Arrow Pharmaceuticals Ltd v Merck & Co Inc

In the case of Arrow Pharmaceuticals Ltd v Merck & Co Inc, the dispute centred on the validity of certain patent claims related to the use of alendronate, a bisphosphonate compound used in the treatment of bone resorption diseases such as osteoporosis. The primary legal issues addressed by the court involved the assessment of inventive step and novelty of the patent claims, specifically focusing on the method of administration and the dosage forms of alendronate. The court was tasked with determining whether the claims related to the administration of alendronate in tablet or liquid form, or at specific dosages, involved any inventive step that was not already part of the common general knowledge at the priority date of the patent.

The court reasoned that the patent specification did not demonstrate any inventive step in formulating the composition for administration, as it only referenced standard mixing and formulation techniques. The court further noted that even if the dosage regime was novel, it did not inherently confer novelty on the method of administration or the substance itself. The evidence presented indicated that tablets containing up to 40 mg of alendronate were already available in the market by the priority date, thereby negating the novelty of higher dosage formulations. Consequently, the court concluded that the claims concerning the specific formulations and dosages were invalid.

The court ordered that the proposed claims 1, 2, 3, 5, 6, 9, and 10 be deemed invalid. The proceeding was adjourned to allow the parties to prepare formal orders. The court indicated that Merck should bear the costs of the proceeding for Arrow Pharmaceuticals, excluding those related to particulars of invalidity on the ground of novelty that were not pursued at trial. The court invited the parties to bring any omissions or significant live issues to its attention.