This case concerned the condition of non-obviousness as a prerequisite for patentability. The Supreme Court of the United States (hereinafter: the Court) reinforced the objective analysis approach for applying 35 U.S.C. §103 (i.e. the domestic provision on non-obviousness) as it was established with the three determining factors in Graham v. John Deere.

The Court of Appeal confirmed the invalidity of a patent on a pharmaceutical dosing regimen based on obviousness.

In this case, the U.S. Supreme Court established that the element of non-obviousness must be assessed with the help of the following factors: (1) the scope and content of prior art, (2) the differences between the prior art and the claims at issue and (3) the level of ordinary skill in the concerned art.  Furthermore, secondary considerations may be commercial success, long felt but unresolved needs or the failure of others to find a solution.

This case concerned three main issues in the context of patent infringement litigation: (1) who bears the burden of proving validity or invalidity of the patent; (2) what is required for an invention to be “useful” or “capable of industrial application”; and (3) what degree of similarity is needed for an accused product to infringe a patent. The Circuit Court of Massachusetts/United States decided that the plaintiff in a patent infringement suit bears the burden of proving the validity of its patent by establishing novelty and industrial application.

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).

On 1 April 2013, the Supreme Court of India confirmed the rejection by the Indian Patent Office of a patent application filed by Swiss drug maker Novartis on the anti-cancer medicament “Glivec”. The Supreme Court considered that Glivec did not qualify as a patentable “invention” under Section 3 (d) of the Indian Patents Act.

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.