Merck & Co Inc v Arrow Pharmaceuticals Ltd

Merck & Co Inc and Merck Sharp & Dohme (Australia) Pty Ltd (collectively, "Merck") sought interlocutory relief against Arrow Pharmaceuticals Ltd ("Arrow") to restrain the latter from infringing Merck's patent for a pharmaceutical substance. The dispute concerned Arrow's proposed importation and sale of a generic version of the drug Losec, which contained the active ingredient omeprazole, the subject of Merck's patent.

The primary legal issue before the High Court of Australia was whether Arrow's proposed importation and sale of omeprazole constituted an infringement of Merck's patent. Specifically, the Court had to consider the scope of Merck's patent rights and whether Arrow's actions fell within those rights, particularly in light of the provisions of the Patents Act 1990 (Cth) concerning the importation of patented products.

The High Court, in dismissing Merck's appeal, held that Arrow's proposed importation and sale of omeprazole did not infringe Merck's patent. The Court reasoned that the patent protected the substance omeprazole itself, and not the therapeutic use of that substance. As Arrow was not manufacturing omeprazole in Australia, nor was it selling it for a use that was itself patented, its actions did not constitute infringement. The Court applied the principle that patent rights are territorial and do not extend to acts performed outside the jurisdiction, unless specifically provided for by statute. The Court further clarified that the relevant provisions of the Patents Act did not extend the scope of patent protection to cover the importation and sale of a patented substance for a therapeutic use that was not itself patented.