The “early working” exception, as noted above, may in some cases be considered as part of the experimental use exception. However, given the importance of this issue, and the uncertainty surrounding judicial interpretation, it seems advisable to include a specific provision on the matter. It may include the following:
The patent shall have no effect with respect to any acts, including testing, using, making or selling the invention, solely for purposes reasonably related to the development and submission of information required under any law of ... (country) or of another country that regulates the manufacture, construction, use or sale of any product.
The proposed wording includes, among the possible non-infringing acts, the limited manufacturing of the patented product in order to undertake the tests required by the health authorities. This option would not allow for production and stockpiling before the expiration of the patent.