-file status. In the US, by contrast, inventors do not have to be first to file a patent application, but they must be first to conceive of the invention and they must be diligent in reducing the invention to practice. Practically speaking, the US system places a substantial burden on inventors to document their inventions (i.e. the ideas) and their reduction to practice (i.e. activities and observations supporting the ideas) prior to filing an application. This burden is shared by anyone that desires US patent protection, which is to say nearly everyone in our industry, because the US is the largest single market for drugs and devices. If you work in drug discovery you know this burden first-hand all too well. Switching to a first-to-file system would not eliminate the need to document experimental details and new ideas, but it would reduce the burden on scientists by eliminating some administrative tasks that serve only to meet current US patent requirements (e.g. the need to have lab notebooks signed on a regular basis).

The article suggests that the pharmaceutical industry is against this change to the US system, but it doesn't explain why. At first blush, it seems that everyone would be well served by a European-like inventorship determination, because it would reduce work that doesn't contribute directly to innovation (i.e. it would boost innovation productivity). But remember that patent life is a fixed period that begins with filing of the final patent application. Effective patent life (i.e. actual time for patent protection of a marketed product) is determined by the date of patent filing, the time between filing and product launch, and the time of generic entry into the market. As we all know, there is a relatively long time between initial discovery of a potential therapeutic and its realization as a product, often a decade or more. Under the U.S. patent system, companies are now able to maximize effective patent life by waiting to file their first patent applications, while protecting themselves by documenting the inventions and their reduction to practice internally.

In a first-to-file system this type of strategic patent filing isn't possible. Companies practically cannot wait to file in a first-to-file system, since the filing itself represents the only acceptable way to assert inventor status. All else being equal, the result is that effective patent life for drugs in the US would be reduced relative to the current system. Exactly how much it would be reduced in an individual firm can be estimated by using internal data. Calculate the time interval between the dates of first filings for successfully marketed products and the dates the inventions were first documented in the lab (in the lab notebook). This interval is the maximum reduction in effective patent life that would be expected from a change in inventorship criteria. Actual effective patent life reduction would be less than this, and may be estimated subtrating the amount equal to administrative tasks (i.e. preparation of the filing) plus the time interval between the idea and the filing filing (approximated as the time between the provisional and final patent applications). The calculation looks like this: Effective Patent Life Reduction = (Date of actual first final patent filing-Date invention first conceived)-(Time to prepare patent applications+(Date of final patent application-Date of provisional patent application)).

The life science industry won't be alone in opposing this legislation, but they will be in the minority. Few industries use patents to appropriate their inventions as much as the innovative life science industry, and fewer still have the long development times "enjoyed" by the drug industry. In particular, industries such as software and consumer electronics strongly favor the first-to-file criterion. Look for spirited debate in Congress--assuming legislation reaches the point of debate--fueled by intensive lobyying activity behind the scenes.

Source: Drug Companies Threatened By Proposed Patent Legislation