In this decision the United States Court of Appeals for the Federal Circuit ruled that the generic paroxetine hydrochloride anhydrate product which Apotex Corp., Apotex Inc., and TorPharm, Inc. (hereinafter collectively: Apotex) intended to produce would infringe upon claim 1 of U.S. Patent No. 4,721,723 held by SmithKline Beecham Corporation. However, it found claim 1 to be invalid as anticipated under 35 U.S.C. §102(b) (exceptions to novelty).

The Supreme Court of the United States decided that:  

The U.S. Supreme Court upheld a decision by the Court of Customs and Patent Appeals to grant a patent on a process using an abstract formula. It therewith held that an invention in the form of a process including an as such not patentable element is patent-eligible if it meets the requirements of patentability as a whole.

On 17 March 1980, the United States Supreme Court confirmed the decision of the Court of Customs and Patent Appeals to grant a patent for a bacterium capable of breaking down crude oil (Pseudomonas putida). The Supreme Court therewith established that whether or not an invention is a living thing is irrelevant to the question of its patentability.

The U.S. Supreme Court affirmed on 28 June 2010 the rejection by the Federal Circuit of a patent application concerning a claimed invention which explains a hedging and investment strategy in an energy market. It held that the abstract strategy was not patentable subject matter.

The U.S. Supreme Court decided on 13 June 2013 unanimously that isolated naturally occurring genes are not patent eligible subject matter. Synthetically created composite DNA, however, is patent eligible.

In this decision, the Court of Appeals for the Federal Circuit ruled on the patent eligibility of a claim concerning a natural phenomenon. To evaluate the patentability, the Court utilized the criteria developed in previous case law to determine a) whether the claim is directed to a natural process/phenomenon; b) if so, whether the claim contains an eligible subject matter that can transform the claim itself into a patent eligible one.

In this case, a United States district court ruled that successfully defending a patent infringement dispute is not a necessary requirement for a generic manufacturer to benefit from a 180-day exclusivity period. US law provides, under certain circumstances, a 180-day period of exclusivity to reward the first launch of a generic copy of an originator drug.

This case addresses the extent to which an applicant for a process patent needs to demonstrate utility (industrial application) of the process and the resulting product. The Supreme Court held that the practical utility of the compound produced by a chemical process is an essential element in establishing a prima facie case for the patentability of the process.