The United States Supreme Court decided that the use by a purchaser of self-replicating soybeans for planting purposes amounts to a reproduction of new soybeans and is therefore not covered by patent exhaustion.

 The Court held that:

The Court of Appeals for the Federal Circuit interpreted the US experimental use exception in a very restrictive way. Regardless of whether a particular institution or entity is engaged in an endeavour for commercial gain, so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the experimental use defense.

The Supreme Court held that the scope of the regulatory review exemption covers the use of patented inventions reasonably related to the development and submission of information needed to obtain marketing approval of medical devices under the Federal Food, Drug, and Cosmetic Act.

It was held that the mere fact that the purpose of a use is commercial is no rebuttal of the statutory defence of experimental use. A more complete consideration of the defence requires consideration whether the immediate purpose of the transaction in question is to generate revenue. There is a need to consider the defendant's preponderant purposes.

The Court ruled that the export/import of samples of a biological product protected by patent for the conduct of stability studies "solely for uses reasonably related to the development and submission of information under" reporting requirements of federal drug laws, is permitted under the regulatory review exemption.

A WTO dispute settlement panel ruled that:

(1) Regulatory review exception – that permits competitors to use a patented invention, without the authorization of the patent holder, for the purposes of obtaining marketing approval – is consistent with the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS);

The Court of Appeals for the Federal Circuit (CAFC) ruled that the experimental use exception in US patent law is truly narrow. Where the subject matter of a patent is made or used as an experiment, whether for the gratification of scientific tastes, or for curiosity, or for amusement, the interests of the patentee are not antagonized, the sole effect being of an intellectual character in the promotion of the employer's knowledge or the relaxation afforded to his mind.

In this case Teva Pharmaceutical Industries Ltd challenged the validity of Pfizer Pharmaceuticals Inc’s patent for the drug Viagra. Teva stated that Pfizer had not met the disclosure requirements set out in the Canadian Patent Act. The main issue on appeal was whether Pfizer had failed to properly disclose its invention when it obtained the patent for Viagra.

This case addresses the distinction between the requirements to disclose an invention to the public in general terms (enablement) and the separate requirement to disclose the best mode of carrying out the invention. The district court found the patents at issue invalid due to lack of enablement. The United States Court of Appeals affirmed the judgment of the district court, but on different legal grounds, i.e. due to the failure to disclose the best mode of practicing the invention.