Prophetic examples are key to efficient innovation.

Patent applications with prophetic examples can be filed earlier than applications with working examples because writing a prophetic example is faster than conducting even the simplest of real experiments.119 Moreover, real experiments might not work or might produce unexpected data, necessitating a potentially time-consuming change to protocols or development of a new procedure. Prophetic examples do not have this potential. Thus, applicants who choose prophetic examples will be able to file a patent application earlier than applicants who choose to conduct experiments, a particular advantage in competitive and fast-moving fields.120

Prophetic examples also help applicants obtain broader patents. Patents must teach others how to make and use their inventions, and a broader patents covering more material require more teaching. To get a patent on one molecule, one experimental protocol is generally enough to teach how to synthesize the molecule.121 To get a patent on many different molecules, many synthesis protocols will be needed. Thus, patent drafters will try to include more examples to support broader claims.122 Prophetic examples are instrumental to this function.123 Prophetic examples also allow applicants to seek a broad patent without conducting expensive experiments, which reduces the cost of patents.

The following example illustrates how prophetic examples allow for broader, cheaper, and earlier-filed patents. Para-dichlorobenzene, the molecule historically used in scented deodorizers, was suspected to be toxic.124 To solve this problem, a pair of inventors discovered a new molecule that could be combined with various scents and would slowly releases those scents over time – useful for products like air fresheners. 125 If the inventors had wanted a narrow patent covering only one type of scent, including one example in the patent might have been enough. However, the inventors sought a broader patent – covering slow release of many different “fragrant substances.”126 Thus, it was necessary to include more examples in the patent. Perhaps lacking the time or money to conduct experiments with many different types of fragrant substances, the inventors wrote 7 prophetic examples with instructions for how to make these compositions.127 These included ingredients, amounts, and mixing instructions for making scents such as “Sea Breeze,” “Lilac perfume oil,” and “Lily of the valley.”128 Though these protocols were all predictions, rather than tested conclusions, but they were enough for the examiner to grant the broad patent.

Finding an alternative to carcinogenic deodorizers is a worthwhile innovation of the type we hope to incentivize with patents. If these inventors could only have gotten a narrow patent covering one scent, it might not have been enough of a reward to incentivize the initial invention. Prophetic examples allowed the inventor to get a broader patent. Without prophetic examples, this technology may never have been made available to the public.

2. Special Situations

Prophetic examples may be useful in a variety of situations where the inventor is not able to conduct a real experiment. In these situations, prophetic examples create exclusivity where it would not otherwise be available, potentially incentivizing innovation. One such situation occurs when a small company cannot afford to conduct a large number of experiments (to get a broader patent) before a patent is filed. Prophetic examples may help equalize the availability of broad patents between companies with resources and those without.129

Another such special situation where prophetic examples are needed for filing a patent is the catch-22 situation where a funder will not provide capital without a patent, but the experiments necessary to get the patent cannot be done without funding. Using prophetic examples to file before the experiment is actually conducted also helps patentees who risk losing the ability to patent if they obtain data before filing a patent. This occurs because an inventor’s own public disclosure about the invention can bar him from later filing for a patent on the invention.130 What precisely constitutes a public disclosure is contextual, but it may occur if samples are sent out for testing131 or manufacturing.132 A particularly contentious issue is the question of clinical trials, where a drug must be distributed to doctors and patients and certain disclosures must be made. Though appropriate confidentiality agreements can prevent clinical trials on a drug from blocking later patenting of the drug, it is a sufficiently problematic issue that the question is frequently litigated.133

Moreover, there may be regulatory obstacles to conducting real experiments. It is conventional in the pharmaceutical industry to file patents on treatments that show promise in in vitro – lab based – experiments.134 It can take years, and hundreds of millions of dollars, to obtain FDA permission for human experiments and to conduct those experiments.135 It is risky to make this investment without patent protection. Thus, pharmaceutical companies generally require a patent early in a drug’s lifecycle and, crucially, before human data can possibly be obtained.136 Though it is not strictly necessary to include human data to obtain a patent on a drug, patents lacking human data have occasionally been invalidated, therefore pharmaceutical companies prefer to include human trials.137

For instance, the patent applicant in Bone Care International sought a patent on a method of treating osteoporosis using the molecule doxercalciferol.138 The applicant had created a detailed plan for a clinical trial of this drug, but, probably for the reasons described above, could not wait until completion of all trials to file the patent.139 The applicant therefore filed a patent with working examples reporting stage I and stage II clinical trials and several prophetic examples detailing a double-blind trial and its (prophetic) results.140

A twelve-month double-blind placebo-controlled clinical trial is conducted with thirty-five men and women…Analysis of the clinical data shows that [doxercalciferol] increases…intestinal calcium absorption, as determined by direct measurement…141

Because the PTO permits prophetic examples, the applicant could use the results of the clinical trial to support the patentability of the compound – even before the clinical trial had been conducted.142 Without prophetic examples, the applicant may not have felt secure enough to invest in the necessary clinical trials, depriving the public of a valuable drug. With prophetic examples, Bone Care filed the patent, got FDA approval, and has sold millions of doses of the drug under the brand name Hectorol®.143

In situations of the types outlined above, it is simply not practical for an inventor to conduct real experiments. This means that, were prophetic examples not allowed, these inventors might not be able to get a patent. Without prophetic examples, we might see reduced innovation from small companies or those in the pharmaceutical space.

The case for prophetic examples is founded on their benefits to patentees. The sections above describe specific ways in which prophetic examples help patentees. From this, we can extract several testable hypotheses. Prophetic examples should allow patents to be (1) broader; (2) filed earlier; and (3) be particularly useful in specific situations such as for patents filed by small entities, experiments that are expensive and cannot be done without funding, and experiments involving clinical trials.