"How does Patent law work into this equation?"

Generally in Ag Chem and Pharma products there are only two types of patents that are really worth filing.  By far the most important is called a composition of matter patent.  This type of patent simply discloses the chemical structure of the compound of interest, plus generally the chemical structures of a bunch of related analogs most of which are of zero interest even at filing time.  So, by looking at such a patent, which is generally issued roughly at the time of first public field testing or public clinical trial, you can not even be sure what chemical structure the patent holder is going to attempt to commercialize.  The key to getting a composition of matter patent in Ag or Pharma is to argue that some activity you see is not obvious to someone skilled in the state of the art just from the structure.  This is not so hard to do.  All you need to show is closely related compounds are inactive or have only trace activity and that the structure
 claimed is a new chemical not previously reported.

The second class of useful patents are any unique formulation patents that can be shown to enhance the activity toward targets or make the activity safer to non targets.  Rarely there is a third type that is important and that is a process patent describing how to make the chemical.  Such patents are often not issued until the product is about ready for commercial sales.  The only real purpose of most process patents is to extend the overall patent life by restarting the clock.

Sometimes you can patent a known chemical for a novel use not obvious to a person skilled in the art.  Such patents have nuisance value and generally not a lot more.  There are also other kinds of such nuisance value patents also.

Regulatory agencies generally do not have any interest at all in looking at what patents the company has and do not use the information to judge safety as there typically is no meaningful safety information included.  Besides, nothing included in a patent needs to be generated by good lab practices (GLP) or good manufacturing practices (GMP) and EPA and FDA are only interested in studies that adhere to those guidelines.  If patents did ever require data generated under those practices you would simply shut down all discovery and no patents would ever be filed.  The cost of the paper work blizzard associated with either GLP or GMP is mind blowing.

Generally companies submit patent applications and hope the application is rejected.  The initial filing date established who owns the technology even if rejected.  But, if it takes three or four years of haggling with the patent office before they approve the patent the life set by law does not start until the issue date.  Initial applications typically have very broad claims and one or more of those claims results in rejection.  Then you enter a negotiation with the agency to see what claims they will allow and provide added evidence showing why they should allow rejected claims that you really want.  Often at the end of the negotiation you get everything or nearly everything that was in the initial filing.  I had a process patent that took seven or eight years to issue and at the end we got everything we initially asked for.

Dick
" Any discovery made by the human mind can be explained in its essentials to the curious learner."  Professor Benjamin Schumacher talking about teaching quantum mechanics to non scientists.   "For every complex problem there is a solution which is simple, neat and wrong."  H. L. Mencken

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